- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05200130
Effectiveness of Telerehabilitation on Subacromial Pain Syndrome
The Effectiveness of Telerehabilitation With Self Mobilization in Patients With Subacromial Pain Syndrome
The aim of this study is to evaluate the effectiveness of supervised exercise therapy with active soft tissue and joint mobilization.
The effectiveness of telerehabilitation- active mobilization and exercises in the evaluation of pain and function in patients with subacromial pain syndrome will be examined and compared with face-to-face treatment, which is passive manual therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Artuklu
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Mardin, Artuklu, Turkey, 47100
- Erman Berk Celik
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals between the ages of 18-50 who complain of shoulder pain
- Individuals diagnosed with a partial tear of the rotator cuff smaller than 1 cm and As a result of the examination performed by the physician stage 1 or 2 subacromial impingement syndrome.
- Two of the following tests are positive Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests
- Presence of shoulder pain lasting longer than 6 weeks that limits activity.
- Being literate and not having cognitive dysfunction.
Exclusion Criteria:
- Presence of other orthopedic, neurological and systemic problems affecting the neck, shoulder and back complex,
- Patients with heart failure and using a pacemaker,
- Labral tears and other intraarticular structural pathologies
- Signs of adhesive capsulitis
- Grade 3 or full thickness rotator cuff tear
- BMİ > 30 kg/m
- Having been included in a physical therapy program related to the same side shoulder joint in the last 1 year
- Using non-steroidal anti-inflammatory drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Home exercise group
The home exercise program will be explained to the patients in the control group by the physiotherapist and the relevant brochures will be delivered to the patients.
Home exercise program will take 30-45 min.
İt will be applied 5 days a week for 8 weeks.
Patients will receive a reminder message from the physiotherapist once a week.
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The home exercise program includes an educational training program and posture correction exercises.
The program includes stretching and strengthening exercises of the neck and shoulder complex.
|
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Active Comparator: Manual Therapy Group
Patients in the Manual Therapy Group will receive one-to-one physiotherapy sessions in the hospital 2 days a week for 8 weeks.
In these sessions, soft tissue and joint mobilizations and exercises will be applied by physiotherapist.
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Manual Therapy includes deep friction massage and myofascial relaxation techniques to shoulder and neck complex, active and resistant shoulder complex movements, shoulder complex mobilization, mobilization cervical joints. The home exercise program includes an educational training program and posture correction exercises. The program includes stretching and strengthening exercises of the neck and shoulder complex. |
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Experimental: Telerehabilitation Supported Group
Telerehabilitation program will be applied 2 days a week for 8 weeks to patients in the telerehabilitation group.
İt will take 30-45 min.
A physiotherapist will meet with patients via videoconferencing over the internet and guide the program.
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The telerehabilitation program applied to the same home exercise group.
In addition, to the home exercises, these patients will apply active mobilization called self-mobilization.
Self-myofascial release, active glenohumeral joint mobilization, thoracic mobilization, and active cervical mobilization.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Pain at 8 weeks and 12 weeks
Time Frame: Change from Baseline in Pain at 8 weeks and 12 weeks
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Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain.
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Change from Baseline in Pain at 8 weeks and 12 weeks
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Change from Baseline in Short-Form Mcgill Pain questionnaire (SF-MPQ) at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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The McGill Pain questionnaire will be used to evaluate a person experiencing significant pain.. The pain rating index has 2 subscales:
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Baseline, 8 weeks, and 12 weeks
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Change from Baseline in Posture Analysis at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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Corbin posture analysis will be used.
This form include lateral and posterior analyzes.
Physiotherapist marks between 0 = none 3= severe point to disorders.
Total score will calculate excellent = 0-2 to Poor = 12 or more
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Baseline, 8 weeks, and 12 weeks
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Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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Range of motion of the shoulder will be evaluated with a standard goniometer.
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Baseline, 8 weeks, and 12 weeks
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Kibler classification for changes in position and scapular movements at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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Kibler classification will be use assessment of Scapular Dyskinesia.
Identifying changes in position and scapular movements that predispose to shoulder injuries.
Identifying the type of abnormal scapular movement: type I, type II and type III.
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Baseline, 8 weeks, and 12 weeks
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Lateral Scapular Slide test at 8 weeks and 12 weeks
Time Frame: Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks
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Lateral Scapular Slide test will be use assessment of Scapular Dyskinesia.
The Measurement should not vary more than 1 to 1.5 cm, more the 1.5 cm difference significant.
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Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks
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Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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GIRD is a condition resulting in the loss of internal rotation of the glenohumeral joint as compared to the contralateral side.
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Baseline, 8 weeks, and 12 weeks
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Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, and 12 weeks
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QuickDASH will be used for assessing functional ability of the patients.
The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
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Baseline, 8 weeks, and 12 weeks
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Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 12 weeks
Time Frame: Baseline, 8 weeks, 12 weeks
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The SPADI will be used to assess shoulder pain and dysfunction.
It consists of 13 items that assess two different areas.
The first five items measure the pain, and the next eight items assess patient's disability.
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Baseline, 8 weeks, 12 weeks
|
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Patient Satisfaction questionnaire at 8 weeks.
Time Frame: 8 weeks
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The Patient Satisfaction questionnaire will be used to assess the patient's satisfaction with the treatment received.
Patient Satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aysenur Tuncer, PhD, Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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