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Comparison of Treatment Outcomes in Chronic Coccygodynia Patients Treated With Ganglion Impar Blockade Versus Caudal Epidural Steroid Injection: A Prospective Randomized Comparison Study
Sponsor study identifier
interventional
97
1 country
1
Study Start
June 1, 2019
Actual (reported)Primary Completion
January 1, 2021
Actual (reported)Study Completion
March 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2019
Actual (reported)January 1, 2021
Actual (reported)March 1, 2021
Actual (reported)May 21, 2021
Actual (reported)May 26, 2021
Actual (reported)Change in pain severity of patients from baseline to each checkpoints
Defining the change in Numeric Rating Scale (NRS) score
from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
Change in number of patients with neuropathic pain from baseline to each checkpoints
from pre-interventional time to post-interventional 3rd week, 3rd month
Change the patient reported quality of life assessment from baseline to each checkpoints
from pre-interventional time to post-interventional 3rd week, 3rd month
Fluoroscopy-guided ganglion impar block is applied to patients in this group.
Fluoroscopy-guided caudal epidural steroid injection is applied to patients in this group.
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.
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899, Turkey (Türkiye)
Savas Sencan, MD
Marmara University
97 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2021
First Posted
May 26, 2021
Study Start
June 1, 2019
Actual (reported)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.
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Primary Completion
January 1, 2021
Actual (reported)Study Completion
March 1, 2021
Actual (reported)Last Updated
May 26, 2021
Record last verified: 2021-05
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