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Clinical Trials/NCT07060313
NCT07060313CompletedPhase 3

TARGETING DUAL PATHWAYS IN REFRACTORY COCCYDYNIA: A COMPARATIVE STUDY OF GANGLION IMPAR BLOCK ALONE VERSUS COMBINED WITH PERICOCCYGEAL INJECTION

Istanbul University1 site in 1 country60 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Pain Assessment with Numeric Rating Scale 11

Study Overview

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.

Detailed Description

Study Design and Population This retrospective study compared the effects of GIB alone versus GIB combined with pericoccygeal injection in coccydynia patients treated at the Pain Clinic of Kanuni Sultan Süleyman Training and Research Hospital. The study cohort was drawn from patients 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. Patients 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 were excluded. A total of 60 patients aged 18-65 years who underwent either GIB or GIB with pericoccygeal injection were included. The sample size was determined using a power analysis (effect size: 0.84, power: 80%, error margin: 5%), based on previously published studies reporting significant differences in pain and functional outcomes following ganglion impar block interventions. Accordingly, a minimum of 30 patients per group was required, and a total of 60 patients were enrolled.

Intervention 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 anterior-posterior and lateral imaging was performed to confirm the appropriate spread of contrast. After this confirmation, 2 mL of 0.5% bupivacaine, 2 mL of saline, and 40 mg of methylprednisolone acetate were injected.

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.

After the procedure, all patients were monitored and observed for at least two hours. Patients who had no additional complaints during follow-up visits were discharged.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

Ganglion Impar Block Group

Active Comparator

This group of participants received ganglion impar block only.

Intervention: Ganglion Impar Block (Procedure)

Combination Therapy Group

Active Comparator

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

Intervention: Ganglion Impar Block and Pericoccygeal Injection (Procedure)

Outcomes

Primary Outcomes

Pain Assessment with Numeric Rating Scale 11

Time Frame: From the beginning of the treatment to the 3 month follow-up

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mert Zure

Mert Zure

Saglik Bilimleri Universitesi

Study Sites (1)

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