SPG Pulsed Radiofrequency for Chronic Cluster Headache
ConditionHeadache, Cluster
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or breastfeeding;
Presence of cardiac pacemaker or other neuromodulatory devices;
Pyschiatric and cognitive disorders;
Serious drug habituation or overuse of acute-headache medication;
Trial design
Design model
Parallel
Treatments tested in this trial
PRF
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: PRF groupExperimental treatment 1 intervention
Group B: Nerve Block GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
Mean attack frequency
Mean change in mean attack frequency
Time frame
From baseline to each 4-week interval through 1 year after procedure2
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 procedure3
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 procedure4
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 procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov