Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking University People's Hospital
About this trial
Patients with pudendal neuralgia suffer from long-term pain, which severely affects their quality of life. Due to unclear etiology, there is a lack of specific treatment methods. The aim of this study is to evaluate the efficacy of combined pulsed radiofrequency with ganglion impar block therapy helps evaluate the effectiveness of this treatment method for pudendal neuralgia, comparing it with traditional treatments or single interventions, and providing guidance for clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years old;
Diagnosis of pudendal neuralgia meets the Nantes criteria. essential criteria include the following：1）Pain in the territory of the pudendal nerve；2） Pain is predominantly experienced while sitting；3) The pain does not wake the patient at night；4）Pain with no objective sensory impairment；5）Pain relieved by diagnostic pudendal nerve block；
Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects.
Capable of signing informed consent form.
Disqualifiers
Pain caused by pelvic malignant diseases or autoimmune diseases;
Pain caused by pelvic surgery;
Taking anticoagulant drugs or having abnormal coagulation function;
Pregnancy;
Trial design
Design model
Single group
Treatments tested in this trial
Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
Procedure/SurgeryCombined pulsed radiofrequency of the pudendal nerve with ganglion impar block
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: enrolled patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Time frame
1month2
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Time frame
2months3
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Time frame
3months4
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Time frame
6monthsSecondary outcomes
1
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Time frame
1month2
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Time frame
2months3
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Time frame
3months4
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Time frame
6monthsSponsors and contacts
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Source ClinicalTrials.gov