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| ID | Type | Description | Link |
|---|---|---|---|
| 14256810 | Other Grant/Funding Number | HT9425-25-MHSRP (Defense Health Agency) |
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| Name | Class |
|---|---|
| Tripler Army Medical Center | FED |
| Madigan Army Medical Center | FED |
| C.R.Darnall Army Medical Center | FED |
| University of Utah |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Greenlee, PhD | Contact | 210-539-9638 | sammc@militaryclinicalresearch.org | |
| Cedar Sexton | Contact | 210-916-8634 | militaryclinicalresearch@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center | Tripler AMC | Hawaii | 96859 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19418100 | Background | 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. | |
| 26755406 | Background | 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. |
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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
Within one year
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| OTHER |
Parallel arm randomized clinical trial
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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.
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| 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. |
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| Pain Self-Efficacy Questionnaire (PSEQ) | 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) | 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 | 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) | 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 |
| Carl R. Darnall Army Medical Center | Fort Hood | Texas | 76544 | United States |
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| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
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| Madigan Army Medical Center | Joint Base Lewis McChord | Washington | 98431 | United States |
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| 26461996 | Background | 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. |
| 38257659 | Background | 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. |
| 38213759 | Background | 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. |
| 34114965 | Background | 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. |
| 36882030 | Background | 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. |
| 25880898 | Background | 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. |
| 34940962 | Background | 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. |
| 32175566 | Background | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |