Chronic Musculoskeletal PainFORTNCT06898866
Functional and Occupational Rehabilitation of Troops
An observational study of Chronic Musculoskeletal Pain, run by The University of Texas Health Science Center at San Antonio.
Trial summary
The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Musculoskeletal Pain
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jan 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Active duty military personnel diagnosed with chronic musculoskeletal pain.
Who may be able to join
- "patient referred to functional restoration program by provider"
Who cannot join
- "patient not referred to functional restoration program by provider"
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel
The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.
Read the detailed description
This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.
- Conditions
- Chronic Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | At their assigned step, each site will receive 6 months of Treatment as Usual (TAU). This step will include patients seen at each of the six study sites who participate in the current interdisciplinary chronic pain management program that is available at those sites prior to the initiation of the FORT Implementation Facilitation. | |
| Implementation Facilitation + FORT | At their assigned step, each site will receive 6 months of External Facilitation kicked off with an initial site visit. At the site visit, the external facilitators will meet with key stakeholders, clinic providers, and staff. Together, the team will review the FORT Implementation Site-Assessment Survey as a baseline assessment of implementation as well as the FORT Program Implementation Planning Guide. The team will work together to develop a site-specific implementation blueprint called the Site Action Plan. | |
| FORT Functional Restoration | During the subsequent 6 months, the site action plan will be executed, monitored, and refined to meet the implementation goals. As per Implementation Facilitation, the facilitator will apply many different implementation strategies to support the uptake of FORT, tailoring strategies to the needs of the site and the stakeholders engaged in the process. Implementation Facilitation will be conducted virtually through a combination of scheduled video teleconferences or phone calls. Regular implementation team meetings will be scheduled to support the implementation process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Impact Score (PIS)
The Pain Impact Score (PIS) is based on the Defense and Veterans Pain Rating Scale (DVPRS), which measures 7-day average pain intensity (0-10 scale) and adaptive PROMIS pain interference and physical function using numeric, color, facial, and word descriptors and is validated. PROMIS T-scores are converted to compute the PIS, ranging from 8-50 with a higher score indicating greater pain.
Measured: Baseline to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study startJun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898866
- Sponsor's protocol ID
- STUDY00001264
- Other IDs
- W81XWH-22-2-0041
- Acronym
- FORT
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel
- ClinicalTrials.gov ID
- NCT06898866
- Acronym / sponsor ID
- FORT / STUDY00001264
- Conditions
- Chronic Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Washington
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Mar 2025 (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.
The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.
Detailed description
This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | – | –At their assigned step, each site will receive 6 months of Treatment as Usual (TAU). This step will include patients seen at each of the six study sites who participate in the current interdisciplinary chronic pain management program that is available at those sites prior to the initiation of the FORT Implementation Facilitation. |
| Implementation Facilitation + FORT | – | –At their assigned step, each site will receive 6 months of External Facilitation kicked off with an initial site visit. At the site visit, the external facilitators will meet with key stakeholders, clinic providers, and staff. Together, the team will review the FORT Implementation Site-Assessment Survey as a baseline assessment of implementation as well as the FORT Program Implementation Planning Guide. The team will work together to develop a site-specific implementation blueprint called the Site Action Plan. |
| FORT Functional Restoration | – | –During the subsequent 6 months, the site action plan will be executed, monitored, and refined to meet the implementation goals. As per Implementation Facilitation, the facilitator will apply many different implementation strategies to support the uptake of FORT, tailoring strategies to the needs of the site and the stakeholders engaged in the process. Implementation Facilitation will be conducted virtually through a combination of scheduled video teleconferences or phone calls. Regular implementation team meetings will be scheduled to support the implementation process |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Active duty military personnel diagnosed with chronic musculoskeletal pain.
Key inclusion criteria (1 listed)
- "patient referred to functional restoration program by provider"
Key exclusion criteria (1 listed)
- "patient not referred to functional restoration program by provider"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Impact Score (PIS)
Time frame: Baseline to 13 months
The Pain Impact Score (PIS) is based on the Defense and Veterans Pain Rating Scale (DVPRS), which measures 7-day average pain intensity (0-10 scale) and adaptive PROMIS pain interference and physical function using numeric, color, facial, and word descriptors and is validated. PROMIS T-scores are converted to compute the PIS, ranging from 8-50 with a higher score indicating greater pain.
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Musculoskeletal Pain, run by The University of Texas Health Science Center at San Antonio.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Alan L Peterson, PhD (210.562.6700, Petersona3@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Impact Score (PIS) (time frame: Baseline to 13 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 20 Jan 2026.