Conventional vs Pulsed RF in Coccydynia

NCT07497269 | Not Yet Recruiting

• 1 other identifier: BAEK-68
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Back Pain

Keywords

Radiofrequency Ablation; low back pain; quality of life; coccyx

Outcome Measures

Primary Outcomes (1)

• The Numeric Rating Scale (NRS)

  Pain intensity was assessed using the Numeric Rating Scale (NRS), a linear pain scale ranging from 0 (no pain) to 10 (the worst imaginable pain)."

  From enrollment to the end of treatment at 12th months

Secondary Outcomes (3)

• Oswestry Disability Index (ODI)

  From enrollment to the end of treatment at 12th months

• Pittsburgh Sleep Quality Index (PSQI)

  From enrollment to the end of treatment at 12 months

• Global Perceived Effect (GPE)

  From enrollment to the end of treatment at 12th months

Study Arms (2)

Pulse RF Group

ACTIVE COMPARATOR

Radiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Pulsed RFA is applied at 42 °C for 4 minutes. Pulsed RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure

Procedure: Pulsed Radiofrequency

Conventional RF Group

ACTIVE COMPARATOR

Conventional RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure Radiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Conventional RFA is applied for two cycles of 90 seconds at 80 °C.

Procedure: Conventional Radiofrequency

Interventions

Pulsed Radiofrequency PROCEDURE

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.

Pulse RF Group

Conventional Radiofrequency PROCEDURE

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.

Conventional RF Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years.
• Chronic pain in the coccygeal region lasting longer than 3 months, unresponsive to analgesics, anti-inflammatory drugs, and other conservative treatment methods.
• Patients scheduled to undergo ganglion impar treatment with either conventional or pulsed radiofrequency ablation (RFA).

You may not qualify if:

• Incomplete medical records.
• Loss to follow-up.
• Technical failure during the block procedure.
• Local infection, bleeding disorders, allergy to contrast agents, or history of spinal surgery.
• History of malignancy.
• Refusal to participate in the study.
• Diagnosed psychological disorders.
• Individuals unable to communicate effectively or understand instructions.
• Age under 18 or over 80 years.

Sponsors & Collaborators

• Adana City Training and Research Hospital: lead

Study Sites (2)

Adana City Training and Research Hospital

Adana, Adana, Turkey (Türkiye)

Location

Tobb Etü Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 1-Adas, C., Ozdemir, U., Toman, H., Luleci, N., Luleci, E., & Adas, H. (2016). Transsacrococcygeal approach to ganglion impar: radiofrequency application for the treatment of chronic intractable coccydynia. Journal of pain research, 1173-1177. 2-Romanukha, D. M., & Biloshytsky, V. V. (2024). Minimally Invasive Interventions on Ganglion Impar in Treatment of Patients with Coccygodynia. Ukr Neurosurg J, 1, 43-52. 3-Nasiri, A., Vajari, F. F., Sane, S., & Afsargharehbagh, R. (2024). Assessment of ganglion impar block effect on treatment results of coccydynia: a cross-sectional study. Anesthesiology and Pain Medicine, 14(2), e142137. 4-Turchan, A., Fahmi, A., & Subianto, H. (2018). Impar ganglion block with combination of neurolysis drugs and radiofrequency thermocoagulation for perineal pain. Asian Journal of Neurosurgery, 13(03), 838-841. 5-Gupta, M., & Das, G. (2020). Ganglion Impar block and neurolysis for chronic pain: A review. Journal on Musculoskeletal Ultrasound and Pain Medicine, 6(1), 24-28. 6-Usmani H, Dureja GP, Andleeb R, Tauheed N, Asif N. Conventional Radiofrequency Thermocoagulation vs Pulsed Radiofrequency Neuromodulation of Ganglion Impar in Chronic Perineal Pain of Nononcological Origin. Pain Med.2018;19(12):2348-2356. doi:10.1093/pm/pnx244. PMID: 29329442)

  BACKGROUND

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Derya Bayram, MD

  Adana City Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya Bayram, MD

CONTACT

+905433400430; deryak.bayram@gmail.com

Dostali Aliyev, MD

CONTACT

+905514351936; dr.dostalialiyev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Two groups of patients with coccydynia

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)