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

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ClinicalTrials.gov Identifier: NCT03884764
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Diab Fuad Hetta, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: pulsed radiofrequency Procedure: ganglion impar denervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRF on S3 + ganglion impar denervation
patients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol
 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
Active Comparator: ganglion impar denervation
patients will receive ganglion impar denervation by alcohol
 Procedure: 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


Outcome Measures
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Primary Outcome Measures :
  1. the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score [ Time Frame: patients will be evaluated at 3 months postoperatively ]
    VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884764


Locations
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Egypt
Diab Recruiting
Assiut, Assuit, Egypt, 71515
Contact: Diab Hetta, MD    +201091090009    diabgetta25@gmail.com   
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Diab Fuad Hetta, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03884764    
Other Study ID Numbers: SECI-IRB-IORG0009563-724
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations