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The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

Primary Purpose

Subacromial Pain Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Standard Physiotherapy
Home Exercise Group
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Pain Syndrome focused on measuring Subacromial Pain Syndrome, Subacromial ImpingementSyndrome, telerehabilitation, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cam and Sakura City Hospital
  • Medipol Mega University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Telerehabilitation

Standard Physiotherapy

Home exercise group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2021
Last Updated
July 19, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04738461
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
postponed to a later date
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome
Keywords
Subacromial Pain Syndrome, Subacromial ImpingementSyndrome, telerehabilitation, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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
Intervention Name(s)
Standard Physiotherapy
Intervention Description
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
Intervention Name(s)
Home Exercise Group
Intervention Description
The same exercise program applied to telerehabilitation group.
Primary Outcome Measure Information:
Title
Change from Baseline Pain Intensity at 1 and 3 months
Description
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.
Time Frame
Baseline, one and three month after the randomisation
Secondary Outcome Measure Information:
Title
Change from Baseline SPADI total score at 1 and 3 months
Description
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.
Time Frame
Baseline, one and three month after the randomisation
Other Pre-specified Outcome Measures:
Title
Change from baseline range of motion of shoulder at 1 and 3 months
Description
Range of motion of the Shoulder will be evaluated with a standard goniometer.
Time Frame
Baseline, one and three month after the randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bugra Ince, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustafa Huseyin Temel, MD
Organizational Affiliation
Uskudar State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cam and Sakura City Hospital
City
Istanbul
Country
Turkey
Facility Name
Medipol Mega University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be done on request
Citations:
PubMed Identifier
29202926
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.
Results Reference
background
PubMed Identifier
30441330
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.
Results Reference
background

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The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

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