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

Primary Purpose

Chronic Pain

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

pulsed radiofrequency

ganglion impar denervation

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

DiabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF on S3 + ganglion impar denervation

ganglion impar denervation

Arm Description

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

patients will receive ganglion impar denervation by alcohol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03884764

First Posted

March 20, 2019

Last Updated

September 12, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03884764

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRF on S3 + ganglion impar denervation

Arm Type

Experimental

Arm Description

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

Arm Title

ganglion impar denervation

Arm Type

Active Comparator

Arm Description

patients will receive ganglion impar denervation by alcohol

Intervention Type

Procedure

Intervention Name(s)

pulsed radiofrequency

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

ganglion impar denervation

Intervention Description

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

Primary Outcome Measure Information:

Title

the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score

Description

VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable

Time Frame

patients will be evaluated at 3 months postoperatively

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Diab

City

Assiut

State/Province

Assuit

ZIP/Postal Code

71515

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diab Hetta, MD

Phone

+201091090009

diabgetta25@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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