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

NCT05919121 | Unknown DMC

• 1 other identifier: MOHSEN_IBRAHIM_phd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Impingement Syndrome; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Therapeutic exercise group

ACTIVE COMPARATOR

Therapeutic exercise group, group A.

Other: Therapeutic exercise

hydrocortisone phonophoresis group

EXPERIMENTAL

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; Other: hydrocortisone phonophoresis

hydrocortisone iontophoresis group

EXPERIMENTAL

This group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis.

Other: Therapeutic exercise; Other: hydrocortisone iontophoresis

Interventions

Therapeutic exercise OTHER

1. Stretching exercise of posterior shoulder capsule 2. Strengthening exercises: consists of 6 strengthening exercises all of which have been recommended as essential for any shoulder rehabilitation program. 3. 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

Therapeutic exercise group; hydrocortisone iontophoresis group; hydrocortisone phonophoresis group

hydrocortisone phonophoresis OTHER

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

hydrocortisone phonophoresis group

hydrocortisone iontophoresis OTHER

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.

hydrocortisone iontophoresis group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy, horus university, egypt

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Mohsen Ibrahim

  Horus University in Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohsen Ibrahim

CONTACT

+201001407064; mabouelsoud@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 26, 2023
• Study Start: May 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

EG (1)