Back to resultsEffect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
Primary Purpose
Impingement Syndrome, Subacromial Impingement Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Therapeutic exercise
hydrocortisone phonophoresis
hydrocortisone iontophoresis
Sponsored by
About this trial
This is an interventional treatment trial for Impingement Syndrome
Eligibility Criteria
Inclusion Criteria: All patients were diagnosed as unilateral SIS with stage II Neer classification > 3 months. Positive impingement sign (Neer's test or Hawkins-Kennedy test), / painful arc during active arm elevation, pain or weakness with resisted isometric external rotation or resisted scapular plane abduction with the humeral internal rotation (empty can test) The age of patients ranged from 18 - 60 years old. Both genders will be involved. Shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10. Failure to respond to conservative NSAID. Exclusion Criteria: Frozen shoulders. Arthritis of the shoulder. Shoulder instability. Pregnant women. A pacemaker. Previous shoulder surgery. History of dislocation of the shoulder. Internal metallic fixation. Malignancy. Previous corticosteroid injection. Rheumatoid arthritis Partial or Full thickness tear of the rotator cuff. Cervical radiculopathy. Physiotherapeutic shoulder treatment within the last 3 months. The patients will randomly be assigned into 3 equal groups, 20 patients for each group.
Sites / Locations
- Outpatient clinic faculty of physical therapy, horus university, egyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Therapeutic exercise group
hydrocortisone phonophoresis group
hydrocortisone iontophoresis group
Arm Description
Therapeutic exercise group, group A.
This group (B) will receive the same exercise program in addition to hydrocortisone phonophoresis. Patients will receive topical medium phonophoresis of 10% hydrocortisone gel.
This group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis.
Outcomes
Primary Outcome Measures
Assessing the change in isometric shoulder strength
A handheld Lafayette dynamometer will be used to evaluate the peak shoulder External Rotation muscles isometric strength
Assessing the change in Shoulder Pain and Disability
By using Shoulder Pain and Disability Index (SPADI). SPADI has been found to be the quickest (within five minutes) and easiest to complete, as well as being more responsive to change. The SPADI is considered to be, by comparison, one of the most useful instruments about the shoulder joint, and has been tested in various clinical settings. The SPADI is a 13-item shoulder function index on the ability of responders to carry out basic activities of daily living. Each item is scored by a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help).
Assessing the change in shoulder Range Of Motion
In this study shoulder ROM will be measured by using Electrogoniometer (flexion, abduction and internal rotation ranges will be measured in degrees), which eliminates the need to manually score each measurement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05919121
Brief Title
Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
Official Title
Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study will be to compare the efficacy of adding hydrocortisone phonophoresis or iontophoresis on pain, function, range of motion and shoulder external rotation isometric strength in patients with subacromial impingement syndrome.
Detailed Description
Routine physiotherapy has been advocated was an effective treatment for SIS. However, there is lack of best exercise treatment and lots of studies are under consideration. According to published data focused on management of shoulder pain, it looks like that therapeutic exercise is not sufficient to treat SIS and it is compulsory to combine with other remedies to get the best results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impingement Syndrome, Subacromial Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic exercise group
Arm Type
Active Comparator
Arm Description
Therapeutic exercise group, group A.
Arm Title
hydrocortisone phonophoresis group
Arm Type
Experimental
Arm Description
This group (B) will receive the same exercise program in addition to hydrocortisone phonophoresis. Patients will receive topical medium phonophoresis of 10% hydrocortisone gel.
Arm Title
hydrocortisone iontophoresis group
Arm Type
Experimental
Arm Description
This group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
Stretching exercise of posterior shoulder capsule
Strengthening exercises: consists of 6 strengthening exercises all of which have been recommended as essential for any shoulder rehabilitation program.
The remaining 2 exercises are the seated press-up and the elbow push up. Both will be performed to fatigue or for a maximum of 25 repetitions. The quality of all repetitions of each exercise will continuously monitored by the investigator of the study
Intervention Type
Other
Intervention Name(s)
hydrocortisone phonophoresis
Intervention Description
In this study, the effective area of radiation (ERA) in the mode continuous (100 percent) is 5 cm2, in 1 MHz and 0.7 W/cm2, with four ERA treated areas. Therapy lasted five minutes (three minutes in the insertion of the supraspinatus and 37 two minutes in the infraspinatus insertion) three times weekly over 6 weeks in addition to therapeutic exercises
Intervention Type
Other
Intervention Name(s)
hydrocortisone iontophoresis
Intervention Description
A direct current electrical stimulation unit will be used to apply iontophoresis. The unit has two electrodes; one electrode is for the negative current, and one is for the positive current. The Active (Negative) electrode will be placed on the anterolateral aspect of the shoulder joint. The passive electrode: will be placed on the upper arm region. Intensity of the current: Between the range of 3-5 mA at the point of sensation of patient was set. Treatment duration: Calculated accordingly with intensity of current. Method of application: hydrocortisone gel 10% will be administered by applying on the active rubber electrode for each session three times weekly over 6 weeks in addition to therapeutic exercises.
Primary Outcome Measure Information:
Title
Assessing the change in isometric shoulder strength
Description
A handheld Lafayette dynamometer will be used to evaluate the peak shoulder External Rotation muscles isometric strength
Time Frame
at baseline and after 6 weeks of intervention
Title
Assessing the change in Shoulder Pain and Disability
Description
By using Shoulder Pain and Disability Index (SPADI). SPADI has been found to be the quickest (within five minutes) and easiest to complete, as well as being more responsive to change. The SPADI is considered to be, by comparison, one of the most useful instruments about the shoulder joint, and has been tested in various clinical settings. The SPADI is a 13-item shoulder function index on the ability of responders to carry out basic activities of daily living. Each item is scored by a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help).
Time Frame
at baseline and after 6 weeks of intervention
Title
Assessing the change in shoulder Range Of Motion
Description
In this study shoulder ROM will be measured by using Electrogoniometer (flexion, abduction and internal rotation ranges will be measured in degrees), which eliminates the need to manually score each measurement.
Time Frame
at baseline and after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients were diagnosed as unilateral SIS with stage II Neer classification > 3 months.
Positive impingement sign (Neer's test or Hawkins-Kennedy test), / painful arc during active arm elevation, pain or weakness with resisted isometric external rotation or resisted scapular plane abduction with the humeral internal rotation (empty can test)
The age of patients ranged from 18 - 60 years old.
Both genders will be involved.
Shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10.
Failure to respond to conservative NSAID.
Exclusion Criteria:
Frozen shoulders.
Arthritis of the shoulder.
Shoulder instability.
Pregnant women.
A pacemaker.
Previous shoulder surgery.
History of dislocation of the shoulder.
Internal metallic fixation.
Malignancy.
Previous corticosteroid injection.
Rheumatoid arthritis
Partial or Full thickness tear of the rotator cuff.
Cervical radiculopathy.
Physiotherapeutic shoulder treatment within the last 3 months.
The patients will randomly be assigned into 3 equal groups, 20 patients for each group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohsen Ibrahim
Phone
+201001407064
Email
mabouelsoud@horus.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen Ibrahim
Organizational Affiliation
Horus University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy, horus university, egypt
City
Damieta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen Ibrahim
Phone
+201001407064
Email
mabouelsoud@horus.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
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