Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AT010555 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.
In this study, participants with chronic low back pain will be randomized to receive a 12-week physical activity intervention (2 times per week with encouragement for home practice). The experimental condition will entail physical activity with components for strengthening emotion regulation skills, behaviors, and attitudes while the control condition will entail physical activity alone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity + emotion regulation group | Experimental | Participants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. |
|
| Physical activity control group | Active Comparator | Participants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity + emotion regulation intervention | Behavioral | The intervention meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention will be led by certified instructors trained in working with back pain patients. The instructor leads participants through a series of physical activity exercises at a slow-moderate pace. Participants will be asked to practice every day for 20 minutes to maximize the benefit of the intervention. Participants also receive a home practice manual containing some basic, safe postures that can be performed on days they are not attending the formal in-person sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Emotion Regulation Abilities | Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity/Interference | 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) | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups |
Not provided
Inclusion Criteria:
- Age > 18;
Report of low back pain >3 of last 6 months;
Willing to attend 12-weeks of yoga or stretching (twice per week);
Willing to complete 4 assessments;
English Literacy;
No changes in pain treatments in the past month;
Willing to not change pain treatments during study unless medically necessary;
Have not practiced yoga > 2x in the last 12 months;
Exclusion Criteria:
- back surgery within the last 1 year;
back pain due to specific systemic problem (e.g., lupus);
lower extremity weakness (motor strength 4/5 of the quads, gluts, hamstrings, EHL);
sciatica or (+) straight leg raise (SLR);
coexisting chronic pain problem (migraine headaches, fibromyalgia);
Serious or unstable psychiatric illness (e.g. psychosis, mania, history of suicide attempt);
major coexisting medical illness (e.g., cancer, COPD, morbid obesity);
Positive Romberg test (with or without sensory neuropathy).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Crystal Park, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs Mansfield | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38483469 | Derived | Starkweather AR, Xu W, Gnall KE, Emrich M, Garnsey CL, Magin ZE, Wu W, Fetta J, Groessl EJ, Park C. Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 14;13:e56016. doi: 10.2196/56016. |
Not provided
Not provided
All of the individual participant data that are part of National Institute of Health (NIH) designated common data elements collected during the trial, after de-identification have been submitted to NIH. Data can be accessed by directly submitting requests at that website.
Upon completion of all study analyses and publication of study results, anticipated to be December 2024
Researchers who are actively conducting physical activity studies for participants with pain.
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Emotion Regulation Abilities | Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation | Attrition or missing response | Posted | Mean | Standard Deviation | Scores | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up |
|
From enrollment until end of study, up to 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Park | University of Connecticut | 860.486.3520 | crystal.park@uconn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 | May 26, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
We will employ blinding whenever possible. Assessments, evaluations, and data analysis will be conducted without knowledge of participants' assigned group. Study personnel will be blinded to the assigned condition of subjects when conducting data collection by using unique study identification numbers, by following a strict script to refrain from discussing participant activities, and by using different members of the study team to coordinate assigned condition activities and to collect data. De-identified data with codes for assigned condition will facilitate blinded data analysis.
|
| Physical activity control intervention | Behavioral | The interventions meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention is designed to require a similar amount of physical exertion. Classes involve conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that stretch all the major muscle groups, with an emphasis on the trunk and legs. The intervention will include all 12 stretching exercises used in the exercise intervention of previous studies that have successfully used it in comparison to yoga, plus 3 additional stretches (hip internal rotators, hip adductors and hip flexion).Participants will be asked to practice every day for 20 minutes home as well. Printed handouts will be provided to facilitate home practice. In addition, a video demonstrating all the exercises will be provided to assist participants in practicing safely. Classes will be led by a licensed physical therapist who has previous experience leading exercise classes. |
|
| Pain Sensitization |
Quantitative sensory testing, Brief Pain Inventory - Change over time |
| Baseline and 6 weeks and 3 months and 6 months |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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) |
|
|
| Secondary | Pain Severity/Interference | 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) | Attrition or missing response | Posted | Mean | Standard Deviation | Pain Severity/Interference Scores | Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups |
|
|
|
| Secondary | Pain Sensitization | Quantitative sensory testing, Brief Pain Inventory - Change over time | Not Posted | Baseline and 6 weeks and 3 months and 6 months | Participants |
| 0 |
| 105 |
| 0 |
| 105 |
| 8 |
| 105 |
| EG001 | 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) | 0 | 99 | 0 | 99 | 7 | 99 |
Not provided
Not provided
Not provided
| T2 Pain Severity Score (6 weeks) |
|
|
| T3 Pain Severity Score (12 weeks) |
|
|
| T4 Pain Severity Score (3 month follow-up) |
|
|
| T5 Pain Severity Score (6 month follow-up) |
|
|
| T1 Pain Interference Score (baseline) |
|
|
| T2 Pain Interference Score (6 weeks) |
|
|
| T3 Pain Interference Score (12 weeks) |
|
|
| T4 Pain Interference Score (3 month follow-up) |
|
|
| T5 Pain Interference Score (6 month follow-up) |
|
|