Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain (P4P)

University of Minnesota (UMN)

Status: Enrolling

Conditions: Back Pain; Self-management; Chronic Pain; Complementary Therapies; Neck Pain

Treatments: Behavioral: Partners4Pain; Behavioral: Keys to Wellbeing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06696352

R33AT012309 (U.S. NIH Grant/Contract)

STUDY00017917 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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376 participants in 2 patient groups

Partners4Pain

Experimental group

Description:

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.

Treatment:

Behavioral: Partners4Pain

Keys to Wellbeing

Active Comparator group

Description:

Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises.

Treatment:

Behavioral: Keys to Wellbeing