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Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF group | Experimental |
| |
| Nerve Block Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF | Procedure | After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean attack frequency in the last 4 weeks (week 8-12) after procedure | The overall mean change from baseline in mean weekly attack frequency | In the last 4 weeks (week 8-12) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean attack frequency | Mean change in mean attack frequency | From baseline to each 4-week interval through 1 year after procedure |
| 50% reduction of mean attack frequency | Percentage of patients with a 50% reduction in mean attack frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | 59976661 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fang Luo | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31701891 | Background | Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9. | |
| 36268950 |
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Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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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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| NB | Procedure | After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine. |
|
| From baseline to each 4-week interval through 1 year after procedure |
| 30% reduction of mean attack frequency | Percentage of patients with a 30% reduction in mean attack frequency | From baseline to each 4-week interval through 1 year after procedure |
| Patient Global Impression of Improvement | Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'') | At month 1, month 2, month 3, month 6, and month 12 after procedure |
| Mean attack intensity | 0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible | From baseline to each 4-week interval through 1 year after procedure |
| Patient satisfaction scores | 0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is. | At month 1, month 2, month 3, month 6, and month 12 after procedure |
| The incidence of perioperative adverse events | Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve | Across 1 year after procedure |
| Result |
| Schoenen J, Snoer AH, Brandt RB, Fronczek R, Wei DY, Chung CS, Diener HC, Dodick DW, Fontaine D, Goadsby PJ, Matharu MS, May A, McGinley JS, Tepper SJ, Jensen RH, Ferrari MD; IHS Standing Committee for Clinical Trials; IHS cluster headache trial guideline subcommittee. Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache. Cephalalgia. 2022 Dec;42(14):1450-1466. doi: 10.1177/03331024221120266. Epub 2022 Oct 21. |
| 34146510 | Result | Wilbrink LA, de Coo IF, Doesborg PGG, Mulleners WM, Teernstra OPM, Bartels EC, Burger K, Wille F, van Dongen RTM, Kurt E, Spincemaille GH, Haan J, van Zwet EW, Huygen FJPM, Ferrari MD; ICON study group. Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial. Lancet Neurol. 2021 Jul;20(7):515-525. doi: 10.1016/S1474-4422(21)00101-0. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |