The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome: a Randomized Controlled Trial

Conditions
-----------------
Subacromial Pain Syndrome

Intervention / Treatment
-----------------
* Other: Telerehabilitation
* Other: Standard Physiotherapy
* Other: Home Exercise Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having subacromial pain for at least 2 weeks Positive result of Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests . To have internet access and equipment to participate in videoconference . Being literate and not having cognitive dysfunction. Exclusion Criteria: Positive drop arm test Signs of adhesive capsulitis (restriction in range of motion-especially in abduction and external rotation) Grade 3 or full thickness rotator cuff tear Labral tears and other intraarticular structural pathologies History of shoulder surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br>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. | Other: Telerehabilitation<br>* 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.<br>|
| Active Comparator: Standard Physiotherapy<br>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. | Other: Standard Physiotherapy<br>* 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.<br>|
| Active Comparator: Home exercise group<br>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. | Other: Home Exercise Group<br>* The same exercise program applied to telerehabilitation group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline, one and three month after the randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subacromial Pain Syndrome, Subacromial ImpingementSyndrome, telerehabilitation, physiotherapy