Impingement SyndromeNCT05919121
Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
A study testing Therapeutic exercise, hydrocortisone phonophoresis and hydrocortisone iontophoresis in people with Impingement Syndrome and Subacromial Impingement Syndrome, run by Horus University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Syndrome, Subacromial Impingement Syndrome
- What is being tested?
- Therapeutic exercise, hydrocortisone phonophoresis and hydrocortisone iontophoresis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Frozen shoulders.
- Arthritis of the shoulder.
- Shoulder instability.
- Pregnant women.
- A pacemaker.
- Previous shoulder surgery.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic faculty of physical therapy, horus university, egypt
Damietta
Mohsen Ibrahim, +201001407064, mabouelsoud@horus.edu.eg
About this study
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.
Read the 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
- Being tested
- Therapeutic exercise, hydrocortisone phonophoresis, hydrocortisone iontophoresis
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
- 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 phonophoresisOther
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 iontophoresisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise group | Active comparator | Therapeutic exercise group, group A. Receives: 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. Receives: Other: Therapeutic exercise; Other: hydrocortisone phonophoresis |
| hydrocortisone iontophoresis group | Experimental | This group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis. Receives: Other: Therapeutic exercise; Other: hydrocortisone iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in isometric shoulder strength
A handheld Lafayette dynamometer will be used to evaluate the peak shoulder External Rotation muscles isometric strength
Measured: 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).
Measured: 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.
Measured: at baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 May 2023
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Ibrahim, Horus University
- Investigators
- Mohsen Ibrahim, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919121
- Sponsor's protocol ID
- MOHSEN_IBRAHIM_phd
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Hydrocortisone Phonophoresis Versus Iontophoresis In Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05919121
- Acronym / sponsor ID
- MOHSEN_IBRAHIM_phd
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise group | Active comparator | Other: Therapeutic exerciseTherapeutic exercise group, group A. |
| hydrocortisone phonophoresis group | Experimental | Other: Therapeutic exercise, Other: hydrocortisone phonophoresisThis group (B) will receive the same exercise program in addition to hydrocortisone phonophoresis. Patients will receive topical medium phonophoresis of 10% hydrocortisone gel. |
| hydrocortisone iontophoresis group | Experimental | Other: Therapeutic exercise, Other: hydrocortisone iontophoresisThis group (C) will receive the same exercise program in addition to hydrocortisone iontophoresis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Frozen shoulders.
- Arthritis of the shoulder.
- Shoulder instability.
- Pregnant women.
- A pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercise1. 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 | Therapeutic exercise group, hydrocortisone iontophoresis group, hydrocortisone phonophoresis group |
| hydrocortisone phonophoresisIn 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 | Other | hydrocortisone phonophoresis group |
| hydrocortisone iontophoresisA 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. | Other | hydrocortisone iontophoresis group |
Primary outcome
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
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen Ibrahim principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise, hydrocortisone phonophoresis and hydrocortisone iontophoresis in people with Impingement Syndrome and Subacromial Impingement Syndrome, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Ibrahim (+201001407064, mabouelsoud@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in isometric shoulder strength (time frame: at baseline and after 6 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.