Chronic cervicogenic headache 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 cervicogenic headache. 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 cervicogenic headache. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or dorsal rami blocks of C2 spinal nerves. 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 cervicogenic headache 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,036
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.
Patients in the nerve block group received ultrasound-guided bilateral dorsal root ganglion blocks of C2 spinal nerve. The injection solution was prepared using 1 ml of 2% lidocaine and 1 ml of triamcinolone acetonide (40 mg/mL), with a volume of 1 ml administered per side.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGNRS pain scores
The pain intensity of the headache will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: at the 4-weeks
NRS pain scores
The pain intensity of the headache 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 weeks
Attack frequency and duration
The frequency of headache and its duration
Time frame: at the 2, 4, 8, 12, and 24 weeks
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 weeks
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 year
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