Efficacy and Safety of Irregular Pulsed Radiofrequency (Sluijter-Teixera Poisson) Versus Regular Pulsed Radiofrequency to the Gasserian Ganglion for Treatment of Primary Trigeminal Neuralgia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSohag University

About this trial

This study aims to compare between the Efficacy and safety of irregular pulsed radiofrequency STP versus regular pulsed radiofrequency to the gasserian ganglion for treatment of primary trigeminal neuralgia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)

Age between 18 and 75 years

Severe trigeminal neuralgia not adequately relieved by conservative medical therapy, including carbamazepine or oxcarbazepine

Numeric Rating Scale (NRS-11) pain score of 7 or higher prior to the procedure

Disqualifiers

Secondary trigeminal neuralgia, including trigeminal neuralgia attributed to space-occupying lesions or multiple sclerosis

Infection at the puncture site

History of psychiatric disease

Clinically significant abnormalities in routine laboratory tests, including hepatic, renal, or coagulation function, or abnormalities on electrocardiogram or chest X-ray

Trial design

Design model

Parallel

Treatments tested in this trial

  • Irregular pulsed Radiofrequency

    Procedure/Surgery

    irregular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia

  • Regular pulsed Radiofrequency

    Procedure/Surgery

    Regular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Irregular pulsed radiofrequency STP groupExperimental treatment 1 intervention
Group B: Regular pulsed radiofrequency groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in pain intensity

• Pain intensity of the attacks using VAS (''0'' no pain to ''10'' worst possible pain) day 1, after 1and 2 weeks and after 1,2,3 and 6 months. And dose of carbamazepine or oxcarbazepine will be recorded on day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure.

Time frame
day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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