NCT06242587

Brief Summary

The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

January 13, 2024

Last Update Submit

March 7, 2024

Conditions

Coccyx InjuryCoccygeal Body Tumor

Keywords

CoccigodyniaCoccigeal pain treatmentPericoccigeal nerve blockImpar ganglion block

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    A Visual Analogue Scale (VAS) is the pain rating scales. Numbers 0-10 represent the severity of the patients' pain. No pain : 0, Most severe pain : 10

    Before treatment, week 4 and week 12

Secondary Outcomes (1)

  • PARIS coccidini scale

    Before treatment, week 4 and week 12

Study Arms (2)

Group Pericoccygeal block

ACTIVE COMPARATOR

Patients undergoing pericoccygeal block

Device: Pericoccygeal nerve block

Group Impar ganglion block

ACTIVE COMPARATOR

Patients undergoing impar ganglion block

Procedure: Impar ganglion block

Interventions

Pericoccygeal nerve blockDEVICE

The coccygeal corneas are visualised with a linear probe under ultrasound guidance. The pericoccygeal nerves are located medial to the cornu and a combination of local anaesthetic and dexamethasone is injected.

Group Pericoccygeal block
Impar ganglion blockPROCEDURE

The sacrum is visualised with fluoroscopy. A needle is inserted through the sacrococcygeal junction. The optimal image is obtained by administering contrast material. A combination of local anaesthetic and dexamethasone is injected.

Group Impar ganglion block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coccygeal pain

You may not qualify if:

  • Malignite
  • Infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gevher Rabia Genç Perdecioğlu

Ankara, Çankaya, 06010, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 13, 2024

First Posted

February 5, 2024

Study Start

November 2, 2023

Primary Completion

April 18, 2024

Study Completion

May 19, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

TU(1)