Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index

May 25, 2022 updated by: Volkan Şah, Yuzuncu Yıl University

Comparation of Radial and Focused Extracorporeal Shock Wave Therapies According to Age and Body Mass Index in the Treatment of Coccydynia.

To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.

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
        • Yuzuncu Yil University

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

18 years to 65 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Focused extracorporeal shock wave therapy
Device: ESWT (wave type: focused)
Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy
ACTIVE_COMPARATOR: Radial extracorporeal shock wave therapy
Device: ESWT (wave type: radial)
Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
SHAM_COMPARATOR: Sham extracorporeal shock wave therapy
Device: ESWT (wave type: sham)
Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

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 a worse outcome.
1 minute
Oswestry Disability Index
Time Frame: 5 minutes
functional status of low back pain, higher scores mean a worse outcome.
5 minutes

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)

February 1, 2022

Primary Completion (ACTUAL)

March 1, 2022

Study Completion (ACTUAL)

April 25, 2022

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (ACTUAL)

January 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • University of Yuzuncu Yil

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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