Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06512727

Conditions

Musculoskeletal Pain

Chronic Pain

Osteoarthritis

Pain, Chronic

Movement Evoked Pain

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

PROACTIVE Intervention

Study Details

Brief summary:

Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).

Conditions

Musculoskeletal Pain

Chronic Pain

Osteoarthritis

Pain, Chronic

Movement Evoked Pain

Study ID

NCT06512727

Start date

May 7, 2025

Status verified date

Jun, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
2. Age 50-92 years
3. Self-report chronic musculoskeletal pain (CMP) as defined as persistent or recurrent pain lasting 6 months or longer that arises as part of a disease or injurious process directly affecting bone(s), joint(s), muscle(s), or related soft tissue(s)
4. Self-report a chronic musculoskeletal condition (e.g., osteoarthritis, chronic low back pain) in at least one lower extremity joint (hip, knee, low back, or ankle pain)
5. Report chronic musculoskeletal symptoms: aching, stiffness, or swelling in a major lower extremity joint or low back on most days (4-5/7) of the week
6. Have (or be eligible for) a healthcare insurance plan in the state of Florida (Medicare, Medicaid, Medicare Advantage plans, Blue Cross/Blue Shield, Humana, Aetna, etc.)
7. Able to read, write, and understand English at sixth-grade level

Exclusion Criteria:

1. Unwilling to be randomized to either study arm
2. Self-reported diagnosis of sickle cell disease or related thalassemias
3. History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
4. Major cardiovascular problem in the past 6 months that would cause shortness of breath and/or chest pain (e.g. myocardial infarction, coronary artery bypass graft, or valve replacement, pulmonary embolism or deep venous thrombosis) or uncontrolled Hypertension (Systolic Blood Pressure (SBP) > 170 mmHg, Diastolic Blood Pressure (DBP) > 90 mmHg) OR Hypotension (SBP <90 mmHg, DBP <60 mmHg)
5. Currently undergoing curative or palliative chemotherapy or radiation for active cancer
6. Severe physical impairment (e.g., a major activity of daily living disability requiring use of wheelchair as primary method of mobility, or unable to dress, bath, use the toilet, or transfer independently)
7. Serious mental health disorder requiring hospitalization within past 12 months
8. Severe sensory deficit (severe hearing loss or blindness)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care (Control Group)

The control group will continue their usual pain treatment and self-management (SM) routines.

Participations will not receive in-depth culturally congruent education, prayer skills, or financial counseling. Usual care is expected to vary between participants.

experimental: PROACTIVE

This is a four-session pain self-management (SM) intervention designed to reduce movement-evoked pain by providing participants with behavioral support that addresses social determinants of health: (1) culturally congruent SM education + SM resource toolkit, (3) active prayer support, and (3) financial counseling.

Interventions

PROACTIVE Intervention

Duration: Once-weekly face-to-face sessions Session Time: 1.5-2 hours Intervention: (1) culturally congruent self-management (SM) education and + SM resource toolkit, (3) active prayer support, and (3) financial counseling/insurance navigation Reinforcement: daily ecological momentary intervention support using Apple smartwatches

Primary outcome measure

  • Change in movement-evoked pain from baseline to 4 weeks (post-intervention) [ Time Frame: Baseline, Week 4, 1-month, 3-months ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator:

Staja Booker, PhD, RN

More Information

Sponsor

University of Florida

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • chronic musculoskeletal pain
  • chronic pain
  • Black
  • African Americans
  • pain self-management
  • prayer
  • social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-04.