Comparing the Treatment Outcomes of Two Interventional Pain Procedures in Chronic Coccygodynia
Condition: Tailbone Disorders
Study type: Interventional

Summary: 
      Coccygodynia is a disabling pain in the coccyx exacerbated by sitting or rising from sitting.
      The pain is often pulling or lancinating in quality, may radiate to the sacrum or buttock,
      and may coexist with lower back pain. Contributing of many physiologic and psychological
      factors to its etiology, it may be traumatic or idiopathic in origin. Many risk factors are
      known such as trauma, female gender and obesity. Despite the identification of chronic
      coccygeal pain hundreds of years ago, its treatment can be difficult and sometimes
      controversial because of the multifactorial nature of coccygeal pain. Most cases of
      coccygodynia resolve within weeks to months with or without conservative treatment, but for a
      few patients, the pain can become chronic and debilitating. First-line treatment options
      include analgesic drugs, cushion, sit baths, and manuel therapy. Interventional procedures
      for pain management can be applied to patients who have no response to other conservative
      modalities. Ganglion impar block and caudal epidural steroid injection are two treatment
      options for chronic coccygodynia and both of them can be applied by guidance of fluoroscopy
      and ultrasonography. Radiofrequency ablation is the other option for treatment and
      eventually, surgical intervention can be done for patients who have refractory pain despite
      other treatments.

      Although efficacy of two interventional procedure for chronic coccygodynia, ganglion impar
      block and caudal epidural steroid injection, has been well known, no study is exist comparing
      the efficacy of them. We aimed to compare the efficacy of ganglion impar block and caudal
      epidural steroid injection in chronic coccygodynia.
    

Detailed description: 
      The main purpose of this prospective study is the compare the efficacy of fluoroscopy-guided
      ganglion impar block and caudal epidural steroid injection in patients with chronic
      coccygodynia. Patients with chronic coccygeal pain are randomly divided into two groups based
      on the type of the interventional procedure: Group A, fluoroscopy-guided ganglion impar block
      group and, group B, fluoroscopy-guided caudal epidural steroid injection group. The patients
      who have chronic coccygeal pain not responding to other conservative treatments will be
      recruited from physical medicine&rehabilitation and pain medicine outpatient clinics.
      Detailed information including all aspects of interventional procedures will be given to
      patients, and inform consent will be obtained. Pain severity will be assessed using Numerical
      Rating Scale (NRS) as primary outcome. Quality of life and neuropathic pain component will be
      evaluated with Short Form-12 (SF-12) Questionnaire and Leeds Assessment of Neuropathic
      Symptoms&Signs Pain Scale (LANSS) as secondary outcomes, respectively. All assessments will
      be done at pre-interventional period, three weeks and three months after the procedure, with
      the exception of NRS, it will be also assessed at first hour post-procedure. All assessments
      will be done by clinician blinding the treatment groups.
    

Intervention name(s): Fluoroscopy-guided ganglion impar block; Fluoroscopy-guided caudal epidural steroid injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Being most commonly used technic, transsacrococcygeal technique, a 22-gauge, 1.5-inch spinal needle is advanced through the sacrococcygeal disk and positioned carefully anterior to the sacrococcygeal junction. Injection of contrast results in a classical comma sign. A mixture of steroid and local anesthetic is given.; Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. An 18-gauge epidural needle (Tuohy) is advanced at an angle of 45° to the skin until a 'give-way' sensation is felt and position of the needle is confirmed by lateral and anteroposterior fluoroscopic images. Then 5 ml of iohexol solution is injected through it to confirm the position. A properly placed needle would produce a classical 'inverted fern tree' appearance in anteroposterior view after dye injection or a 'filling defect'. The needle is introduced up to S3 level for proper spread of the drug. A mixture of steroid and local anesthetics is given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment