Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia

April 27, 2022 updated by: Volkan Şah, Yuzuncu Yıl University
Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

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, 65080
        • Yüzüncü Yıl Üniversitesi Tıp Fakültesi

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
  • be aged ≥18 at the time of diagnosis
  • be give informed consent

Exclusion Criteria:

  • Malignancy
  • Those who have received ESWT treatment before
  • Pediatric patients
  • Patients with infection.

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: Focus extracorporeal shock wave therapy
A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area
Device: ESWT
Extracorporeal Shock-wave Therapy
Active Comparator: Radial extracorporeal shock wave therapy
A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area
Device: ESWT
Extracorporeal Shock-wave Therapy
Sham Comparator: Sham extracorporeal shock wave therapy
A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area
Device: ESWT
Extracorporeal Shock-wave Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 1 minute
pain evaluation, higher scores mean worse outcome.
1 minute
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 5 minutes
higher scores mean better outcome.
5 minutes

Collaborators and Investigators

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

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Director: Volkan Şah, Yüzüncü Yıl Üniversitesi Tıp Fakültesi

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)

August 15, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

April 27, 2022

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Yuzuncu Yıl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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