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| Name | Class |
|---|---|
| People's Hospital of Zhengzhou University | OTHER |
| Huadong Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in the weekly frequency of cluster headache attacks | the overall mean change from baseline 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
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the percentage of patients with a reduction from baseline 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 | the degree of pain during headache attacks (NRS scores) | At 1day, 3days, 1week, 2weeks, 1month, 3months, 6months and 1year after the operation. |
| the duration of each headache attack | 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 | the dose of auxiliary analgesic drugs taken | At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure. |
| self-rated patient satisfaction | the self-rated patient satisfaction, from 0 point for unsatisfied to 10 points for very satisfied. | At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure. |
| WHOQOL-BREF | the degree of patient satisfaction measured by WHOQOL-BREF (World Health Organization Quality of Life Questionnaire). | At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure. |
| adverse events | 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. | At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure. |
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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