Actively Recruiting
Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Led by Peking University People's Hospital · Updated on 2024-06-17
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with pudendal neuralgia experience long-term pain that significantly reduces their quality of life. This research aims to assess how well a combined treatment using pulsed radiofrequency of the pudendal nerve along with ganglion impar block works compared to traditional treatments or single interventions. The study focuses on evaluating this approach to provide guidance for clinical care of pudendal neuralgia. The treatment involves ultrasound-guided pulsed radiofrequency applied to the pudendal nerve combined with an X-ray-guided ganglion impar block. Patients first receive a diagnostic pudendal nerve block before undergoing this combined procedure. The study observes patients at 1, 2, 3, and 6 months after treatment to monitor changes in pain and overall condition using several assessment tools. Participants undergo assessments including pain evaluations, anxiety and depression scales, catastrophizing, and pain sensitivity measures before treatment. Main outcomes measured are the Patient Global Impression of Change and the Numeric Rating Scale for pain at multiple time points after treatment. Researchers analyze these results to understand correlations with the initial assessments. The study is sponsored by Peking University People's Hospital and runs until the end of 2024.
CONDITIONS
Brief Title
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosis of pudendal neuralgia according to the Nantes criteria, including pain in the pudendal nerve area, pain mainly while sitting, no night pain, no objective sensory loss, and pain relieved by diagnostic pudendal nerve block
- Received conservative treatment for more than 3 months with poor response or intolerable medication side effects
- Able to provide informed consent
You will not qualify if you...
- Pain caused by pelvic malignant or autoimmune diseases
- Pain resulting from pelvic surgery
- Use of anticoagulant medications or abnormal blood clotting function
- Pregnancy
- Presence of systemic infectious diseases
- Unable to complete required scale assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up over 6 months
Participants receive combined pulsed radiofrequency of the pudendal nerve with ganglion impar block after diagnostic pudendal nerve block.
1 treatment visit and 4 follow-up visits at 1, 2, 3, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
People's Hospital of Peking University
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yifan Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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