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

Primary Purpose

Cluster Headache

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed Radiofrequency treatment
Nerve Block treatment
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache focused on measuring Cluster Headache, pulsed radiofrequency

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed Radiofrequency Group

Nerve Block Group

Arm Description

This group will undergo pulsed radiofrequency treatment.

This group will undergo nerve block treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Headache attack frequency
The number of attacks per day
Duration of each headache attack
Duration of each headache attack after treatment
Dose of auxiliary analgesic drugs
Dose of auxiliary analgesic drugs per day
Duration of remission period
From the end of this cluster period to the beginning of the next cluster period
Patient satisfaction
Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).
Effective rate
The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.

Full Information

First Posted
May 22, 2018
Last Updated
October 24, 2021
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Sanbo Brain Hospital, Jilin Province People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03567590
Brief Title
The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Sanbo Brain Hospital, Jilin Province People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
Keywords
Cluster Headache, pulsed radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Radiofrequency Group
Arm Type
Experimental
Arm Description
This group will undergo pulsed radiofrequency treatment.
Arm Title
Nerve Block Group
Arm Type
Active Comparator
Arm Description
This group will undergo nerve block treatment.
Intervention Type
Procedure
Intervention Name(s)
Pulsed Radiofrequency treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nerve Block treatment
Intervention Description
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 Outcome Measure Information:
Title
Duration of the cluster period
Description
The duration of the cluster period is defined as the total duration of the headache, including the pain attack time before and after treatment.
Time Frame
Within 1 year (the cluster period is not over 3 months generally)
Secondary Outcome Measure Information:
Title
The degree of pain during headache attacks after treatment
Description
Evaluated by numeric rating scale (NRS, 0 points for no pain and 10 points for the most severe pain)
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Headache attack frequency
Description
The number of attacks per day
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Duration of each headache attack
Description
Duration of each headache attack after treatment
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Dose of auxiliary analgesic drugs
Description
Dose of auxiliary analgesic drugs per day
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Duration of remission period
Description
From the end of this cluster period to the beginning of the next cluster period
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Patient satisfaction
Description
Patient satisfactory scale (PSS) evaluation (0 for unsatisfactory, and 10 for very satisfied).
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery
Title
Effective rate
Description
The effectiveness rate is calculated as follows: effectiveness rate = the number of effective patients / total number of patients in this group × 100%.
Time Frame
1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Sanbo Brain Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100093
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23939643
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
23630400
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.
Results Reference
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PubMed Identifier
27676681
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.
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Cluster Headache

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