Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.

November 28, 2022 updated by: Volkan Şah, Yuzuncu Yıl University

Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65040
        • Volkan Şah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

  • other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Large-Focused Extracorporeal Shock Wave Therapy
Device: Extracorporeal Shock Wave Therapy (ESWT)
The ESWT device is product of Elettronica Pagani, Italy.
Sham Comparator: Sham Extracorporeal Shock Wave Therapy
Device: Extracorporeal Shock Wave Therapy (ESWT)
The ESWT device is product of Elettronica Pagani, Italy.
Active Comparator: Controlled-Unfocused Extracorporeal Shock Wave Therapy
Device: Extracorporeal Shock Wave Therapy (ESWT)
The ESWT device is product of Elettronica Pagani, Italy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: at baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
at baseline.
Visual Analogue Scale (VAS)
Time Frame: 4 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
4 weeks after baseline.
Visual Analogue Scale (VAS)
Time Frame: 8 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
8 weeks after baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: at baseline.
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
at baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 4 weeks after baseline.
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
4 weeks after baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 8 weeks after baseline.
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
8 weeks after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Van Yuzuncu Yil University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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