Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access (TELE-MC)
2026년 7월 10일 업데이트: 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).
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
210
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Tina Greenlee, PhD
- 전화번호: 210-539-9638
- 이메일: sammc@militaryclinicalresearch.org
연구 연락처 백업
- 이름: Cedar Sexton
- 전화번호: 210-916-8634
- 이메일: militaryclinicalresearch@gmail.com
연구 장소
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Hawaii
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Tripler AMC, Hawaii, 미국, 96859
- Tripler Army Medical Center
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연락하다:
- Kaitlyn Foster, PT, DPT, PhD, SCS, FAAOMPT
- 전화번호: 808-433-5963
- 이메일: researchschofield@gmail.com
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Texas
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Fort Hood, Texas, 미국, 76544
- Carl R. Darnall Army Medical Center
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연락하다:
- Cedar Sexton
- 이메일: sammc@militaryclinicalresearch.org
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Fort Sam Houston, Texas, 미국, 78234
- Brooke Army Medical Center
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연락하다:
- Taylor Rossi, PT, DPT, FAAOMPT
- 전화번호: 210-539-9638
- 이메일: militaryclinicalresearch@gmail.com
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Washington
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Joint Base Lewis McChord, Washington, 미국, 98431
- Madigan Army Medical Center
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연락하다:
- Jeremy Steiner, PT, DPT
- 전화번호: 253-448-2453
- 이메일: jblmresearch@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain, Enjoyment, and General Activity Scale (PEG-3)
기간: 12 Weeks
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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.
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12 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PROMIS-29
기간: 12 Weeks
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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.
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12 Weeks
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Pain Self-Efficacy Questionnaire (PSEQ)
기간: 12 Weeks
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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.
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12 Weeks
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Patient Global Assessment of Change (PGIC)
기간: 12 Weeks
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Participants' satisfaction with their intervention will be based on the single-item Patient Global Assessment of Change (PGIC).
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12 Weeks
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PROMIS Short Form Prescription Pain Medication Misuse
기간: 26 Weeks
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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).
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26 Weeks
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EuroQoL (EQ-5D)
기간: 12 Weeks
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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.
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12 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 3월 1일
연구 완료 (추정된)
2028년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 10일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- C.2026.052d
- 14256810 (기타 보조금/기금 번호: HT9425-25-MHSRP (Defense Health Agency))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Within one year
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .