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

NCT03567590 | Completed

• 1 other identifier: KY 2018-027-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cluster Headache

Keywords

Cluster Headache, pulsed radiofrequency

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• The degree of pain during headache attacks after treatment

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

• Headache attack frequency

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

• Duration of each headache attack

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

• Dose of auxiliary analgesic drugs

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

• Duration of remission period

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

Study Arms (2)

Pulsed Radiofrequency Group

EXPERIMENTAL

This group will undergo pulsed radiofrequency treatment.

Procedure: Pulsed Radiofrequency treatment

Nerve Block Group

ACTIVE COMPARATOR

This group will undergo nerve block treatment.

Procedure: Nerve Block treatment

Interventions

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.

Pulsed Radiofrequency Group

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.

Nerve Block Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Sanbo Brain Hospital: collaborator
• Jilin Province People's Hospital: collaborator

Study Sites (3)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing Sanbo Brain Hospital

Beijing, Beijing Municipality, 100093, China

Location

Jilin Province People's Hospital

Changchun, Jilin, 130021, China

Location

Related Publications (7)

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

  PMID: 23939643 BACKGROUND

• 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.

  PMID: 22143727 BACKGROUND

• 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.

  PMID: 23630400 BACKGROUND

• 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.

  PMID: 27676681 BACKGROUND

• 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.

  PMID: 28083804 BACKGROUND

• 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.

  PMID: 27461394 BACKGROUND

• 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.

  PMID: 30904875 DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 26, 2018
• Study Start: July 5, 2018
• Primary Completion: April 24, 2020
• Study Completion: January 5, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

CN (3)