Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05919121
Other study ID # MOHSEN_IBRAHIM_phd
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date September 15, 2023

Study information

Verified date June 2023
Source Horus University
Contact Mohsen Ibrahim
Phone +201001407064
Email mabouelsoud@horus.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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
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
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.

Locations

Country Name City State
Egypt Outpatient clinic faculty of physical therapy, horus university, egypt Damieta

Sponsors (1)

Lead Sponsor Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Terminated NCT03913702 - Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement Phase 2
Completed NCT05071469 - Comparison of Two Different Treatment Methods N/A
Active, not recruiting NCT04660682 - A Comparison of the Long Term Effects of the Traditional and Modified Posterior Shoulder Stretching Exercise in Subacromial Impingement Syndrome N/A
Completed NCT03186287 - Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome N/A
Completed NCT04915430 - Training in Subacromial Impingement Syndrome N/A
Recruiting NCT01691157 - Exercise in the Physiotherapy Management of Shoulder Impingement N/A
Completed NCT01753271 - Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement N/A
Withdrawn NCT01449448 - Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome N/A
Not yet recruiting NCT05794633 - Acupuncture Therapy in Patients With Subacromial Impingement Syndrome N/A
Active, not recruiting NCT06324487 - A New Application in Subacromial Impingement Syndrome N/A
Not yet recruiting NCT06023914 - Analysis of the Effect of Neuromuscular Electro-stimulation on the Performance of Isometric Rotator Cuff Strength. Phase 2/Phase 3
Recruiting NCT04644042 - The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment. N/A
Completed NCT05549674 - Copenhagen Cohort of Patients With Shoulder Pain
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Completed NCT03888586 - Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome N/A
Completed NCT03303001 - Comparison Between Subacromial Infiltrations N/A
Recruiting NCT03658707 - Validity and Reliability of the Turkish Version of the Functional Shoulder Score
Recruiting NCT02374125 - Teres Major Muscle and Subacromial Impingement Syndrome N/A
Active, not recruiting NCT03326466 - Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).
Completed NCT04169880 - Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome N/A