Comparing Two Nerve Block Techniques for Treating Chronic Refractory Migraine: A Clinical Trial

Phase 3

Not yet recruiting

• Conditions: Chronic migraine without aura, (2) ICD-10 Condition: G437||Chronic migraine without aura,

• Registration Number: CTRI/2025/04/085036
• Lead Sponsor: Dr Ajit Kumar

Brief Summary

This open-label randomized controlled trial aims to compare the clinical effectiveness of ultrasound-guided stellate ganglion block versus ultrasound-guided sphenopalatine ganglion block in patients with chronic refractory migraine. Patients aged 18 to 60 years who meet the International Classification of Headache Disorders ICHD criteria and have not responded to conservative treatments will be enrolled. Participants will be randomized into two groups receiving either stellate or sphenopalatine ganglion blockade under ultrasound guidance. The primary outcome will be reduction in pain intensity measured on the Numerical Rating Scale NRS. Secondary outcomes will include frequency and duration of migraine episodes and assessment of adverse events. This study will help determine the more effective interventional approach for managing chronic refractory migraine.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-17
• Study Start: 2025-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Age between 18 and 60 years Diagnosed with migraine by expert physicians Diagnoses made according to International Classification of Headache Disorders criteria Pain unresponsive to conservative treatment including medical management physical therapy and previous interventions Average pain score of 4 or more on an 11 point Numerical Rating Scale Competent to understand the study protocol willing to provide voluntary written informed consent and willing to participate in the assessment of outcome measurements.

Exclusion Criteria

• Patient refusal Pain for less than 6 months Patients with a space occupying lesions in radiological investigations CT or MRI Patients with bilateral migraine attacks Coagulopathy and or patients on anticoagulants.
• Infection at the site of injection.
• Hypersensitivity to local anesthetic agent.
• Evidence of severe psychiatric illness.
• Uncontrolled or unstable opioid use Any conditions that might compromise the interpretation of outcome assessments.
• Pregnancy or lactation.
• History of any major comorbid medical conditions those interfere with recording of study outcomes neurological disorders auto-immune diseases multiple sclerosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief as assessed by Migraine disability assessment score MIDAS Annexure I at baseline and at 3 months after the procedure	at baseline and at 3 months after the procedure

Secondary Outcome Measures

Name	Time	Method
Pain relief as assessed by Numerical Rating Scale NRS on a scale of 1 to 10	Analgesic usage Procedural complications if any

Trial Locations

Locations (1)

aiims rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

aiims rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Dr Ajit Kumar

Principal investigator

9910789377

ajitdr.ajit@gmail.com