Musculoskeletal PainPROACTIVENCT06512727
The PROACTIVE Study for Black Elders
A study testing PROACTIVE Intervention in people with Musculoskeletal Pain and Chronic Pain, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 92 years
- Conditions the study is for
- Musculoskeletal Pain, Chronic Pain, Osteoarthritis
- What is being tested?
- PROACTIVE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
- Age 50-92 years
- 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)
- 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)
- 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
- 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.)
- Able to read, write, and understand English at sixth-grade level
Who cannot join
- Unwilling to be randomized to either study arm
- Self-reported diagnosis of sickle cell disease or related thalassemias
- History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
- 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)
- Currently undergoing curative or palliative chemotherapy or radiation for active cancer
- 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)
- Serious mental health disorder requiring hospitalization within past 12 months
- Severe sensory deficit (severe hearing loss or blindness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32610
Staja Booker, PhD, RN
Staja Booker, PhD, RN
About this study
Official title: Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Carefully Tailored InterVEntions (PROACTIVE) Intervention: A Randomized Controlled Trial
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).
Read the detailed description
Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial inequalities. MEP affects more Black/African Americans (B/AAs) and is reported as more severe than in White participants. Compounded by race, age, and more disadvantageous social determinants of health (SDoH), this unequal burden of pain becomes even greater in health disparity populations like older B/AAs. Many B/AA older adults rely on non-pharmacological pain self-management (SM) strategies. Yet, current chronic musculoskeletal pain (CMP) SM interventions do not measure MEP as a primary endpoint nor address faith/spirituality, Black culture, and other underlying potentially modifiable SDoH (e.g., health literacy, financial hardship). The investigator team propose to enhance older B/AAs' capacity to manage MEP by investigating the effects of a socioculturally congruent pain SM intervention (Pain Relief for musculOskeletal conditions and Arthritis using Culturally-Tailored InterVentions for Black Elders [PROACTIVE]). This intervention will provide culturally congruent pain SM education with a SM resource toolkit, active prayer skills, and financial counseling to explain participants' healthcare/insurance benefits for pain care. This study will enroll 120 B/AAs (50 years and older) with CMP into a parallel group, single-blind, randomized controlled trial to test whether PROACTIVE decreases MEP in the immediate post-intervention period (n= 60) (Aim 1) and over time (Sub-Aim 1a) compared to a usual care control group (n= 60). To determine efficacy, this study will use state-of-the-art and real-time technologies to measure primary outcome as well as pain interference, pain coping, and physical function (secondary outcomes) (Sub-Aim 1b). The PROACTIVE group will work with a faith-community nurse and financial counselor over four weeks to enhance knowledge of CMP SM, utilization of active prayer and faith, and financial literacy of health insurance benefits and resources available to cover treatments for pain. Each weekly session will last up to 2 hours and will be followed by six days of ecological momentary assessments of pain and SM outcomes and ecological momentary interventions guiding participants through weekly SM practice skills. A fourth booster session will reinforce content and training and help sustain SM. Another goal is to examine the differential effects of PROACTIVE on MEP according to demographic (sex as a biological variable, gender, age), psychosocial, and SDoH factors (Aim 2). The proposed intervention is expected to produce meaningful reductions in MEP in B/AA older adults experiencing disabling chronic musculoskeletal conditions. Ideally, this study will identify precision behavior targets and responders to inform intervention refinement. This study is innovative because it: (1) addresses three key social determinants of health central to B/AAs' pain experience- health literacy, faith, and finances, (2) embeds community-engaged research methodologies, (3) tests active prayer as a novel faith-based, culturally relevant intervention, (4) uses real-time ecological momentary assessment (EMA) to measure pain and related outcomes and use just-in-time ecological momentary interventions (EMI) to deliver pain SM decision support and active prayers, and (5) measures MEP as a primary endpoint in a clinical trial.
- Being tested
- PROACTIVE Intervention
- Keywords
- chronic musculoskeletal pain, chronic pain, Black, African Americans, pain self-management, prayer, social determinants of health
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROACTIVE InterventionBehavioural
Also called FAITH (Finding Arthritis Interventions That Help)
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
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Control Group) | No intervention | 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. |
| PROACTIVE | Experimental | 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. Receives: Behavioral: PROACTIVE Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement-evoked pain from baseline to 4 weeks (post-intervention)
Defense and Veterans Pain Rating Scale (DVPRS) is a validated, self-reported and preferred pain scale for assessing pain intensity and its impact on activities. Possible scores range from 0 (no pain) to 10 (as bad as it could be). Movement-evoked pain (MEP) intensity during the Short Physical Performance Battery (SPPB), a physical performance test that evaluates lower extremity functioning by assessing: standing balancing, gait speed, and repeated chair stand ability.
Change:
- Week 4 score - Baseline score
- 1 month score - Baseline score
- 3-months score - Baseline score
Measured: Baseline, Week 4, 1-month, 3-months
Secondary outcomes (4)
Pain interference
PROMIS (Patient-Reported Outcomes Measurement Information System) Adult Short Form v1.0- Pain interference 6b, a is a validated, 6-item self-report instrument with strong reliability and validity. Pain interference measures the degree of interference with usual social, work, physical, and emotional functioning. Questions ask people to recall how much pain has interfered social, cognitive, emotional, physical, and recreational activities in the last seven day (1=not at all to 5=very much).
Measured: Baseline, Week 4, 1-month, 3-months
Pain coping
Coping Strategies Questionnaire is a valid and reliable survey with six cognitive (diverting attention, reinterpreting pain sensations, coping self-statements, ignoring pain sensations, praying or hoping, and catastrophizing) and one behavioral (increasing activity level) pain coping subscales where 0 (never do) to 6 (always do that when in pain). A score from 0-36 points is calculated for each subscale.
Measured: Baseline, Week 4, 1-month, 3-months
Physical function- Short Physical Performance Battery
Performance-based activities, such as the Short Physical Performance Battery (SPPB) will evaluate physical function. The SPPB measures standing balance, 4-meter gait speed, and ability to rise from chair. Each task is score 0-4 and total scores range from 0-12, with lower scores indicating greater impairment.
Measured: Baseline, Week 4, 1-month, 3-months
Physical function- 3-Minute Walk
The 3-minute walk test requires participants to walk continuously for 3 minutes, and it measures endurance and aerobic capacity. Time walked, number of meters walked, and pain intensity (i.e., MEP) will be recorded.
Measured: Baseline, Week 4, 1-month, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start7 May 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Staja Q Booker, PhD, RN, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512727
- Sponsor's protocol ID
- IRB202302085
- Other IDs
- 1R01NR021183-01
- Acronym
- PROACTIVE
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public Use Data: All deidentified study data that are not designated as restricted use will be made available as public use data to the research community. Users of public data must agree to terms of use from Mendeley Data repository and the PI, which are designed to protect study participants. Data users also agree not to share or redistribute any data downloads. The dataset can only be used for studying health or biomedical conditions. Restricted Access Data: Data that are determined to be potentially identifiable through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use. These restricted data will include separate files with geospatial indicators below the level of state, such as county, census tract, block-group, and block for all years; and linkages to contextual social determinants of health data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Pain Relief of musculOskeletal Conditions and Arthritis Using Carefully Tailored InterVEntions (PROACTIVE) Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06512727
- Acronym / sponsor ID
- PROACTIVE / IRB202302085
- Keywords
- chronic musculoskeletal pain, chronic pain, Black, African Americans, pain self-management, prayer, social determinants of health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial inequalities. MEP affects more Black/African Americans (B/AAs) and is reported as more severe than in White participants. Compounded by race, age, and more disadvantageous social determinants of health (SDoH), this unequal burden of pain becomes even greater in health disparity populations like older B/AAs. Many B/AA older adults rely on non-pharmacological pain self-management (SM) strategies. Yet, current chronic musculoskeletal pain (CMP) SM interventions do not measure MEP as a primary endpoint nor address faith/spirituality, Black culture, and other underlying potentially modifiable SDoH (e.g., health literacy, financial hardship). The investigator team propose to enhance older B/AAs' capacity to manage MEP by investigating the effects of a socioculturally congruent pain SM intervention (Pain Relief for musculOskeletal conditions and Arthritis using Culturally-Tailored InterVentions for Black Elders [PROACTIVE]). This intervention will provide culturally congruent pain SM education with a SM resource toolkit, active prayer skills, and financial counseling to explain participants' healthcare/insurance benefits for pain care. This study will enroll 120 B/AAs (50 years and older) with CMP into a parallel group, single-blind, randomized controlled trial to test whether PROACTIVE decreases MEP in the immediate post-intervention period (n= 60) (Aim 1) and over time (Sub-Aim 1a) compared to a usual care control group (n= 60). To determine efficacy, this study will use state-of-the-art and real-time technologies to measure primary outcome as well as pain interference, pain coping, and physical function (secondary outcomes) (Sub-Aim 1b). The PROACTIVE group will work with a faith-community nurse and financial counselor over four weeks to enhance knowledge of CMP SM, utilization of active prayer and faith, and financial literacy of health insurance benefits and resources available to cover treatments for pain. Each weekly session will last up to 2 hours and will be followed by six days of ecological momentary assessments of pain and SM outcomes and ecological momentary interventions guiding participants through weekly SM practice skills. A fourth booster session will reinforce content and training and help sustain SM. Another goal is to examine the differential effects of PROACTIVE on MEP according to demographic (sex as a biological variable, gender, age), psychosocial, and SDoH factors (Aim 2). The proposed intervention is expected to produce meaningful reductions in MEP in B/AA older adults experiencing disabling chronic musculoskeletal conditions. Ideally, this study will identify precision behavior targets and responders to inform intervention refinement. This study is innovative because it: (1) addresses three key social determinants of health central to B/AAs' pain experience- health literacy, faith, and finances, (2) embeds community-engaged research methodologies, (3) tests active prayer as a novel faith-based, culturally relevant intervention, (4) uses real-time ecological momentary assessment (EMA) to measure pain and related outcomes and use just-in-time ecological momentary interventions (EMI) to deliver pain SM decision support and active prayers, and (5) measures MEP as a primary endpoint in a clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Control Group) | No intervention | –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. |
| PROACTIVE | Experimental | Behavioral: PROACTIVE InterventionThis 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. |
Who may qualify
- Ages
- 50 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identify as being part of the Black American diaspora (Black/African American, Afro-Caribbean)
- Age 50-92 years
- 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)
- 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)
- 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
Key exclusion criteria (8 listed)
- Unwilling to be randomized to either study arm
- Self-reported diagnosis of sickle cell disease or related thalassemias
- History of major neurological event (e.g., stroke) or current neurological disease (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
- 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)
- Currently undergoing curative or palliative chemotherapy or radiation for active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROACTIVE InterventionAlso: FAITH (Finding Arthritis Interventions That Help)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 | Behavioural | PROACTIVE |
Primary outcome
Change in movement-evoked pain from baseline to 4 weeks (post-intervention)
Time frame: Baseline, Week 4, 1-month, 3-months
Defense and Veterans Pain Rating Scale (DVPRS) is a validated, self-reported and preferred pain scale for assessing pain intensity and its impact on activities. Possible scores range from 0 (no pain) to 10 (as bad as it could be). Movement-evoked pain (MEP) intensity during the Short Physical Performance Battery (SPPB), a physical performance test that evaluates lower extremity functioning by assessing: standing balancing, gait speed, and repeated chair stand ability. Change: 1. Week 4 score - Baseline score 2. 1 month score - Baseline score 3. 3-months score - Baseline score
4 secondary outcomes
Pain interference
Time frame: Baseline, Week 4, 1-month, 3-months
Pain coping
Time frame: Baseline, Week 4, 1-month, 3-months
Physical function- Short Physical Performance Battery
Time frame: Baseline, Week 4, 1-month, 3-months
Physical function- 3-Minute Walk
Time frame: Baseline, Week 4, 1-month, 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Public Use Data: All deidentified study data that are not designated as restricted use will be made available as public use data to the research community. Users of public data must agree to terms of use from Mendeley Data repository and the PI, which are designed to protect study participants. Data users also agree not to share or redistribute any data downloads. The dataset can only be used for studying health or biomedical conditions. Restricted Access Data: Data that are determined to be potentially identifiable through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use. These restricted data will include separate files with geospatial indicators below the level of state, such as county, census tract, block-group, and block for all years; and linkages to contextual social determinants of health data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Staja Q Booker, PhD, RN principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROACTIVE Intervention in people with Musculoskeletal Pain and Chronic Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Staja Q Booker, PhD, RN (352-273-6351, bookers@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in movement-evoked pain from baseline to 4 weeks (post-intervention) (time frame: Baseline, Week 4, 1-month, 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.