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

NCT05786508 | Completed Results

• 1 other identifier: 1R61AT012309
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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/)"

Conditions

Neck Pain; Low Back Pain; Chronic Pain

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Partners4Pain program

EXPERIMENTAL

adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status

Other: Partners4Pain program

Key to Wellbeing program

ACTIVE COMPARATOR

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

Interventions

Partners4Pain program OTHER

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

Partners4Pain program

Key to Wellbeing program OTHER

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

Key to Wellbeing program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Neck Pain; Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Results Point of Contact

• Title: Brent Leininger
• Organization: University of Minnesota

lein0122@umn.edu

6126266477

Study Officials

• Roni Evans, PhD, DC,MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Brent Leininger, PhD, DC, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 27, 2023
• Study Start: August 28, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Locations

US (1)