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Cluster HeadacheNCT03567590

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

A study testing Pulsed Radiofrequency treatment and Nerve Block treatment in people with Cluster Headache, run by Beijing Tiantan Hospital at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cluster Headache
What is being tested?
Pulsed Radiofrequency treatment and Nerve Block treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesChina
Study dates
5 Jul 2018to 5 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing Sanbo Brain Hospital

    Beijing, Beijing Municipality, 100093

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: A Prospective, Multicentre, Randomized, Controlled, Blinded-endpoint Study to Evaluate 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.

Read the detailed description

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.

Being tested
Pulsed Radiofrequency treatment, Nerve Block treatment
Keywords
Cluster Headache, pulsed radiofrequency
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsed Radiofrequency treatmentProcedure or surgery

    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 or surgery

    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.

Study groups in NCT03567590
Study groupRoleWhat they receive
Pulsed Radiofrequency GroupExperimentalThis group will undergo pulsed radiofrequency treatment.
Receives: Procedure: Pulsed Radiofrequency treatment
Nerve Block GroupActive comparatorThis group will undergo nerve block treatment.
Receives: Procedure: Nerve Block treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of the cluster period

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

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

Secondary outcomes (7)

  1. The degree of pain during headache attacks after treatment

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

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

  2. Headache attack frequency

    The number of attacks per day

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

  3. Duration of each headache attack

    Duration of each headache attack after treatment

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

  4. Dose of auxiliary analgesic drugs

    Dose of auxiliary analgesic drugs per day

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

  5. Duration of remission period

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

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

  6. Patient satisfaction

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

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

  7. Effective rate

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2018
  2. Study start5 Jul 2018
  3. Primary completion24 Apr 2020
  4. Study completion5 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03567590
Sponsor's protocol ID
KY 2018-027-02
Status last verified
Oct 2021
First submitted
22 May 2018
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013 Jul 15;88(2):122-8.

    PubMed 23939643

  • Penarrocha-Diago M, Boronat A, Penarrocha-Oltra D, Ata-Ali J, Bagan JV, Penarrocha-Diago M. Clinical course of patients with episodic cluster headache treated with corticosteroids inproximity to the sphenopalatine ganglion: a preliminary study of 23 patients. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e477-82. doi: 10.4317/medoral.17578.

    PubMed 22143727

  • Lepper A, Frese A, Summ O, Nofer JR, Evers S. Hypothalamic dopaminergic stimulation in cluster headache. Cephalalgia. 2013 Oct;33(14):1155-9. doi: 10.1177/0333102413487445. Epub 2013 Apr 29.

    PubMed 23630400

  • Loomba V, Upadhyay A, Kaveeshvar H. Radiofrequency Ablation of the Sphenopalatine Ganglion Using Cone Beam Computed Tomography for Intractable Cluster Headache. Pain Physician. 2016 Sep-Oct;19(7):E1093-6.

    PubMed 27676681

  • Kohlmeier C, Behrens P, Boger A, Ramachandran B, Caparso A, Schulze D, Stude P, Heiland M, Assaf AT. Improved surgical procedure using intraoperative navigation for the implantation of the SPG microstimulator in patients with chronic cluster headache. Int J Comput Assist Radiol Surg. 2017 Dec;12(12):2119-2128. doi: 10.1007/s11548-016-1512-2. Epub 2017 Jan 12.

    PubMed 28083804

  • Barloese MC, Jurgens TP, May A, Lainez JM, Schoenen J, Gaul C, Goodman AM, Caparso A, Jensen RH. Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months. J Headache Pain. 2016 Dec;17(1):67. doi: 10.1186/s10194-016-0658-1. Epub 2016 Jul 26.

    PubMed 27461394

  • Li J, Ren H, Wang B, Wu D, Luo F. Multicentre, prospective, randomised, controlled, blinded-endpoint study to evaluate the efficacy and safety of pterygopalatine ganglion pulsed radiofrequency treatment for cluster headache: study protocol. BMJ Open. 2019 Mar 23;9(3):e026608. doi: 10.1136/bmjopen-2018-026608.

    PubMed 30904875

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Radiofrequency treatment and Nerve Block treatment in people with Cluster Headache, run by Beijing Tiantan Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of the cluster period (time frame: Within 1 year (the cluster period is not over 3 months generally)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567590, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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