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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03884764
Other study ID # SECI-IRB-IORG0009563-724
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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