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

Официальное название

Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Musculoskeletal Pain(CMP), Chronic Migraine and Cervicogenic Headache

Обзор

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.

Вмешательства

• Процедура MTrPs Injection
  The volume of infiltration solution is determined by the number of trigger points, with each trigger point receiving 1 mL of injection volume. The injection solution is prepared by combining 1 mL of triamcinolone acetonide (40 mg/mL), lidocaine, and normal saline, resulting in a final lidocaine concentration of 1%. A 25-gauge needle is used to inject perpendicular to the skin surface at the selected tender points, with the solution administered as a single bolus into each tender point within 10
• Процедура Greater occipital nerve block group
  Patients in the nerve block group received ultrasound-guided bilateral greater occipital nerve blocks. The injection solution was prepared with 1 ml of 2% lidocaine and 1 ml of triamcinolone acetonide (40 mg/mL), administered at a volume of 1 ml per side.

Первичные конечные точки

• NRS pain scores [Срок оценки: at the 4-weeks]

Вторичные конечные точки (4)

• NRS pain scores [Срок оценки: at the 2, 4, 8, 12, and 24 weeks]
• Attack frequency and duration [Срок оценки: at the 2, 4, 8, 12, and 24 weeks]
• The Patient Global Impression of Change (PGIC) scale [Срок оценки: at the 2, 4, 8, 12, and 24 weeks]
• Adverse Reactions [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07347067 · KY2025-317-02-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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