Clinical trial NCT06653218: Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Platelet-rich Plasma
Chronic Migraine
Keywords: Platelet-rich Plasma
Chronic Migraine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Qinghai People's Hospital
First posted: 2024-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 75 years;
2. BMI between 15 and 35 kg/m2 ;
3. 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);
4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥7;
5. Scheduled for lidocaine acting on SGB treatment for CM；
6. Signed informed consent.

Exclusion Criteria:

1. Previously received SGB treatment;
2. Combined with other types of headaches;
3. Platelet count \<105\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
4. Infection or mass near the puncture site;
5. A history of other neurological disorders;
6. A history of severe cardiopulmonary, hepatic or renal dysfunction;
7. A history of psychological disorders;
8. A history of narcotic drug abuse;
9. Changes in neck anatomic structure caused by radiotherapy or surgery;
10. A history of allergies to any research drugs;
11. Pregnancy or lactation period.

Primary outcomes:
measure: the change from baseline in mean headache days across the 1-month follow-up period.
timeFrame: 1-month period
Secondary outcomes:
measure: 50% responder rate
timeFrame: at weeks 4, 8, 12.
measure: Mean VAS score during headache attack
timeFrame: at baseline and weeks 4, 8, 12.
measure: Analgesic consumption
timeFrame: at baseline and weeks 4, 8, 12.
measure: Patient satisfaction (PS) scores
timeFrame: at weeks 4, 8, 12.
measure: Headache impact test version 6 (HIT-6)
timeFrame: at baseline and weeks 4, 8,12.
measure: Migraine disability assessment (MIDAS) scores
timeFrame: at baseline and weeks 4, 8, 12.
measure: Hospital anxiety and depression scale (HADS) scores
timeFrame: at baseline and weeks 4, 8, 12.
measure: Pittsburgh sleep quality index (PSQI) scores
timeFrame: at baseline and weeks 4, 8, 12
measure: Adverse events
timeFrame: at day 0, 1, weeks 1, 4, 8, 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fang Luo
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: