Trial Outcomes & Findings for Optimize Low Back Pain (NCT NCT03859713)
NCT ID: NCT03859713
Last Updated: 2026-03-06
Results Overview
Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
749 participants
Primary outcome timeframe
baseline, 10 weeks
Results posted on
2026-03-06
Participant Flow
Trial enrollment began in March, 2019. In March, 2020 the trial suspended enrollments across all sites due to COVID restrictions. Enrollment resumed in April, 2021 and was completed in September, 2023.
A total 751 participants were randomized. Three participants were determined to be false inclusions after randomization. One false inclusion was the result of not meeting the minimum disability threshold for eligibility. This participant continued in the study. The other two false inclusions were persons with medical conditions that were exclusions. These two participants did not participate in the study. Therefore study results are reported for 749 participants.
Participant milestones
| Measure |
PT Followed by Switching to CBT in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
|
PT Followed by Mindfulness in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
|
CBT Followed by Switching to PT in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
|
CBT Followed by Mindfulness in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
|
Responder: Phase I PT Treatment Alone
This arm includes participants assigned to PT who respond in Phase I
|
Responder: Phase I CBT Treatment Alone
This arm includes participants assigned to CBT who respond in Phase I
|
|---|---|---|---|---|---|---|
|
Phase I
STARTED
|
0
|
0
|
0
|
0
|
374
|
375
|
|
Phase I
COMPLETED
|
0
|
0
|
0
|
0
|
296
|
280
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
78
|
95
|
|
Phase II
STARTED
|
103
|
101
|
110
|
109
|
73
|
38
|
|
Phase II
COMPLETED
|
91
|
87
|
100
|
93
|
69
|
35
|
|
Phase II
NOT COMPLETED
|
12
|
14
|
10
|
16
|
4
|
3
|
|
Long-term Follow-Up
STARTED
|
91
|
87
|
100
|
93
|
69
|
35
|
|
Long-term Follow-Up
COMPLETED
|
91
|
83
|
88
|
93
|
62
|
30
|
|
Long-term Follow-Up
NOT COMPLETED
|
0
|
4
|
12
|
0
|
7
|
5
|
Reasons for withdrawal
| Measure |
PT Followed by Switching to CBT in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
|
PT Followed by Mindfulness in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
|
CBT Followed by Switching to PT in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
|
CBT Followed by Mindfulness in Phase II for Nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
|
Responder: Phase I PT Treatment Alone
This arm includes participants assigned to PT who respond in Phase I
|
Responder: Phase I CBT Treatment Alone
This arm includes participants assigned to CBT who respond in Phase I
|
|---|---|---|---|---|---|---|
|
Phase I
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
22
|
49
|
|
Phase I
Lost to Follow-up
|
0
|
0
|
0
|
0
|
56
|
46
|
|
Phase II
Withdrawal by Subject
|
5
|
4
|
4
|
4
|
0
|
0
|
|
Phase II
Lost to Follow-up
|
7
|
10
|
6
|
12
|
4
|
3
|
|
Long-term Follow-Up
Lost to Follow-up
|
0
|
4
|
12
|
0
|
7
|
5
|
Baseline Characteristics
BMI missing for 6 participants
Baseline characteristics by cohort
| Measure |
Phase I PT Treatment
n=374 Participants
This arm includes all participants assigned to PT for Phase I treatment
|
Phase I CBT Treatment
n=375 Participants
This arm includes all participants assigned to CBT in Phase I
|
Total
n=749 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 11.8 • n=374 Participants
|
46.5 Years
STANDARD_DEVIATION 11.9 • n=375 Participants
|
46.5 Years
STANDARD_DEVIATION 11.8 • n=749 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=374 Participants
|
28 Participants
n=375 Participants
|
75 Participants
n=749 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
324 Participants
n=374 Participants
|
342 Participants
n=375 Participants
|
666 Participants
n=749 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=374 Participants
|
5 Participants
n=375 Participants
|
8 Participants
n=749 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=374 Participants
|
3 Participants
n=375 Participants
|
4 Participants
n=749 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=374 Participants
|
8 Participants
n=375 Participants
|
14 Participants
n=749 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=374 Participants
|
3 Participants
n=375 Participants
|
6 Participants
n=749 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=374 Participants
|
73 Participants
n=375 Participants
|
142 Participants
n=749 Participants
|
|
Race (NIH/OMB)
White
|
262 Participants
n=374 Participants
|
257 Participants
n=375 Participants
|
519 Participants
n=749 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=374 Participants
|
13 Participants
n=375 Participants
|
25 Participants
n=749 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=374 Participants
|
18 Participants
n=375 Participants
|
39 Participants
n=749 Participants
|
|
Body Mass Index
|
32.6 kg/m2
STANDARD_DEVIATION 8.8 • n=370 Participants • BMI missing for 6 participants
|
31.9 kg/m2
STANDARD_DEVIATION 8.8 • n=373 Participants • BMI missing for 6 participants
|
32.3 kg/m2
STANDARD_DEVIATION 8.8 • n=743 Participants • BMI missing for 6 participants
|
|
Current Smoker
|
38 Participants
n=372 Participants • Smoking status was not reported by four participants
|
48 Participants
n=373 Participants • Smoking status was not reported by four participants
|
86 Participants
n=745 Participants • Smoking status was not reported by four participants
|
|
Highest Education Level Completed
Less Than High School
|
13 Participants
n=372 Participants • Four participants did not report education level
|
27 Participants
n=373 Participants • Four participants did not report education level
|
40 Participants
n=745 Participants • Four participants did not report education level
|
|
Highest Education Level Completed
Completed High School
|
160 Participants
n=372 Participants • Four participants did not report education level
|
139 Participants
n=373 Participants • Four participants did not report education level
|
299 Participants
n=745 Participants • Four participants did not report education level
|
|
Highest Education Level Completed
Completed College Degree
|
199 Participants
n=372 Participants • Four participants did not report education level
|
207 Participants
n=373 Participants • Four participants did not report education level
|
406 Participants
n=745 Participants • Four participants did not report education level
|
|
Prior Lumbar Spine Surgery
|
42 Participants
n=372 Participants • Two participants did not provide prior surgey information
|
57 Participants
n=375 Participants • Two participants did not provide prior surgey information
|
99 Participants
n=747 Participants • Two participants did not provide prior surgey information
|
|
Leg Pain with Back Pain
|
91 Participants
n=372 Participants • Two participants did not provide leg pain responses
|
100 Participants
n=375 Participants • Two participants did not provide leg pain responses
|
191 Participants
n=747 Participants • Two participants did not provide leg pain responses
|
|
Provided Opioids at Index Healthcare Visit
|
78 Participants
n=367 Participants • 10 participants did not provide information on opioids at index visit
|
84 Participants
n=372 Participants • 10 participants did not provide information on opioids at index visit
|
162 Participants
n=739 Participants • 10 participants did not provide information on opioids at index visit
|
|
Duration of Opioid Use at Baseline
None
|
307 Participants
n=369 Participants • Seven participants did not provide opioid use duration information
|
296 Participants
n=373 Participants • Seven participants did not provide opioid use duration information
|
603 Participants
n=742 Participants • Seven participants did not provide opioid use duration information
|
|
Duration of Opioid Use at Baseline
<30 days
|
13 Participants
n=369 Participants • Seven participants did not provide opioid use duration information
|
9 Participants
n=373 Participants • Seven participants did not provide opioid use duration information
|
22 Participants
n=742 Participants • Seven participants did not provide opioid use duration information
|
|
Duration of Opioid Use at Baseline
30 days - 1 year
|
11 Participants
n=369 Participants • Seven participants did not provide opioid use duration information
|
14 Participants
n=373 Participants • Seven participants did not provide opioid use duration information
|
25 Participants
n=742 Participants • Seven participants did not provide opioid use duration information
|
|
Duration of Opioid Use at Baseline
> 1 year
|
38 Participants
n=369 Participants • Seven participants did not provide opioid use duration information
|
54 Participants
n=373 Participants • Seven participants did not provide opioid use duration information
|
92 Participants
n=742 Participants • Seven participants did not provide opioid use duration information
|
|
Time From First Low Back Pain Episode
< 1 year ago
|
40 Participants
n=372 Participants • Two participants did not provide information on duration since first back pain episode
|
43 Participants
n=375 Participants • Two participants did not provide information on duration since first back pain episode
|
83 Participants
n=747 Participants • Two participants did not provide information on duration since first back pain episode
|
|
Time From First Low Back Pain Episode
1-5 years ago
|
95 Participants
n=372 Participants • Two participants did not provide information on duration since first back pain episode
|
98 Participants
n=375 Participants • Two participants did not provide information on duration since first back pain episode
|
193 Participants
n=747 Participants • Two participants did not provide information on duration since first back pain episode
|
|
Time From First Low Back Pain Episode
6-10 years ago
|
57 Participants
n=372 Participants • Two participants did not provide information on duration since first back pain episode
|
67 Participants
n=375 Participants • Two participants did not provide information on duration since first back pain episode
|
124 Participants
n=747 Participants • Two participants did not provide information on duration since first back pain episode
|
|
Time From First Low Back Pain Episode
>10 years ago
|
180 Participants
n=372 Participants • Two participants did not provide information on duration since first back pain episode
|
167 Participants
n=375 Participants • Two participants did not provide information on duration since first back pain episode
|
347 Participants
n=747 Participants • Two participants did not provide information on duration since first back pain episode
|
|
Oswestry Disability Index
|
41.2 units on a scale
STANDARD_DEVIATION 12.8 • n=374 Participants
|
41.4 units on a scale
STANDARD_DEVIATION 12.7 • n=375 Participants
|
41.3 units on a scale
STANDARD_DEVIATION 12.8 • n=749 Participants
|
|
Numeric Pain Intensity Rating
|
5.4 units on a scale
STANDARD_DEVIATION 1.6 • n=374 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.8 • n=375 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.7 • n=749 Participants
|
|
Patient-reported outcomes measurement information system (PROMIS) - pain interference
|
63.4 T score
STANDARD_DEVIATION 5.6 • n=367 Participants • 13 participants did not provide a PROMIS pain interference score
|
63.2 T score
STANDARD_DEVIATION 6.0 • n=369 Participants • 13 participants did not provide a PROMIS pain interference score
|
63.3 T score
STANDARD_DEVIATION 5.8 • n=736 Participants • 13 participants did not provide a PROMIS pain interference score
|
|
Patient-reported outcomes measurement information system (PROMIS) - physical function
|
38.5 T score
STANDARD_DEVIATION 5.2 • n=369 Participants • 12 participants did not complete the PROMIS - physical function at baseline
|
38.8 T score
STANDARD_DEVIATION 5.7 • n=368 Participants • 12 participants did not complete the PROMIS - physical function at baseline
|
38.6 T score
STANDARD_DEVIATION 5.4 • n=737 Participants • 12 participants did not complete the PROMIS - physical function at baseline
|
|
Patient-reported outcomes measurement information system (PROMIS) - depression
|
51.3 T score
STANDARD_DEVIATION 10.0 • n=370 Participants • 4 participants did not complete the PROMIS - depression at baseline
|
52.5 T score
STANDARD_DEVIATION 10.3 • n=375 Participants • 4 participants did not complete the PROMIS - depression at baseline
|
51.9 T score
STANDARD_DEVIATION 10.2 • n=745 Participants • 4 participants did not complete the PROMIS - depression at baseline
|
|
Patient-reported outcomes measurement information system (PROMIS) - anxiety
|
54.6 T score
STANDARD_DEVIATION 10.1 • n=370 Participants • 9 participants did not complete the PROMIS - anxiety at baseline
|
54.5 T score
STANDARD_DEVIATION 10.5 • n=370 Participants • 9 participants did not complete the PROMIS - anxiety at baseline
|
54.5 T score
STANDARD_DEVIATION 10.3 • n=740 Participants • 9 participants did not complete the PROMIS - anxiety at baseline
|
|
Patient-reported outcomes measurement information system (PROMIS) - social roles
|
45.0 T score
STANDARD_DEVIATION 6.4 • n=369 Participants • 5 participants did not complete the PROMIS - social roles at baseline
|
44.7 T score
STANDARD_DEVIATION 6.5 • n=375 Participants • 5 participants did not complete the PROMIS - social roles at baseline
|
44.9 T score
STANDARD_DEVIATION 6.5 • n=744 Participants • 5 participants did not complete the PROMIS - social roles at baseline
|
|
Patient-reported outcomes measurement information system (PROMIS) - sleep disturbance
|
55.9 T score
STANDARD_DEVIATION 8.0 • n=370 Participants • 11 participants did not complete the PROMIS - sleep disturbance at baseline
|
56.9 T score
STANDARD_DEVIATION 7.4 • n=368 Participants • 11 participants did not complete the PROMIS - sleep disturbance at baseline
|
56.4 T score
STANDARD_DEVIATION 7.7 • n=738 Participants • 11 participants did not complete the PROMIS - sleep disturbance at baseline
|
|
Patient-reported outcomes measurement information system (PROMIS) - fatigue
|
57.7 T score
STANDARD_DEVIATION 9.6 • n=367 Participants • 12 participants did not complete the PROMIS - Fatigue
|
57.4 T score
STANDARD_DEVIATION 9.3 • n=370 Participants • 12 participants did not complete the PROMIS - Fatigue
|
57.5 T score
STANDARD_DEVIATION 9.4 • n=737 Participants • 12 participants did not complete the PROMIS - Fatigue
|
|
Sex/Gender, Customized
Female
|
237 Participants
n=374 Participants
|
236 Participants
n=375 Participants
|
473 Participants
n=749 Participants
|
|
Sex/Gender, Customized
Male
|
137 Participants
n=374 Participants
|
137 Participants
n=375 Participants
|
274 Participants
n=749 Participants
|
|
Sex/Gender, Customized
Missing or Other
|
0 Participants
n=374 Participants
|
2 Participants
n=375 Participants
|
2 Participants
n=749 Participants
|
PRIMARY outcome
Timeframe: baseline, 10 weeksBack pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Oswestry Disability Index From Baseline to 10 Weeks
|
-8.8 Units on a scale
Standard Error 0.81
|
-6.1 Units on a scale
Standard Error 0.80
|
PRIMARY outcome
Timeframe: 10 weeks, 52 weeksPopulation: Note that as specified in the study protocol and statistical analysis plan, non-responders randomized to swtich treatments or to mindfulness are combined across Phase I treatment groups.
Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=213 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=210 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Oswestry Disability Index From 10-weeks to 52 Weeks
|
-5.4 Units on a scale
Standard Error 0.96
|
-4.9 Units on a scale
Standard Error 0.97
|
PRIMARY outcome
Timeframe: baseline, 10 weeks0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity.
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks
|
-1.2 Units on a scale
Standard Error 0.11
|
-0.84 Units on a scale
Standard Error 0.11
|
PRIMARY outcome
Timeframe: 10 weeks, 52 weeksPopulation: Note that as specified in the study protocol and statistical analysis plan, non-responders randomized to swtich treatments or to mindfulness are combined across Phase I treatment groups.
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity.
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=213 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=210 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks
|
-0.53 Units on a scale
Standard Error 0.15
|
-0.48 Units on a scale
Standard Error .15
|
SECONDARY outcome
Timeframe: baseline, 10 weeks, 26 weeks, 52 weeksPROMIS-29 subscales scores reported across 7 domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference.
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Pain Interference From Baseline to 10 Weeks
|
-4.0 T score
Standard Error 0.43
|
-2.2 T score
Standard Error 0.36
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue.
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Fatigue From Baseline to !0 Weeks
|
-1.2 T score
Standard Error 0.50
|
0.25 T score
Standard Error 0.48
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Sleep Disturbance From Baseline to 10 Weeks
|
-2.1 T score
Standard Error 0.40
|
-0.60 T score
Standard Error 0.42
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Anxiety From Baseline to 10 Weeks
|
0.43 T score
Standard Error 0.49
|
2.5 T score
Standard Error 0.51
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Depression From Baseline to 10 Weeks
|
1.3 T score
Standard Error 0.49
|
2.0 T score
Standard Error 0.47
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPatient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Change in Social Role Participation From Baseline to 10 Weeks
|
1.9 T score
Standard Error 0.44
|
0.50 T score
Standard Error 0.36
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPopulation: All participants included in analyses with multiple imputation for missing data.
Use of either MRI or CT for low back pain
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks
|
27 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPopulation: All participants included in analysis with multiple imputation used for missing data
Long-term use of opioids for pain management defined as use on all or most days in the past 90 days
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Opioid Utilization at 10-week Assessment
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Participants analyzed include those who initiated Phase I treatment
Self-reported physical or psychological side effects of study treatments
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=254 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=219 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Treatment Side Effects
|
46 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPopulation: Analysis population is participants providing a 10-week assessment ODI score
Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=296 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=280 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Treatment Responder
|
73 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPopulation: All participants included in analyses based on Phase I treatment assignment with multiple imputation for missing data.
Use of injections for low back pain
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Health Care Utilization of Injections for Back Pain Over 10 Weeks
|
12 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: baseline, 10 weeksPopulation: All participants included in analyses based on Phase I treatment assignment with multiple imputation for missing data.
Use of radiographs for low back pain
Outcome measures
| Measure |
Phase I Non-Responders Assigned to Switching in Phase II
n=374 Participants
Includes all non-responders in Phase I who were re-randomized to Switching treatments in Phase II
|
Phase I Non-Responders Assigned to Mindfulness in Phase II
n=375 Participants
Includes all Phase I non-responders who were re-randomized to receive Mindfulness in Phase II
|
|---|---|---|
|
Health Care Utilization of Radiographs for Back Pain Over 10 Weeks
|
14 Participants
|
16 Participants
|
Adverse Events
Phase I PT Treatment
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I CBT Treatment
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I Non-Responders Re-Randomized to CBT
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I Non-Responders Re-Randomized to PT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase I Non-Responders Re-Randomized to Mindfulness
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I PT Treatment
n=374 participants at risk
This arm includes participants assigned to PT as their Phase I treatment
Physical Therapy: Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
|
Phase I CBT Treatment
n=375 participants at risk
This arm includes participants assigned to CBT for their Phase I treatment
Cognitive Behavioral Therapy: Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
|
Phase I Non-Responders Re-Randomized to CBT
n=103 participants at risk
Includes all Non-Responders in Phase I who were re-randomized to CBT in Phase II
Cognitive Behavioral Therapy: Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
Phase I Treatment: Includes all participants receiving any Phase I intervention
|
Phase I Non-Responders Re-Randomized to PT
n=110 participants at risk
Includes all Non-Responders in Phase I who were re-randomized to PT in Phase II
Physical Therapy: Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
Phase I Treatment: Includes all participants receiving any Phase I intervention
|
Phase I Non-Responders Re-Randomized to Mindfulness
n=197 participants at risk
Phase I Treatment: Includes all participants receiving any Phase I intervention who were re-randomized to Mindfulness.
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
Phase I Treatment: Includes all participants receiving any Phase I intervention
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
Back Surgery
|
1.6%
6/374 • Number of events 6 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
1.9%
7/375 • Number of events 7 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
1.9%
2/103 • Number of events 2 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
1.8%
2/110 • Number of events 2 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
3.0%
6/197 • Number of events 6 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Infections and infestations
COVID Hospitalization
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/375 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
1.0%
2/197 • Number of events 2 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Injury or Fracture
|
0.27%
1/374 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.53%
2/375 • Number of events 2 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.51%
1/197 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Injury, poisoning and procedural complications
Hopsitalization following accident
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.27%
1/375 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.91%
1/110 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/197 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Gastrointestinal disorders
Hospitalized for abdominal pain
|
0.27%
1/374 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/375 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/197 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Cardiac disorders
Hospitalized for Chest Pain
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.27%
1/375 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/197 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Infections and infestations
Hopsitalized for Osteomyelitis of humerus
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.27%
1/375 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/197 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Gastrointestinal disorders
Appendectomy
|
0.27%
1/374 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/375 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/197 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Vascular disorders
Hopsitalized with DVT
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/375 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.51%
1/197 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
|
Gastrointestinal disorders
Hopsitalized for rectal bleeding
|
0.00%
0/374 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/375 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/103 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.00%
0/110 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
0.51%
1/197 • Number of events 1 • Adverse events for Phase I interventions were collected over the first 10 weeks. Adverse events for Phase II interventions were collected from 10 weeks through 1 year follow-up.
Note that categories 1 and 2 include adverse events occuring during Phase I or at longer term follow-ups among participants who were not re-randomized in Phase II. Adverse events listed for non-responders who were re-randomized occurred during Phase II treatment or at longer-term follow-up time points.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place