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

June 22, 2023 updated by: Mohsen Ibrahim, Horus University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Damieta, Egypt
        • Recruiting
        • Outpatient clinic faculty of physical therapy, horus university, egypt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Therapeutic exercise group
Therapeutic exercise group, group A.
Other: Therapeutic exercise
  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
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
  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
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
  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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessing the change in isometric shoulder strength
Time Frame: at baseline and after 6 weeks of intervention
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
Time Frame: at baseline and after 6 weeks of intervention
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
Time Frame: at baseline and after 6 weeks of intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohsen Ibrahim, Horus University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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