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NCT Number: NCT07247565

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

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

Primary outcomes

  1. pain relief using Numeric Pain score scale

    Time frame: 1 month

    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

  2. pain relief of chronic non cancer coccydynia

    Time frame: 6 months after the procedure

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

  3. patient global impression of change (PGIC)

    Time frame: 6 months

    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".

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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