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CoccydyniaPhase 3NCT07060313

TARGETING DUAL PATHWAYS IN REFRACTORY COCCYDYNIA

A Phase 3 study testing Ganglion Impar Block and Ganglion Impar Block and Pericoccygeal Injection in people with Coccydynia, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Coccydynia
What is being tested?
Ganglion Impar Block and Ganglion Impar Block and Pericoccygeal Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 2 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University Istanbul Kanuni Sultan Süleyman Training and Research Hospital

    Istanbul, 34303

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Data Collection Data were extracted from patient files following ethical approval. Recorded information included demographic details (age, sex), body mass index (BMI), symptom duration, comorbidities, prior medical treatments, procedure details, coccydynia etiology, and outcome measures.

Outcome Measures Pain Assessment with the Numeric Rating Scale (NRS-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.

Oswestry Disability Index (ODI) Functional disability was assessed using the Oswestry Disability Index (ODI), a validated questionnaire designed to evaluate the impact of pain on daily functioning. The ODI consists of 10 domains-pain intensity, lifting, self-care, walking, sitting, sexual function, standing, social life, sleep quality, and travel-each scored on a 0-5 scale. The total score is expressed as a percentage (0-100%), with higher scores indicating greater disability. This comprehensive tool captures the multidimensional impact of pain on patients' lives . ODI scores were collected pre-procedure and at 1 and 3 months post-procedure to monitor improvements in functional capacity following the intervention.

The Paris Functional Coccydynia Impact Questionnaire (PFCIQ) To specifically address coccyx-related functional limitations, the Paris Functional Coccydynia Impact Questionnaire (PFCIQ) was employed. This targeted questionnaire evaluates the unique challenges associated with coccydynia, including difficulties with sitting, standing, or performing activities that exacerbate coccyx pain. The PFCIQ provides a detailed assessment of how coccyx-specific impairments affect patients' quality of life and daily activities. Like the other metrics, PFCIQ scores were recorded before the procedure and at 1 and 3 months post-procedure, enabling a focused evaluation of the intervention's impact on coccyx-related functional outcomes.

Ethical Considerations The study was approved by the institutional ethics committee of Kanuni Sultan Süleyman Training and Research Hospital on 26/09/2024 (ID: KAEK/2024.09.200). As it is a retrospective cohort study, no additional patient consent beyond routine clinical consent was required. Data collection occurred between October 1, 2024, and December 1, 2024.

Conditions
Coccydynia
Being tested
Ganglion Impar Block, Ganglion Impar Block and Pericoccygeal Injection
Keywords
Coccydynia, Spinal Injections, Pain Management
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ganglion Impar BlockProcedure or surgery

    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 and Pericoccygeal InjectionProcedure or surgery

    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.

Study groups in NCT07060313
Study groupRoleWhat they receive
Ganglion Impar Block GroupActive comparatorThis group of participants received ganglion impar block only.
Receives: Procedure: Ganglion Impar Block
Combination Therapy GroupActive comparatorThis group of participants underwent pericoccygeal injection in addition to impar block.
Receives: Procedure: Ganglion Impar Block and Pericoccygeal Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Oswestry Disability Index (ODI)

    Functional disability was assessed using the Oswestry Disability Index (ODI), a validated questionnaire designed to evaluate the impact of pain on daily functioning. The ODI consists of 10 domains-pain intensity, lifting, self-care, walking, sitting, sexual function, standing, social life, sleep quality, and travel-each scored on a 0-5 scale. The total score is expressed as a percentage (0-100%), with higher scores indicating greater disability. This comprehensive tool captures the multidimensional impact of pain on patients' lives. ODI scores were collected pre-procedure and at 1 and 3 months post-procedure to monitor improvements in functional capacity following the intervention.

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

  2. The Paris Functional Coccydynia Impact Questionnaire (PFCIQ)

    To specifically address coccyx-related functional limitations, the Paris Functional Coccydynia Impact Questionnaire (PFCIQ) was employed. This targeted questionnaire evaluates the unique challenges associated with coccydynia, including difficulties with sitting, standing, or performing activities that exacerbate coccyx pain. The PFCIQ provides a detailed assessment of how coccyx-specific impairments affect patients' quality of life and daily activities. Like the other metrics, PFCIQ scores were recorded before the procedure and at 1 and 3 months post-procedure, enabling a focused evaluation of the intervention's impact on coccyx-related functional outcomes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start1 Jun 2022
  3. Primary completion1 Jun 2024
  4. Study completion2 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060313
Sponsor's protocol ID
Health Sciences University
Status last verified
Jul 2025
First submitted
8 Jul 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39398734
  • 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.

    PubMed 34966017

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ganglion Impar Block and Ganglion Impar Block and Pericoccygeal Injection in people with Coccydynia, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assessment with Numeric Rating Scale 11 (time frame: From the beginning of the treatment to the 3 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060313, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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