Comparative Study Between Conventional Radiofrequency Ablation vs Chemical Neurolysis of Ganglion Impar for Treatment of Chronic Non Cancer Related Coccydynia

NCT07247565 | Active Not Recruiting

• 1 other identifier: non cancer coccydynia
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: compare effectiveness (satisfaction) and duration of pain relief between patients who perform the conventional thermal radiofrequency on the ganglion impar vs patients who perform the chemical neurolysis with alcohol in patients with non cancer coccydynia patients with non cancer coccydynia not responding to medical treatment will be divided into 2 groups before intervention , control group will receive conventional radiofrequency ablation of ganglion impar , while the study group will receive alcohol neurolysis

Conditions

Pain Management

Keywords

coccydinea; pain; radiofrequency; alcohol neurolysis

Outcome Measures

Primary Outcomes (3)

• pain relief using Numeric Pain score scale

  patients will be asked to describe their pain on Numeric pain scale ( an 11 numbers scale where 0 describes no pain and 10 describes the worst pain ) and compare it to before the procedure

  1 month

• pain relief of chronic non cancer coccydynia

  patients will be asked to describe their pain on Numeric pain scale and compare it to before the procedure

  6 months after the procedure

• patient global impression of change (PGIC)

  one-item questionnaire that asks patients to rate their overall improvement after a treatment.he scale typically includes ratings such as "very much improved," "much improved," "minimally improved," "unchanged," or "worse".

  6 months

Study Arms (2)

radiofrequency group

ACTIVE COMPARATOR

patients with non cancer coccydynia in this group will receive conventional radiofrequency on ganglion impar

Procedure: Radiofrequency ablation alone

alcohol neurolysis group

EXPERIMENTAL

patients in this group will receive alcohol neurolysis on ganglion impar

Procedure: Alcohol injection

Interventions

Radiofrequency ablation alone PROCEDURE

The entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion of a radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views. 10 ml of lidocaine 1 % was injected to tolerate the ablation then in the 1st group placing of the radiofrequency cable followed by ablation will be done at 80 degrees for 90 seconds.

radiofrequency group

Alcohol injection PROCEDURE

The entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion 22 G spinal needle targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views. 10 ml of lidocaine 1 % was injected to tolerate the ablation then injection of 5 ml 70% alcohol will be performed

alcohol neurolysis group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non cancer coccydynia
• Both genders
• Age between 20-70 years.
• ASA 1,2 \& 3 physical status
• xray coccyx lateral position showing normal joints and bones with no fractures

You may not qualify if:

• Neurological disorders. (previous central and peripheral CNS affection).
• coagulopathy INR \> 1.8 or platelets \< 50,000.
• Infection at or near the injection site.
• Presence of pacemaker or defibrillator.
• known allergy to used medications.
• patients with previous history of Radiotherapy, chemotherapy or metastasis
• pregnant patients.
• patients with rheumatological disorders (rheumatoid arthritis, diffuse idiopathic skeletal hyerostosis, psoriatic arthritis)
• age \<20 or \>70
• Xray coccyx showing fractures or abnormalities

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Fogel GR, Cunningham PY 3rd, Esses SI. Coccygodynia: evaluation and management. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):49-54. doi: 10.5435/00124635-200401000-00007.

  PMID: 14753797 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Radiofrequency Ablation; Ethanol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , intensive care and pain management

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: March 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

EG (1)