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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200130
Other study ID # 2021/074
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date August 8, 2023

Study information

Verified date November 2023
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Shoulder pain is common in the population. Various treatment modalities are used. Due to the Coronavirus disease (COVID-19), 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. In addition, as a new treatment application, its effectiveness will be measured in patients with shoulder pain.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 8, 2023
Est. primary completion date August 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 - BMI > 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Home Exercise Group
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.
Manual Therapy Group
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.
Telerehabilitation Group
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.

Locations

Country Name City State
Turkey Erman Berk Celik Mardin Artuklu

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Pain at 8 weeks and 12 weeks 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. Change from Baseline in Pain at 8 weeks and 12 weeks
Primary Change from Baseline in Short-Form Mcgill Pain questionnaire (SF-MPQ) at 8 weeks and 12 weeks The McGill Pain questionnaire will be used to evaluate a person experiencing significant pain..
The pain rating index has 2 subscales:
Sensory subscale with 11 words
Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Baseline, 8 weeks, and 12 weeks
Primary Change from Baseline in Posture Analysis at 8 weeks and 12 weeks 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 Baseline, 8 weeks, and 12 weeks
Primary Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks Range of motion of the shoulder will be evaluated with a standard goniometer. Baseline, 8 weeks, and 12 weeks
Primary Kibler classification for changes in position and scapular movements at 8 weeks and 12 weeks 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. Baseline, 8 weeks, and 12 weeks
Primary Lateral Scapular Slide test at 8 weeks and 12 weeks 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. Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks
Primary Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 8 weeks and 12 weeks GIRD is a condition resulting in the loss of internal rotation of the glenohumeral joint as compared to the contralateral side. Baseline, 8 weeks, and 12 weeks
Primary Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 8 weeks and 12 weeks 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. Baseline, 8 weeks, and 12 weeks
Primary Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 12 weeks 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. Baseline, 8 weeks, 12 weeks
Primary Patient Satisfaction questionnaire at 8 weeks. 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. 8 weeks
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