Back to resultsPulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
Primary Purpose
Pain, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional pulsed radiofrequency
pulse dosed pulsed radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
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.
Sites / Locations
- Saeid Metwaly Elsawy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional pulsed radiofrequency
pulse dosed pulsed radiofrequency
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024682
Brief Title
Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
Official Title
Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2022 (Anticipated)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
February 3, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional pulsed radiofrequency
Arm Type
Experimental
Arm Title
pulse dosed pulsed radiofrequency
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
conventional pulsed radiofrequency
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
pulse dosed pulsed radiofrequency
Intervention Description
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).
Primary Outcome Measure Information:
Title
visual analogue score
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Saeid Metwaly Elsawy
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
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Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
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