Trial Outcomes & Findings for Veterans Response to Dosage in Chiropractic Therapy (NCT NCT04087291)
NCT ID: NCT04087291
Last Updated: 2026-08-11
Results Overview
Proportion of participants achieving a clinically meaningful improvement in low back-related disability, defined as ≥30% relative improvement from baseline to 10 weeks in the Roland Morris Disability Questionnaire (RMDQ; range 0-24, higher scores indicate greater disability).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
766 participants
Primary outcome timeframe
Baseline to Week 10
Results posted on
2026-08-11
Participant Flow
Veterans with chronic low back pain were recruited from four VA chiropractic clinics (Iowa City, IA; West Haven, CT; Minneapolis, MN; Los Angeles, CA) between February 2021 and May 2024. Recruitment used three strategies: existing VA chiropractic referrals, EHR prescreening, and self-referral. Invitations were sent by postal mail, with email added after IRB approval. Screening and enrollment were coordinated by site study coordinators.
Potential participants were screened using a standardized five-step process: identification and notification, phone screening, informed consent and baseline visit (virtual or in person), eligibility questionnaires, and in-person chiropractic consultation to confirm clinical eligibility. Veterans who were uninterested, ineligible, or unable to complete screening before consultation were excluded. A total of 3,667 veterans were screened; 766 met criteria and were enrolled and randomized.
Participant milestones
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Chiropractic Chronic Pain Management (CCPM)
Participants who completed Phase 1 and consented to continue participation were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care. CCPM visits included multimodal chiropractic care delivered according to clinician judgment.
|
Phase 2: No Chiropractic Chronic Pain Management (No CCPM)
Participants who completed Phase 1 and consented to continue participation were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care. Participants could continue to access other VA healthcare services as clinically indicated.
|
|---|---|---|---|---|
|
Phase 1 (0-10 Weeks)
STARTED
|
382
|
384
|
0
|
0
|
|
Phase 1 (0-10 Weeks)
COMPLETED
|
344
|
333
|
0
|
0
|
|
Phase 1 (0-10 Weeks)
NOT COMPLETED
|
38
|
51
|
0
|
0
|
|
Phase 2 (10-52 Weeks)
STARTED
|
0
|
0
|
341
|
336
|
|
Phase 2 (10-52 Weeks)
Received Low-Dose Chiropractic Care in Phase 1
|
0
|
0
|
172
|
172
|
|
Phase 2 (10-52 Weeks)
Received Higher-Dose Chiropractic Care in Phase 1
|
0
|
0
|
169
|
164
|
|
Phase 2 (10-52 Weeks)
COMPLETED
|
0
|
0
|
316
|
304
|
|
Phase 2 (10-52 Weeks)
NOT COMPLETED
|
0
|
0
|
25
|
32
|
Reasons for withdrawal
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Chiropractic Chronic Pain Management (CCPM)
Participants who completed Phase 1 and consented to continue participation were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care. CCPM visits included multimodal chiropractic care delivered according to clinician judgment.
|
Phase 2: No Chiropractic Chronic Pain Management (No CCPM)
Participants who completed Phase 1 and consented to continue participation were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care. Participants could continue to access other VA healthcare services as clinically indicated.
|
|---|---|---|---|---|
|
Phase 1 (0-10 Weeks)
Lost to Follow-up
|
15
|
17
|
0
|
0
|
|
Phase 1 (0-10 Weeks)
Withdrawal by Subject
|
2
|
6
|
0
|
0
|
|
Phase 1 (0-10 Weeks)
Participant died from an event unrelated to the study intervention or study procedures.
|
0
|
1
|
0
|
0
|
|
Phase 1 (0-10 Weeks)
Did not enter Phase 2
|
21
|
27
|
0
|
0
|
|
Phase 2 (10-52 Weeks)
Lost to Follow-up
|
0
|
0
|
19
|
25
|
|
Phase 2 (10-52 Weeks)
Withdrawal by Subject
|
0
|
0
|
6
|
5
|
|
Phase 2 (10-52 Weeks)
Participant died from an event unrelated to the study intervention or study procedures.
|
0
|
0
|
0
|
2
|
Baseline Characteristics
All participants randomized to Phase 1.
Baseline characteristics by cohort
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Total
n=766 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 Years
n=54 Participants • All participants randomized to Phase 1.
|
51 Years
n=54 Participants • All participants randomized to Phase 1.
|
51 Years
n=27 Participants • All participants randomized to Phase 1.
|
|
Sex: Female, Male
Female
|
81 Participants
n=54 Participants • All participants randomized to Phase 1.
|
82 Participants
n=54 Participants • All participants randomized to Phase 1.
|
163 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Sex: Female, Male
Male
|
301 Participants
n=54 Participants • All participants randomized to Phase 1.
|
302 Participants
n=54 Participants • All participants randomized to Phase 1.
|
603 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=54 Participants • All participants randomized to Phase 1.
|
4 Participants
n=54 Participants • All participants randomized to Phase 1.
|
6 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=54 Participants • All participants randomized to Phase 1.
|
7 Participants
n=54 Participants • All participants randomized to Phase 1.
|
12 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=54 Participants • All participants randomized to Phase 1.
|
2 Participants
n=54 Participants • All participants randomized to Phase 1.
|
8 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=54 Participants • All participants randomized to Phase 1.
|
73 Participants
n=54 Participants • All participants randomized to Phase 1.
|
131 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
White
|
272 Participants
n=54 Participants • All participants randomized to Phase 1.
|
260 Participants
n=54 Participants • All participants randomized to Phase 1.
|
532 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=54 Participants • All participants randomized to Phase 1.
|
5 Participants
n=54 Participants • All participants randomized to Phase 1.
|
8 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=54 Participants • All participants randomized to Phase 1.
|
33 Participants
n=54 Participants • All participants randomized to Phase 1.
|
69 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=54 Participants • All participants randomized to Phase 1.
|
31 Participants
n=54 Participants • All participants randomized to Phase 1.
|
76 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
321 Participants
n=54 Participants • All participants randomized to Phase 1.
|
330 Participants
n=54 Participants • All participants randomized to Phase 1.
|
651 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=54 Participants • All participants randomized to Phase 1.
|
23 Participants
n=54 Participants • All participants randomized to Phase 1.
|
39 Participants
n=27 Participants • All participants randomized to Phase 1.
|
|
Roland Morris Disability Questionnaire (baseline score)
|
12.2 score on a scale (0-24)
STANDARD_DEVIATION 5.3 • n=54 Participants • All participants randomized to Phase 1 with available baseline data.
|
12.2 score on a scale (0-24)
STANDARD_DEVIATION 5.0 • n=54 Participants • All participants randomized to Phase 1 with available baseline data.
|
12.2 score on a scale (0-24)
STANDARD_DEVIATION 5.2 • n=27 Participants • All participants randomized to Phase 1 with available baseline data.
|
|
Pain Intensity (baseline)
|
6.2 score on a scale (0-10)
STANDARD_DEVIATION 1.7 • n=54 Participants • All participants randomized to Phase 1 with available baseline data.
|
6.1 score on a scale (0-10)
STANDARD_DEVIATION 1.7 • n=54 Participants • All participants randomized to Phase 1 with available baseline data.
|
6.1 score on a scale (0-10)
STANDARD_DEVIATION 1.7 • n=27 Participants • All participants randomized to Phase 1 with available baseline data.
|
|
PEG Pain Severity (baseline)
|
6.2 score on a scale (0-10)
STANDARD_DEVIATION 1.8 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
6.2 score on a scale (0-10)
STANDARD_DEVIATION 1.8 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
6.2 score on a scale (0-10)
STANDARD_DEVIATION 1.8 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Global Physical Health
|
62.6 T-score (PROMIS standardized score)
STANDARD_DEVIATION 6.1 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
62.9 T-score (PROMIS standardized score)
STANDARD_DEVIATION 5.5 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
62.8 T-score (PROMIS standardized score)
STANDARD_DEVIATION 5.8 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Pain Interference
|
63.7 T-score (PROMIS standardized score)
STANDARD_DEVIATION 4.8 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
63.6 T-score (PROMIS standardized score)
STANDARD_DEVIATION 4.9 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
63.7 T-score (PROMIS standardized score)
STANDARD_DEVIATION 4.9 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Fatigue
|
61.5 T-score (PROMIS standardized score)
STANDARD_DEVIATION 7.8 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
61.7 T-score (PROMIS standardized score)
STANDARD_DEVIATION 7.6 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
61.6 T-score (PROMIS standardized score)
STANDARD_DEVIATION 7.7 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Sleep Disturbance
|
60.2 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.1 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
60.2 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.3 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
60.2 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.2 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Social Roles Satisfaction
|
59.0 T-score (PROMIS standardized score)
STANDARD_DEVIATION 6.8 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
58.9 T-score (PROMIS standardized score)
STANDARD_DEVIATION 6.9 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
59.0 T-score (PROMIS standardized score)
STANDARD_DEVIATION 6.8 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Physical and Social Health at Baseline (PROMIS)
Global Mental Health
|
59.2 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.7 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
59.7 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.1 • n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
59.4 T-score (PROMIS standardized score)
STANDARD_DEVIATION 8.4 • n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
|
Average Number of Days Per Week With Low Back Pain at Baseline
|
7 days per week (0-7)
n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
7 days per week (0-7)
n=54 Participants • All participants randomized to Phase 1 with baseline data available.
|
7 days per week (0-7)
n=27 Participants • All participants randomized to Phase 1 with baseline data available.
|
PRIMARY outcome
Timeframe: Baseline to Week 10Population: All participants randomized to Phase 1.
Proportion of participants achieving a clinically meaningful improvement in low back-related disability, defined as ≥30% relative improvement from baseline to 10 weeks in the Roland Morris Disability Questionnaire (RMDQ; range 0-24, higher scores indicate greater disability).
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From Baseline to Week 10
|
140 Participants
|
157 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: All participants rerandomized to Phase 2.
Back-related disability was measured using the Roland Morris Disability Questionnaire (RMDQ), a 24-item scale with scores ranging from 0 to 24. Higher scores indicate greater disability (worse outcome), and lower scores indicate less disability.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Back-Related Disability Change From Baseline to Week 52 (RMDQ)
|
3.08 score on a scale (0-24)
Interval 2.24 to 3.92
|
2.08 score on a scale (0-24)
Interval 1.24 to 2.92
|
2.54 score on a scale (0-24)
Interval 1.71 to 3.38
|
3.29 score on a scale (0-24)
Interval 2.43 to 4.15
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: All participants randomized to Phase 1 with available pain intensity data; change from baseline to Week 10 is reported.
Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Low Back Pain Intensity Change From Baseline to Week 10
|
0.88 score on a scale (0-10)
Interval 0.69 to 1.07
|
1.17 score on a scale (0-10)
Interval 0.98 to 1.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: All participants randomized to Phase 1 with available PEG scores; change from baseline to Week 10 is reported.
PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
PEG Pain Severity Change From Baseline to Week 10
|
1.03 score on a scale (0-10)
Interval 0.82 to 1.23
|
1.44 score on a scale (0-10)
Interval 1.24 to 1.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: All participants randomized to Phase 1 with available PROMIS data; change from baseline to Week 10 is reported.
PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
Global Physical Health
|
1.58 T-score (PROMIS standardized score)
Interval 1.03 to 2.12
|
2.70 T-score (PROMIS standardized score)
Interval 2.15 to 3.25
|
—
|
—
|
|
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
Pain Interference
|
2.49 T-score (PROMIS standardized score)
Interval 1.89 to 3.08
|
3.24 T-score (PROMIS standardized score)
Interval 2.64 to 3.84
|
—
|
—
|
|
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
Fatigue
|
2.31 T-score (PROMIS standardized score)
Interval 1.58 to 3.04
|
3.12 T-score (PROMIS standardized score)
Interval 2.38 to 3.86
|
—
|
—
|
|
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
Sleep Disturbance
|
1.95 T-score (PROMIS standardized score)
Interval 1.23 to 2.67
|
2.83 T-score (PROMIS standardized score)
Interval 2.11 to 3.55
|
—
|
—
|
|
Physical and Social Health Change From Baseline to Week 10 (PROMIS)
Social Roles Satisfaction
|
1.86 T-score (PROMIS standardized score)
Interval 1.19 to 2.52
|
1.85 T-score (PROMIS standardized score)
Interval 1.18 to 2.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: All participants randomized to Phase 1 with available PROMIS Mental Health data; change from baseline to Week 10 is reported.
PROMIS Global Mental Health assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better mental health (better outcome), and lower scores indicate worse mental health.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS)
|
0.99 T-score (PROMIS standardized score)
Interval 0.37 to 1.6
|
1.35 T-score (PROMIS standardized score)
Interval 0.73 to 1.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: All participants randomized to Phase 1 with available data at Week 10.
Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Average Number of Days Per Week With Low Back Pain at Week 10
|
7 days per week (0-7)
Interval 5.0 to 7.0
|
7 days per week (0-7)
Interval 4.0 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All participants rerandomized to Phase 2 with available pain intensity data; change from baseline to Week 52 is reported.
Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Low Back Pain Intensity Change From Baseline to Week 52
|
1.01 score on a scale (0-10)
Interval 0.69 to 1.34
|
0.46 score on a scale (0-10)
Interval 0.14 to 0.79
|
0.93 score on a scale (0-10)
Interval 0.6 to 1.25
|
0.82 score on a scale (0-10)
Interval 0.49 to 1.15
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All participants rerandomized to Phase 2 with available PEG data; change from baseline to Week 52 is reported.
PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
PEG Pain Severity Change From Baseline to Week 52
|
1.34 score on a scale (0-10)
Interval 1.0 to 1.68
|
0.58 score on a scale (0-10)
Interval 0.24 to 0.92
|
1.30 score on a scale (0-10)
Interval 0.96 to 1.64
|
0.99 score on a scale (0-10)
Interval 0.65 to 1.34
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All participants rerandomized to Phase 2 with available PROMIS data; change from baseline to Week 52 is reported.
PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range \~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Global Physical Health
|
2.88 T-score (PROMIS standardized score)
Interval 1.96 to 3.8
|
0.99 T-score (PROMIS standardized score)
Interval 0.08 to 1.9
|
3.14 T-score (PROMIS standardized score)
Interval 2.23 to 4.05
|
1.94 T-score (PROMIS standardized score)
Interval 1.01 to 2.87
|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Pain Interference
|
3.57 T-score (PROMIS standardized score)
Interval 2.57 to 4.58
|
1.50 T-score (PROMIS standardized score)
Interval 0.5 to 2.5
|
3.29 T-score (PROMIS standardized score)
Interval 2.29 to 4.3
|
1.90 T-score (PROMIS standardized score)
Interval 0.87 to 2.93
|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Fatigue
|
3.76 T-score (PROMIS standardized score)
Interval 2.57 to 4.96
|
1.60 T-score (PROMIS standardized score)
Interval 0.41 to 2.78
|
2.23 T-score (PROMIS standardized score)
Interval 1.04 to 3.42
|
1.78 T-score (PROMIS standardized score)
Interval 0.56 to 3.01
|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Sleep Disturbance
|
4.08 T-score (PROMIS standardized score)
Interval 2.92 to 5.25
|
1.86 T-score (PROMIS standardized score)
Interval 0.7 to 3.02
|
2.47 T-score (PROMIS standardized score)
Interval 1.31 to 3.64
|
2.42 T-score (PROMIS standardized score)
Interval 1.23 to 3.62
|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Social Roles Satisfaction
|
2.69 T-score (PROMIS standardized score)
Interval 1.64 to 3.75
|
1.94 T-score (PROMIS standardized score)
Interval 0.89 to 2.99
|
2.03 T-score (PROMIS standardized score)
Interval 0.98 to 3.08
|
1.59 T-score (PROMIS standardized score)
Interval 0.52 to 2.67
|
|
Physical and Social Health Change From Baseline to Week 52 (PROMIS)
Global Mental Health
|
1.80 T-score (PROMIS standardized score)
Interval 0.78 to 2.83
|
0.13 T-score (PROMIS standardized score)
Interval -0.9 to 1.15
|
1.97 T-score (PROMIS standardized score)
Interval 0.95 to 2.99
|
1.15 T-score (PROMIS standardized score)
Interval 0.1 to 2.21
|
SECONDARY outcome
Timeframe: Week 52Population: All participants rerandomized to Phase 2 with available number of days per week with low back pain during the prior week, self-reported at 52 weeks.
Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain.
Outcome measures
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=172 Participants
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10-week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 Participants
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|
|
Average Number of Days Per Week With Low Back Pain at Week 52
|
7 days per week (0-7)
Interval 4.0 to 7.0
|
7 days per week (0-7)
Interval 5.0 to 7.0
|
7 days per week (0-7)
Interval 5.0 to 7.0
|
7 days per week (0-7)
Interval 5.0 to 7.0
|
Adverse Events
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
Serious events: 13 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase 2: Low Dose → Chiropractic Chronic Pain Management (CCPM)
Serious events: 19 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Low Dose → No CCPM
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
Serious events: 19 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2: Higher Dose → No CCPM
Serious events: 13 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 participants at risk
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 participants at risk
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Low Dose → Chiropractic Chronic Pain Management (CCPM)
n=172 participants at risk
Veterans with cLBP who completed Phase 1 in the low#dose chiropractic care group were re#randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10#week treatment period, in addition to usual VA care.
|
Phase 2: Low Dose → No CCPM
n=172 participants at risk
Veterans with cLBP who completed Phase 1 in the low-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow#up period after the initial 10#week treatment phase, in addition to usual VA care.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 participants at risk
Veterans with cLBP who completed Phase 1 in the higher#dose chiropractic care group were re#randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10#week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 participants at risk
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|---|---|
|
General disorders
Alcohol or Substance Use-Related Hospitalization
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.61%
1/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Cardiac disorders
Atrial Fibrillation / Atrial Flutter
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
General disorders
Cancer Diagnosis or Progression
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.26%
1/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Infections and infestations
COVID-19 Infection (Serious)
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
General disorders
Death (Any Cause)
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.26%
1/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Gastrointestinal disorders
Gastrointestinal Emergency (Non-Cancer)
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.3%
5/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Musculoskeletal and connective tissue disorders
Major Orthopedic Surgery
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.52%
2/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
2.9%
5/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.7%
3/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
2.4%
4/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Endocrine disorders
Metabolic or Electrolyte Disorder (Serious)
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.26%
1/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.61%
1/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Hospitalization (Serious)
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Nervous system disorders
Neurologic Serious Event
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Cardiac disorders
Other Major Cardiac Events (Non-Arrhythmia)
|
0.26%
1/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.26%
1/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
2.4%
4/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.61%
1/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
General disorders
Other Major Surgery (Non-Orthopedic)
|
0.52%
2/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
2.3%
4/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Renal and urinary disorders
Renal / Urological Serious Event
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Infections and infestations
Serious Infection (Including Respiratory and Systemic)
|
0.79%
3/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
2.4%
4/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.8%
3/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Psychiatric disorders
Serious Psychiatric Event
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.52%
2/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
1.2%
2/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.58%
1/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.61%
1/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
Other adverse events
| Measure |
Phase 1: Low Dose Chiropractic Care (1-5 Visits)
n=382 participants at risk
Veterans with cLBP were randomized to receive a low-dose multimodal, evidence-based chiropractic care consisting of 1 to 5 visits delivered over a 10-week period. Chiropractic care was provided by licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 1: Higher Dose Chiropractic Care (8-12 Visits)
n=384 participants at risk
Veterans with cLBP were randomized to receive a higher dose of multimodal, evidence-based chiropractic care consisting of 8 to 12 visits delivered over a 10-week period. Chiropractic care was provided by a licensed VA doctors of chiropractic and could include spinal manipulation, other manual therapies, exercise instruction, education, and self-management advice as clinically indicated. Participants who completed Phase 1 were eligible for re-randomization to Phase 2.
|
Phase 2: Low Dose → Chiropractic Chronic Pain Management (CCPM)
n=172 participants at risk
Veterans with cLBP who completed Phase 1 in the low#dose chiropractic care group were re#randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10#week treatment period, in addition to usual VA care.
|
Phase 2: Low Dose → No CCPM
n=172 participants at risk
Veterans with cLBP who completed Phase 1 in the low-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow#up period after the initial 10#week treatment phase, in addition to usual VA care.
|
Phase 2: Higher Dose → Chiropractic Chronic Pain Management (CCPM)
n=169 participants at risk
Veterans with cLBP who completed Phase 1 in the higher#dose chiropractic care group were re#randomized to receive chiropractic chronic pain management (CCPM), consisting of one scheduled chiropractic visit per month for 10 months following the initial 10#week treatment period, in addition to usual VA care.
|
Phase 2: Higher Dose → No CCPM
n=164 participants at risk
Veterans with cLBP who completed Phase 1 in the higher-dose chiropractic care group were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Mild Infection
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Symptoms (Non-Serious)
|
0.00%
0/382 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/384 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/172 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.59%
1/169 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
0.00%
0/164 • From initiation of study intervention through 52 weeks
Serious adverse events were assessed throughout the study via participant self-report using structured questionnaires and clinician reporting. Serious adverse events were defined using FDA criteria and followed up by study staff to determine severity, duration, and relatedness to study participation. All reported events were reviewed centrally and assessed for expectedness and relatedness to study participation. No serious events were related to study participation.
|
Additional Information
Cynthia R. Long, PhD, PStat® | Professor, Dean of Research | Director-ODM & Biostatistics
Palmer College of Chiropractic
Phone: 563-884-5157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place