Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Subacromial Impingement Syndrome; Impingement Syndrome
• Intervention / Treatment: Other: Therapeutic exercise; Other: hydrocortisone phonophoresis; Other: hydrocortisone iontophoresis

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohsen Ibrahim; Phone Number: +201001407064; Email: mabouelsoud@horus.edu.eg

Study Locations

• Egypt
  • Damieta, Egypt
    • Recruiting
    • Outpatient clinic faculty of physical therapy, horus university, egypt
    • Contact: Mohsen Ibrahim; Phone Number: +201001407064; Email: mabouelsoud@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. All patients were diagnosed as unilateral SIS with stage II Neer classification > 3 months.
2. 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)
3. The age of patients ranged from 18 - 60 years old.
4. Both genders will be involved.
5. Shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10.
6. Failure to respond to conservative NSAID.

Exclusion Criteria:

1. Frozen shoulders.
2. Arthritis of the shoulder.
3. Shoulder instability.
4. Pregnant women.
5. A pacemaker.
6. Previous shoulder surgery.
7. History of dislocation of the shoulder.
8. Internal metallic fixation.
9. Malignancy.
10. Previous corticosteroid injection.
11. Rheumatoid arthritis
12. Partial or Full thickness tear of the rotator cuff.
13. Cervical radiculopathy.
14. Physiotherapeutic shoulder treatment within the last 3 months.
15. The patients will randomly be assigned into 3 equal groups, 20 patients for each group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Therapeutic exercise group; Therapeutic exercise group, group A.	Other: Therapeutic exercise; 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
Experimental: hydrocortisone phonophoresis group; This group (B) will receive the same exercise program in addition to hydrocortisone phonophoresis. Patients will receive topical medium phonophoresis of 10% hydrocortisone gel.	Other: Therapeutic exercise; 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; Other: hydrocortisone phonophoresis; 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
Experimental: hydrocortisone iontophoresis group; This group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis.	Other: Therapeutic exercise; 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; Other: hydrocortisone iontophoresis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change in isometric shoulder strength	A handheld Lafayette dynamometer will be used to evaluate the peak shoulder External Rotation muscles isometric strength	at baseline and after 6 weeks of intervention
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).	at baseline and after 6 weeks of intervention
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.	at baseline and after 6 weeks of intervention

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Mohsen Ibrahim, Horus University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): August 15, 2023
• Study Completion (Estimated): September 15, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome; Anti-Inflammatory Agents; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• Other Study ID Numbers: MOHSEN_IBRAHIM_phd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No