- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786508
Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
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/)"
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Partners4Pain program
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
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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 |
Active Comparator: Key to Wellbeing program
adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Recruitment
Time Frame: 2 months
|
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants
|
2 months
|
Participant Recruitment
Time Frame: 2 months
|
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;
|
2 months
|
Participant Retention Feasibility
Time Frame: 2 months
|
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention
|
2 months
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Intervention Delivery Feasibility
Time Frame: 9 weeks
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Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions
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9 weeks
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Intervention Fidelity
Time Frame: 9 weeks
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Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities 90% of the time
|
9 weeks
|
Data Collection Feasibility
Time Frame: 2 months
|
Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)
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2 months
|
Safety and Tolerability of the Interventions
Time Frame: 9 weeks
|
Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the intervention(s)
|
9 weeks
|
Safety and Tolerability of the Interventions
Time Frame: 9 weeks
|
Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants attend at least 6 of 9 sessions;
|
9 weeks
|
Safety and Tolerability of the Interventions
Time Frame: 9 weeks
|
Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program
|
9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roni Evans, PhD, DC,MS, University of Minnesota
- Principal Investigator: Brent Leininger, PhD, DC, MS, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR61AT012309
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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