Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07347028
Status
Recruiting
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Conditions

  • Cervicogenic Headache
  • Chronic Musculoskeletal Pain
  • Migraine
  • Myofascial Trigger Points

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Joint Cavity Injection — PROCEDURE
    Patients in the intra-articular injection group will receive an intra-articular knee injection via an anterolateral approach. The injection solution is prepared using 7 mL of 1% lidocaine and 1 mL of triamcinolone acetonide (40 mg/mL).

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
1,036 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Joint cavity injection group
    Joint cavity injection with triamcinolone acetonide
  • Experimental: MTrPs injection group
    MTrPs injection with triamcinolone acetonide.

Primary Outcome Measure

NRS pain scores [ Time Frame: at the 4-weeks ]

Central Contacts

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