Clinical trial NCT05786508: Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
Official title: Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Low Back Pain
Chronic Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-03-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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/)"


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility: # of Enrolled Participants
timeFrame: 2 months
measure: Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups
timeFrame: 2 months
measure: Participant Retention Feasibility: Primary Outcome Measurement
timeFrame: 2 months
measure: Intervention Delivery Feasibility: Participant Engagement
timeFrame: 9 weeks
measure: Intervention Fidelity: Facilitator Delivery of Required Activities
timeFrame: 9 weeks
measure: Data Collection Feasibility: Completion of Self-reported Outcomes
timeFrame: 2 months
measure: Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events
timeFrame: 9 weeks
measure: Safety and Tolerability of the Interventions: Satisfaction With Program
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Roni Evans, PhD, DC,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Brent Leininger, PhD, DC, MS
role: PRINCIPAL_INVESTIGATOR
References: