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NCT Number: NCT06882278

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. change in the weekly frequency of cluster headache attacks

    Time frame: At 1 week, 2 weeks, 3 weeks after the operation

    The overall mean change from baseline in the weekly frequency of cluster headache attacks across weeks 1 through 3

Secondary outcomes

  1. 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 overall mean change from baseline in the weekly frequency of cluster headache attacks

  2. 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 percentage of patients with a reduction from baseline of at least 50% in the weekly frequency of cluster headache attacks

  3. the degree of pain

    Time frame: At 1day, 3days, 1week, 2weeks, 1month, 3months, 6months and 1year after the operation.

    the degree of pain during headache attacks (NRS scores)

  4. the duration of each headache attack

    Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.

    the duration of each headache attack

  5. dose of auxiliary analgesic drugs

    Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.

    the dose of auxiliary analgesic drugs taken

  6. self-rated patient satisfaction

    Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.

    the self-rated patient satisfaction, from 0 point for unsatisfied to 10 points for very satisfied.

  7. WHOQOL-BREF

    Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.

    the degree of patient satisfaction measured by WHOQOL-BREF (World Health Organization Quality of Life Questionnaire).

  8. adverse events

    Time frame: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.

    For intraoperative AEs, the occurrence of puncture pain, headache, dizziness, nausea, vomiting, facial haematoma and other effects will be recorded. For postoperative AEs, headache, dizziness, facial numbness and other effects will also be recorded.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Huadong Hospital
  • People's Hospital of Zhengzhou University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 18, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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