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

Last updated: December 5, 2024
Sponsor: University of Minnesota
Overall Status: Completed

Phase

N/A

Condition

Neck Pain

Pain

Chronic Pain

Treatment

Key to Wellbeing program

Partners4Pain program

Clinical Study ID

NCT05786508
1R61AT012309
1R61AT012309
  • Ages > 18
  • All Genders

Study Summary

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/)"

Eligibility Criteria

Inclusion

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, orneck 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 GeneralActivity (PEG) scale (0 to 10)

  • Be a member of one or more of the following NIH-designated health disparitypopulations: American Indian/Alaska Native, Asian, Black/African American,Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000)

Exclusion

Exclusion Criteria:

  • Hospitalization for severe mental illness in past six months because the mindfulnessand behavioral mind-body practices (e.g., meditation, progressive muscle relaxation,etc.) in the experimental intervention may aggravate symptoms of severe mentalillness

  • Active psychotic symptoms, suicidal ideation, or manic episodes in the past threemonths for the same reasons noted in #1

  • Self-reported cancer with active treatment involving radiation or chemotherapy dueto the potential for complications of their back or neck pain and impact on healthoutcomes

  • Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion ofcognitive impairment due to safety risks (e.g., not being able to follow directionsfor safe physical exercise)

  • Self-reported pregnancy due to the fact that back pain is often associated withpregnancy and differs from non-pregnancy related back pain and thus might havedifferent impacts on health outcomes

  • Children under the age of 18

Study Design

Total Participants: 51
Treatment Group(s): 2
Primary Treatment: Key to Wellbeing program
Phase:
Study Start date:
August 28, 2023
Estimated Completion Date:
December 19, 2023

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

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