Back to resultsEffect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
Primary Purpose
Shoulder Impingement Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High intensity shoulder exercise
Conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome
Eligibility Criteria
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
Sites / Locations
- facult of physical therapy,MTIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High intensity exercise + Conventional physical therapy
Conventional physical therapy
Arm Description
Patients in this group will receive High-intensity exercise + Conventional physical therapy
Patients in this group will receive Conventional physical therapy
Outcomes
Primary Outcome Measures
pain and function
Shoulder pain and disability index (SPADI)
Supraspinatus muscle thickness
Diagnostic Ultrasound
Secondary Outcome Measures
Sub acromial space (Acromiohumeral distance).
Diagnostic Ultrasound
External and internal rotators muscle strength.
Hand-held dynamometer
supuraspinatus muscle strength
Hand-held dynamometer
shoulder performance
Timed push up test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05950880
Brief Title
Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
Official Title
Effect of Adding High Intensity Exercises to Conventional Physical Therapy in Treatment of Athlete Patients With Shoulder Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purposes of the study
To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High intensity exercise + Conventional physical therapy
Arm Type
Experimental
Arm Description
Patients in this group will receive High-intensity exercise + Conventional physical therapy
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Patients in this group will receive Conventional physical therapy
Intervention Type
Other
Intervention Name(s)
High intensity shoulder exercise
Intervention Description
Exercises that target the rotator cuff muscles using 90% of one repetition maximum only for 5 repetitions
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Conventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises
Primary Outcome Measure Information:
Title
pain and function
Description
Shoulder pain and disability index (SPADI)
Time Frame
Change from Baseline pain and function at 6 weaks
Title
Supraspinatus muscle thickness
Description
Diagnostic Ultrasound
Time Frame
Change from Baseline Supraspinatus muscle thickness at 6 weaks
Secondary Outcome Measure Information:
Title
Sub acromial space (Acromiohumeral distance).
Description
Diagnostic Ultrasound
Time Frame
Change from Baseline Sub acromial space at 6 weaks
Title
External and internal rotators muscle strength.
Description
Hand-held dynamometer
Time Frame
Change from Baseline External and internal rotators muscle strength at 6 weaks
Title
supuraspinatus muscle strength
Description
Hand-held dynamometer
Time Frame
Change from Baseline supuraspinatus muscle strength at 6 weaks
Title
shoulder performance
Description
Timed push up test
Time Frame
Change from Baseline shoulder performance at 6 weaks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdallah Gamiel, MSc
Phone
+201012012323
Email
abdalla.gamil123456@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Gamiel, MSc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
facult of physical therapy,MTI
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdallah Gamiel, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
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