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Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access (TELE-MC)

10 juillet 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Hawaii
      • Tripler AMC, Hawaii, États-Unis, 96859
        • Tripler Army Medical Center
        • Contact:
    • Texas
    • Washington
      • Joint Base Lewis McChord, Washington, États-Unis, 98431
        • Madigan Army Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autre: In-person physical therapy (PT)
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.
Expérimental: 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.
Autre: Telehealth physical therapy (TH-PT)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain, Enjoyment, and General Activity Scale (PEG-3)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PROMIS-29
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Brooke Army Medical Center

Collaborateurs

University of Utah
Madigan Army Medical Center
C.R.Darnall Army Medical Center
Tripler Army Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 mars 2028

Achèvement de l'étude (Estimé)

1 juillet 2028

Dates d'inscription aux études

Première soumission

10 juillet 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • C.2026.052d
  • 14256810 (Autre subvention/numéro de financement: HT9425-25-MHSRP (Defense Health Agency))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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

Délai de partage IPD

Within one year

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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