An interventional study of PRF and NB in Headache, Cluster, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 108 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: PRF
Procedure: NB
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.
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.
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
Time frame: In the last 4 weeks (week 8-12) after procedure
Mean attack frequency
Mean change in mean attack frequency
Time frame: 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
Time frame: 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
Time frame: 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'')
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Across 1 year after procedure
Plan to share: Yes — Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2029, 59 months after the start.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's planned 59 months is above that.
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