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

Cluster Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567590
• Other study ID #: KY 2018-027-02
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: October 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 5, 2021
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Sanbo Brain Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Jilin Province People's Hospital	Changchun	Jilin

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Sanbo Brain Hospital, Jilin Province People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Barloese MC, Jürgens 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. — View Citation

Kohlmeier C, Behrens P, Böger 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. — View Citation

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. — View Citation

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. — View Citation

Peñarrocha-Diago M, Boronat A, Peñarrocha-Oltra D, Ata-Ali J, Bagan JV, Peñarrocha-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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 year (the cluster period is not over 3 months generally)
Secondary	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)	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Headache attack frequency	The number of attacks per day	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Duration of each headache attack	Duration of each headache attack after treatment	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Dose of auxiliary analgesic drugs	Dose of auxiliary analgesic drugs per day	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Duration of remission period	From the end of this cluster period to the beginning of the next cluster period	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Patient satisfaction	Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Secondary	Effective rate	The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.	1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery