Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access (TELE-MC)
2026年7月10日 更新者：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).
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
210
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Tina Greenlee, PhD
- 電話番号：210-539-9638
- メール：sammc@militaryclinicalresearch.org
研究連絡先のバックアップ
- 名前：Cedar Sexton
- 電話番号：210-916-8634
- メール：militaryclinicalresearch@gmail.com
研究場所
-
-
Hawaii
-
Tripler AMC、Hawaii、アメリカ、96859
- Tripler Army Medical Center
-
コンタクト：
- Kaitlyn Foster, PT, DPT, PhD, SCS, FAAOMPT
- 電話番号：808-433-5963
- メール：researchschofield@gmail.com
-
-
Texas
-
Fort Hood、Texas、アメリカ、76544
- Carl R. Darnall Army Medical Center
-
コンタクト：
- Cedar Sexton
- メール：sammc@militaryclinicalresearch.org
-
Fort Sam Houston、Texas、アメリカ、78234
- Brooke Army Medical Center
-
コンタクト：
- Taylor Rossi, PT, DPT, FAAOMPT
- 電話番号：210-539-9638
- メール：militaryclinicalresearch@gmail.com
-
-
Washington
-
Joint Base Lewis McChord、Washington、アメリカ、98431
- Madigan Army Medical Center
-
コンタクト：
- Jeremy Steiner, PT, DPT
- 電話番号：253-448-2453
- メール：jblmresearch@gmail.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain, Enjoyment, and General Activity Scale (PEG-3)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PROMIS-29
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2028年3月1日
研究の完了 (推定)
2028年7月1日
試験登録日
最初に提出
2026年7月10日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月10日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- C.2026.052d
- 14256810 (その他の助成金/資金番号：HT9425-25-MHSRP (Defense Health Agency))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Within one year
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。