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

NCT06696352 | Active Not Recruiting DMC

• 2 other identifiers: R33AT012309STUDY00017917
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Self-Management; Chronic Pain; Neck Pain; Low Back Pain; Complementary Therapies; Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain, Interference with Enjoyment of Life and General Activity

  Measured using the Pain, Enjoyment of Life and General Activity (PEG) scale that measures average pain intensity, interference with enjoyment of life, and interference with general activity in the past week. Each item is measured on a 0 (no pain/does not interfere) to 10 numeric rating scale (pain as bad as you can imagine/completely interferes).

  Baseline, 2, 4, 6 months

Secondary Outcomes (20)

• Graded Chronic Pain Scale

  Baseline, 2, 6 months

• Self-efficacy for Managing Chronic Conditions

  Baseline, 2, 4, 6 months

• Domain Specific Life Satisfaction

  Baseline, 2, 4, 6 months

• Quality of Life and Health Satisfaction

  Baseline, 2, 4, 6 months

• Physical Functioning

  Baseline, 2, 4, 6 months

Study Arms (2)

Partners4Pain

EXPERIMENTAL

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

Keys to Wellbeing

ACTIVE COMPARATOR

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

Interventions

Partners4Pain BEHAVIORAL

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.

Partners4Pain

Keys to Wellbeing BEHAVIORAL

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.

Keys to Wellbeing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Pain; Back Pain; Neck Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roni L Evans, DC, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Brent Leininger, DC, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 20, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
• Access Criteria: Data will be shared as allowed by the informed consents and institutional certification. Controlled Access will follow Data Use Limitations (DULs) to maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality. Data will only be made available to the requester by the data repository after approval of the request by the data repository's independent review panel process.

Locations

US (1)