Coccygeal Nerve Radiofrequency Treatment in Coccydynia

NCT05596448 | Unknown

• 1 other identifier: Coccygeal Nerve
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccyx Disorder

Keywords

coccydinia; coccygeal nerve; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual analog scale (VAS)

  4 weeks

Study Arms (2)

Cocygeal nerve radiofrequency ablation group

ACTIVE COMPARATOR

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

Conservative treatment group

NO INTERVENTION

This group includes patients receiving conservative treatment such as nonsteroidal anti-inflammatory group drugs, physical therapy, and exercise for coccygeal pain.

Interventions

Coccygeal nerve radiofrequency ablation PROCEDURE

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.

Cocygeal nerve radiofrequency ablation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coccygeal pain

You may not qualify if:

• Malignancy
• İnfection
• Coagulation disorders

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• Ömer Taylan Akkaya

  Diskapi Yildirim Beyazıt Teaching and Research Hospital

  STUDY DIRECTOR

• Gevher Rabia Genç Perdecioğlu

  Diskapi Yildirim Beyazıt Teaching and Research Hospital

  STUDY CHAIR

• Hüseyin Alp Alptekin

  Diskapi Yildirim Beyazıt Teaching and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 27, 2022
• Study Start: October 22, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

TU (1)