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The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

NCT03567590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-10-26

No results posted yet for this study

Summary

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

Conditions

  • Cluster Headache

Interventions

PROCEDURE

Pulsed Radiofrequency treatment

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.

PROCEDURE

Nerve Block treatment

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.

Sponsors & Collaborators

  • Beijing Sanbo Brain Hospital

    collaborator OTHER

  • Jilin Province People's Hospital

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo, M.D. · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2020-04-24
Completion
2021-01-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567590 on ClinicalTrials.gov