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

NCT05024682 | Unknown DMC FDA Device

• 1 other identifier: wx1569
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• visual analogue score

  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.

  3 months

Study Arms (2)

conventional pulsed radiofrequency

EXPERIMENTAL

Device: conventional pulsed radiofrequency

pulse dosed pulsed radiofrequency

EXPERIMENTAL

Device: pulse dosed pulsed radiofrequency

Interventions

conventional pulsed radiofrequency DEVICE

After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 120 seconds pulse mode which consisted of four cycles (8 minutes)

conventional pulsed radiofrequency

pulse dosed pulsed radiofrequency DEVICE

After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 240 seconds pulse dose mode which consisted of two cycles (8 minutes).

pulse dosed pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Saeid Metwaly Elsawy

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 27, 2021
• Study Start: January 3, 2022
• Primary Completion: January 3, 2023
• Study Completion: February 3, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

EG (1)