Myofascial Trigger PointsNCT07347067
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Migraine
A study testing MTrPs Injection and Greater occipital nerve block group in people with Myofascial Trigger Points and Chronic Migraine Headache, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Trigger Points, Chronic Migraine Headache, Greater Occipital Nerve Block
- What is being tested?
- MTrPs Injection and Greater occipital nerve block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, +86 13611326978, 13611326978@163.com
About this study
Official title: 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.
- Being tested
- MTrPs Injection, Greater occipital nerve block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTrPs InjectionProcedure or surgery
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.
Greater occipital nerve block groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| MTrPs injection group | Experimental | MTrPs injection with triamcinolone acetonide. Receives: Procedure: MTrPs Injection |
| Greater occipital nerve block group | Active comparator | Greater occipital nerve block with triamcinolone acetonide. Receives: Procedure: Greater occipital nerve block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the 4-weeks
Secondary outcomes (4)
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.
Measured: at the 2, 4, 8, 12, and 24 weeks
Attack frequency and duration
The frequency of migraine attack and its duration
Measured: 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."
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger PointsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347067
- Sponsor's protocol ID
- KY2025-317-02-04
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Musculoskeletal Pain(CMP), Chronic Migraine and Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT07347067
- Acronym / sponsor ID
- KY2025-317-02-04
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,036 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTrPs injection group | Experimental | Procedure: MTrPs InjectionMTrPs injection with triamcinolone acetonide. |
| Greater occipital nerve block group | Active comparator | Procedure: Greater occipital nerve block groupGreater occipital nerve block with triamcinolone acetonide. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTrPs InjectionThe 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. | Procedure or surgery | MTrPs injection group |
| Greater occipital nerve block groupPatients 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. | Procedure or surgery | Greater occipital nerve block group |
Primary outcome
NRS pain scores
Time frame: at the 4-weeks
The pain intensity of the migraine will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTrPs Injection and Greater occipital nerve block group in people with Myofascial Trigger Points and Chronic Migraine Headache, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pain scores (time frame: at the 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.