Physical Activity Interventions To Heal Chronic Low Back Pain

NCT04678297 | Completed DMC

• 2 other identifiers: H19-191R01AT010555
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain, physical activity, emotion regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain severity/interference

  Baseline and 6 weeks and 3 months and 6 months

• Pain sensitization

  Baseline and 6 weeks and 3 months and 6 months

Study Arms (2)

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.

Behavioral: Physical activity + emotion regulation intervention

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.

Behavioral: Physical activity control intervention

Interventions

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.

Physical activity + emotion regulation group

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.

Physical activity control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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;

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• University of Connecticut: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Connecticut

Storrs Mansfield, Connecticut, 06269, United States

Location

Related Publications (1)

• 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.

  PMID: 38483469 DERIVED

MeSH Terms

Conditions

Motor Activity; Emotional Regulation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Crystal Park, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 21, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon completion of all study analyses and publication of study results, anticipated to be December 2024
• Access Criteria: Researchers who are actively conducting physical activity studies for participants with pain.

Locations

US (1)