Physical Activity Interventions To Heal Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Emotion Regulation on Low Back Pain Outcomes

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Physical activity + emotion regulation intervention
* Behavioral: Physical activity control intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity + emotion regulation group<br>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. | Behavioral: Physical activity + emotion regulation intervention<br>* 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.<br>|
| Active Comparator: Physical activity control group<br>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. | Behavioral: Physical activity control intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 and 6 weeks and 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity/interference | Brief Pain Inventory - Change over time; Brief Pain Inventory consists of 2 subscales: Pain Intensity (range from 0-40, higher scores are worse pain) and pain interference (range is 0-60, higher scores is greater interference) | Baseline and 6 weeks and 3 months and 6 months | 
| Pain sensitization | Quantitative sensory testing, Brief Pain Inventory - Change over time | Baseline and 6 weeks and 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, physical activity, emotion regulation