- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05950880
Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
March 28, 2024 updated by: Abdallah Gamiel Ayed, Cairo University
Effect of Adding High Intensity Exercises to Conventional Physical Therapy in Treatment of Athlete Patients With Shoulder Impingement Syndrome
Purposes of the study
To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized into either High-intensity shoulder exercise group or Conventional physical therapy group.
Patients will receive the intervention for six weeks.
Outcomes will be assessed at baseline and post-intervention.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- facult of physical therapy,MTI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Athletic patients
- Age of the patients between 18 - 35 years
- Unilateral shoulder pain more than 3 months.
- Positive Hawkins test.
- Positive empty or full cane test.
- Pain at night or incapable of lying on the shoulder.
- Pain with active shoulder elevation in the scapular plane.
- History of pain in the C5-C6 dermatome.
- Pain with palpation of the rotator cuff tendons.
- The patient had pain with resisted isometric abduction
Exclusion Criteria:
- History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
- Clinical sign of cervical radiculopathy.
- History of acromio -clavicular pain.
- Rheumatoid Arthritis.
- Adhesive capsulitis.
- Tumors
- Labrum lesions
- Capsular or ligamentous tears or avulsions
- Cartilage lesions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High intensity exercise + Conventional physical therapy
Patients in this group will receive High-intensity exercise + Conventional physical therapy
|
Exercises that target the rotator cuff muscles using 90% of one repetition maximum only for 5 repetitions
Conventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises
|
|
Active Comparator: Conventional physical therapy
Patients in this group will receive Conventional physical therapy
|
Conventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain and function
Time Frame: Change from Baseline pain and function at 6 weaks
|
Shoulder pain and disability index (SPADI)
|
Change from Baseline pain and function at 6 weaks
|
|
Supraspinatus muscle thickness
Time Frame: Change from Baseline Supraspinatus muscle thickness at 6 weaks
|
Diagnostic Ultrasound
|
Change from Baseline Supraspinatus muscle thickness at 6 weaks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sub acromial space (Acromiohumeral distance).
Time Frame: Change from Baseline Sub acromial space at 6 weaks
|
Diagnostic Ultrasound
|
Change from Baseline Sub acromial space at 6 weaks
|
|
External and internal rotators muscle strength.
Time Frame: Change from Baseline External and internal rotators muscle strength at 6 weaks
|
Hand-held dynamometer
|
Change from Baseline External and internal rotators muscle strength at 6 weaks
|
|
supuraspinatus muscle strength
Time Frame: Change from Baseline supuraspinatus muscle strength at 6 weaks
|
Hand-held dynamometer
|
Change from Baseline supuraspinatus muscle strength at 6 weaks
|
|
shoulder performance
Time Frame: Change from Baseline shoulder performance at 6 weaks
|
Timed push up test
|
Change from Baseline shoulder performance at 6 weaks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdallah Gamiel, MSc, Cairo university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
December 25, 2023
Study Completion (Actual)
December 25, 2023
Study Registration Dates
First Submitted
July 5, 2023
First Submitted That Met QC Criteria
July 15, 2023
First Posted (Actual)
July 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Shoulder Impingement Syndrome
-
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