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

NCT03884764 | Unknown

• 1 other identifier: SECI-IRB-IORG0009563-724
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PRF on S3 + ganglion impar denervation

EXPERIMENTAL

patients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol

Procedure: pulsed radiofrequency

ganglion impar denervation

ACTIVE COMPARATOR

patients will receive ganglion impar denervation by alcohol

Procedure: ganglion impar denervation

Interventions

pulsed radiofrequency PROCEDURE

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

PRF on S3 + ganglion impar denervation

ganglion impar denervation PROCEDURE

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

ganglion impar denervation

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
• VAS pain score more than 5
• failed analgesic drug treatment

You may not qualify if:

• coagulopathy
• neurogenic bladder
• infection at site of procedure

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 15, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)