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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05224674

Collaborator

(none)

150

Enrollment

Location

Arms

7.9

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis	Device: Extracorporeal Shock Wave Therapy (ESWT)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 29, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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.
Active Comparator: Controlled-Unfocused 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.

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.

Active Comparator: Controlled-Unfocused 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.

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale (VAS) [at baseline.]
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Visual Analogue Scale (VAS) [4 weeks after baseline.]
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Visual Analogue Scale (VAS) [8 weeks after baseline.]
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) [at baseline.]
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) [4 weeks after baseline.]
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) [8 weeks after baseline.]
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Volkan Şah	Van		Turkey	65040

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

Principal Investigator: Volkan Şah, Yüzüncü Yıl Üniversitesi Tıp Fakültesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Volkan Şah, Principal Investigator, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT05224674

Other Study ID Numbers:

Van Yuzuncu Yil University

First Posted:

Feb 4, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Hip

Study Results

No Results Posted as of Aug 16, 2022