Cluster HeadacheNCT06882278
Pulsed Radiofrequency Combined With Platelet-Rich Plasma Applied to the Sphenopalatine Ganglion in Treating Episodic Cluster Headache
An observational study of Cluster Headache and Pain Management, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cluster Headache, Pain Management, Episodic Cluster Headache
- Type of treatment
- Injection or infusion
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- An implantable pulse generator;
- Previous history of invasive treatments such as pterygopalatine ganglion radiofrequency thermocoagulation and chemical destruction;
- Current pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, M.D., 86 13611326978, 13611326978@163.com
About this study
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
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
- Medical subject headings
- Cluster Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 week, 2 weeks, 3 weeks after the operation
Secondary outcomes (8)
change in the weekly frequency of cluster headache attacks
the overall mean change from baseline in the weekly frequency of cluster headache attacks
Measured: 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
the percentage of patients with a reduction from baseline of at least 50% in the weekly frequency of cluster headache attacks
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At 1day, 3days, 1week, 2weeks, 3 weeks, 1month, 3months, 6months and 1year after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Zhengzhou University, Huadong Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882278
- Sponsor's protocol ID
- KY 2023-263-03-05
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06882278
- Acronym / sponsor ID
- KY 2023-263-03-05
- Conditions
- Cluster Headache, Pain Management, Episodic Cluster Headache
- Keywords
- Episodic Cluster Headache, Pain management, Pulsed Radiofrequency, Platlet-rich Plasma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- People's Hospital of Zhengzhou University, Huadong Hospital
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache and Pain Management, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the weekly frequency of cluster headache attacks (time frame: At 1 week, 2 weeks, 3 weeks after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.