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postponed to a later date
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The main hypothesis of the study is that telerehabilitation is an effective treatment method and it is not inferior than standard physiotherapy.The aim of this study is to evaluate the effectiveness of telerehabilitation in patients with subacromial pain syndrome by comparing it with standard physiotherapy.
Subacromial pain syndrome formerly known as subacromial impingement syndrome is the cause of approximately 44% to 65% of pain complaints related to the shoulder. Methods such as immobilization, drug therapy, injection techniques, physical therapy modalities and therapeutic exercises, manual therapy, acupuncture and surgery can be used in the treatment of the disease. Due to the Coronavirus disease 2019 (COVID-19) pandemic that started in Wuhan province of China in December 2019, the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. This method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. Although there are many studies on the effectiveness of telerehabilitation in the literature, there is no study on the superiority of telerehabilitation, physical therapy under supervision and home exercise program over each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Telerehabilitation program will be applied 5 days a week for 3 weeks to patients in the telerehabilitation group. A physiatrist will meet with patients via videoconferencing over the internet and guide the program. |
|
| Standard Physiotherapy | Active Comparator | Patients in the standard physiotherapy group will receive one-to-one physiotherapy sessions in the hospital 5 days a week for 3 weeks. In these sessions, active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs. |
|
| Home exercise group | Active Comparator | The home exercise program was explained to the patients in the control group by the physiotherapist and the relevant brochures were delivered to the patients. Home exercise program will consist of telerehabilitation group exercises. However, patients will be not under any supervision and exercise themselves at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Other | The Posterior Glenohumeral Capsule Stretching Exercise, Pectoral Stretching Exercise, Push-up Against Wall Exercise, Scapular Plan Exercise, 90 Degree Shoulder Flexion Exercise, Isometric External Rotation Exercise and Isometric Internal Rotation Exercise will be applied according to the severity of the disease and the size of the disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Pain Intensity at 1 and 3 months | Patients will be asked to mark their pain by giving a score between zero (no pain) and 10 (the most severe pain) on a 10 cm long visual analog scale (VAS) during each visits. | Baseline, one and three month after the randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline SPADI total score at 1 and 3 months | The Shoulder Pain and Disability Index (SPADI) is a questionnaire with a total of 13 questions developed to measure shoulder pain and associated disability. In the subgroup of the pain, the patient is asked to express the severity of him/her pain by giving a score between zero (no pain) and 10 (the most severe pain) during different activities in the last week. In the subgroup of disability, the patient is asked to score between zero (no difficulty) and 10 (receiving assistance) how hard they have experienced during different activities in the last week. Zero points indicate maximum well-being, 130 points indicate maximum disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline range of motion of shoulder at 1 and 3 months | Range of motion of the Shoulder will be evaluated with a standard goniometer. | Baseline, one and three month after the randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bugra Ince, MD | Bezmialem Vakif University | Principal Investigator |
| Mustafa Huseyin Temel, MD | Uskudar State Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cam and Sakura City Hospital | Istanbul | Turkey (Türkiye) | ||||
| Medipol Mega University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29202926 | Background | Garving C, Jakob S, Bauer I, Nadjar R, Brunner UH. Impingement Syndrome of the Shoulder. Dtsch Arztebl Int. 2017 Nov 10;114(45):765-776. doi: 10.3238/arztebl.2017.0765. | |
| 30441330 | Background | Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371. |
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Data sharing will be done on request
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study. 3 arms of the study were planned to consist of telerehabilitation group, standard physiotherapy group and home exercise group.
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Participants will not be able to be blinded due the inherent of interventions. Staff members who are responsible for statistical analysis, investigators and outcome assessors will be blinded.
|
| Standard Physiotherapy | Other | Active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs. |
|
| Home Exercise Group | Other | The same exercise program applied to telerehabilitation group. |
|
| Baseline, one and three month after the randomisation |
| Istanbul |
| Turkey (Türkiye) |
| 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 |