Clinical trial NCT05596448: Coccygeal Nerve Radiofrequency Treatment in Coccydynia
Official title: Investigation of the Efficiency of Coccygeal Nerve Radiofrequency Treatment in Coccydynia'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coccyx Disorder
Keywords: coccydinia
coccygeal nerve
radiofrequency ablation
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coccydynia or coccygeal pain is a painful syndrome that affects the coccyx region. The most important etiological factors in the formation of coccidynia are; external and internal trauma. Patients with coccydynia typically complain of coccyx pain. This pain increases with prolonged sitting, bending backwards during sitting, standing for long periods of time, and standing up after sitting. Conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), levator sudden relaxation exercises, seat cushions, and transcutaneous electrical simulation have all been used to relieve pain, but these methods are ineffective in 10% of patients. In the patient group unresponsive to conservative treatments, there are various interventional treatment options, including caudal epidural steroid injection, ganglion impar blocks, radiofrequency ablation of the sacral nerves, block of the coccygeal nerves and radiofrequency ablation, and coccygectomy.

Detailed description: In algoloji clinic, routinely apply ultrasound-guided coccygeal nerve block and radiofrequency ablation to patients with coccydynia. During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds. Patients are followed for a while in our post-procedure service for possible hypotension and allergic reactions. In this study, it was planned to apply the Visual Pain Scale (VAS) and Paris Functional Coccydynia Questionnaire at the 1st week, 1st month and 3rd months after the treatment to patients who had coccygeal nerve block and radiofrequency ablation in our clinic due to the complaint of coccydynia resistant to conservative treatment methods. In this way, it is planned to evaluate the efficacy of treatment.

Eligibility criteria: Inclusion Criteria:

* Coccygeal pain

Exclusion Criteria:

* Malignancy
* İnfection
* Coagulation disorders

Primary outcomes:
measure: Paris Functional Coccydynia Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazıt Teaching and Research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Ömer Taylan Akkaya
role: STUDY_DIRECTOR
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Gevher Rabia Genç Perdecioğlu
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazıt Teaching and Research Hospital
name: Hüseyin Alp Alptekin
role: STUDY_CHAIR
References: