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

NCT06882278 | Not Yet Recruiting DMC

• 1 other identifier: KY 2023-263-03-05
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Episodic Cluster Headache; Pain management; Pulsed Radiofrequency; Platlet-rich Plasma

Outcome Measures

Primary Outcomes (1)

• change in the weekly frequency of cluster headache attacks

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

  At 1 week, 2 weeks, 3 weeks after the operation

Secondary Outcomes (8)

• change in the weekly frequency of cluster headache attacks

  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

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

• the degree of pain

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

• the duration of each headache attack

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

• dose of auxiliary analgesic drugs

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

Study Arms (2)

Pulse Radiofrequency combined with Platelet Rich Plasma

The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. After removing the radiofrequency electrode, 2 ml of LP-PRP mixture will be injected slowly into the sphenopalatine ganglion. Additional analgesics will be administered for participants' comfort during and after the procedure. If the patients were not satisfied with the outcome after one month, other treatment options will be available.

Pulse Radiofrequency alone

The pulse treatment generator will be set to the automatic pulsed radiofrequency mode, with a temperature of 42°C, pulse frequency of 2Hz, pulse width of 20ms and treatment duration of 360s. Patient from this group will not receive PRP injection.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suitable participants will be screened at the pain management centre of Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University in Beijing, China; Department of Pain Management, Henan Provincial People's Hospital, Henan, China; Department of Pain Management, Huadong Hospital, Fudan University, Shanghai. to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• People's Hospital of Zhengzhou University: collaborator
• Huadong Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Cluster Headache; Agnosia

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)