- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06535750
Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises With Rotator Cuff Syndrome
Comparison Of The Effects Of Conventional Physiotherapy And Strengthening Exercises Additional To Conventional Physiotherapy On Pain, Muscle Strength, Joint Range Of Motion, Functionality And Quality Of Life In Patients With Rotator Cuff Syndrome
Various options are available for the treatment of rotator cuff syndrome, including conservative and surgical. Conservative treatment methods include activity modification, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections (CSIs), and physiotherapy. Physiotherapy methods include various interventions such as manual therapy, exercise, and electrotherapy. Although these treatments do not directly treat the specific pathology, they help correct rotator cuff and scapular muscle weakness and dysfunction, reduce the tightness of the posterior capsule and other soft tissues, and relieve pain and dysfunction. It focuses on correcting the postural abnormalities that contribute to the disease.
In our study, the investigators aimed to determine the effects of rehabilitation components in the conservative treatment of patients with rotator cuff syndrome and to determine the effects of strengthening exercises on the functional status of the patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rotator cuff syndrome (RCS), also known as rotator cuff tendonitis, is characterised by intense pain, functional impairment, loss of shoulder range of motion (ROM), nocturnal pain, and limitations in activities of daily living. It is a common problem in the ageing population and its patophysiology may be the result of tendon degeneration resulting from microtrauma (repetitive activities, overload) or traumatic injury.
Groups Participants were randomly divided into two treatment groups. There are 10 patients in each group. The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week. Details of the study groups are given below.
Control Group
Patients in the control group received a standard treatment programme. This programme included the following:
Passive stretching exercises were performed 10 repetitions for each movement (shoulder flexion, abduction, adduction, internal rotation, external rotation). Codman exercises were performed 15 repetitions (with 1kg dumbbell). Shoulder isometric exercises were performed 15 repetitions for each movement (ball press, clockwise and anti-clockwise ball rotation, finger slide on the wall). Wand exercises were performed 15 repetitions (shoulder abduction, internal rotation, external rotation). Electrotherapy was applied for 20 minutes and ice therapy was applied for 20 minutes.7-9 Experimental Group
Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following:
Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Turkey, 34303
- Physical Therapy and Rehabilitation Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- having complaints for at least three months
- having positive Empty can test
- having rotator cuff injury
- having loss of function in the shoulder and volunteering to participate in the study
Exclusion Criteria:
- cardiovascular disease that would interfere with the rehabilitation process,
- who had neurological or systemic musculoskeletal disease
- who had undergone upper extremity surgery
- who had upper extremity scapula fracture
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 |
|---|---|
|
Experimental: Rotator Cuff Patients with used to conventional rehabilitation
Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. |
Participants were randomly divided into two treatment groups.
There are 10 patients in each group.
The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme.
Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week.
Details of the study groups are given below.
|
|
Experimental: Rotator Cuff Patients with used to conventional rehabilitation add to strenght exercise.
Patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme. This programme included the following: Strengthening Exercises: Low-row, biceps strengthening, shoulder horizontal abduction and shoulder horizontal adduction, external rotation. After the pain decreased, strengthening exercises for subscapularis, infraspinatus, supraspinatus, teres minor, deltoid and scapulothoracic muscles were performed. The colour of the Theraband was chosen between yellow, red, green, blue and red to the extent tolerated by the patient. |
Participants were randomly divided into two treatment groups.
There are 10 patients in each group.
The patients in the control group received a standard treatment programme, while the patients in the experimental group received strengthening exercises with theraband in addition to the standard treatment programme.
Treatment sessions for both groups lasted 50-55 minutes and were performed three days a week.
Details of the study groups are given below.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability Questionnaire for Arm, Shoulder and Hand (Quick DASH):
Time Frame: 3 months
|
Quick DASH was used as the primary outcome measure because it is a questionnaire that assesses upper extremity injuries and symptoms and measures their impact on patients' activities of daily living.
Each section of the Quick-DASH questionnaire yields a score between 0 and 100 (0= no disability, 100= maximum disability).10,11
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 1 months
|
WORC was used to assess the impact of rotator cuff problems on quality of life.(Kirkley
Alvarez) Each question is answered with a 100mm VAS.
The total is between 0 and 2100, with lower scores indicating higher quality of life.
|
1 months
|
|
Nothingam Health Profile (NSP):
Time Frame: 1 months
|
The NSP was used to measure the general health status and quality of life of the patients.
The scoring of the sections ranges from 0-100, with higher scores indicating health problems.
|
1 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yasemin ŞAHBAZ, Istanbul Beykent University
Publications and helpful links
General Publications
- Gomoll AH, Katz JN, Warner JJ, Millett PJ. Rotator cuff disorders: recognition and management among patients with shoulder pain. Arthritis Rheum. 2004 Dec;50(12):3751-61. doi: 10.1002/art.20668. No abstract available.
- Galetta MD, Keller RE, Sabbag OD, Linderman SE, Fury MS, Medina G, O'Donnell EA, Cheng TTW, Harris E, Oh LS. Rehabilitation variability after rotator cuff repair. J Shoulder Elbow Surg. 2021 Jun;30(6):e322-e333. doi: 10.1016/j.jse.2020.11.016. Epub 2021 Jan 5.
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
- UBeykent-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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