Supraspinatus TendinitisNCT06386926
Radial Shockwave Versus Ultrasound Phonophoresis
A study testing Electro Therapy in people with Supraspinatus Tendinitis, run by Cairo University at 1 site in Egypt.
Trial summary
Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supraspinatus Tendinitis
- What is being tested?
- Electro Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to Sep 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 18 years to 60
- with Unilateral Chronic Supraspinatus Tendinitis.
- Tenderness is found over the supraspinatus as it passes sub-acrominal and anterolateral.
- The patient reported with positive Jobe's test (empty can test)
- The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes).
- The patient reported pain with resisted isometric abduction
Who cannot join
- Case reports, treatments after surgery, did not meet our specified outcome parameters, traumatic incidents,
- Partial tears at surgery
- Massive retracted tears at surgery
- Frozen shoulder.
- Rotator cuff tear.
- Glenohumeral or acromioclavicular arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radial Shockwave Versus Ultrasound Phonophoresis in Management of Chronic Supraspinatus Tendinitis
Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy)
- Conditions
- Supraspinatus Tendinitis
- Being tested
- Electro Therapy
- Keywords
- Shockwave , phonophoresis , supraspinatus tendinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro TherapyOther
radial shockwave 3 sessions one session per week for four consecutive weeks ,receive Ultrasound phonophoresis using diclofenac Na+ 12 session, 3 sessions per week and conventional physical therapy modalities in the form of 3 sessions every week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | 23 subjects will Receive radial shockwave by ( Storz Medical /SN:BS.3517 ) for 3 sessions one session per week for four consecutive weeks and conventional physical therapy Receives: Other: Electro Therapy |
| Experimental group 2 | Experimental | 23 subjects will receive Ultrasound phonophoresis using diclofenac Na+( voltaren) by ( Sonopuls 490 / SN : 36 602 ) for 12 session, 3 sessions per week and same conventional physical therapy Receives: Other: Electro Therapy |
| Control group | Other | 23 subjects will receive conventional physical therapy modalities in the for 3 sessions per week for 4 weeks in form of Stretching Exercise in form of exercise of posterior shoulder capsule, strengthening exercises all have been recommended as essential for any shoulder rehabilitation program. These exercise include shoulder flexion, scaption.
,Tens applied for 20 minutes per session using (Enraf Nonius (Endomed 482) SN : 36853 ) Receives: Other: Electro Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the thickness of supraspinatus tendon
Ultrasonography
Measured: before start of treatment and 4 weeks following end of treatment
change in pain intesity
VAS ( visual analog scale score)
Measured: before start of treatment and 4 weeks following end of treatment , score from 0-10 ,0=no pain , 10= unbearable pain
Change in shoulder range of motion
electro goniometer
Measured: before start of treatment and 4 weeks following end of treatment
Secondary outcomes (2)
Function of the Upper Limb
Quick DASH Questionnaire score
Measured: before start of treatment and 4 weeks following end of treatment, it measure the disability/symptom section (11 items, scored 1-5)
measure weight in kg and height in cm
Weight and height scale for determining BMI
Measured: before starting the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Bahaaldin Alkadry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386926
- Sponsor's protocol ID
- P.T.REC/012/005075
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- 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 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Shockwave Versus Ultrasound Phonophoresis in Management of Chronic Supraspinatus Tendinitis
- ClinicalTrials.gov ID
- NCT06386926
- Acronym / sponsor ID
- P.T.REC/012/005075
- Conditions
- Supraspinatus Tendinitis
- Keywords
- Shockwave , phonophoresis , supraspinatus tendinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Apr 2024 (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.
Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Other: Electro Therapy23 subjects will Receive radial shockwave by ( Storz Medical /SN:BS.3517 ) for 3 sessions one session per week for four consecutive weeks and conventional physical therapy |
| Experimental group 2 | Experimental | Other: Electro Therapy23 subjects will receive Ultrasound phonophoresis using diclofenac Na+( voltaren) by ( Sonopuls 490 / SN : 36 602 ) for 12 session, 3 sessions per week and same conventional physical therapy |
| Control group | Other | Other: Electro Therapy23 subjects will receive conventional physical therapy modalities in the for 3 sessions per week for 4 weeks in form of Stretching Exercise in form of exercise of posterior shoulder capsule, strengthening exercises all have been recommended as essential for any shoulder rehabilitation program. These exercise include shoulder flexion, scaption. ,Tens applied for 20 minutes per session using (Enraf Nonius (Endomed 482) SN : 36853 ) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years to 60
- with Unilateral Chronic Supraspinatus Tendinitis.
- Tenderness is found over the supraspinatus as it passes sub-acrominal and anterolateral.
- The patient reported with positive Jobe's test (empty can test)
- The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and overhead playing athletes).
Key exclusion criteria (6 listed)
- Case reports, treatments after surgery, did not meet our specified outcome parameters, traumatic incidents,
- Partial tears at surgery
- Massive retracted tears at surgery
- Frozen shoulder.
- Rotator cuff tear.
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 |
|---|---|---|
| Electro Therapyradial shockwave 3 sessions one session per week for four consecutive weeks ,receive Ultrasound phonophoresis using diclofenac Na+ 12 session, 3 sessions per week and conventional physical therapy modalities in the form of 3 sessions every week for 8 weeks | Other | Control group, Experimental group 1, Experimental group 2 |
Primary outcome
change in the thickness of supraspinatus tendon
Time frame: before start of treatment and 4 weeks following end of treatment
Ultrasonography
change in pain intesity
Time frame: before start of treatment and 4 weeks following end of treatment , score from 0-10 ,0=no pain , 10= unbearable pain
VAS ( visual analog scale score)
Change in shoulder range of motion
Time frame: before start of treatment and 4 weeks following end of treatment
electro goniometer
2 secondary outcomes
Function of the Upper Limb
Time frame: before start of treatment and 4 weeks following end of treatment, it measure the disability/symptom section (11 items, scored 1-5)
measure weight in kg and height in cm
Time frame: before starting the assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro Therapy in people with Supraspinatus Tendinitis, run by Cairo 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 6 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 Apr 2024. 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 Shady Alkadry (+201128398533, shad.bahaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the thickness of supraspinatus tendon (time frame: before start of treatment and 4 weeks following end of treatment). 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 Apr 2024.