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NCT Number: NCT07347730

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

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.

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Key information

Conditions

Myofascial Trigger Points Brain Diseases Central Nervous System Diseases Cervicogenic Headache Dorsal Root Ganglion Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

+86 13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with cervicogenic headache 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.

Treatment and study plan

MTrPs Injection

Procedure

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.

C2 dorsal root ganglion blocks

Procedure

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.

Primary outcomes

  1. NRS pain scores

    Time frame: at the 4-weeks

    The pain intensity of the headache will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

Secondary outcomes

  1. NRS pain scores

    Time frame: at the 2, 4, 8, 12, and 24 weeks

    The pain intensity of the headache will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

  2. Attack frequency and duration

    Time frame: at the 2, 4, 8, 12, and 24 weeks

    The frequency of headache and its duration

  3. The Patient Global Impression of Change (PGIC) scale

    Time frame: at the 2, 4, 8, 12, and 24 weeks

    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."

  4. Adverse Reactions

    Time frame: Through study completion, an average of 1 year

    Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection and bleeding at the puncture site.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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