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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05786508
• Other study ID #: IR61AT012309
• Status: Completed
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/)"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Neck Pain

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Recruitment	Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants	2 months
Primary	Participant Recruitment	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
Primary	Participant Retention Feasibility	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
Primary	Intervention Delivery Feasibility	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	9 weeks
Primary	Intervention Fidelity	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
Primary	Data Collection Feasibility	Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)	2 months
Primary	Safety and Tolerability of the Interventions	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
Primary	Safety and Tolerability of the Interventions	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
Primary	Safety and Tolerability of the Interventions	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