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

NCT05192746 | Unknown

• 1 other identifier: P.T.REC/120/03319
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Supraspinatus Tendinitis

Keywords

extracorporeal shock wave; high power pain threshold ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

group A "Control group"

EXPERIMENTAL

Twenty two patients will receive conventional treatment hot pack and exercise (control group). .

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.

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

Device: high power pain threshold ultrasound

Interventions

control group OTHER

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.

group A "Control group"

extracorporeal shock wave therapy DEVICE

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

group B"Extracorporeal shock wave group":

high power pain threshold ultrasound DEVICE

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,

Group C"High power pain threshold ultrasound group":

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Control Groups; Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: pre post intervention study

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: January 14, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share