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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine Headache; Myofascial Trigger Points; Greater Occipital Nerve Block
• Intervention / Treatment: Procedure: MTrPs Injection; Procedure: Greater occipital nerve block group

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTrPs injection group; MTrPs injection with triamcinolone acetonide.	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 seconds.
Active Comparator: Greater occipital nerve block group; Greater occipital nerve block with triamcinolone acetonide.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the 4-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	at the 2, 4, 8, 12, and 24 weeks
Adverse Reactions	Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection and bleeding at the puncture site.	Through study completion, an average of 1 year
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.	at the 2, 4, 8, 12, and 24 weeks
Attack frequency and duration	The frequency of migraine attack and its duration	at the 2, 4, 8, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY2025-317-02-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No