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

University of Minnesota (UMN)

Status: Completed

Conditions: Chronic Pain; Neck Pain; Low Back Pain

Treatments: Other: Partners4Pain program; Other: Key to Wellbeing program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05786508

1R61AT012309 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility.

Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide a signed and dated informed consent form
• State willingness to comply with all study procedures outlined in the consent form
• Be 18 years of age or older
• Have 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
• Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10)
• Be a 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

• Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness
• Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1
• Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes
• Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise)
• Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes
• Children under the age of 18

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Partners4Pain program

Experimental group

Description:

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Treatment:

Other: Partners4Pain program

Key to Wellbeing program

Active Comparator group

Description:

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Treatment:

Other: Key to Wellbeing program