Physical Activity Interventions To Heal Chronic Low Back Pain (PATH)

Role of Emotion Regulation on Low Back Pain Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Physical activity + emotion regulation intervention; Behavioral: Physical activity control intervention

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 Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs Mansfield, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity + emotion regulation group; 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; 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.
Active Comparator: Physical activity control group; 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; 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.

What is the study measuring?

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, 6 weeks, and 12 weeks and 3 months and 6 months follow-up

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 0-10, 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
Pain Sensitization	Quantitative sensory testing, Brief Pain Inventory - Change over time	Baseline and 6 weeks and 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Crystal Park, PhD, University of Connecticut

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: chronic low back pain, physical activity, emotion regulation
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Self-Control; Motor Activity; Emotional Regulation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: H19-191; R01AT010555 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon completion of all study analyses and publication of study results, anticipated to be December 2024
• IPD Sharing Access Criteria: Researchers who are actively conducting physical activity studies for participants with pain.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No