Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
NCT ID: NCT05786508
Last Updated: 2024-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2023-08-28
2023-12-19
Brief Summary
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Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Partners4Pain program
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
Partners4Pain program
Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises.
The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks
Key to Wellbeing program
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
Key to Wellbeing program
Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials).
The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks
Interventions
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Partners4Pain program
Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises.
The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks
Key to Wellbeing program
Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials).
The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Roni Evans, PhD, DC,MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Brent Leininger, PhD, DC, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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