Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MTrPs Injection, Greater occipital nerve block group.
- Who it may be relevant to
- Registry conditions: Myofascial Trigger Points, Chronic Migraine Headache, Greater Occipital Nerve Block. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Musculoskeletal Pain(CMP), Chronic Migraine and Cervicogenic Headache
Overview
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.
Interventions
- Procedure 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 - Procedure 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.
Primary outcome measures
- NRS pain scores [Time frame: at the 4-weeks]
Secondary outcome measures (4)
- NRS pain scores [Time frame: at the 2, 4, 8, 12, and 24 weeks]
- Attack frequency and duration [Time frame: at the 2, 4, 8, 12, and 24 weeks]
- The Patient Global Impression of Change (PGIC) scale [Time frame: at the 2, 4, 8, 12, and 24 weeks]
- Adverse Reactions [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT07347067 · KY2025-317-02-04