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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Management
• Intervention / Treatment: Procedure: Radiofrequency ablation alone; Procedure: Alcohol injection

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• non cancer coccydynia

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: radiofrequency group; patients with non cancer coccydynia in this group will receive conventional radiofrequency on ganglion impar	Procedure: Radiofrequency ablation alone; 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.
Experimental: alcohol neurolysis group; patients in this group will receive alcohol neurolysis on ganglion impar	Procedure: Alcohol injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain; radiofrequency; coccydinea; alcohol neurolysis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia; Organic Chemicals; Therapeutics; Surgical Procedures, Operative; Alcohols; Ablation Techniques; Radiofrequency Therapy; Ethanol; Radiofrequency Ablation
• Other Study ID Numbers: non cancer coccydynia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No