- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07705945
Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access (TELE-MC)
July 10, 2026 updated by: Dan Rhon, Brooke Army Medical Center
Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access: The TELE-MC Trial
The purpose of this study is to explore and compare the effectiveness of in-person versus remote physical therapy (PT) for the treatment of musculoskeletal (MSK) pain within the Military Health System (MHS).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will explore the effect of remote two-way video conference telehealth physical therapy sessions compared to standard of care in-person physical therapy.
Eligible participants will be randomized into one of the 2 treatment arms.
Specific aims will compare the effectiveness of physical therapy delivery strategies on the primary outcome of Pain, Enjoyment, and General Activity (PEG-3) Scale, which measures pain interference, and secondary outcomes of PROMIS short forms (mood, physical function, fatigue, sleep disturbance, and prescription medication misuse), patient global impression of change, and pain self-efficacy.
Study Type
Interventional
Enrollment (Estimated)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tina Greenlee, PhD
- Phone Number: 210-539-9638
- Email: sammc@militaryclinicalresearch.org
Study Contact Backup
- Name: Cedar Sexton
- Phone Number: 210-916-8634
- Email: militaryclinicalresearch@gmail.com
Study Locations
-
-
Hawaii
-
Tripler AMC, Hawaii, United States, 96859
- Tripler Army Medical Center
-
Contact:
- Kaitlyn Foster, PT, DPT, PhD, SCS, FAAOMPT
- Phone Number: 808-433-5963
- Email: researchschofield@gmail.com
-
-
Texas
-
Fort Hood, Texas, United States, 76544
- Carl R. Darnall Army Medical Center
-
Contact:
- Cedar Sexton
- Email: sammc@militaryclinicalresearch.org
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Contact:
- Taylor Rossi, PT, DPT, FAAOMPT
- Phone Number: 210-539-9638
- Email: militaryclinicalresearch@gmail.com
-
-
Washington
-
Joint Base Lewis McChord, Washington, United States, 98431
- Madigan Army Medical Center
-
Contact:
- Jeremy Steiner, PT, DPT
- Phone Number: 253-448-2453
- Email: jblmresearch@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages 18-64
- TRICARE Beneficiary (active duty, retiree, dependent)
- Health care visit for their MSK condition in the past 6 weeks
- Diagnosed with an MSK condition that has persisted for at least 2 weeks
- Has a computer (either smartphone, tablet or laptop), with video and audio capabilities for telehealth, including access to internet
- Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires
- Available to attend treatment sessions over the next 2 months
Exclusion Criteria:
- Surgery for any MSK condition in the past 6 months
- Currently known to be pregnant
- Medical contraindication to exercise
- Currently receiving or scheduled to receive invasive or other nonpharmacologic interventions for any MSK condition (e.g., chiropractic, injections, etc.) with the exception of a physical therapy referral, an issued profile or duty restriction, or other related patient education
- Anyone separating from the military within 9 months (other than normal military retirement), pending a medical or physical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
- Signs of serious or systemic pathology that could be responsible for the musculoskeletal pain (i.e. ankylosing spondylitis, rheumatoid arthritis, gout, lupus, vertebral osteomyelitis, or psoriatic arthritis), currently receiving treatment for cancer other than skin cancer or acute fracture (in the last 3 months) of the musculoskeletal region.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: In-person physical therapy (PT)
Participants will receive individual treatment sessions provided in-person based on the preference and clinical expertise of the clinician.
All sessions will be supervised in a clinic.
A digital exercise prescription and patient education platform will be available for their use.
|
Participants assigned to in-person PT will receive individual treatment sessions provided by a licensed, on-site PT.
Participants will receive 1-on-1 sessions based on the preference and clinical expertise of the clinician.
Participants assigned to in-person physical therapy will receive individual treatment sessions provided by a licensed, on-site physical therapist at the participating military treatment facility.
Physical therapists delivering in-person physical therapy will have the option to provide participants a digital home exercise program, however this will not be required.
If you choose to download and use either app, you will have to accept the app's terms of service.
|
|
Experimental: Telehealth physical therapy (TH-PT)
Participants will receive individual treatment sessions provided remotely via a 2-way video conferencing platform.
The core components of the treatment sessions include: 1) education, particularly on the biopsychosocial aspects of pain, 2) individualized exercise instruction, and 3) pain coping strategies for self-management.
A digital exercise prescription and patient education platform will be available for their use.
|
Participants assigned to telehealth physical therapy will use two-way video conferencing with a licensed physical therapist via a secure platform approved for patient care.
Video conferencing will be accessible via a mobile app or web browser on your home computer.
Participants assigned to telehealth physical therapy will be provided a digital home exercise program.
The home exercise program is accessible via a mobile app or web browser on your home computer.
This is an app that some military clinics already use as standard of care for providing home exercise programs to their patients, so there is a chance you would be receiving your exercises by this method even if you didn't participate in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain, Enjoyment, and General Activity Scale (PEG-3)
Time Frame: 12 Weeks
|
The PEG-3 measure includes 3 items evaluating 1) pain severity; and interference of pain with 2) enjoyment and 3) general activity.
Item response options range from 0-10.
The PEG-3 score is expressed as the mean of all item scores ranging from 0-10.
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS-29
Time Frame: 12 Weeks
|
The PROMIS-29 assesses additional domains relevant to patients with MSK pain including physical function, fatigue, depression, anxiety, pain intensity, ability to participate in social roles, and sleep disturbance.
The PROMIS-29 can also be used to calculate a physical and mental health summary score and can be used in cost-effectiveness analyses.
|
12 Weeks
|
|
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: 12 Weeks
|
Because of its role in patients' capacity of selfmanagement, we will use the 10 item Pain Self-Efficacy Questionnaire (PSEQ) to quantify an individual's confidence in performing activities despite pain.
|
12 Weeks
|
|
Patient Global Assessment of Change (PGIC)
Time Frame: 12 Weeks
|
Participants' satisfaction with their intervention will be based on the single-item Patient Global Assessment of Change (PGIC).
|
12 Weeks
|
|
PROMIS Short Form Prescription Pain Medication Misuse
Time Frame: 26 Weeks
|
The PROMIS short form 7a assesses the abuse of prescription pain medication.
The short form uses fixed items from the PROMIS item bank to provide a T-score with population mean = 50 (sd=10).
|
26 Weeks
|
|
EuroQoL (EQ-5D)
Time Frame: 12 Weeks
|
The EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions.
The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems."
Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222).
The EQ-5D yields a total of 243 possible health states.
Valuations for each health state are available.
The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
- Fritz JM, Magel JS, McFadden M, Asche C, Thackeray A, Meier W, Brennan G. Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 13;314(14):1459-67. doi: 10.1001/jama.2015.11648.
- Molloy JM, Pendergrass TL, Lee IE, Chervak MC, Hauret KG, Rhon DI. Musculoskeletal Injuries and United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. Mil Med. 2020 Sep 18;185(9-10):e1461-e1471. doi: 10.1093/milmed/usaa027.
- Abiero B, Gliner M, Beamer S, Sackett A, Marshall-Aiyelawo K, Ellison J, McDavid T, de Geus J. Military Medical Readiness and Patient Experience with Access to Care. Med J (Ft Sam Houst Tex). 2022 Jan-Mar;(Per 22-01/02/03):3-10.
- Ojha HA, Wyrsta NJ, Davenport TE, Egan WE, Gellhorn AC. Timing of Physical Therapy Initiation for Nonsurgical Management of Musculoskeletal Disorders and Effects on Patient Outcomes: A Systematic Review. J Orthop Sports Phys Ther. 2016 Feb;46(2):56-70. doi: 10.2519/jospt.2016.6138. Epub 2016 Jan 11.
- Lopez-Marcos JJ, Diaz-Arribas MJ, Valera-Calero JA, Navarro-Santana MJ, Izquierdo-Garcia J, Ortiz-Gutierrez RM, Plaza-Manzano G. The Added Value of Face-to-Face Supervision to a Therapeutic Exercise-Based App in the Management of Patients with Chronic Low Back Pain: A Randomized Clinical Trial. Sensors (Basel). 2024 Jan 16;24(2):567. doi: 10.3390/s24020567.
- Hunter R, Beattie M, O'Malley C, Gorely T. Mobile apps to self-manage chronic low back pain: A realist synthesis exploring what works, for whom and in what circumstances. PEC Innov. 2023 Jun 16;3:100175. doi: 10.1016/j.pecinn.2023.100175. eCollection 2023 Dec 15.
- Chen M, Wu T, Lv M, Chen C, Fang Z, Zeng Z, Qian J, Jiang S, Chen W, Zhang J. Efficacy of Mobile Health in Patients With Low Back Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2021 Jun 11;9(6):e26095. doi: 10.2196/26095.
- Madsen C, Poropatich R, Koehlmoos TP. Telehealth in the Military Health System: Impact, Obstacles, and Opportunities. Mil Med. 2023 Mar 6;188(Suppl 1):15-23. doi: 10.1093/milmed/usac207.
- Childs JD, Fritz JM, Wu SS, Flynn TW, Wainner RS, Robertson EK, Kim FS, George SZ. Implications of early and guideline adherent physical therapy for low back pain on utilization and costs. BMC Health Serv Res. 2015 Apr 9;15:150. doi: 10.1186/s12913-015-0830-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
July 10, 2026
First Submitted That Met QC Criteria
July 10, 2026
First Posted (Actual)
July 15, 2026
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.2026.052d
- 14256810 (Other Grant/Funding Number: HT9425-25-MHSRP (Defense Health Agency))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study data will be made available upon reasonable request, and pursuant to any Data Sharing Agreement requirements from the US Defense Health Agency.
DSA applications and information can be found at health.mil
IPD Sharing Time Frame
Within one year
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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