NCT05176431

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

28 days

First QC Date

November 30, 2021

Last Update Submit

May 25, 2022

Conditions

Coccyx Disorder

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    pain evaluation, higher scores mean a worse outcome.

    1 minute

  • Oswestry Disability Index

    functional status of low back pain, higher scores mean a worse outcome.

    5 minutes

Study Arms (3)

Focused extracorporeal shock wave therapy

ACTIVE COMPARATOR
Device: ESWT (wave type: focused)

Radial extracorporeal shock wave therapy

ACTIVE COMPARATOR
Device: ESWT (wave type: radial)

Sham extracorporeal shock wave therapy

SHAM COMPARATOR
Device: ESWT (wave type: sham)

Interventions

ESWT (wave type: focused)DEVICE

Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy

Focused extracorporeal shock wave therapy
ESWT (wave type: radial)DEVICE

Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

Radial extracorporeal shock wave therapy
ESWT (wave type: sham)DEVICE

Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy

Sham extracorporeal shock wave therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2021

First Posted

January 4, 2022

Study Start

February 1, 2022

Primary Completion

March 1, 2022

Study Completion

April 25, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)