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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05192746
Other study ID # P.T.REC/120/03319
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date October 2022

Study information

Verified date December 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 the use of therapeutic ultrasound in a continuous mode; with the probe placed directly on affected area (supraspinatus tendon)


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - 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. - 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 Exclusion Criteria: - • 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 - Bone infection - Shoulder instability - Epilepsy - Coagulation diseases - Rheumatological diseases (rheumatoid arthritis and gouty arthritis)

Study Design


Intervention

Other:
control group
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.
Device:
extracorporeal shock wave therapy
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 ultrasound
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,

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to four weeks
Primary 2.range of motion range of motion will be measured by gravititional inclinometer up to four weeks
See also
  Status Clinical Trial Phase
Completed NCT05627102 - Structural and Functional Changes in Supraspinatus Tendinopathy Thtough Percutaneous Electrolysis and Neuromodulation Combined Therapy. A Single-blinded Randomized clínical Trial. N/A
Completed NCT03184181 - Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise N/A
Withdrawn NCT05184985 - TrueRelief Efficacy for Supraspinatus Tendonitis N/A
Completed NCT05241977 - MINIMUM EFFECTIVE VOLUME OF BUPIVACAİNE FOR ANTERIOR SUPRASCAPULAR NERVE BLOCK
Completed NCT05793918 - Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy. N/A
Completed NCT04851951 - Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis
Completed NCT03744195 - Effect of Kinesotaping on Management of Supraspinatus Tendinitis N/A