Back to resultsComparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.
Primary Purpose
Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (ESWT)
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- unilateral or bilateral hip osteoarthritis
Exclusion Criteria:
- other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before
Sites / Locations
- Volkan Şah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Large-Focused Extracorporeal Shock Wave Therapy
Controlled-Unfocused Extracorporeal Shock Wave Therapy
Sham Extracorporeal Shock Wave Therapy
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Full Information
NCT ID
NCT05224674
First Posted
January 18, 2022
Last Updated
November 28, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05224674
Brief Title
Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.
Official Title
Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in 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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Large-Focused Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Title
Controlled-Unfocused Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Title
Sham Extracorporeal Shock Wave Therapy
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy (ESWT)
Intervention Description
The ESWT device is product of Elettronica Pagani, Italy.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Time Frame
at baseline.
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Time Frame
4 weeks after baseline.
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Time Frame
8 weeks after baseline.
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Time Frame
at baseline.
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Time Frame
4 weeks after baseline.
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Time Frame
8 weeks after baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral or bilateral hip osteoarthritis
Exclusion Criteria:
other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Şah
Organizational Affiliation
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Volkan Şah
City
Van
ZIP/Postal Code
65040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.
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