Supraspinatus TendinitisRESWTHPPTUNCT05192746
Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy in Supraspinatus Tendinitis
A study testing extracorporeal shock wave therapy and high power pain threshold ultrasound in people with Supraspinatus Tendinitis, run by Cairo University.
Trial summary
Extra corporeal shock wave therapy is a treatment method in which high-amplitude sound waves are focused on the targeted body tissue Recently, Extra corporeal shock wave therapy has been proposed as an alternative treatment in patients not responding to pharmaceutical treatment.High power pain threshold ultrasound is… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Supraspinatus Tendinitis
- What is being tested?
- extracorporeal shock wave therapy and high power pain threshold ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Oct 2022
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' age ranges from 30 to 50 years old.
- Patients are males and females.
- BMI of all subjects were <30 Kg/m2.
- Patients will be diagnosed as supraspinatus tendinitis.
- All patients are medically stable.
- All patients should be conscious and ambulant.
Show all 9Show fewer
- Patients don't have any nervous system problems
- Patients don't have shoulder disorder other than tendenities
- Patients that didn't undergo any surgery in shoulder joint
Who cannot join
- • Patients who received intra articular injection from duration less than 3 months.
- Patients with supraspinatus tendonitis secondary to trauma.
- Patients with metal implants.
- Patient who had malignancy in the affected area.
- Patient with acute infection in the treated area.
- Diabetic patients
Show all 11Show fewer
- Bone infection
- Shoulder instability
- Epilepsy
- Coagulation diseases
- Rheumatological diseases (rheumatoid arthritis and gouty arthritis)
About this study
Official title: Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy on Pain,Pressure Threshold Supraspinatus Trigger Point
Extra corporeal shock wave therapy is a treatment method in which high-amplitude sound waves are focused on the targeted body tissue Recently, Extra corporeal shock wave therapy has been proposed as an alternative treatment in patients not responding to pharmaceutical treatment.High power pain threshold ultrasound is the use of therapeutic ultrasound in a continuous mode; with the probe placed directly on affected area (supraspinatus tendon)
Read the detailed description
Shock wave therapy is an effective method of dissolving calcification and stimulating tissue healing. Extra corporeal shock wave therapy is a treatment method in which high-amplitude sound waves are focused on the targeted body tissue Recently, Extra corporeal shock wave therapy has been proposed as an alternative treatment in patients not responding to pharmaceutical treatment.US have been widely used for more than 40 years in the treatment of musculoskeletal disorders such as tendinitis, tenosynovitis, epicondylitis, bursitis and osteoarthritis. High power pain threshold ultrasound is the use of therapeutic ultrasound in a continuous mode; with the probe placed directly on affected area (supraspinatus tendon) "the intensity of ultrasound is first increased to the threshold pain level (to 1.5 W/cm) and then reduced to one half of that intensity. It was kept at that level for 4 to 5 seconds and then reduced to the half-intensity level for another 15 seconds .
- Conditions
- Supraspinatus Tendinitis
- Being tested
- control group, extracorporeal shock wave therapy, high power pain threshold ultrasound
- Keywords
- extracorporeal shock wave, high power pain threshold ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
Exercise Therapy and hot pack This tendon exercise program is very effective if done consistently. There are five steps to the program: warm up, stretching exercise, strengthening exercise, stretching exercise, and heat.
extracorporeal shock wave therapyDevice
Shock Master 500 device will be applied once a week for four weeks in total. Each treatment consists of 2000 shocks 3 bar pressure, 20 Hz. Each rESWT session will take about 10 minutes. rESWT application will be performed on the supraspinatus trigger point. In successive treatments, there will be using of an energy density equal to 0.28 mJ/mm2
high power pain threshold ultrasoundDevice
High-power, pain-threshold, ultrasound therapy application (in W/cm2) in continuousmodes, to elicit threshold pain, the ultrasound probe must be kept static on the tendon.
Intensity will be gradually increased to the level of maximum pain the patient could bear. It will be kept at that level for 4 to 5 seconds and then will be reduced to the half-intensitylevel for another 15 seconds. This procedure will be repeated 3 times.High-power,
| Study group | Role | What they receive |
|---|---|---|
| group A "Control group" | Experimental | Twenty two patients will receive conventional treatment hot pack and exercise (control group).
. Receives: Other: control group |
| group B"Extracorporeal shock wave group": | Experimental | Twenty two patients will receive Radial Extra corporeal Shock Wave Therapy plus conventional treatment hot pack and exercise. Receives: Device: extracorporeal shock wave therapy |
| Group C"High power pain threshold ultrasound group": | Experimental | Twenty two patients will receive High-Power Pain Threshold Ultrasound therapy plus conventional treatment hot pack and exercise Receives: Device: high power pain threshold ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. pain intensity[Time Frame:]
pain will be measured by visual analogue scale higher score mean worse outcome ten centimeter line from zero to ten, zero mean no pain and ten mean maximum pain
Measured: up to four weeks
2.range of motion
range of motion will be measured by gravititional inclinometer
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (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
- Model description
- pre post intervention study
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Hamza, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192746
- Sponsor's protocol ID
- P.T.REC/120/03319
- Acronym
- RESWTHPPTU
- Status last verified
- Dec 2021
- First submitted
- 27 Oct 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy on Pain,Pressure Threshold Supraspinatus Trigger Point
- ClinicalTrials.gov ID
- NCT05192746
- Acronym / sponsor ID
- RESWTHPPTU / P.T.REC/120/03319
- Conditions
- Supraspinatus Tendinitis
- Keywords
- extracorporeal shock wave, high power pain threshold ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 14 Jan 2022 (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.
Extra corporeal shock wave therapy is a treatment method in which high-amplitude sound waves are focused on the targeted body tissue Recently, Extra corporeal shock wave therapy has been proposed as an alternative treatment in patients not responding to pharmaceutical treatment.High power pain threshold ultrasound is the use of therapeutic ultrasound in a continuous mode; with the probe placed directly on affected area (supraspinatus tendon)
Detailed description
Shock wave therapy is an effective method of dissolving calcification and stimulating tissue healing. Extra corporeal shock wave therapy is a treatment method in which high-amplitude sound waves are focused on the targeted body tissue Recently, Extra corporeal shock wave therapy has been proposed as an alternative treatment in patients not responding to pharmaceutical treatment.US have been widely used for more than 40 years in the treatment of musculoskeletal disorders such as tendinitis, tenosynovitis, epicondylitis, bursitis and osteoarthritis. High power pain threshold ultrasound is the use of therapeutic ultrasound in a continuous mode; with the probe placed directly on affected area (supraspinatus tendon) "the intensity of ultrasound is first increased to the threshold pain level (to 1.5 W/cm) and then reduced to one half of that intensity. It was kept at that level for 4 to 5 seconds and then reduced to the half-intensity level for another 15 seconds .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- pre post intervention study
| Arm | Type | Receives |
|---|---|---|
| group A "Control group" | Experimental | Other: control groupTwenty two patients will receive conventional treatment hot pack and exercise (control group). . |
| group B"Extracorporeal shock wave group": | Experimental | Device: extracorporeal shock wave therapyTwenty two patients will receive Radial Extra corporeal Shock Wave Therapy plus conventional treatment hot pack and exercise. |
| Group C"High power pain threshold ultrasound group": | Experimental | Device: high power pain threshold ultrasoundTwenty two patients will receive High-Power Pain Threshold Ultrasound therapy plus conventional treatment hot pack and exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients' age ranges from 30 to 50 years old.
- Patients are males and females.
- BMI of all subjects were <30 Kg/m2.
- Patients will be diagnosed as supraspinatus tendinitis.
- All patients are medically stable.
Key exclusion criteria (11 listed)
- • Patients who received intra articular injection from duration less than 3 months.
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 |
|---|---|---|
| control groupExercise Therapy and hot pack This tendon exercise program is very effective if done consistently. There are five steps to the program: warm up, stretching exercise, strengthening exercise, stretching exercise, and heat. | Other | group A "Control group" |
| extracorporeal shock wave therapyShock Master 500 device will be applied once a week for four weeks in total. Each treatment consists of 2000 shocks 3 bar pressure, 20 Hz. Each rESWT session will take about 10 minutes. rESWT application will be performed on the supraspinatus trigger point. In successive treatments, there will be using of an energy density equal to 0.28 mJ/mm2 | Device | group B"Extracorporeal shock wave group": |
| high power pain threshold ultrasoundHigh-power, pain-threshold, ultrasound therapy application (in W/cm2) in continuousmodes, to elicit threshold pain, the ultrasound probe must be kept static on the tendon. Intensity will be gradually increased to the level of maximum pain the patient could bear. It will be kept at that level for 4 to 5 seconds and then will be reduced to the half-intensitylevel for another 15 seconds. This procedure will be repeated 3 times.High-power, | Device | Group C"High power pain threshold ultrasound group": |
Primary outcome
1. pain intensity[Time Frame:]
Time frame: up to four weeks
pain will be measured by visual analogue scale higher score mean worse outcome ten centimeter line from zero to ten, zero mean no pain and ten mean maximum pain
2.range of motion
Time frame: up to four weeks
range of motion will be measured by gravititional inclinometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Supraspinatus Tendinitis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
HILT vs ESWT in Supraspinatus Tendinitis
Supraspinatus Tendinitis
Recruiting
Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Blood Flow Restriction Therapy and Eccentric Exercise in Patients of Supraspinatus Tendinitis.
Supraspinatus Tendinitis
Recruiting
Reverse Fly Exercise On Supraspinatus Tendinitis In Patients Receiving Aromatase Inhibitors Therapy After Mastectomy
Mastectomy, Aromatase Inhibitors Therapy
Active, not recruiting
Anatomical Evaluation of Supraspinatus Through Ultrasonography and Biomechanical Measurements Following Different Combinations of Physical Therapies in Patients of Supraspinatus Tendinitis
Supraspinatus Tendinitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shock wave therapy and high power pain threshold ultrasound in people with Supraspinatus Tendinitis, run by Cairo University.
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 9 inclusion and 11 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. pain intensity[Time Frame:] (time frame: up to four weeks). The study lists 2 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 14 Jan 2022.