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Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shock Wave Therapy
Ultrasound
Sponsored by
Universitatea de Medicina si Farmacie Iuliu Hatieganu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

  • other disorders that are contraindications for shockwave or ultrasound application

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment group

    Control group

    Arm Description

    Shock Wave therapy on the affected hip, for 10 days, 1 application every 2 days

    Ultrasound therapy on the affected hip, for 10 days, 1 application daily

    Outcomes

    Primary Outcome Measures

    change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days
    10mm to 100mm, higher scores mean a worse outcome

    Secondary Outcome Measures

    change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days
    24-item questionnaire for osteoarthritis, higher scores mean a worse outcome

    Full Information

    First Posted
    December 16, 2019
    Last Updated
    December 19, 2019
    Sponsor
    Universitatea de Medicina si Farmacie Iuliu Hatieganu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04206722
    Brief Title
    Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
    Official Title
    Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitatea de Medicina si Farmacie Iuliu Hatieganu

    4. Oversight

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

    5. Study Description

    Brief Summary
    The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.
    Detailed Description
    The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Shock Wave therapy on the affected hip, for 10 days, 1 application every 2 days
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound therapy on the affected hip, for 10 days, 1 application daily
    Intervention Type
    Device
    Intervention Name(s)
    Shock Wave Therapy
    Intervention Description
    Shock Wave therapy - hip osteoarthritis program
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Intervention Description
    Ultrasound 0.7W/cm2
    Primary Outcome Measure Information:
    Title
    change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days
    Description
    10mm to 100mm, higher scores mean a worse outcome
    Time Frame
    at baseline, after 10 days, after 30 days
    Secondary Outcome Measure Information:
    Title
    change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days
    Description
    24-item questionnaire for osteoarthritis, higher scores mean a worse outcome
    Time Frame
    at baseline, after 10 days, after 30 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: unilateral or bilateral hip osteoarthritis Exclusion Criteria: other disorders that are contraindications for shockwave or ultrasound application
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Irsay Laszlo, MD, PhD
    Organizational Affiliation
    University of Medicine and Pharmacy Iuliu Hatieganu
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    upon request

    Learn more about this trial

    Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis

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