Myofascial Trigger PointsNCT07347028
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
A study testing MTrPs Injection and Intra-articular(IA) Injection in people with Myofascial Trigger Points and Migraine, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Knee osteoarthritis is a common type of CMP. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Myofascial Trigger Points, Migraine, Cervicogenic Headache
- What is being tested?
- MTrPs Injection and Intra-articular(IA) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Jan 2027
- Phase
- Interventional
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee osteoarthritis with radiographic evidence of osteoarthritis (Kellgren-Lawrence grade 1-4) confirmed by at least two orthopedic surgeons, pain specialists, or general practitioners, with physical examination confirming at least one myofascial trigger point;
- Disease duration exceeding 3 months;
- Age ≥ 45 years;
- Numerical Rating Scale (NRS) score ≥ 3 points despite prior 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.;
- Intra-articular injection within the past 6 months or planned joint replacement surgery;
- 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 musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Knee osteoarthritis is a common type of CMP. 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 knee osteoarthritis. 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 complex intra-articular injection in treating knee osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC 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 knee osteoarthritis 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, Intra-articular(IA) Injection
- Medical subject headings
- Migraine Disorders, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTrPs InjectionProcedure or surgery
Each MTrP is identified by palpation, no more than 10 of the most painful MTrPS are selected for injection. Prior to treatment, the assessed MTrPs are marked with a permanent marker. Each MTrP receiving 1 mL of injection volume. The injection solution is prepared with normal saline, lidocaine and 0.5 ml TA (40mg/ml) to the volume required for treatment. A 25-gauge needle is used to inject perpendicular to the skin surface at the selected MTrPs, with the solution administered as a single bolus into each MTrP within 10 seconds.
Intra-articular(IA) InjectionProcedure or surgery
Patients in the IA injection group will receive an IA knee injection via an anterolateral approach. The injection solution is prepared using 0.5 mL of 1% lidocaine and 0.5 mL of TA (40 mg/mL). The IA injection will be performed under ultrasound guidance to guarantee and reduce the incidence of bleeding or infection.
| Study group | Role | What they receive |
|---|---|---|
| Joint cavity injection group | Active comparator | Joint cavity injection with triamcinolone acetonide Receives: Procedure: Intra-articular(IA) Injection |
| MTrPs injection group | Experimental | MTrPs injection with triamcinolone acetonide. Receives: Procedure: MTrPs Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in the WOMAC score
The WOMAC assesses pain, stiffness, and physical function, with higher scores indicating more severe symptoms and greater functional limitation.
Measured: at the 4-weeks
Secondary outcomes (8)
the change from baseline in the WOMAC scores
The WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) is a standardized instrument specifically designed to assess symptoms and function in patients with knee/hip osteoarthritis. It comprises three dimensions with a total of 24 items: pain (5 items), stiffness (2 items), and physical function in daily activities (17 items). It utilizes a Likert scale (0-4 points, 0 = no symptoms), with a total score range of 0-96 points (or standardized to 0-100 points). Higher scores indicate greater functional impairment.
Measured: at the weeks 2, 4, 8, 12, and 24
NRS pain scores
The pain intensity of the knee will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: At the weeks 2, 4, 8, 12 and 24
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 weeks 2, 4, 8, 12, and 24
Knee performance
including nee flexion, extension deficit, maximal flexion, and total range of motion
Measured: at baseline and at the weeks 4, 12, and 24
Myofascial outcomes
including the number of active myofascial trigger points, pressure pain thresholds at predefined trigger-point sites, pain intensity during standardized palpation, and reproduction of the participant's usual knee pain
Measured: at baseline and at the weeks 4, 12, and 24
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
Measured: at baseline and the weeks 4, 12, and 24
Rescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrence
Rescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrence
Measured: throughout the 24-week follow-up period
Adverse Reactions
Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection at the puncture site, and intra-articular infection.
Measured: throughout the 24-week follow-up period.
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 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University, Beijing Aerospace General Hospital, Beijing Jianjia Rehabilitation Hospital, Yangyuan Youyi Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347028
- Sponsor's protocol ID
- KY2025-317-02-01
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes