Pudendal NeuralgiaPRFNCT06461312
Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
A study testing Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block in people with Pudendal Neuralgia and Pulsed Radiofrequency, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pudendal Neuralgia, Pulsed Radiofrequency
- What is being tested?
- Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pain caused by pelvic malignant diseases or autoimmune diseases;
- Pain caused by pelvic surgery;
- Taking anticoagulant drugs or having abnormal coagulation function;
- Pregnancy;
- Systemic infectious diseases;
- Inability to complete scale assessments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Yiming Liu, MD, 88325206, enayanyan0227@126.com
About this study
Official title: Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
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.
Read the 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.
- Conditions
- Pudendal Neuralgia, Pulsed Radiofrequency
- Being tested
- Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined pulsed radiofrequency of the pudendal nerve with ganglion impar blockProcedure or surgery
Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block
| Study group | Role | What they receive |
|---|---|---|
| enrolled patients | Experimental | Enrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block Receives: Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Measured: 1month
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Measured: 2months
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Measured: 3months
Patient Global Impression of Change
0 -100%#0=no change,100%= complete relief of pain symptoms.
Measured: 6months
Secondary outcomes (4)
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Measured: 1month
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Measured: 2months
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Measured: 3months
Numeric Rating Scale
0-10#0 =no pain, 10 = the most severe pain.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yiming Liu, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461312
- Sponsor's protocol ID
- 2024PHB200-001
- Acronym
- PRF
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pulsed Radiofrequency of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia
- ClinicalTrials.gov ID
- NCT06461312
- Acronym / sponsor ID
- PRF / 2024PHB200-001
- Conditions
- Pudendal Neuralgia, Pulsed Radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enrolled patients | Experimental | Procedure: Combined pulsed radiofrequency of the pudendal nerve with ganglion impar blockEnrolled patients underwent pulsed radiofrequency of the pudendal nerve combined with ganglion impar block after pudendal nerve diagnostic block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Pain caused by pelvic malignant diseases or autoimmune diseases;
- Pain caused by pelvic surgery;
- Taking anticoagulant drugs or having abnormal coagulation function;
- Pregnancy;
- Systemic infectious diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined pulsed radiofrequency of the pudendal nerve with ganglion impar blockCombined pulsed radiofrequency of the pudendal nerve with ganglion impar block | Procedure or surgery | enrolled patients |
Primary outcome
Patient Global Impression of Change
Time frame: 1month
0 -100%#0=no change,100%= complete relief of pain symptoms.
Patient Global Impression of Change
Time frame: 2months
0 -100%#0=no change,100%= complete relief of pain symptoms.
Patient Global Impression of Change
Time frame: 3months
0 -100%#0=no change,100%= complete relief of pain symptoms.
Patient Global Impression of Change
Time frame: 6months
0 -100%#0=no change,100%= complete relief of pain symptoms.
4 secondary outcomes
Numeric Rating Scale
Time frame: 1month
Numeric Rating Scale
Time frame: 2months
Numeric Rating Scale
Time frame: 3months
Numeric Rating Scale
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Pudendal Neuralgia
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Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
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Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
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Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
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Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Neurostimulation on Pain, 1 Month After an Infiltration of Local Anaesthetic, in the Treatment of Pudendal Neuralgia.
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RecruitingObservational study
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
Pudendal Neuralgia, Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiming Liu, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined pulsed radiofrequency of the pudendal nerve with ganglion impar block in people with Pudendal Neuralgia and Pulsed Radiofrequency, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Yang, MD (18701545165, enayanyan0227@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (time frame: 1month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.