Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy in Supraspinatus Tendinitis (RESWTHPPTU)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Supraspinatus Tendinitis
• Intervention / Treatment: Other: control group; Device: extracorporeal shock wave therapy; Device: high power pain threshold ultrasound

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A "Control group"; Twenty two patients will receive conventional treatment hot pack and exercise (control group). .	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.
Experimental: group B"Extracorporeal shock wave group": Twenty two patients will receive Radial Extra corporeal Shock Wave Therapy plus conventional treatment hot pack and exercise.	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
Experimental: Group C"High power pain threshold ultrasound group": Twenty two patients will receive High-Power Pain Threshold Ultrasound therapy plus conventional treatment hot pack and exercise	Device: 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
2.range of motion	range of motion will be measured by gravititional inclinometer	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: January 1, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 1, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: high power pain threshold ultrasound; extracorporeal shock wave
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: P.T.REC/120/03319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No