- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05951322
Extra Corporeal Shock Wave Versus Phonophoresis in Sub Acromial Impingement Syndrome.
The Influence of Extra Corporeal Shock Wave Versus Phonophoresis on Pain Severity and Functional Disability in Patients With Sub Acromial Impingement Syndrome. A Randomized Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Riyadh
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Al Kharj, Riyadh, Saudi Arabia, 11942
- Dr. Gopal Nambi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient reported a positive "Neer sign" and" Hawkins sign".
- The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and over head playing athletes).
- The patient reported pain with palpation of the rotator cuff tendons.
- The patient reported pain with resisted isometric abduction.
Exclusion Criteria:
- Frozen shoulder.
- Rotator cuff tear.
- Glenohumeral or acromioclavicular arthritis.
- Implented pace maker.
- Pregnancy
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: Shockwave therapy
All patients were received (ESWT) at sitting position, exposed the affected shoulder, the shoulder adducted and elbow extended and the shock wave applicator was directed in most tender point near the insertion of rotator cuff at greater tuberosity under the acromion [23]. The treatment area was prepared with a coupling gel to minimize the loss of shockwave at the interface between applicator tip and skin. Each patient was received (6000 shocks,21000 shock/ session, 3 session 2 weeks apart, energy flux density 0.22 mJ/mm2, energy level 5-7, pulse rate 160/min., 2-3Hz) |
Radial extracorporeal shock wave device, it is serial number (1107394), medispec and connected to electrical supply 115/220 A C frequency.
|
Active Comparator: Phonophoresis
Pagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz.
|
Pagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Baseline
|
Pain assessed by (Visual analog scale (VAS).
VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
|
Baseline
|
Pain intensity
Time Frame: 6 weeks
|
Pain assessed by (Visual analog scale (VAS).
VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional disability
Time Frame: Baseline
|
It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability.
It consists of two parts, part one which assesses pain and part two which assesses functional disability.
Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen.
In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis.
Final score for each part was statistically analyzed separately.
|
Baseline
|
Functional disability
Time Frame: 6 weeks
|
It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability.
It consists of two parts, part one which assesses pain and part two which assesses functional disability.
Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen.
In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis.
Final score for each part was statistically analyzed separately.
|
6 weeks
|
Range of motion
Time Frame: Baseline
|
In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer).
It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time.
It measure any joint angle quickly and accurately.
It has range of 0 to 360 and stores up to 80 data points.
The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.
|
Baseline
|
Range of motion
Time Frame: 6 weeks
|
In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer).
It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time.
It measure any joint angle quickly and accurately.
It has range of 0 to 360 and stores up to 80 data points.
The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.
|
6 weeks
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECM#2023-1102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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.
Clinical Trials on Sub Acromial Impingement Syndrome
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