Clinical trial NCT06696352: Partners4Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
Official title: Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Back Pain
Neck Pain
Self-management
Complementary Therapies
Health Inequity
Keywords: Self-Management
Chronic Pain
Neck Pain
Low Back Pain
Complementary Therapies
Health Inequity
Back Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-11-20
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 pain (back or neck pain) from populations who experience health disparities (BP-PEHD). 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 minoritized by race, ethnicity, or income (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 disparity factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between disparity factors.

AIM 3. To describe important disparity mitigating and implementation related measures that can impact and inform sustained translation of the program with community partner organizations.

Eligibility criteria: 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 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)

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

Primary outcomes:
measure: Pain, Interference with Enjoyment of Life and General Activity
timeFrame: Baseline, 2, 4, 6 months
Secondary outcomes:
measure: Graded Chronic Pain Scale
timeFrame: Baseline, 2, 6 months
measure: Self-efficacy for Managing Chronic Conditions
timeFrame: Baseline, 2, 4, 6 months
measure: Domain Specific Life Satisfaction
timeFrame: Baseline, 2, 4, 6 months
measure: Quality of Life and Health Satisfaction
timeFrame: Baseline, 2, 4, 6 months
measure: Physical Functioning
timeFrame: Baseline, 2, 4, 6 months
measure: Pain Catastrophizing
timeFrame: Baseline, 2, 4, 6 months
measure: Interoceptive Awareness
timeFrame: Baseline, 2, 4, 6 months
measure: Overall Improvement
timeFrame: Months 2, 4, 6
measure: Intervention Satisfaction
timeFrame: Months 2, 4, 6
measure: Social Isolation
timeFrame: Baseline, 2, 4, 6 months
measure: Healthcare Use
timeFrame: Baseline, 2, 4, 6 months
measure: Medication Use
timeFrame: Baseline, 2, 4, 6 months
measure: Complementary Integrative Health Self-Management Use
timeFrame: Baseline, 2, 4, 6 months
measure: Adverse Events
timeFrame: 2, 4, 6, months
measure: Sleep Disturbance
timeFrame: Baseline, 2, 6 months
measure: Sleep Duration
timeFrame: Baseline, 2, 6 months
measure: Anxiety
timeFrame: Baseline, 2, 6 months
measure: Depression
timeFrame: Baseline, 2, 6 months
measure: Participation in Social Roles and Activities
timeFrame: Baseline, 2, 6 months
measure: Substance Use
timeFrame: Baseline, 2, 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: