Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access (TELE-MC)
10 de julho de 2026 atualizado por: 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
210
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Tina Greenlee, PhD
- Número de telefone: 210-539-9638
- E-mail: sammc@militaryclinicalresearch.org
Estude backup de contato
- Nome: Cedar Sexton
- Número de telefone: 210-916-8634
- E-mail: militaryclinicalresearch@gmail.com
Locais de estudo
-
-
Hawaii
-
Tripler AMC, Hawaii, Estados Unidos, 96859
- Tripler Army Medical Center
-
Contato:
- Kaitlyn Foster, PT, DPT, PhD, SCS, FAAOMPT
- Número de telefone: 808-433-5963
- E-mail: researchschofield@gmail.com
-
-
Texas
-
Fort Hood, Texas, Estados Unidos, 76544
- Carl R. Darnall Army Medical Center
-
Contato:
- Cedar Sexton
- E-mail: sammc@militaryclinicalresearch.org
-
Fort Sam Houston, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
-
Contato:
- Taylor Rossi, PT, DPT, FAAOMPT
- Número de telefone: 210-539-9638
- E-mail: militaryclinicalresearch@gmail.com
-
-
Washington
-
Joint Base Lewis McChord, Washington, Estados Unidos, 98431
- Madigan Army Medical Center
-
Contato:
- Jeremy Steiner, PT, DPT
- Número de telefone: 253-448-2453
- E-mail: jblmresearch@gmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain, Enjoyment, and General Activity Scale (PEG-3)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PROMIS-29
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de março de 2028
Conclusão do estudo (Estimado)
1 de julho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
10 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2026
Primeira postagem (Real)
15 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C.2026.052d
- 14256810 (Número de outro subsídio/financiamento: HT9425-25-MHSRP (Defense Health Agency))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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
Prazo de Compartilhamento de IPD
Within one year
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .