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

NCT06882278 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2025-03-24

No results posted yet for this study

Summary

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.

Conditions

  • Cluster Headache
  • Pain Management
  • Episodic Cluster Headache

Sponsors & Collaborators

  • People's Hospital of Zhengzhou University

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-05-01
Completion
2029-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882278 on ClinicalTrials.gov