Back to resultsPhysical Activity Interventions To Heal Chronic Low Back Pain (PATH)
Primary Purpose
Chronic Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity + emotion regulation intervention
Physical activity control intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Low Back Pain focused on measuring chronic low back pain, physical activity, emotion regulation
Eligibility 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).
Sites / Locations
- University of ConnecticutRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical activity + emotion regulation group
Physical activity control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Emotion regulation abilities
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
Secondary Outcome Measures
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)
Pain sensitization
Quantitative sensory testing, Brief Pain Inventory - Change over time
Full Information
NCT ID
NCT04678297
First Posted
December 17, 2020
Last Updated
October 31, 2022
Sponsor
University of Connecticut
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04678297
Brief Title
Physical Activity Interventions To Heal Chronic Low Back Pain
Acronym
PATH
Official Title
Role of Emotion Regulation on Low Back Pain Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain, physical activity, emotion regulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical activity + emotion regulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical activity control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity + emotion regulation intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity control intervention
Intervention Description
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 Outcome Measure Information:
Title
Emotion regulation abilities
Description
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
Time Frame
Baseline and 6 weeks and 3 months and 6 months
Secondary Outcome Measure Information:
Title
Pain severity/interference
Description
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)
Time Frame
Baseline and 6 weeks and 3 months and 6 months
Title
Pain sensitization
Description
Quantitative sensory testing, Brief Pain Inventory - Change over time
Time Frame
Baseline and 6 weeks and 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Starkweather, PhD
Phone
(860) 486-0549
Email
angela.starkweather@uconn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Park, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Starkweather, PhD
Phone
860-486-0549
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Physical Activity Interventions To Heal Chronic Low Back Pain
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