Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

Recruiting

• Conditions: Platelet-rich Plasma; Chronic Migraine

• Registration Number: NCT06653218
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Study Start: 2024-10-20
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-20
• Study First Posted: 2024-10-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change from baseline in mean headache days across the 1-month follow-up period.	1-month period	the change from baseline in mean headache days across the 1-month follow-up period.

Secondary Outcome Measures

Name	Time	Method
50% responder rate	at weeks 4, 8, 12.	the proportion of patients who achieved a ≥50% reduction in monthly headache days.
Analgesic consumption	at baseline and weeks 4, 8, 12.	including the number of days, the specific drug used, and the dose of drugs.
Mean VAS score during headache attack	at baseline and weeks 4, 8, 12.	evaluation of the average severity of headache days
Patient satisfaction (PS) scores	at weeks 4, 8, 12.	It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction
Headache impact test version 6 (HIT-6)	at baseline and weeks 4, 8,12.	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
Migraine disability assessment (MIDAS) scores	at baseline and weeks 4, 8, 12.	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.
Hospital anxiety and depression scale (HADS) scores	at baseline and weeks 4, 8, 12.	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
Pittsburgh sleep quality index (PSQI) scores	at baseline and weeks 4, 8, 12	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.
Adverse events	at day 0, 1, weeks 1, 4, 8, 12	9. including SGB-related complication and medication-related complication.

Trial Locations

Locations (1)

Fang Luo; 🇨🇳 Beijing, Beijing, China