NCT05753514

Brief Summary

The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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

January 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

February 12, 2023

Last Update Submit

March 30, 2023

Conditions

Coccyx Injury

Outcome Measures

Primary Outcomes (1)

  • Management of coccydynia

    Management of coccydynia (pain in the coccyx). The main presenting symptom is pain. its management is the primary goal of treatment. The pain VAS was used to monitor patient response and clinical improvement throughout treatment, with patients ranking the severity of their pain at rest, between "no pain" (0) and "worst imaginable pain" (10). Patients were asked their pain level before treatment at each session; although, this did not form part of our formal data collection. Treatment continued until patients reported a VAS pain level ≤3, at which point they were discharged from the clinic.

    12 months

Study Arms (1)

ESWT

EXPERIMENTAL

Effect of ESWT in alleviating pain

Other: ESWT

Interventions

ESWTOTHER

ESWT

ESWT

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • VAS pain level ≥6
  • Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)

You may not qualify if:

  • Age \<18 years
  • Local or systemic neurological disease
  • Rheumatological disease
  • Malignant disease
  • Previous spinal surgery or spinal disease
  • Coagulopathies
  • Pregnancy
  • VAS pain level \<6
  • Recent (≤6 weeks) trauma to the coccyx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 3, 2023

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share