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Completed

NCT Number: NCT04678297

Physical Activity Interventions To Heal Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain Behavior Emotional Regulation Motor Activity Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs Mansfield, Connecticut, 06269, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 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.

Primary outcomes

  1. Emotion Regulation Abilities

    Time frame: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-up

    Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation

Secondary outcomes

  1. Pain Severity/Interference

    Time frame: Baseline, 6 weeks, and 12 weeks and 3 months and 6 months follow-ups

    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)

  2. Pain Sensitization

    Time frame: Baseline and 6 weeks and 3 months and 6 months

    Quantitative sensory testing, Brief Pain Inventory - Change over time

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Role of Emotion Regulation on Low Back Pain Outcomes

Acronym: PATH

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2020
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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