Physical Activity Interventions to Heal Chronic Low Back Pain

Not Applicable

Active, not recruiting

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: Physical activity control intervention; Behavioral: Physical activity + emotion regulation intervention

• Registration Number: NCT04678297
• Lead Sponsor: University of Connecticut

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-03-31
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity control group	Physical activity control intervention	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.
Physical activity + emotion regulation group	Physical activity + emotion regulation intervention	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.

Primary Outcome Measures

Name	Time	Method
Emotion regulation abilities	Baseline and 6 weeks and 3 months and 6 months	Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation

Secondary Outcome Measures

Name	Time	Method
Pain severity/interference	Baseline and 6 weeks and 3 months and 6 months	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)
Pain sensitization	Baseline and 6 weeks and 3 months and 6 months	Quantitative sensory testing, Brief Pain Inventory - Change over time

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs Mansfield, Connecticut, United States