[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07705945":3,"trial-entities:NCT07705945":176,"trial-summary:NCT07705945":179},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":48,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":86,"locations":88,"central_contacts":138,"overall_officials":142,"references":143,"see_also_links":175},"NCT07705945","C.2026.052d","Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access","Using Telehealth to Improve Musculoskeletal Care Through Expanded Physical Therapy Access: The TELE-MC Trial","NOT_YET_RECRUITING","2028-07-01","2026-07","2026-07-15","2026-07-01","Brooke Army Medical Center","FED",true,"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.",[19],"Musculoskeletal Pain",[21,22,23,24,25],"musculoskeletal pain","tele-health","stepped care","physical thrapy access","cost-effective care","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},210,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"OTHER","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.",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"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.",[40],[44],{"measure":45,"description":46,"timeFrame":47},"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",[49,52,55,58,62],{"measure":50,"description":51,"timeFrame":47},"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.",{"measure":53,"description":54,"timeFrame":47},"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.",{"measure":56,"description":57,"timeFrame":47},"Patient Global Assessment of Change (PGIC)","Participants' satisfaction with their intervention will be based on the single-item Patient Global Assessment of Change (PGIC).",{"measure":59,"description":60,"timeFrame":61},"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",{"measure":63,"description":64,"timeFrame":47},"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\u002Fdiscomfort, and anxiety\u002Fdepression. 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.","ALL","18 Years","64 Years",false,{"inclusion":70,"exclusion":78,"raw_text":85},[71,72,73,74,75,76,77],"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",[79,80,81,82,83,84],"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.","Inclusion Criteria:\n\n* Ages 18-64\n* TRICARE Beneficiary (active duty, retiree, dependent)\n* Health care visit for their MSK condition in the past 6 weeks\n* Diagnosed with an MSK condition that has persisted for at least 2 weeks\n* Has a computer (either smartphone, tablet or laptop), with video and audio capabilities for telehealth, including access to internet\n* Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires\n* Available to attend treatment sessions over the next 2 months\n\nExclusion Criteria:\n\n* Surgery for any MSK condition in the past 6 months\n* Currently known to be pregnant\n* Medical contraindication to exercise\n* 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\n* 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\n* 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.",[87],"ADULT",[89,101,114,125],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"contacts":95},"Tripler Army Medical Center","Tripler AMC","Hawaii","96859","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Kaitlyn Foster, PT, DPT, PhD, SCS, FAAOMPT","CONTACT","808-433-5963","researchschofield@gmail.com",{"facility":102,"city":103,"state":104,"zip":105,"country":94,"contacts":106,"geoPoint":111},"Carl R. Darnall Army Medical Center","Fort Hood","Texas","76544",[107],{"name":108,"role":98,"phoneExt":109,"email":110},"Cedar Sexton","210-916-8634","sammc@militaryclinicalresearch.org",{"lat":112,"lon":113},31.25483,-97.70913,{"facility":13,"city":115,"state":104,"zip":116,"country":94,"contacts":117,"geoPoint":122},"Fort Sam Houston","78234",[118],{"name":119,"role":98,"phone":120,"email":121},"Taylor Rossi, PT, DPT, FAAOMPT","210-539-9638","militaryclinicalresearch@gmail.com",{"lat":123,"lon":124},29.45303,-98.4417,{"facility":126,"city":127,"state":128,"zip":129,"country":94,"contacts":130,"geoPoint":135},"Madigan Army Medical Center","Joint Base Lewis McChord","Washington","98431",[131],{"name":132,"role":98,"phone":133,"email":134},"Jeremy Steiner, PT, DPT","253-448-2453","jblmresearch@gmail.com",{"lat":136,"lon":137},47.10787,-122.57694,[139,141],{"name":140,"role":98,"phone":120,"email":110},"Tina Greenlee, PhD",{"name":108,"role":98,"phone":109,"email":121},[],[144,148,151,154,157,160,163,166,169,172],{"pmid":145,"type":146,"citation":147},"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\u002Fs11606-009-0981-1. Epub 2009 May 6.",{"pmid":149,"type":146,"citation":150},"26755406","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\u002Fjospt.2016.6138. Epub 2016 Jan 11.",{"pmid":152,"type":146,"citation":153},"26461996","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\u002Fjama.2015.11648.",{"pmid":155,"type":146,"citation":156},"38257659","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\u002Fs24020567.",{"pmid":158,"type":146,"citation":159},"38213759","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\u002Fj.pecinn.2023.100175. eCollection 2023 Dec 15.",{"pmid":161,"type":146,"citation":162},"34114965","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\u002F26095.",{"pmid":164,"type":146,"citation":165},"36882030","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\u002Fmilmed\u002Fusac207.",{"pmid":167,"type":146,"citation":168},"25880898","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\u002Fs12913-015-0830-3.",{"pmid":170,"type":146,"citation":171},"34940962","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\u002F02\u002F03):3-10.",{"pmid":173,"type":146,"citation":174},"32175566","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\u002Fmilmed\u002Fusaa027.",[],{"nct_id":4,"conditions":177,"biomarkers":178},[19],[],{"nct_id":4,"found":15,"summary":180,"prompt_version":190},{"design":181,"status":182,"heading":183,"summary":184,"follow_up":185,"word_count":186,"commitments":187,"compensation":188,"drugs_mentioned":189},"This study will involve about 210 participants who will be randomly assigned to one of two treatment groups: in-person physical therapy or telehealth physical therapy.","completed","Comparing Telehealth and In-Person Physical Therapy for Musculoskeletal Pain","This study is comparing two ways to deliver physical therapy (PT) for musculoskeletal (MSK) pain: in-person PT and telehealth physical therapy (TH-PT). You would be assigned to either receive individual sessions with a licensed physical therapist in person, or through secure two-way video calls on your computer or mobile device. The study aims to see which method is more effective in reducing pain and improving your enjoyment and general activity levels after 12 weeks. To join, you need to be between 18 and 64 years old, a TRICARE beneficiary, have had MSK pain for at least two weeks, and have a device with video and internet access. The current recruitment status is unclear.","Participants will be followed for at least 12 weeks to measure the primary outcome.",113,"Participants will receive individual physical therapy sessions. The primary outcome will be measured at 12 weeks.","Not stated in the trial record.",[40],"v2"]