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Clinical Trials/NCT06242587
NCT06242587Active, not recruitingNot Applicable

Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia

Diskapi Teaching and Research Hospital2 sites in 2 countries32 target enrollmentStarted: November 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
32
Locations
2
Primary Endpoint
Visual analogue scale

Study Overview

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.

Detailed Description

Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Coccygeal pain

Exclusion Criteria

  • Malignite
  • Infection
  • Pregnancy

Arms & Interventions

Group Pericoccygeal block

Active Comparator

Patients undergoing pericoccygeal block

Intervention: Pericoccygeal nerve block (Device)

Group Impar ganglion block

Active Comparator

Patients undergoing impar ganglion block

Intervention: Impar ganglion block (Procedure)

Outcomes

Primary Outcomes

Visual analogue scale

Time Frame: Before treatment, week 4 and week 12

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

Secondary Outcomes

  • PARIS coccidini scale(Before treatment, week 4 and week 12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Damla Yürük

medical doctor

Diskapi Teaching and Research Hospital

Study Sites (2)

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