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: Completed
• Conditions: Low Back Pain; Chronic Pain; Neck Pain
• Intervention / Treatment: Other: Partners4Pain program; Other: Key to Wellbeing program

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

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	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
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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility: # of Enrolled Participants	Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants	2 months
Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups	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: Primary Outcome Measurement	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
Intervention Delivery Feasibility: Participant Engagement	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
Intervention Fidelity: Facilitator Delivery of Required Activities	Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions	9 weeks
Data Collection Feasibility: Completion of Self-reported Outcomes	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
Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events	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 interventions	9 weeks
Safety and Tolerability of the Interventions: Satisfaction With Program	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: University of Minnesota
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Center for Complementary and Integrative Health (NCCIH)
• 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): August 28, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: 1R61AT012309 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No