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| ID | Type | Description | Link |
|---|---|---|---|
| FMED-001446 | Other Identifier | Universidad Autónoma de Yucatán |
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The purpose of this prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial is to determine whether a telerehabilitation program is non-inferior to a conventional rehabilitation program in patients with subacromial pain. Subacromial pain is a prevalent musculoskeletal condition, and while therapeutic exercise is the cornerstone of conservative management, adherence to home programs is often low. Conversely, conventional in-person physical therapy presents logistical and economic barriers for patients. This study aims to evaluate if a well-designed telerehabilitation program, utilizing information and communication technologies for remote monitoring, can provide an effective, accessible, and non-inferior alternative to conventional care. The primary outcome measured will be the change in shoulder function utilizing the QuickDASH questionnaire at 12 weeks. Secondary outcomes will assess pain intensity (VAS), range of motion (ROM), treatment adherence, and long-term functional outcomes.
Chronic subacromial pain represents a significant public health challenge and the most common musculoskeletal disorder after back and neck pain. Its etiology is multifactorial, causing substantial functional limitations, work disability, and a decrease in quality of life. The management of subacromial pain is primarily conducted through conservative interventions, with therapeutic exercise constituting the cornerstone of treatment to reduce joint pain, optimize shoulder function, and improve muscle strength.
Despite its efficacy, adherence to home exercise programs is often low due to a lack of supervision and motivation, which compromises long-term outcomes. While supervised, conventional in-person physical therapy improves adherence and functional outcomes, it presents significant logistical and economic barriers, such as travel costs, distance, and difficulty accommodating appointments within work schedules. This creates a gap in care, preventing many patients from receiving the necessary amount of therapy for optimal recovery.
Telerehabilitation, a remote healthcare delivery modality utilizing information and communication technologies, emerges as a promising solution to mitigate these barriers. Assisted digital therapy programs can be utilized to maximize treatment intensity, provide real-time biofeedback, and allow physical therapists to progressively adjust exercise complexity under remote guidance. This approach can potentially improve treatment adherence and reduce indirect costs for patients by eliminating travel needs and decreasing time off work.
Although current evidence provides compelling data regarding the efficacy of telerehabilitation, establishing its superiority over static home exercise programs, there is a lack of standardized protocols. Furthermore, a clear consensus has not been established regarding its non-inferiority to the conventional in-person model within a standard, non-pandemic clinical setting.
To address this gap, this study proposes a prospective, randomized, parallel-group, single-center, controlled non-inferiority clinical trial. The primary objective is to compare the change in shoulder function, as measured by the QuickDASH, at the end of a 12-week program between a telerehabilitation group and a conventional rehabilitation group. Secondary objectives include comparing changes in pain intensity (VAS) and range of motion (flexion, abduction, and external rotation), as well as evaluating treatment adherence, patient satisfaction, and long-term functional outcomes at 6 months. Answering this question will lay the groundwork for establishing a standardized, evidence-based telerehabilitation protocol as a highly accessible and sustainable care modality for patients with subacromial pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | A 12- to 24-week digital intervention program including a structured exercise protocol, health education, and cognitive-behavioral therapy (CBT) delivered via the Moodle platform. Exercises focus on mobility, stretching, and gradual strengthening of the shoulder/scapular muscles, recommended 3-4 sessions per week (30 minutes daily). |
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| Conventional Rehabilitation | Active Comparator | High-dose, in-person physical therapy at the clinic. The program includes therapeutic exercises with graded exposure to movement, manual therapy, and verbal education. Recommended 2-3 in-person sessions per week (30 minutes per session), complemented by home exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Physical Therapy (Telerehabilitation) | Other | Multimodal digital intervention delivered via the Moodle platform. It includes a structured therapeutic exercise program (mobility, stretching, and progressive strengthening of rotator cuff and periscapular muscles), asynchronous remote monitoring by a physical therapist, and digital health education. Cognitive-behavioral therapy (CBT) components focused on pain reconceptualization and coping strategies are also integrated. Patients perform 30-minute daily sessions, 3-4 times per week, for a duration of 12 to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Function | Measured by the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). The QuickDASH is an 11-item self-report questionnaire that measures physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome). | Baseline, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Measured by the Visual Analog Scale (VAS). Participants rate their subjective intensity of pain on a continuous line or numeric rating scale. Scores range from 0 to 10, where 0 indicates "no pain" (best outcome) and 10 indicates the "worst imaginable pain" (worst outcome). | Baseline, 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Carlos Pech Argüelles, MD | Contact | 9991520786 | drrobertopech@hotmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39716615 | Background | Petersson AH, Bjornsson Hallgren HC, Adolfsson LE, Holmgren TM. No need for subacromial decompression in responders to specific exercise treatment: a 10-year follow-up of a randomized controlled trial. J Shoulder Elbow Surg. 2025 Jun;34(6):e477-e487. doi: 10.1016/j.jse.2024.10.027. Epub 2024 Dec 21. | |
| 40486802 | Background |
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| Conventional Physical Therapy | Other | Standard in-person rehabilitation program conducted at the clinic. The intervention consists of supervised therapeutic exercises (similar to the experimental group), manual therapy techniques (joint mobilization and soft tissue manipulation as clinically indicated), and verbal health education provided by the physical therapist. Patients attend 2-3 in-person sessions per week, each lasting 30 minutes, for 12 to 24 weeks, complemented by printed home exercise instructions. |
|
| Change in Range of Motion (ROM) |
Measurement of active and passive range of motion of the affected shoulder using a clinical goniometer. The assessment includes the measurement in degrees of forward flexion, abduction, external rotation, and internal rotation. An increase in degrees indicates an improvement in mobility (better outcome). |
| Baseline, 12 and 24 weeks |
| Treatment Adherence | Defined as the degree to which the participant complies with the prescribed exercise plan. It is calculated as the percentage (%) of completed exercise sessions relative to the total number of scheduled sessions. For the telerehabilitation group, adherence is derived from the Moodle platform metrics (login days, resources accessed, time spent). For the control group, it is manually recorded via the physical therapist's log. | Baseline, 12 and 24 weeks |
| Patient Satisfaction | Participant's level of conformity or satisfaction with the assigned rehabilitation program. It is assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates "completely dissatisfied" (worst outcome) and 10 indicates "extremely satisfied" (best outcome). | Baseline, 12 and 24 weeks |
| Long-Term Shoulder Function | Long-term functional outcomes evaluated using the QuickDASH questionnaire. Scores range from 0 to 100, where 0 indicates no disability (best outcome) and 100 indicates the most severe disability (worst outcome). | 24 weeks postintervention |
| Sheth U, Nam D, Richards R, Palinkas V, Wainwright A, Dunn PC, Razmjou H. Agreement on clinical examination and management between virtual videoconferencing and in-person assessment in a tertiary shoulder center. JSES Int. 2025 Jan 28;9(3):859-863. doi: 10.1016/j.jseint.2024.12.021. eCollection 2025 May. |
| 30451774 | Background | Martinez-Rico S, Lizaur-Utrilla A, Sebastia-Forcada E, Vizcaya-Moreno MF, de Juan-Herrero J. The Impact of a Phone Assistance Nursing Program on Adherence to Home Exercises and Final Outcomes in Patients Who Underwent Shoulder Instability Surgery: A Randomized Controlled Study. Orthop Nurs. 2018 Nov/Dec;37(6):372-378. doi: 10.1097/NOR.0000000000000501. |
| 32197766 | Background | Kane LT, Thakar O, Jamgochian G, Lazarus MD, Abboud JA, Namdari S, Horneff JG. The role of telehealth as a platform for postoperative visits following rotator cuff repair: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2020 Apr;29(4):775-783. doi: 10.1016/j.jse.2019.12.004. |
| 33525951 | Background | Sabbagh R, Shah N, Jenkins S, Macdonald J, Foote A, Matar R, Steffensmeier A, Grawe B. The COVID-19 pandemic and follow-up for shoulder surgery: The impact of a shift toward telemedicine on validated patient-reported outcomes. J Telemed Telecare. 2023 Jul;29(6):484-491. doi: 10.1177/1357633X21990997. Epub 2021 Feb 1. |
| 38432330 | Background | Huang T, Zhang W, Yan B, Liu H, Girard O. Comparing Telerehabilitation and Home-based Exercise for Shoulder Disorders: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2024 Nov;105(11):2214-2223. doi: 10.1016/j.apmr.2024.02.723. Epub 2024 Mar 2. |
| 39143625 | Background | Zhang B, Fang Z, Nian K, Sun B, Ji B. The effects of telemedicine on Rotator cuff-related shoulder function and pain symptoms: a meta-analysis of randomized clinical trials. J Orthop Surg Res. 2024 Aug 14;19(1):478. doi: 10.1186/s13018-024-04986-4. |
| 37490337 | Background | Pak SS, Janela D, Freitas N, Costa F, Moulder R, Molinos M, Areias AC, Bento V, Cohen SP, Yanamadala V, Souza RB, Correia FD. Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 18;25:e49236. doi: 10.2196/49236. |
| 31726386 | Background | Gutierrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Alvarez-Bueno C, Martinez-Vizcaino V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis. Phys Ther Sport. 2020 Jan;41:34-42. doi: 10.1016/j.ptsp.2019.11.003. Epub 2019 Nov 6. |
| 35230167 | Background | Gava V, Ribeiro LP, Barreto RPG, Camargo PR. Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Clin Rehabil. 2022 Jun;36(6):715-725. doi: 10.1177/02692155221083496. Epub 2022 Mar 1. |
| 33935152 | Background | Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780. |
| 39048996 | Background | Kromer TO, Kohl M, Bastiaenen CHG. Factors predicting long-term outcomes following physiotherapy in patients with subacromial pain syndrome: a secondary analysis. BMC Musculoskelet Disord. 2024 Jul 24;25(1):579. doi: 10.1186/s12891-024-07686-6. |
| 38848304 | Background | Lafrance S, Charron M, Dube MO, Desmeules F, Roy JS, Juul-Kristensen B, Kennedy L, McCreesh K. The Efficacy of Exercise Therapy for Rotator Cuff-Related Shoulder Pain According to the FITT Principle: A Systematic Review With Meta-analyses. J Orthop Sports Phys Ther. 2024 Aug;54(8):499-512. doi: 10.2519/jospt.2024.12453. |
| 33020137 | Background | Paavola M, Kanto K, Ranstam J, Malmivaara A, Inkinen J, Kalske J, Savolainen V, Sinisaari I, Taimela S, Jarvinen TL; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial. Br J Sports Med. 2021 Jan;55(2):99-107. doi: 10.1136/bjsports-2020-102216. Epub 2020 Oct 5. |
| 34666734 | Background | Back M, Paavola M, Aronen P, Jarvinen TLN, Taimela S; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up. BMC Musculoskelet Disord. 2021 Oct 19;22(1):889. doi: 10.1186/s12891-021-04768-7. |
| 38921347 | Background | Aguilar Garcia M, Gonzalez Munoz A, Perez Montilla JJ, Aguilar Nunez D, Hamed Hamed D, Pruimboom L, Navarro Ledesma S. Which Multimodal Physiotherapy Treatment Is the Most Effective in People with Shoulder Pain? A Systematic Review and Meta-Analyses. Healthcare (Basel). 2024 Jun 20;12(12):1234. doi: 10.3390/healthcare12121234. |
| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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