Comparison of Impar Ganglion Block and Sacral Erector Spinae Plane Block in Patients with Coccygodynia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

Coccygodynia is a condition that causes pain in the tailbone (coccyx) area. While it can develop after trauma, such as a fall or fracture, in some cases, no clear cause is identified. Patients who do not experience relief from standard treatments like pain medications, physical therapy, and posture adjustments may be referred to specialized pain management clinics for further treatment options.

Several interventional procedures can help manage coccygodynia. These include impar ganglion block, radiofrequency ablation, caudal epidural steroid injections, sacral erector spinae plane (ESP) block, and coccygeal nerve blocks. These procedures are commonly performed in pain treatment centers and aim to reduce discomfort by targeting specific nerves responsible for transmitting pain signals.

Impar ganglion block is one of the most frequently used treatments for coccygodynia. It involves injecting a local anesthetic, with or without steroids, into a small nerve cluster in front of the sacrococcygeal joint. This procedure is performed under ultrasound and/or fluoroscopic (X-ray) guidance in a sterile operating room setting to ensure accuracy and safety. While the goal is to relieve pain, potential risks include temporary worsening of pain, bleeding, infection, or, in rare cases, rectal injury.

Another interventional option is the sacral erector spinae plane (ESP) block, a technique that delivers local anesthetic under the erector spinae muscles in the sacrum. This procedure, also performed under ultrasound guidance in a sterile environment, is used to block pain signals from the coccyx and surrounding areas. Like the impar ganglion block, it can be effective for pain relief, but possible side effects include temporary pain increase, bleeding, and infection at the injection site.

Both procedures are minimally invasive.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those who have had chronic coccygodynia for at least 3 months

Being between the ages of 18-65

Patients who do not respond to conservative treatments (analgesics, physical therapy modalities etc.) and are scheduled for interventional pain procedures

Disqualifiers

Patients who have undergone surgery to the coccyx region

Having undergone an interventional pain procedure in the lumbar, sacral and coccyx regions within the last year

Patients with systemic infection, local infection at the application site, and coagulopathy

Pregnant and breastfeeding patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ganglion Impar Block

    Procedure/Surgery

    Block of the ganglion impar is performed by injecting a mixture of steroid and local anaesthetic in front of the sacrococcygeal joint. This procedure is performed in a sterile operating theatre under ultrasound and/or fluoroscopic (X-ray) guidance. Radiopaque agents are also used during the procedure to confirm the location.

  • Sacral Erector Spinae Plane Block

    Procedure/Surgery

    The sacral erector spina plan block is performed with ultrasound guidance by injecting a high volume mixture of local anaesthetic and steroid into the fascia under the erector spina muscles in the sacral region.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Ganglion İmpar Block GroupActive comparator 1 intervention
Group B: Sacral Erector Spinae Plane BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Rating Scale

The Numeric Rating Scale (NRS) is an 11-point scale (0-10) used to assess pain intensity, with 0 indicating 'no pain' and 10 representing 'worst possible pain.

Time frame
Preprocedural, Week 1, Week 4, Week 12

Secondary outcomes

1

Short Form-12

The Short Form-12 (SF-12) is a validated questionnaire assessing health-related quality of life. It generates separate Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, where higher scores indicate better physical and mental health, while lower scores reflect poorer health status.

Time frame
Preprocedural, Week 1, Week 4, Week 12
2

Pain-free sitting duration

Patients will be asked to assess and record their pain-free sitting durations on the hard and soft surfaces they regularly use during pre-procedural and post-procedural follow-ups. They will be specifically instructed to perform these assessments using the same hard and soft surfaces each time.

Time frame
Preprocedural, Week 1, Week 4, Week 12
3

Oswetry Disability Index

The Oswestry Disability Index (ODI) was used to assess the degree of disability. The ODI consists of 10 items, evaluating pain intensity, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling, and pain-related distress.

Time frame
Preprocedural, Week 1, Week 4, Week 12

Other outcomes

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