CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Pulsed Radiofrequency treatment +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03567590
NCT03567590N/ACompleted
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A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

Beijing Tiantan Hospital·interventional·Posted Jun 26, 2018·Updated Oct 26, 2021

In Brief

A clinical study evaluating Pulsed Radiofrequency treatment and Nerve Block treatment for Cluster Headache. Completed, enrolled 80 participants across 3 sites.

Detailed Summary

The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCluster Headache
CountriesChina
CollaboratorsBeijing Sanbo Brain Hospital, Jilin Province People's Hospital

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartJul 5, 2018
Primary CompletionApr 24, 2020
Study CompletionJan 5, 2021
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 8.0 years ago

Interventions

Pulsed Radiofrequency treatmentprocedure

The pulse treatment generator (PMF-21-100-5, Baylis Medical Inc., Montreal, Canada) with a length of 10 cm, 21-gauge, and an active tip length of 5 mm is inserted vertically into the puncture point. The pulse treatment generator is set to the pulsed radiofrequency automatic mode, with a temperature of 42 °C, pulse frequency of 2 Hz, pulse width of 20 ms, and treatment duration of 360s.

Nerve Block treatmentprocedure

A mixture of 40 mg Triamcinolone + 2 ml of 1% Bupivacaine + 2 ml of 2% mepivacaine + 1:100000 epinephrine is injected for nerve block treatment using a puncture needle.