Physical Activity To Heal Back Pain (PATH)

• ClinicalTrials.gov Identifier: NCT04678297
• Recruitment Status: Recruiting
• First Posted: December 21, 2020
• Last Update Posted: December 21, 2020
• Sponsor: University of Connecticut
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Crystal Park, University of Connecticut

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Behavioral: Physical activity + emotion regulation intervention; Behavioral: Physical activity control intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: Role of Emotion Regulation on Low Back Pain Outcomes
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: September 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Physical activity + emotion regulation group	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	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.

Outcome Measures

Primary Outcome Measures :

1. Emotion regulation abilities [ Time Frame: Baseline and 6 weeks and 3 months and 6 months ]
   Difficulties in Emotion Regulation Scale - Change over time

Secondary Outcome Measures :

1. Pain severity/interference [ Time Frame: Baseline and 6 weeks and 3 months and 6 months ]
   Quantitative sensory testing, Brief Pain Inventory - Change over time
2. Pain sensitization [ Time Frame: Baseline and 6 weeks and 3 months and 6 months ]
   Quantitative sensory testing, Brief Pain Inventory - Change over time

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Contacts

Contact: Angela Starkweather, PhD; (860) 486-0549; angela.starkweather@uconn.edu

Locations

United States, Connecticut

University of Connecticut; Recruiting

Storrs, Connecticut, United States, 06269

Contact: Angela Starkweather, PhD 860-486-0549

Sponsors and Collaborators

University of Connecticut

National Center for Complementary and Integrative Health (NCCIH)

National Institutes of Health (NIH)

More Information

• Responsible Party: Crystal Park, Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT04678297
• Other Study ID Numbers: H19-191; R01AT010555 ( U.S. NIH Grant/Contract )
• First Posted: December 21, 2020
• Last Update Posted: December 21, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

• 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

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations