Coccygeal Nerve Radiofrequency Treatment in Coccydynia

Investigation of the Efficiency of Coccygeal Nerve Radiofrequency Treatment in Coccydynia'

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coccyx Disorder
• Intervention / Treatment: Procedure: Coccygeal nerve radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Diskapi Yildirim Beyazıt Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Coccygeal pain

Exclusion Criteria:

• Malignancy
• İnfection
• Coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cocygeal nerve radiofrequency ablation group; 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.	Procedure: Coccygeal nerve radiofrequency ablation; 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.
No Intervention: Conservative treatment group; This group includes patients receiving conservative treatment such as nonsteroidal anti-inflammatory group drugs, physical therapy, and exercise for coccygeal pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paris Functional Coccydynia Questionnaire	It is a scale that measures the severity of coccygeal pain. Scored between ''0: no pain'' and ''10: worst pain.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	It is a scale that measures the severity of pain. In this questionnaire, the patient's pain in sitting position, getting up from sitting position, standing and walking, traveling and at night is recorded. Scored between ''0: no pain'' and ''10: worst pain.	4 weeks

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Ömer Taylan Akkaya, Diskapi Yildirim Beyazıt Teaching and Research Hospital; Study Chair: Gevher Rabia Genç Perdecioğlu, Diskapi Yildirim Beyazıt Teaching and Research Hospital; Study Chair: Hüseyin Alp Alptekin, Diskapi Yildirim Beyazıt Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: radiofrequency ablation; coccydinia; coccygeal nerve
• Other Study ID Numbers: Coccygeal Nerve

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No