Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain

Chronic Pain Clinical Trial

Official title:

for Patients With Chronic Pelvic Pain Due to Chronic Prostatitis, do Combined Ganglion Impar Denervation and Pulsed Radiofrequency on Sacral Root 3 Acheive Better Analgesia Than Ganglion Impar Alone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884764
• Other study ID #: SECI-IRB-IORG0009563-724
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with chronic pelvic pain due to chronic prostatitis for at least 3 months

• VAS pain score more than 5

• failed analgesic drug treatment

Exclusion Criteria:

• coagulopathy

• neurogenic bladder

• infection at site of procedure

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Procedure:
• pulsed radiofrequency
patients with chronic pelvic pain due to chronic prostatitis will receive pulsed radiofrequency on sacral root number 3 and ganglion impar denervation and the patients will be followed for 6 months to assess pain severity radiofrequency procedure: patients will positioned prone on the operating table and under x-ray guidence sacral foramen number 3 will be identified and through it radiofrequency needle will be advanced to target the sacral root ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
• ganglion impar denervation
patients with chronic pelvic pain due to chronic prostatitis will receive ganglion impar denervationand and the patients will be followed for 6 months to assess pain severity ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score	VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable	patients will be evaluated at 3 months postoperatively