Trials Today

Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

Purpose

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. 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.

Conditions

Chronic Pain
Back Pain
Neck Pain
Self-management
Complementary Therapies

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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 populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000) - Reside within the Minneapolis/St. Paul metro region

Exclusion Criteria

Severe unmanaged mental illness - Self-reported cancer with active treatment involving radiation or chemotherapy. - Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment - Self-reported pregnancy

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Investigator)

Arm Groups

Arm	Description	Assigned Intervention
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.	Behavioral: Partners4Pain This is a group program that will teach participants about different things they can do to manage their pain. They will watch educational videos and do workbook activities. They will learn and practice different exercises and mind-body strategies for pain including back and neck exercises (like strengthening and stretching), mind-body exercises (like meditation, relaxed breathing, guided imagery, and muscle relaxation), problem solving, and how to communicate with others about your pain. They will also have an opportunity to take part in discussions with other group members. The program will be delivered via weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference.
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.	Behavioral: Keys to Wellbeing This is a group program that will teach participants about different things they can do to improve their health and wellbeing. Participants will watch educational videos and do workbook activities. They will learn different back and neck exercises (like strengthening and stretching) and be introduced to different health-related topics including information and tips about health, pain and wellbeing; keeping active and well; the importance of rest and relaxation; and working with meaning and purpose in your life. They will also have an opportunity to take part in discussions with other group members. The program will be delivered in weekly 90 minute sessions over 9 weeks and will be offered in-person or via videoconference.

Recruiting Locations

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455

More Details

NCT ID: NCT06696352
Status: Recruiting
Sponsor: University of Minnesota

Study Contact

Roni L Evans, DC, MS, PhD
612-626-6477
partners4pain@umn.edu

Detailed Description

This project is a full-scale, multi-level randomized hybrid effectiveness implementation trial (n=376) of 'Partners4Pain', a community supported self-management program for individuals with back or neck pain. Partners4Pain will be compared to an active control, Keys to Wellbeing. Both programs were optimized and feasibility tested in an earlier R61 pilot study of 51 individuals (NCT05786508). Aims for the hybrid effectiveness implementation trial are: AIM 1. To assess the relative effectiveness of Partners4Pain versus Keys to Wellbeing in terms of: - Primary effectiveness outcomes of pain intensity and interference over 6 months using bi-monthly assessments. - Secondary effectiveness outcomes of pain impact, self-efficacy and other HEAL outcomes. AIM 2. To assess the impact of health factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between factors. AIM 3. To describe important implementation related measures that can impact and inform sustained translation of the program with community partner organizations.