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

NCT07347028 | Recruiting DMC

• 1 other identifier: KY2025-317-02-01
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  at the 4-weeks

Secondary Outcomes (4)

• NRS pain scores

  At the weeks 2, 4, 8, 12 and 24

• WOMAC scores

  at the weeks 2, 4, 8, 12, and 24

• The Patient Global Impression of Change (PGIC) scale

  at the weeks 2, 4, 8, 12, and 24

• Adverse Reactions

  Through study completion, an average of 1 year

Study Arms (2)

Joint cavity injection group

ACTIVE COMPARATOR

Joint cavity injection with triamcinolone acetonide

Procedure: Joint Cavity Injection

MTrPs injection group

EXPERIMENTAL

MTrPs injection with triamcinolone acetonide.

Procedure: MTrPs Injection

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.

MTrPs injection group

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).

Joint cavity injection group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 16, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)