The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

NCT ID: NCT04738461

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subacromial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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Telerehabilitation

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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type 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.

Standard Physiotherapy

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.

Group Type ACTIVE_COMPARATOR

Standard Physiotherapy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Home Exercise Group

Intervention Type OTHER

The same exercise program applied to telerehabilitation group.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Home Exercise Group

The same exercise program applied to telerehabilitation group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bugra Ince, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Mustafa Huseyin Temel, MD

Role: PRINCIPAL_INVESTIGATOR

Uskudar State Hospital

Locations

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Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Medipol Mega University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29202926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30441330 (View on PubMed)

Other Identifiers

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BI280121

Identifier Type: -

Identifier Source: org_study_id

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