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

NCT06653218 | Completed DMC

• 1 other identifier: KY-2023-263-03-06
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-rich Plasma; Chronic Migraine

Keywords

Platelet-rich Plasma; Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  1-month period

Secondary Outcomes (9)

• 50% responder rate

  at weeks 4, 8, 12.

• Mean VAS score during headache attack

  at baseline and weeks 4, 8, 12.

• Analgesic consumption

  at baseline and weeks 4, 8, 12.

• Patient satisfaction (PS) scores

  at weeks 4, 8, 12.

• Headache impact test version 6 (HIT-6)

  at baseline and weeks 4, 8,12.

Study Arms (2)

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

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

Other: Not have interventions

Interventions

No interventions OTHER

It is a observational study

PRP+Lidocaine group

Not have interventions OTHER

It is a observational study

Lidocaine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Qinghai People's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Fang Luo

Beijing, Beijing Municipality, 100070, China

Location

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of pain management

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: October 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)