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

NCT ID: NCT05192746

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-10-31

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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A "Control group"

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

.

Group Type: EXPERIMENTAL

control group

Intervention Type: 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 B"Extracorporeal shock wave group":

Twenty two patients will receive Radial Extra corporeal Shock Wave Therapy plus conventional treatment hot pack and exercise.

Group Type: EXPERIMENTAL

extracorporeal shock wave therapy

Intervention Type: 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 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

Group Type: EXPERIMENTAL

high power pain threshold ultrasound

Intervention Type: 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,

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: 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,

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hayam Hamza

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/120/03319

Identifier Type: -

Identifier Source: org_study_id