Back to resultsEffectiveness of Telerehabilitation on Subacromial Pain Syndrome
Primary Purpose
Subacromial Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Exercise Group
Manual Therapy Group
Telerehabilitation Group
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Pain Syndrome focused on measuring Pain, Functionality, Patient Satisfaction
Eligibility Criteria
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.
Sites / Locations
- Erman Berk CelikRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Home exercise group
Manual Therapy Group
Telerehabilitation Supported Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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 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.
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
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.
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.
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 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.
Change from Baseline in Subacromial space at 8 weeks.
Subacromial space will be measured from radiographic results. Subacromial space is defined by the humeral head inferiorly, the anterior edge and under surface of the anterior third of the acromion, coracoacromial ligament and the acromioclavicular joint superiorly Interposed between these two osseous structures are the rotator cuff tendons.
Change from Baseline in Critical Shoulder Angle (CSA) at 8 weeks.
CSA will be measured by MRI results. CSA is the angle between the plane of the glenoid fossa (the line from the inferior edge of the glenoid to the superior edge of the glenoid) and a line drawn from the inferior edge of the glenoid to the lateral edge of the acromion.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05200130
First Posted
December 7, 2021
Last Updated
January 19, 2022
Sponsor
Hasan Kalyoncu University
1. Study Identification
Unique Protocol Identification Number
NCT05200130
Brief Title
Effectiveness of Telerehabilitation on Subacromial Pain Syndrome
Official Title
The Effectiveness of Telerehabilitation With Self Mobilization in Patients With Subacromial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu 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 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Pain Syndrome
Keywords
Pain, Functionality, Patient Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home exercise group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Therapy Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telerehabilitation Supported Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Exercise Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain at 8 weeks and 12 weeks
Description
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.
Time Frame
Change from Baseline in Pain at 8 weeks and 12 weeks
Title
Change from Baseline in Short-Form Mcgill Pain questionnaire (SF-MPQ) at 8 weeks and 12 weeks
Description
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.
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Change from Baseline in Posture Analysis at 8 weeks and 12 weeks
Description
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
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks
Description
Range of motion of the shoulder will be evaluated with a standard goniometer.
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Kibler classification for changes in position and scapular movements at 8 weeks and 12 weeks
Description
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.
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Lateral Scapular Slide test at 8 weeks and 12 weeks
Description
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.
Time Frame
Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks
Title
Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 8 weeks and 12 weeks
Description
GIRD is a condition resulting in the loss of internal rotation of the glenohumeral joint as compared to the contralateral side.
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Change from Baseline in Subacromial space at 8 weeks.
Description
Subacromial space will be measured from radiographic results. Subacromial space is defined by the humeral head inferiorly, the anterior edge and under surface of the anterior third of the acromion, coracoacromial ligament and the acromioclavicular joint superiorly Interposed between these two osseous structures are the rotator cuff tendons.
Time Frame
Baseline and 8 weeks
Title
Change from Baseline in Critical Shoulder Angle (CSA) at 8 weeks.
Description
CSA will be measured by MRI results. CSA is the angle between the plane of the glenoid fossa (the line from the inferior edge of the glenoid to the superior edge of the glenoid) and a line drawn from the inferior edge of the glenoid to the lateral edge of the acromion.
Time Frame
Baseline and 8 weeks
Title
Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 8 weeks and 12 weeks
Description
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.
Time Frame
Baseline, 8 weeks, and 12 weeks
Title
Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 12 weeks
Description
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.
Time Frame
Baseline, 8 weeks, 12 weeks
Title
Patient Satisfaction questionnaire at 8 weeks.
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysenur Tuncer, PhD
Phone
+90-342 2118080
Email
aysenur.tuncer@hku.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Erman Berk Celik, MSC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Erman Berk Celik
City
Mardin
State/Province
Artuklu
ZIP/Postal Code
47100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erman B Celik, MSC
Phone
05436777823
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Telerehabilitation on Subacromial Pain Syndrome
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