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

Primary Purpose

Supraspinatus Tendinitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
control group
extracorporeal shock wave therapy
high power pain threshold ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraspinatus Tendinitis focused on measuring extracorporeal shock wave, high power pain threshold ultrasound

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    group A "Control group"

    group B"Extracorporeal shock wave group":

    Group C"High power pain threshold ultrasound group":

    Arm Description

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

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

    Twenty two patients will receive High-Power Pain Threshold Ultrasound therapy plus conventional treatment hot pack and exercise

    Outcomes

    Primary Outcome Measures

    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
    2.range of motion
    range of motion will be measured by gravititional inclinometer

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2021
    Last Updated
    January 1, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05192746
    Brief Title
    Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy in Supraspinatus Tendinitis
    Acronym
    RESWTHPPTU
    Official Title
    Radial Extracorporeal Shock Wave Therapy Versus High Power Pain Threshold Ultrasound Therapy on Pain,Pressure Threshold Supraspinatus Trigger Point
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Supraspinatus Tendinitis
    Keywords
    extracorporeal shock wave, high power pain threshold ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    pre post intervention study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A "Control group"
    Arm Type
    Experimental
    Arm Description
    Twenty two patients will receive conventional treatment hot pack and exercise (control group). .
    Arm Title
    group B"Extracorporeal shock wave group":
    Arm Type
    Experimental
    Arm Description
    Twenty two patients will receive Radial Extra corporeal Shock Wave Therapy plus conventional treatment hot pack and exercise.
    Arm Title
    Group C"High power pain threshold ultrasound group":
    Arm Type
    Experimental
    Arm Description
    Twenty two patients will receive High-Power Pain Threshold Ultrasound therapy plus conventional treatment hot pack and exercise
    Intervention Type
    Other
    Intervention Name(s)
    control group
    Intervention Description
    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
    Device
    Intervention Name(s)
    extracorporeal shock wave therapy
    Intervention Description
    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
    Intervention Name(s)
    high power pain threshold ultrasound
    Intervention Description
    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,
    Primary Outcome Measure Information:
    Title
    1. pain intensity[Time Frame:]
    Description
    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
    Time Frame
    up to four weeks
    Title
    2.range of motion
    Description
    range of motion will be measured by gravititional inclinometer
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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