Clinical trial NCT04738461: The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome
Official title: The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subacromial Pain Syndrome
Keywords: Subacromial Pain Syndrome
Subacromial ImpingementSyndrome
telerehabilitation
physiotherapy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Pain Intensity at 1 and 3 months
timeFrame: Baseline, one and three month after the randomisation
Secondary outcomes:
measure: Change from Baseline SPADI total score at 1 and 3 months
timeFrame: Baseline, one and three month after the randomisation
Other outcomes:
measure: Change from baseline range of motion of shoulder at 1 and 3 months
timeFrame: Baseline, one and three month after the randomisation
Locations:
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
Study officials:
affiliation: Bezmialem Vakif University
name: Bugra Ince, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uskudar State Hospital
name: Mustafa Huseyin Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.