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

N/AActive Not RecruitingNCT07247565

Ain Shams University74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Pain Management

Interventions

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.

Alcohol injectionPROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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".

Time frame: 6 months