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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04738461
Other study ID # BI280121
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date June 2022

Study information

Verified date July 2022
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation
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.
Standard Physiotherapy
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
The same exercise program applied to telerehabilitation group.

Locations

Country Name City State
Turkey Cam and Sakura City Hospital Istanbul
Turkey Medipol Mega University Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
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