Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrativ… (NCT06696352) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
United States376 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain, Interference with Enjoyment of Life and General Activity