Trial Outcomes & Findings for Education/Exercise and Chiropractic for Chronic Back Pain (NCT NCT00561652)
NCT ID: NCT00561652
Last Updated: 2015-02-10
Results Overview
Number of participants completing at least 3 of 4 education + exercise visits
COMPLETED
NA
30 participants
12 weeks
2015-02-10
Participant Flow
Veterans were recruited between 1/2008 \& 3/2009 at the Minneapolis VA, with flyers given to patients presenting to Primary Care, Physical Therapy \& Orthopedics clinics with low back pain; recruitment posters; \& mailings to patients previously diagnosed with back pain.
1075 were offered initial phone screening, 71 completed further in-clinic screening, \& 30 were randomized. Participants were randomly assigned to treatment groups at the time of enrollment with no wash out, run-in, or transition between enrollment and group assignment. No enrolled participants were excluded from the trial before group assignment.
Participant milestones
| Measure |
Arm 1
Education plus exercise
|
Arm 2
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
20
|
|
Overall Study
COMPLETED
|
10
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1
Education plus exercise
|
Arm 2
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Education/Exercise and Chiropractic for Chronic Back Pain
Baseline characteristics by cohort
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus Education plus exercise
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Nonhispanic Black
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Nonhispanic White
|
9 participants
n=99 Participants
|
18 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
20 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants completing at least 3 of 4 education + exercise visits
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Education + Exercise Visits
|
9 participants
|
19 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksNumber of participants who completed at least 12 chiropractic visits.
Outcome measures
| Measure |
Arm 1
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Chiropractic Visits
|
—
|
18 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Only arm 1 received "time and attention" visits as their purpose was to balance the chiropractor provider contact time received by arm 2 participants.
Number of participants who completed at least 8 of 10 "time and attention" visits. Note that only arm 1 (nonchiropractic arm) receives "time and attention" visits.
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With "Time and Attention" Visits
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksNumber of participants who completed at least 20 hours of home exercise
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Prescribed Home Exercise
|
2 participants
|
10 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksNumber of participants who completed their week 6 follow-up questionnaire
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Week 6 Follow-up Questionnaire
|
8 participants
|
16 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksNumber of participants who completed their week 12 follow-up questionnaire
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Week 12 Follow-up Questionnaire
|
9 participants
|
18 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksNumber of participants who completed week 26 follow-up questionnaire
Outcome measures
| Measure |
Arm 1
n=10 Participants
Education plus exercise
|
Arm 2
n=20 Participants
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Participant Adherence With Week 26 Follow-up Questionnaire
|
6 participants
|
15 participants
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1
n=10 participants at risk
Education plus exercise
|
Arm 2
n=20 participants at risk
Chiropractic treatment plus education plus exercise
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increase in low back pain
|
60.0%
6/10 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
80.0%
16/20 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
|
Musculoskeletal and connective tissue disorders
New leg pain
|
0.00%
0/10 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
35.0%
7/20 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
|
General disorders
Different pain
|
30.0%
3/10 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
15.0%
3/20 • 12 weeks
Participants were administered a questionnaire asking whether they had or hadn't experienced each of 7 possible adverse effects at each chiropractic and exercise therapist visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place