Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 243 for:    Recruiting, Not yet recruiting, Available Studies | Headache

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567590
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
Beijing Sanbo Brain Hospital
Jilin Province People's Hospital
Information provided by (Responsible Party):
Fang Luo, Beijing Tiantan Hospital

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

Condition or disease Intervention/treatment Phase
Cluster Headache Procedure: Pulsed Radiofrequency treatment Procedure: Nerve Block treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Pulsed Radiofrequency Group
This group will undergo pulsed radiofrequency treatment.
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.

Active Comparator: Nerve Block Group
This group will undergo nerve block treatment.
Procedure: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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%.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567590


Contacts
Layout table for location contacts
Contact: Fang Luo, M.D. +86 13611326978 13611326978@163.com
Contact: Zheng Chen +86 15010130151 zchan1011@yahoo.com

Locations
Layout table for location information
China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Fang Luo, M.D.    +86 13611326978    13611326978@163.com   
Contact: Zheng Chen    +86 15010130151    zchan1011@yahoo.com   
Beijing Sanbo Brain Hospital Recruiting
Beijing, Beijing, China, 100093
Contact: Baoguo Wang, MD    86-10-62856766    wbgttyy@sina.com   
China, Jilin
Jilin Province People's Hospital Recruiting
Changchun, Jilin, China, 130021
Contact: Dasheng Wu, MD    86-15843076619    jlccwds@163.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Beijing Sanbo Brain Hospital
Jilin Province People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Fang Luo, M.D. Beijing Tiantan Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fang Luo, Director of Department of Pain Management, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03567590     History of Changes
Other Study ID Numbers: KY 2018-027-02
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fang Luo, Beijing Tiantan Hospital:
Cluster Headache, pulsed radiofrequency
Additional relevant MeSH terms:
Layout table for MeSH terms
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases