Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain from populations that have been minoritized based on race, ethnicity, or income. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer

• Score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity scale (PEG scale - 0-10)

• Member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000)

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Roni L Evans, DC, MS, PhD
partners4pain@umn.edu
612-626-6477
Backup
Brent Leininger, DC, MS, PhD
partners4pain@umn.org
612-626-6477
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2027-08
Participants
Target number of participants: 376
Treatments
Experimental: Partners4Pain
Community-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises.
Active_comparator: Keys to Wellbeing
Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov