Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Migraine

Capital Medical University

Status: Enrolling

Conditions: Chronic Migraine Headache; Myofascial Trigger Points; Greater Occipital Nerve Block

Treatments: Procedure: Greater occipital nerve block group; Procedure: MTrPs Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07347067

KY2025-317-02-04

Details and patient eligibility

About

Chronic migraine is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with chronic migraine. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and greater occipital nerve block injection in treating chronic migraine. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or greater occipital nerve. After treatment, patients will be followed up for 2 years. Their NRS scores, attack frequency, attack duration, HIT-6 scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for chronic migraine is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.

Enrollment: 1,036 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with migraine by at least two pain specialists or neurologists;
• Disease duration of at least 3 months;
• Age between 18 and 65 years;
• Numerical Rating Scale (NRS) score ≥ 3 despite conservative pharmacological treatment;
• Signed informed consent form.

Exclusion criteria

• History of allergy to trial medications such as corticosteroids;
• Alcohol abuse; long-term use of opioids (exceeding 2 weeks or more than 3 days per week for over 1 month); suspected use of sedative or analgesic medications; patients on long-term steroid therapy;
• Severe neurological disorders, significant hepatic or renal dysfunction, heart failure, coagulation abnormalities, gastric ulcer, diabetes, inflammatory rheumatic diseases, etc.;
• Inability to use pain assessment scales;
• Presence of local or systemic infection;
• Pregnant or lactating patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,036 participants in 2 patient groups

MTrPs injection group

Experimental group

Description:

MTrPs injection with triamcinolone acetonide.

Treatment:

Procedure: MTrPs Injection

Greater occipital nerve block group

Active Comparator group

Description:

Greater occipital nerve block with triamcinolone acetonide.

Treatment:

Procedure: Greater occipital nerve block group