- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07657637
Efficacy of Diclofenac Sodium Shock Wave Phonophoresis on Patients With Subacromial Impingement Syndrome
Efficacy of Diclofenac Sodium Shock Wave Phonophoresis on Patients With Subacromial Impingement Syndrome: A Randomized Controlled Trial
The goal of the study is to determine the effect of radial shock wave Phonophoresis on patients with impingement syndromes. to answer the following questions:
does shock wave Phonophoresis have and effect on pain? does shock wave Phonophoresis have and effect on shoulder function? does shock wave Phonophoresis have and effect on subacromial space? patients will be randomized to two groups: Group (A): patients will receive shock wave Phonophoresis plus conventional physical therapy.
Group (B): Patients will receive shock wave plus conventional Physical therapy.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: radwa fayek lecturer, Phd
- Phone Number: 02-01004466229
- Email: radwa26fayek@yahoo.com
Study Locations
-
-
-
Cairo, Egypt
- Modern University for Technology and Information, Cairo, , Egypt
-
Contact:
- Modern University for Technology and Information
- Phone Number: 19041
- Email: info@mti.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients age range between 25-40 years ago.
- Shoulder pain between 60- 120° with shoulder elevation (positive painful arch test).
- Grade 2 impingement syndrome according to neer classification.
Exclusion Criteria:
- Shoulder affected bilaterally
- Receiving anesthetic or corticosteroid injections within 4 weeks of study enrollment
- Surgery or previous fractures of the ipsilateral humeral head of the affected shoulder
- Osteoarthritis in the acromioclavicular or glenohumeral joints
Study Plan
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: sodium diclofenac radial shock wave Phonophoresis plus conventional physical therapy
sodium diclofenac radial shock wave Phonophoresis plus conventional physical therapyc
|
patients will receive radial shock wave Phonophoresis by ibuprofen in the form of 2000 shocks, 2.4 bars, 10 MHz frequency plus (strengthening and stretching exercises for subraspinatus muscle).
|
|
Active Comparator: radial shock wave plus conventional physical therapy
|
patients will receive radial shock wave therapy ( 2000 shocks, 2.4 bars, 10 MHz), plus conventional physical therapy (strengthening and stretching exercises for subraspinatus muscle).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
shoulder pain
Time Frame: before the first session and after the last session ( four weeks)
|
shoulder pain will be measured by numerical pain scale
|
before the first session and after the last session ( four weeks)
|
|
subacromial space
Time Frame: before the first session and after the last session ( four weeks)
|
before the first session and after the last session ( four weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
shoulder function
Time Frame: Time Frame: before the first session and after the last session ( four weeks)
|
function will be measured by shoulder pain and disability index
|
Time Frame: before the first session and after the last session ( four weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pending (Other Grant/Funding Number: National Institutes of Allery and Infectious Diseases)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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