SPG Pulsed Radiofrequency for Chronic Cluster Headache

Condition(s) studied

Investigational drug(s) / intervention(s)

PRF: 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.

NB: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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