NCT07705945

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Jul 2028

Study Start

First participant enrolled

July 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.7 years

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Musculoskeletal Pain

Keywords

musculoskeletal paintele-healthstepped carephysical thrapy accesscost-effective care

Outcome Measures

Primary Outcomes (1)

  • Pain, Enjoyment, and General Activity Scale (PEG-3)

    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 Outcomes (5)

  • PROMIS-29

    12 Weeks

  • Pain Self-Efficacy Questionnaire (PSEQ)

    12 Weeks

  • Patient Global Assessment of Change (PGIC)

    12 Weeks

  • PROMIS Short Form Prescription Pain Medication Misuse

    26 Weeks

  • EuroQoL (EQ-5D)

    12 Weeks

Study Arms (2)

In-person physical therapy (PT)

ACTIVE COMPARATOR

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.

Other: In-person physical therapy (PT)

Telehealth physical therapy (TH-PT)

EXPERIMENTAL

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.

Other: Telehealth physical therapy (TH-PT)

Interventions

In-person physical therapy (PT)OTHER

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.

In-person physical therapy (PT)
Telehealth physical therapy (TH-PT)OTHER

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.

Telehealth physical therapy (TH-PT)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tripler Army Medical Center

Tripler AMC, Hawaii, 96859, United States

Location

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98431, United States

Location

Related Publications (10)

  • 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.

    PMID: 19418100BACKGROUND

  • 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.

    PMID: 26755406BACKGROUND

  • 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.

    PMID: 26461996BACKGROUND

  • 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.

    PMID: 38257659BACKGROUND

  • 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.

    PMID: 38213759BACKGROUND

  • 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.

    PMID: 34114965BACKGROUND

  • 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.

    PMID: 36882030BACKGROUND

  • 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.

    PMID: 25880898BACKGROUND

  • 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.

    PMID: 34940962BACKGROUND

  • 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.

    PMID: 32175566BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tina Greenlee, PhD

CONTACT

210-539-9638sammc@militaryclinicalresearch.org

Cedar Sexton

CONTACT

210-916-8634militaryclinicalresearch@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Clinicians and patients cannot be blinded to randomized group assignment. Treatment assignments will be blinded for investigators, assessors, and the lead study statistician. Outcomes assessments will be blinded for investigators, interventionists, and the lead study statistician. Study participants will be blinded to all adherence and fidelity assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel arm randomized clinical trial
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Within one year
More information

Locations

US(4)