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Completed

NCT Number: NCT03567590

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sanbo Brain Hospital, Beijing, Beijing Municipality, China

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About this study

The investigators aim to investigate whether the sphenopalatine ganglion pulsed radiofrequency treatment is better than traditional sphenopalatine ganglion nerve block technology and provides medical evidence for the clinical application and promotion of sphenopalatine ganglion pulsed radiofrequency treatment to provide a minimally invasive, safe, and effective treatment for patients with cluster headache who do not respond to drug treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of cluster headache is confirmed according to the diagnostic criteria of the 2018 International Classification of Headache Disorders 3rd edition (ICHD-3);
  • patient's age is between 18 and 60 years;
  • patients seek treatment in the pain clinics of hospitals participating in the study within 5 days of the onset of the cluster period; pain conditions of patients remain the same after conservative treatment of conventional oral medication, or the reduction rates are less than 50% in pain degree during headache attacks, headache attack frequency, duration of each headache attack, and auxiliary analgesic drug dosage; and
  • patients signed the informed consent.

Exclusion criteria

  • abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiogram, and chest radiograph;
  • infection at the puncture site;
  • previous mental illness;
  • previous history of narcotic drug abuse;
  • history of anticoagulant and antiplatelet aggregation drugs;
  • implantable pulse generator;
  • previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
  • pregnant or breastfeeding patients.

Treatment and study plan

Pulsed Radiofrequency treatment

Procedure

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 treatment

Procedure

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.

Primary outcomes

  1. Duration of the cluster period

    Time frame: Within 1 year (the cluster period is not over 3 months generally)

    The duration of the cluster period is defined as the total duration of the headache, including the pain attack time before and after treatment.

Secondary outcomes

  1. The degree of pain during headache attacks after treatment

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    Evaluated by numeric rating scale (NRS, 0 points for no pain and 10 points for the most severe pain)

  2. Headache attack frequency

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    The number of attacks per day

  3. Duration of each headache attack

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    Duration of each headache attack after treatment

  4. Dose of auxiliary analgesic drugs

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    Dose of auxiliary analgesic drugs per day

  5. Duration of remission period

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    From the end of this cluster period to the beginning of the next cluster period

  6. Patient satisfaction

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).

  7. Effective rate

    Time frame: 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

    The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Sanbo Brain Hospital
  • Jilin Province People's Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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