Physical Activity Interventions To Heal Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

— PATH  

Official title:

Role of Emotion Regulation on Low Back Pain Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678297
• Other study ID #: H19-191
• Secondary ID: R01AT010555
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: University of Connecticut
• Contact: Angela Starkweather, PhD
• Phone: (860) 486-0549
• Email: angela.starkweather[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: September 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain severity/interference	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)	Baseline and 6 weeks and 3 months and 6 months
Secondary	Pain sensitization	Quantitative sensory testing, Brief Pain Inventory - Change over time	Baseline and 6 weeks and 3 months and 6 months