Trial Outcomes & Findings for Physical Activity Interventions To Heal Chronic Low Back Pain (NCT NCT04678297)
NCT ID: NCT04678297
Last Updated: 2026-06-23
Results Overview
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up
Results posted on
2026-06-23
Participant Flow
Recruitment ran from September 2021 to September 2024. Recruitment materials advertising an intervention study evaluating "benefits of movement exercise for individuals who experience back pain" were disseminated via social media advertisements, listservs, an IRB-approved pain registry, local public transportation systems, and local outpatient clinical sites and universities.
Participant milestones
| Measure |
Yoga
The yoga intervention was led by registered yoga instructors using a yoga for CLBP protocol. Each class was grounded in a theme consistent with what individuals might encounter in community yoga classes (e.g., awareness, tolerating and accepting discomfort, non-judgment, centering) \[55\]. The protocol consisted of classical hatha yoga with influences from vinyasa and Iyengar yoga, with modifications and adaptations offered throughout. Each session began with a brief breathing and mindfulness meditation (3-10 minutes) followed by 15 minutes of basic postures (poses 1-8) to warm up, 15-20 minutes of standing poses (poses 9-14), 20 minutes of floor poses (poses 15-23), and then 5-7 minutes of relaxation in the standard ending pose "savasana," during which additional positive affirmations were provided.
|
Stretching/Strengthening
The stretching/strengthening intervention was led by physical therapists or certified strength and conditioning specialists, classes consisted of conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that strengthen and stretch all the major muscle groups, with an emphasis on the trunk and legs. This protocol included a 5-minute dynamic warm up (4 exercises), 15-20 minutes of supine trunk and core stability exercises (2-3 sets of 3-6 exercises), 15-20 minutes of seated stretches (3 sets of 2 exercises), 20 minutes of prone/quadruped mobility and strengthening exercises (2-3 sets of 4-5 exercises), 15 minutes of standing stretches and strengthening exercises (3 sets of 3-5 exercises)
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
99
|
|
Overall Study
COMPLETED
|
53
|
62
|
|
Overall Study
NOT COMPLETED
|
52
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity Interventions To Heal Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Yoga
n=105 Participants
The yoga intervention was led by registered yoga instructors using a yoga for CLBP protocol. Each class was grounded in a theme consistent with what individuals might encounter in community yoga classes (e.g., awareness, tolerating and accepting discomfort, non-judgment, centering) \[55\]. The protocol consisted of classical hatha yoga with influences from vinyasa and Iyengar yoga, with modifications and adaptations offered throughout. Each session began with a brief breathing and mindfulness meditation (3-10 minutes) followed by 15 minutes of basic postures (poses 1-8) to warm up, 15-20 minutes of standing poses (poses 9-14), 20 minutes of floor poses (poses 15-23), and then 5-7 minutes of relaxation in the standard ending pose "savasana," during which additional positive affirmations were provided.
|
Stretching/Strengthening
n=99 Participants
The stretching/strengthening intervention was led by physical therapists or certified strength and conditioning specialists, classes consisted of conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that strengthen and stretch all the major muscle groups, with an emphasis on the trunk and legs. This protocol included a 5-minute dynamic warm up (4 exercises), 15-20 minutes of supine trunk and core stability exercises (2-3 sets of 3-6 exercises), 15-20 minutes of seated stretches (3 sets of 2 exercises), 20 minutes of prone/quadruped mobility and strengthening exercises (2-3 sets of 4-5 exercises), 15 minutes of standing stretches and strengthening exercises (3 sets of 3-5 exercises)
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 Years
STANDARD_DEVIATION 16.4 • n=20 Participants
|
42.9 Years
STANDARD_DEVIATION 16.8 • n=20 Participants
|
43.4 Years
STANDARD_DEVIATION 16.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=20 Participants
|
59 Participants
n=20 Participants
|
133 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=20 Participants
|
40 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=20 Participants
|
71 Participants
n=20 Participants
|
150 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=20 Participants
|
89 Participants
n=20 Participants
|
178 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-upPopulation: Attrition or missing response
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
Outcome measures
| Measure |
Yoga
n=105 Participants
The yoga intervention was led by registered yoga instructors using a yoga for CLBP protocol. Each class was grounded in a theme consistent with what individuals might encounter in community yoga classes (e.g., awareness, tolerating and accepting discomfort, non-judgment, centering) \[55\]. The protocol consisted of classical hatha yoga with influences from vinyasa and Iyengar yoga, with modifications and adaptations offered throughout. Each session began with a brief breathing and mindfulness meditation (3-10 minutes) followed by 15 minutes of basic postures (poses 1-8) to warm up, 15-20 minutes of standing poses (poses 9-14), 20 minutes of floor poses (poses 15-23), and then 5-7 minutes of relaxation in the standard ending pose "savasana," during which additional positive affirmations were provided.
|
Stretching/Strengthening
n=99 Participants
The stretching/strengthening intervention was led by physical therapists or certified strength and conditioning specialists, classes consisted of conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that strengthen and stretch all the major muscle groups, with an emphasis on the trunk and legs. This protocol included a 5-minute dynamic warm up (4 exercises), 15-20 minutes of supine trunk and core stability exercises (2-3 sets of 3-6 exercises), 15-20 minutes of seated stretches (3 sets of 2 exercises), 20 minutes of prone/quadruped mobility and strengthening exercises (2-3 sets of 4-5 exercises), 15 minutes of standing stretches and strengthening exercises (3 sets of 3-5 exercises)
|
|---|---|---|
|
Emotion Regulation Abilities
T5 DERS (6 month follow-up)
|
64.26 Scores
Standard Deviation 21.68
|
72.18 Scores
Standard Deviation 24.09
|
|
Emotion Regulation Abilities
T1 DERS (Baseline)
|
63.58 Scores
Standard Deviation 19.21
|
68.25 Scores
Standard Deviation 19.04
|
|
Emotion Regulation Abilities
T2 DERS (6 weeks)
|
64.95 Scores
Standard Deviation 20.96
|
68.89 Scores
Standard Deviation 21.62
|
|
Emotion Regulation Abilities
T3 DERS (12 weeks)
|
63.57 Scores
Standard Deviation 19.63
|
70.23 Scores
Standard Deviation 22.41
|
|
Emotion Regulation Abilities
T4 (3 month follow-up)
|
64.64 Scores
Standard Deviation 21.50
|
71.57 Scores
Standard Deviation 22.69
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-upsPopulation: Attrition or missing response
Brief Pain Inventory - Change over time; Brief Pain Inventory consists of 2 subscales: Pain Intensity (range from 0-10, higher scores are worse pain) and pain interference (range is 0-10, higher scores is greater interference)
Outcome measures
| Measure |
Yoga
n=105 Participants
The yoga intervention was led by registered yoga instructors using a yoga for CLBP protocol. Each class was grounded in a theme consistent with what individuals might encounter in community yoga classes (e.g., awareness, tolerating and accepting discomfort, non-judgment, centering) \[55\]. The protocol consisted of classical hatha yoga with influences from vinyasa and Iyengar yoga, with modifications and adaptations offered throughout. Each session began with a brief breathing and mindfulness meditation (3-10 minutes) followed by 15 minutes of basic postures (poses 1-8) to warm up, 15-20 minutes of standing poses (poses 9-14), 20 minutes of floor poses (poses 15-23), and then 5-7 minutes of relaxation in the standard ending pose "savasana," during which additional positive affirmations were provided.
|
Stretching/Strengthening
n=99 Participants
The stretching/strengthening intervention was led by physical therapists or certified strength and conditioning specialists, classes consisted of conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that strengthen and stretch all the major muscle groups, with an emphasis on the trunk and legs. This protocol included a 5-minute dynamic warm up (4 exercises), 15-20 minutes of supine trunk and core stability exercises (2-3 sets of 3-6 exercises), 15-20 minutes of seated stretches (3 sets of 2 exercises), 20 minutes of prone/quadruped mobility and strengthening exercises (2-3 sets of 4-5 exercises), 15 minutes of standing stretches and strengthening exercises (3 sets of 3-5 exercises)
|
|---|---|---|
|
Pain Severity/Interference
T1 Pain Severity Score (baseline)
|
3.34 Pain Severity/Interference Scores
Standard Deviation 1.49
|
3.35 Pain Severity/Interference Scores
Standard Deviation 1.85
|
|
Pain Severity/Interference
T2 Pain Severity Score (6 weeks)
|
2.66 Pain Severity/Interference Scores
Standard Deviation 1.38
|
2.88 Pain Severity/Interference Scores
Standard Deviation 1.88
|
|
Pain Severity/Interference
T3 Pain Severity Score (12 weeks)
|
2.80 Pain Severity/Interference Scores
Standard Deviation 1.79
|
2.62 Pain Severity/Interference Scores
Standard Deviation 1.94
|
|
Pain Severity/Interference
T4 Pain Severity Score (3 month follow-up)
|
2.91 Pain Severity/Interference Scores
Standard Deviation 2.04
|
2.46 Pain Severity/Interference Scores
Standard Deviation 1.77
|
|
Pain Severity/Interference
T5 Pain Severity Score (6 month follow-up)
|
2.31 Pain Severity/Interference Scores
Standard Deviation 1.94
|
2.37 Pain Severity/Interference Scores
Standard Deviation 1.81
|
|
Pain Severity/Interference
T1 Pain Interference Score (baseline)
|
3.44 Pain Severity/Interference Scores
Standard Deviation 2.04
|
3.16 Pain Severity/Interference Scores
Standard Deviation 2.07
|
|
Pain Severity/Interference
T2 Pain Interference Score (6 weeks)
|
2.67 Pain Severity/Interference Scores
Standard Deviation 1.92
|
2.66 Pain Severity/Interference Scores
Standard Deviation 2.21
|
|
Pain Severity/Interference
T3 Pain Interference Score (12 weeks)
|
2.24 Pain Severity/Interference Scores
Standard Deviation 1.94
|
1.99 Pain Severity/Interference Scores
Standard Deviation 2.04
|
|
Pain Severity/Interference
T4 Pain Interference Score (3 month follow-up)
|
2.65 Pain Severity/Interference Scores
Standard Deviation 2.20
|
1.85 Pain Severity/Interference Scores
Standard Deviation 1.85
|
|
Pain Severity/Interference
T5 Pain Interference Score (6 month follow-up)
|
2.20 Pain Severity/Interference Scores
Standard Deviation 2.16
|
2.17 Pain Severity/Interference Scores
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks and 3 months and 6 monthsQuantitative sensory testing, Brief Pain Inventory - Change over time
Outcome measures
Outcome data not reported
Adverse Events
Yoga
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Stretching/Strengthening
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga
n=105 participants at risk
The yoga intervention was led by registered yoga instructors using a yoga for CLBP protocol. Each class was grounded in a theme consistent with what individuals might encounter in community yoga classes (e.g., awareness, tolerating and accepting discomfort, non-judgment, centering) \[55\]. The protocol consisted of classical hatha yoga with influences from vinyasa and Iyengar yoga, with modifications and adaptations offered throughout. Each session began with a brief breathing and mindfulness meditation (3-10 minutes) followed by 15 minutes of basic postures (poses 1-8) to warm up, 15-20 minutes of standing poses (poses 9-14), 20 minutes of floor poses (poses 15-23), and then 5-7 minutes of relaxation in the standard ending pose "savasana," during which additional positive affirmations were provided.
|
Stretching/Strengthening
n=99 participants at risk
The stretching/strengthening intervention was led by physical therapists or certified strength and conditioning specialists, classes consisted of conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that strengthen and stretch all the major muscle groups, with an emphasis on the trunk and legs. This protocol included a 5-minute dynamic warm up (4 exercises), 15-20 minutes of supine trunk and core stability exercises (2-3 sets of 3-6 exercises), 15-20 minutes of seated stretches (3 sets of 2 exercises), 20 minutes of prone/quadruped mobility and strengthening exercises (2-3 sets of 4-5 exercises), 15 minutes of standing stretches and strengthening exercises (3 sets of 3-5 exercises)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.6%
8/105 • From enrollment until end of study, up to 6 months
|
7.1%
7/99 • From enrollment until end of study, up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place