The Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-rich Plasma for the Trigeminal Neuralgia

March 31, 2025 updated by: Fang Luo, Beijing Tiantan Hospital

The Efficacy and Safety of Pulsed Radiofrequency(PRF) Combined With Platelet-rich Plasma Versus PRF Alone for the Trigeminal Neuralgia

Trigeminal neuralgia (TN), characterized by brief, recurrent paroxysms of lancinating pain in the distribution of 1 or more branches of the trigeminal nerve (fifth cranial nerve [CNV]), is one of the most common, severe forms of neuropathic pain. Current standard of care for TN is the sodium channel blockers such as carbamazepine or oxcarbazepine. Surgical treatments involve percutaneous procedures, stereotactic radiosurgery and open surgical treatment. Each of these treatments have drawback. In recent years, pulsed radiofrequency (PRF) has been shown to be a promising treatment option for TN. But it was reported that the long-term outcomes of PRF was not satisfactory. Thus, there is an overwhelming need for finding a safe, nondestructive treatment option that is more effective for TN. PRP releases a variety of bioactive factors and adhesion proteins, which are responsible for activating hemostatic cascade reaction, synthesizing new connective tissue and vascular reconstruction, to initiate tissue repair processes. Autologous platelet-rich plasma (PRP) is the processed liquid fraction of autologous peripheral blood with a platelet concentration above the baseline. Studies have shown that it can reduce inflammation and promote nerve repair so it has also shown broad prospects in treating neuropathic pain. In 2012, Doss AX. published a case report indicated that PRP might be effective in TN treatment. In 2023, a randomized controlled study showed that CT-guided PRF combined with PRP can effectively treat postherpetic neuralgia (PHN), and the therapeutic effect is better than that of traditional PRF combined with glucocorticoid therapy in patients with PHN, which is similar to TN in pathology. Thus, we suppose that PRF combined with PRP might show better effectiveness than PRF alone for TN and conducted a prospective trail comparing the clinical efficacy and safety of PRP combined with PRF versus PRF alone. This study is designed as a prospective cohort study, open-label study with a 12 months follow-up period, to compare the efficacy of PRF combined with PRP versus PRP alone for TN treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University in Beijing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The main purpose of this study will be to compare the effectiveness of PRF combined with and without PRP, evaluated 1 year after the procedure. The effectiveness of PRF combined PRP group after 1 year is supposed to be 90%, and that of the high-voltage PRF group was 69% (29) (The α is 0.05, and the power is 90%). Power Analysis and Sample Size (PASS) V.15.0 software (NCSS Corporation, Kaysville, UT, USA) was used to compute the sample size. The results show that 73 patients will be required in each group. However, Accounting for 10% loss to follow-up and an additional 40% loss after propensity score matching, 135 patients will be recruited in each group. Therefore the total sample size of this study is supposed to be 270 participants.

Description

Inclusion Criteria:

  1. The diagnosis of TN was established according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (1).
  2. Aged 18 to 75 years.
  3. Had a score of at least 4 on a Numeric Rating Scale (NRS-11) (NRS; range, 0-10; higher scores indicate more severe pain) and could't be alleviated effectively by means of conservative medical therapy, such as carbamazepine, oxcarbazepine.
  4. Agreed to sign the informed consent form.

Exclusion Criteria:

  1. Patients presenting classic TN or secondary TN (i.e., multiple sclerosis).
  2. Infection at the site of needle entry or systemic infecting.
  3. A history of psychiatric disease.
  4. Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest x-ray.
  5. Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (New York Heart Association grade II-III).
  6. A history of abuse of narcotics.
  7. A history of receiving CRF to the Gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, Gamma knife, or any other neuroablative treatments.
  8. A history of receiving microvascular decompression.
  9. Use of anticoagulants or antiplatelet agent, eg. acetylsalicylic acid.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PRF+PRP
The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2 ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve.
Procedure: PRF+PRP, PRF
Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion of the patient. After puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve and PRF group only receive PRF treatment.
PRF
The puncture point was located 3cm outside the corners of the mouth of the affected side, using the Hartel technique. Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion. After accurately puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times.
Procedure: PRF+PRP, PRF
Under CT guidance, the trocar then was inserted through the ipsilateral foramen ovale to the Gasserian ganglion of the patient. After puncturing the foramen ovalis, remove the cannula needle core and connected with RF electrode (PMK-21-100, Baylis, Canada) and the RF generator. Electrical stimulation was carried out at 50 Hz to determine the sensory threshold and at 2 Hz to determine the motor threshold. The RF generator was set to the manual PRF mode with a standard setting of 42°C, the UP knob was turned to increase the output voltage until the maximum voltage (bearable without causing pain in conscious patients)was reached; 120 s, 2 times. After removing the RF electrode in the combined treatment group, 2ml of LP-PRP mixture was injected slowly into the Gasserian ganglion and mandibular nerve and PRF group only receive PRF treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The response rate of treatment
Time Frame: After 12 months
Patients with BNI scores of I to III were considered to respond to treatment (Table 2).
After 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BNI scores
Time Frame: day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
I No pain, off medications II Occasional pain, off medications IIIa No pain, continued use of medications IIIb Pain persists, but adequately controlled with medications IV Pain not adequately controlled with medications V No relief
day 1; after 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure
The response rate of treatment
Time Frame: 1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure
The response rate of treatment
1day, 1 and 2 weeks, 1, 2, 3, and 6 months following the procedure
Anticonvulsant consumption
Time Frame: After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure
Dose of carbamazepine or oxcarbazepine
After 1 day, 1 and 2 weeks, and after 1, 2, 3, 6, and 12 months following the procedure
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Time Frame: After 1, 3, 6, and 12 months following the procedure
Scores on the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
After 1, 3, 6, and 12 months following the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-263-03-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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