Headache, Cluster
Conditions
Brief summary
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.
Interventions
PROCEDUREPRF
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.
PROCEDURENB
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic cluster headache; * At least four attacks per week; * Minimum age of 18 years; * Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.
Exclusion criteria
* Pregnancy or breastfeeding; * Presence of cardiac pacemaker or other neuromodulatory devices; * Pyschiatric and cognitive disorders; * Serious drug habituation or overuse of acute-headache medication; * History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events; * Infection at the puncture site; * Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean attack frequency in the last 4 weeks (week 8-12) after procedure | In the last 4 weeks (week 8-12) after procedure | The overall mean change from baseline in mean weekly attack frequency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50% reduction of mean attack frequency | From baseline to each 4-week interval through 1 year after procedure | Percentage of patients with a 50% reduction in mean attack frequency |
| 30% reduction of mean attack frequency | From baseline to each 4-week interval through 1 year after procedure | Percentage of patients with a 30% reduction in mean attack frequency |
| Patient Global Impression of Improvement | At month 1, month 2, month 3, month 6, and month 12 after procedure | Percentage of patients reporting a score of 1 (''very much better'') or 2 (''much better'') |
| Mean attack frequency | From baseline to each 4-week interval through 1 year after procedure | Mean change in mean attack frequency |
| Patient satisfaction scores | At month 1, month 2, month 3, month 6, and month 12 after procedure | 0 point indicates unsatisfied to 10 points indicate very satisfied. The higher the score, the more dissatisfied the patient is. |
| The incidence of perioperative adverse events | Across 1 year after procedure | Perioperative adverse events (AEs) including headache, dizziness, nausea, vomiting, facial hematoma, and numbness in the area innervated by the maxillary nerve |
| Mean attack intensity | From baseline to each 4-week interval through 1 year after procedure | 0-10 on the numeric rating scale, with 0 equating no pain and 10 the worst pain possible |
Countries
China
Contacts
Primary ContactFang Luo
Outcome results
None listed