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Completed

NCT Number: 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/)"

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Key information

Conditions

Neck Pain Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Recruitment Feasibility: # of Enrolled Participants

    Time frame: 2 months

    Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants

  2. Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups

    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;

  3. Participant Retention Feasibility: Primary Outcome Measurement

    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

  4. Intervention Delivery Feasibility: Participant Engagement

    Time frame: 9 weeks

    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

  5. Intervention Fidelity: Facilitator Delivery of Required Activities

    Time frame: 9 weeks

    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

  6. Data Collection Feasibility: Completion of Self-reported Outcomes

    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)

  7. Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events

    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 interventions

  8. Safety and Tolerability of the Interventions: Satisfaction With Program

    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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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