TARGETING DUAL PATHWAYS IN REFRACTORY COCCYDYNIA

NCT07060313 | Completed Phase 3

• 1 other identifier: Health Sciences University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study included 60 patients aged 18-65 years treated at a tertiary pain clinic between June 2022 and June 2024. Patients received either Ganglion Impar Block (GIB) alone or GIB combined with pericoccygeal injection in a single session under fluoroscopic guidance. Pain severity and functional outcomes were assessed using the Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), and Paris Functional Coccydynia Impact Questionnaire (PFCIQ) before the procedure and at 1 and 3 months post-intervention.

Conditions

Coccydynia

Keywords

Coccydynia; Spinal Injections; Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Assessment with Numeric Rating Scale 11

  Pain levels were measured using the Numeric Rating Scale (NRS-11), a widely recognized tool for quantifying pain intensity. This scale ranges from 0 to 10, where 0 represents no pain and 10 signifies the worst imaginable pain. Patients were asked to rate their pain based on their subjective experience, providing a straightforward and reliable metric for assessing pain severity. The NRS-11 was administered before the procedure and at follow-up intervals of 1 and 3 months post-procedure to track changes in pain levels over time, allowing for a clear evaluation of the intervention's effectiveness in reducing pain.

  From the beginning of the treatment to the 3 month follow-up

Secondary Outcomes (2)

• Oswestry Disability Index (ODI)

  From the beginning of the treatment to the 3 month follow-up

• The Paris Functional Coccydynia Impact Questionnaire (PFCIQ)

  From the beginning of the treatment to the 3 month follow-up

Study Arms (2)

Ganglion Impar Block Group

ACTIVE COMPARATOR

This group of participants received ganglion impar block only.

Procedure: Ganglion Impar Block

Combination Therapy Group

ACTIVE COMPARATOR

This group of participants underwent pericoccygeal injection in addition to impar block.

Procedure: Ganglion Impar Block and Pericoccygeal Injection

Interventions

Ganglion Impar Block PROCEDURE

The ganglion impar was accessed with a Quincke spinal needle, transsacrococcygeally (from between the first and second coccygeal vertebrae if sacrococcygeal access could not be achieved). Then, 1 mL of non-ionic contrast medium was administered, and fluoroscopic anterior-posterior and lateral imaging was performed to confirm the appropriate spread of contrast (Figure 1). After this confirmation, 2 mL of 0.5% bupivacaine, 2 mL of saline, and 40 mg of methylprednisolone acetate were injected.

Ganglion Impar Block Group

Ganglion Impar Block and Pericoccygeal Injection PROCEDURE

In the combination therapy group who underwent pericoccygeal injection in addition to impar block, following the same procedure, 5 mL of 0.25% bupivacaine and 20 mg of methylprednisolone were injected into the posterior pericoccygeal region while the needle was withdrawn, thus also targeting blockade of the anococcygeal nerve.

Combination Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a confirmed diagnosis of coccydynia persistent for at least 3 months as determined by history, clinical examination, and radiological imaging, who had undergone either GIB or GIB with pericoccygeal injection, and had complete medical records available for review between June 2022 and June 2024.

You may not qualify if:

• having a recent intervention (in the past 6 months), morbid obesity (BMI \> 35 kg/m²), severe comorbidities, skin infections, bleeding disorders, pregnancy, or having incomplete records

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Health Sciences University Istanbul Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (2)

• Genc Perdecioglu GR, Yildiz G. Coccygeal Nerve Blockade vs. Impar Ganglion Blockade in Coccydynia: A Randomised Clinical Trial. Cureus. 2024 Sep 10;16(9):e69118. doi: 10.7759/cureus.69118. eCollection 2024 Sep.

  PMID: 39398734 BACKGROUND

• Sencan S, Yolcu G, Bilim S, Kenis-Coskun O, Gunduz OH. Comparison of treatment outcomes in chronic coccygodynia patients treated with ganglion impar blockade versus caudal epidural steroid injection: a prospective randomized comparison study. Korean J Pain. 2022 Jan 1;35(1):106-113. doi: 10.3344/kjp.2022.35.1.106.

  PMID: 34966017 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mert Zure

Model Details: A standard procedure was applied to all patients by the same pain medicine specialist with over 5 years of experience, in a sterile operating room under fluoroscopic guidance and monitored conditions. The patients underwent noninvasive blood pressure monitoring, pulse oximetry, and a five-lead electrocardiogram \[ECG\], and intravenous access was established in the forearm before positioning for the intervention. The position used during the intervention was the prone position, with a pillow placed under the belly. The procedure area was disinfected with povidone-iodine and covered with a sterile drape. Anterior-posterior (AP) imaging was first performed with a C-arm scopy device, which was then placed in the lateral position. The ganglion impar was accessed with a Quincke spinal needle, transsacrococcygeally (from between the first and second coccygeal vertebrae if sacrococcygeal access could not be achieved). Then, 1 mL of non-ionic contrast medium was administered, and fluoroscopic

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 11, 2025
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 2, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

TU (1)