NCT05157022

Brief Summary

Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device

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 Aug 2021

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

Study Start

First participant enrolled

August 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

October 13, 2021

Last Update Submit

April 27, 2022

Conditions

Coccyx Injury

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    pain evaluation, higher scores mean worse outcome.

    1 minute

  • Oswestry Low Back Pain Disability Questionnaire

    higher scores mean better outcome.

    5 minutes

Study Arms (3)

Focus extracorporeal shock wave therapy

ACTIVE COMPARATOR

A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area

Device: ESWT

Radial extracorporeal shock wave therapy

ACTIVE COMPARATOR

A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area

Device: ESWT

Sham extracorporeal shock wave therapy

SHAM COMPARATOR

A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area

Device: ESWT

Interventions

ESWTDEVICE

Extracorporeal Shock-wave Therapy

Focus extracorporeal shock wave therapyRadial extracorporeal shock wave therapySham 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)

Yüzüncü Yıl Üniversitesi Tıp Fakültesi

Van, 65080, Turkey (Türkiye)

Location

Study Officials

  • Volkan Şah

    Yüzüncü Yıl Üniversitesi Tıp Fakültesi

    STUDY DIRECTOR

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

October 13, 2021

First Posted

December 14, 2021

Study Start

August 15, 2021

Primary Completion

March 15, 2022

Study Completion

April 27, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

TU(1)