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| Name | Class |
|---|---|
| Beijing Sanbo Brain Hospital | OTHER |
| Jilin Province People's Hospital | UNKNOWN |
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The investigators aim to investigate the effectiveness and safety of sphenopalatine ganglion pulsed radiofrequency on cluster headache.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Radiofrequency Group | Experimental | This group will undergo pulsed radiofrequency treatment. |
|
| Nerve Block Group | Active Comparator | This group will undergo nerve block treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Headache attack frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100050 | China | ||
| Beijing Sanbo Brain Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23939643 | Background | Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013 Jul 15;88(2):122-8. | |
| 22143727 | 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. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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|
| 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Beijing |
| Beijing Municipality |
| 100093 |
| China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| 23630400 | 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. |
| 27676681 | 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. |
| 28083804 | 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. |
| 27461394 | 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. |
| 30904875 | Derived | 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. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012046 | Rehabilitation |