Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia

Not Applicable

• Conditions: Pain, Chronic
• Interventions: Device: pulse dosed pulsed radiofrequency; Device: conventional pulsed radiofrequency

• Registration Number: NCT05024682
• Lead Sponsor: Assiut University

Brief Summary

The relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process.

Pudendal neuralgia is a syndrome that is characterized by pelvic pain, including bowel, bladder regional pain or discomfort, sexual dysfunction, severe burning sensations and needle-like pain, which are aggravated when seated and relieved after standing. pudendal neuralgias are induced by pudendal nerve damage The mechanism of PRF has been studied repeatedly. It has been verified that PRF has definite safe treatment range, but during the PRF treatment, the tissue surrounding the electrode may have some degree of change and so it is difficult to assess any actual damage.7 Based on electric field intensity, PRF can actually produce tissue changes observable as in vitro changes to ultrastructure in early-phase histologic study. These biological changes were converted to biological effect to alleviate neuropathic pain in animal models.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Study Start: 2022-01-03
• Primary Completion: 2023-01-03
• Study Completion: 2023-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• pain located in the pudendal nerve distribution area
• pain intensity increases in the sitting position;
• no nocturnal pain symptoms;
• pain with no objective sensory impairment
• pain is relieved by diagnostic pudendal
• the pain symptom is associated with sexual dysfunction, with the elimination of obstetrical and gynaecologic, urological and anorectal diseases in the related departments and absence of any physical and mental disorders;
• treatment by other departments is invalid;
• patients should be older than 18 years
• patients should be able to sign an informed consent form

Exclusion Criteria

• patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or have imaging anomalies that may explain the symptoms;
• female patients who are pregnant;
• patients who take anticoagulant drugs or have any coagulation disorder;
• patients who are unable to complete the questionnaire;
• patients with pain, which is caused by malignant or autoimmune diseases and
• patients who are hypersensitive to metals.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulse dosed pulsed radiofrequency	pulse dosed pulsed radiofrequency	-
conventional pulsed radiofrequency	conventional pulsed radiofrequency	-

Primary Outcome Measures

Name	Time	Method
visual analogue score	3 months	The VAS score was used that has 0-10 points. The 0 point represents the painless state and a score from 1 to 3 points represents mild pain, from 4 to 6 points represents moderate pain and from 7 to 10 points represents severe pain.

Trial Locations

Locations (1)

Saeid Metwaly Elsawy; 🇪🇬 Assiut, Egypt