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Conventional vs Pulsed RF in Coccydynia

NCT07497269 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-27

No results posted yet for this study

Summary

The aim of this study is to prospectively evaluate the effects of pulsed and conventional radiofrequency ablation of the ganglion impar on pain, quality of life, and sleep quality in patients with refractory coccydynia, and to determine whether one treatment is superior to the other.

Conditions

Interventions

PROCEDURE

Pulsed Radiofrequency

Once the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space. Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is \<500 ohms. Sensory paresthesia at \<1 V and 50 Hz is observed around the sacrococcygeal region. Pulsed RFA is applied at 42 °C for 4 minutes after stimulation.

PROCEDURE

Conventional Radiofrequency

Once the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space. Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is \<500 ohms. Sensory paresthesia at \<1 V and 50 Hz is observed around the sacrococcygeal region. Neuroablation is applied for 2 cycles of 90 seconds at 80 °C.

Sponsors & Collaborators

  • Adana City Training and Research Hospital

    lead OTHER

Principal Investigators

  • Derya Bayram, MD · Adana City Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-04-01
Completion
2028-04-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497269 on ClinicalTrials.gov