Pain Management
Conditions
Keywords
coccydinea, pain, radiofrequency, alcohol neurolysis
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
Interventions
PROCEDURERadiofrequency 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.
PROCEDUREAlcohol 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain relief using Numeric Pain score scale | 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 |
| pain relief of chronic non cancer coccydynia | 6 months after the procedure | patients will be asked to describe their pain on Numeric pain scale and compare it to before the procedure |
| patient global impression of change (PGIC) | 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. |
Countries
Egypt
Outcome results
None listed