Pulsed Radiofrequency Combined With Platelet-Rich Plasma Applied to the Sphenopalatine Ganglion in Treating Episodic Cluster Headache

Official title

Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet-Rich Plasma Applied to the Sphenopalatine Ganglion in Treating Episodic Cluster Headache: A Study Protocol for a Multi-Center, Prospective, Open-Label, Propensity Score Match Cohort Study

Overview

Cluster headache (CH) is one of the most severe pain accompanied by ipsilateral autonomic symptoms such as lacrimation and conjunctival injection. CH can be categorized into episodic cluster headache (ECH), chronic cluster headache (CCH), and probable CH. Intervention for CH requires a multifaceted and early approach and varies due to the heterogeneity of patients, which makes it difficult to formulate appropriate treatment plan, and the minimally invasive interventional therapy between drug and surgical treatment is still worth looking forward to. The pterygopalatine ganglion, also known as SPG, is a essential proportion in activation of cortical structures and plays an important role in the pathogenesis of CH attacks, which makes it the potential therapeutic target in drug-resistant CH. Percutaneous pulsed radiofrequency (PRF) at SPG is a minimally destructive treatment which shows efficacy, safety, and repeatedly efficacy for refractory CH. PRF is a reliable alternative with few neurological side effects and complications for patients who have not responded to conservative treatment. However, the long term pain relieve is not satisfying. Platelet-rich plasma (PRP) is an autologous blood-derived product of 3 times concentrated platelet above average levels, which contains many growth factors, cytokines, chemokine, and cell-adhesion molecules, therefore function in the activation and synthesis of healing process, tissue proliferation and regeneration. Researches by Michno etc. and Giaccari etc. have proved that PRP combined with PRF therapy may provide more effective outcome than PRF alone in treatment of neuralgia, but whether the combined therapy can improve the efficacy of CH treatment is not clear. ECH occurs in 90% of the CH patients. The investigators assume that PRP combined with PRF acting on SPG might have better therapeutic effect on ECH than PRF alone, by giving combined treatment or PRF therapy alone according to patients willingness, the investigators plan on conducting this prospective trail to compare the clinical efficacy and safety of PRP combined with PRF versus PRF alone.

Primary outcome measures

• change in the weekly frequency of cluster headache attacks [Time frame: At 1 week, 2 weeks, 3 weeks after the operation]

Secondary outcome measures (8)

• change in the weekly frequency of cluster headache attacks [Time frame: At 1day, 3days, 1week, 2weeks, 1month, 3months, 6months and 1year after the operation]
• the percentage of patients with a reduction of at least 50% in the weekly frequency of cluster headache attacks [Time frame: At 1day, 3days, 1week, 2weeks, 1month, 3months, 6months and 1year after the operation.]
• the degree of pain [Time frame: At 1day, 3days, 1week, 2weeks, 1month, 3months, 6months and 1year after the operation.]
• the duration of each headache attack [Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.]
• dose of auxiliary analgesic drugs [Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.]
• self-rated patient satisfaction [Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.]
• WHOQOL-BREF [Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.]
• adverse events [Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.]

Eligibility criteria

Inclusion criteria

• The diagnosis of ECH is confirmed according to the diagnostic criteria of the International Classification of Headache Disorders third edition 3 (Table 2), and the patient is within five days of the current cluster period；
• The patient's age is between 18 and 70 years;
• Patients have had ≥2 bouts previously, ≥4 typical (treated or untreated) attacks per week and usual bouts should last 4 weeks;
• The patient's pain condition remains the same after preventive therapy with drugs available in our hospital such as verapamil, topiramate, lithium or steroids, or there is a reduction of less than 50% in the intensity and frequency of headache attacks, the duration of each attack and the dosage of auxiliary analgesic drugs used.

Exclusion criteria

• Have atypical features: absence of cranial autonomic symptoms, post-traumatic onset, cluster-tic syndrome;
• Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;
• Infection at the puncture site;
• Previous mental illness;
• Previous history of narcotic drug abuse;
• Prior anticoagulant or antiplatelet therapy;
• An implantable pulse generator;
• Previous history of invasive treatments such as pterygopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
• Current pregnancy or breast feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06882278 · KY 2023-263-03-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗