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Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia

Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06461312
Acronym
PRF
Enrollment
40
Registered
2024-06-17
Start date
2023-05-01
Completion date
2024-12-31
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pudendal Neuralgia, Pulsed Radiofrequency

Brief summary

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.

Detailed description

We plan to enroll patients with pudendal neuralgia .Pre-treatment, we collected data including pain assessment, anxiety, depression, catastrophizing, and pain sensitivity scales. Treatment involved ultrasound-guided pudendal nerve pulsed radiofrequency and X-ray-guided ganglion impar block. The Patient Global Impression of Change (PGIC) and Numeric Rating Scale (NRS) were used as the main observation indicators to evaluate the treatment effect at 1, 2, 3, and 6 months postoperatively, followed by correlation analysis with the scores of relevant scales.

Interventions

PROCEDURECombined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age between 18 and 80 years old; 2. 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; 3. Received conservative treatment for more than 3 months, and either had poor response to conservative treatment or intolerable medication side effects. 4. Capable of signing informed consent form.

Exclusion criteria

1. Pain caused by pelvic malignant diseases or autoimmune diseases; 2. Pain caused by pelvic surgery; 3. Taking anticoagulant drugs or having abnormal coagulation function; 4. Pregnancy; 5. Systemic infectious diseases; 6. Inability to complete scale assessments.

Design outcomes

Primary

MeasureTime frameDescription
Patient Global Impression of Change1month0 -100%#0=no change,100%= complete relief of pain symptoms.

Secondary

MeasureTime frameDescription
Numeric Rating Scale1month0-10#0 =no pain, 10 = the most severe pain.

Countries

China

Contacts

Primary ContactYifan Yang, MD
enayanyan0227@126.com18701545165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026