Platelet-rich PlasmaNCT06653218
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine
An observational study of Platelet-rich Plasma and Chronic Migraine, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Platelet-rich Plasma, Chronic Migraine
- What is being tested?
- Not have interventions
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We speculate that the reduction value in monthly headache days after PRP combined lidocaine acting on SGB is expected to 2.0, and the standard deviation (SD) for the PRP group is 9.0. Assuming a 20% rate of loss to follow-up and an additional 40% loss after PSM, a total of 200 participants will provide 90% power to use a 0.05 two tailed alpha to detect the significant difference in the monthly headache days. Three participating centers will compete to enroll patients.
Who may be able to join
- Age between 18 to 75 years;
- BMI between 15 and 35 kg/m2 ;
- Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
- Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
- Scheduled for lidocaine acting on SGB treatment for CM；
- Signed informed consent.
Who cannot join
- Previously received SGB treatment;
- Combined with other types of headaches;
- Platelet count <105*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
- Infection or mass near the puncture site;
- A history of other neurological disorders;
- A history of severe cardiopulmonary, hepatic or renal dysfunction;
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- A history of psychological disorders;
- A history of narcotic drug abuse;
- Changes in neck anatomic structure caused by radiotherapy or surgery;
- A history of allergies to any research drugs;
- Pregnancy or lactation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine: a Protocol of a Multi-center, Prospective, Propensity Score-matched, Cohort Analysis
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.
Read the detailed description
Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM
- Conditions
- Platelet-rich Plasma, Chronic Migraine
- Being tested
- No interventions, Not have interventions
- Keywords
- Platelet-rich Plasma, Chronic Migraine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
It is a observational study
Not have interventionsOther
It is a observational study
| Study group | Role | What they receive |
|---|---|---|
| PRP+Lidocaine group | Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 2.5 ml of PRP combined with 2.5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology Receives: Other: No interventions | |
| Lidocaine group | Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology Receives: Other: Not have interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in mean headache days across the 1-month follow-up period.
the change from baseline in mean headache days across the 1-month follow-up period.
Measured: 1-month period
Secondary outcomes (9)
50% responder rate
the proportion of patients who achieved a ≥50% reduction in monthly headache days.
Measured: at weeks 4, 8, 12.
Mean VAS score during headache attack
evaluation of the average severity of headache days
Measured: at baseline and weeks 4, 8, 12.
Analgesic consumption
including the number of days, the specific drug used, and the dose of drugs.
Measured: at baseline and weeks 4, 8, 12.
Patient satisfaction (PS) scores
It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction
Measured: at weeks 4, 8, 12.
Headache impact test version 6 (HIT-6)
a six-item survey that assesses the adverse impact of headaches on social, role and cognitive functioning, vitality, and psychological distress.A larger score reflects a greater adverse impact. It ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent
Measured: at baseline and weeks 4, 8,12.
Migraine disability assessment (MIDAS) scores
to evaluate headache-related disability using 4-week recall, and is associated with headache frequency and average pain score.The score ranges from 0 to 270. Higher scores indicate greater disability caused by headaches with scores of 21 or greater considered severe.
Measured: at baseline and weeks 4, 8, 12.
Hospital anxiety and depression scale (HADS) scores
a 14-item self-report instrument used to screen for anxiety and depression separately.The range of the scale is 0 to 21, with scores of 8 to 10 being indicative of a probable risk of anxiety or depression, whereas scores of 11 to 21 indicate a high risk of anxiety or depression
Measured: at baseline and weeks 4, 8, 12.
Pittsburgh sleep quality index (PSQI) scores
a 19-item self-report instrument that comprises 7 components used to assess quality of sleep. The range of the scale is 0 to 21,with a higher score indicating more severe sleep disturbances.
Measured: at baseline and weeks 4, 8, 12
Adverse events
- including SGB-related complication and medication-related complication.
Measured: at day 0, 1, weeks 1, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich PlasmaStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qinghai People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653218
- Sponsor's protocol ID
- KY-2023-263-03-06
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine: a Protocol of a Multi-center, Prospective, Propensity Score-matched, Cohort Analysis
- ClinicalTrials.gov ID
- NCT06653218
- Acronym / sponsor ID
- KY-2023-263-03-06
- Conditions
- Platelet-rich Plasma, Chronic Migraine
- Keywords
- Platelet-rich Plasma, Chronic Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qinghai People's Hospital
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 Oct 2024 (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.
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.
Detailed description
Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP+Lidocaine group | – | Other: No interventionsPatients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 2.5 ml of PRP combined with 2.5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology |
| Lidocaine group | – | Other: Not have interventionsPatients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We speculate that the reduction value in monthly headache days after PRP combined lidocaine acting on SGB is expected to 2.0, and the standard deviation (SD) for the PRP group is 9.0. Assuming a 20% rate of loss to follow-up and an additional 40% loss after PSM, a total of 200 participants will provide 90% power to use a 0.05 two tailed alpha to detect the significant difference in the monthly headache days. Three participating centers will compete to enroll patients.
Key inclusion criteria (6 listed)
- Age between 18 to 75 years;
- BMI between 15 and 35 kg/m2 ;
- Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
- Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
- Scheduled for lidocaine acting on SGB treatment for CM；
Key exclusion criteria (11 listed)
- Previously received SGB treatment;
- Combined with other types of headaches;
- Platelet count <105*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
- Infection or mass near the puncture site;
- A history of other neurological disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsIt is a observational study | Other | PRP+Lidocaine group |
| Not have interventionsIt is a observational study | Other | Lidocaine group |
Primary outcome
the change from baseline in mean headache days across the 1-month follow-up period.
Time frame: 1-month period
the change from baseline in mean headache days across the 1-month follow-up period.
9 secondary outcomes
50% responder rate
Time frame: at weeks 4, 8, 12.
Mean VAS score during headache attack
Time frame: at baseline and weeks 4, 8, 12.
Analgesic consumption
Time frame: at baseline and weeks 4, 8, 12.
Patient satisfaction (PS) scores
Time frame: at weeks 4, 8, 12.
Headache impact test version 6 (HIT-6)
Time frame: at baseline and weeks 4, 8,12.
Migraine disability assessment (MIDAS) scores
Time frame: at baseline and weeks 4, 8, 12.
Hospital anxiety and depression scale (HADS) scores
Time frame: at baseline and weeks 4, 8, 12.
Pittsburgh sleep quality index (PSQI) scores
Time frame: at baseline and weeks 4, 8, 12
Adverse events
Time frame: at day 0, 1, weeks 1, 4, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. not yet decided
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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. This study is not recruiting at the moment.
Fang Luo, M.D. principal investigator
Beijing Tiantan Hospital
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 Platelet-rich Plasma and Chronic Migraine, 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline in mean headache days across the 1-month follow-up period. (time frame: 1-month period). 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 12 Feb 2026.