Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
MTrPs Injection
Procedure/SurgeryThe 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 seconds.
Greater occipital nerve block group
Procedure/SurgeryPatients 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.
Treatment groups
1,036 Participants
are divided into 2 treatment groupsGroup A: MTrPs injection groupExperimental treatment 1 intervention
Group B: Greater occipital nerve block groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
NRS pain scores
The pain intensity of the migraine will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
at the 4-weeksSecondary outcomes
1
NRS pain scores
The pain intensity of the migraine will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame
at the 2, 4, 8, 12, and 24 weeks2
Attack frequency and duration
The frequency of migraine attack and its duration
Time frame
at the 2, 4, 8, 12, and 24 weeks3
The Patient Global Impression of Change (PGIC) scale
The Patient Global Impression of Change (PGIC) scale is a patient-rated instrument used to evaluate overall change in status following treatment. It employs a 7-point Likert scale (1 = "very much worse" to 7 = "very much improved"), focusing on the patient's subjective perception of symptoms, function, and quality of life. The evaluation criterion defines a score of 5 or higher as indicative of "improvement" (mild/moderate/marked), a score of 4 as "no change," and scores of 3 or below as "worsening."
Time frame
at the 2, 4, 8, 12, and 24 weeks4
Adverse Reactions
Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection and bleeding at the puncture site.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov