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

NCT ID: NCT07347054

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1036 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-06-01

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. Shoulder 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 shoulder 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 shoulder 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 shoulder 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

Myofascial Trigger Points; Chronic Musculoskeletal Pain; Shoulder Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Joint cavity injection group

Joint cavity injection with triamcinolone acetonide.

Group Type: ACTIVE_COMPARATOR

Joint Cavity Injection

Intervention Type: PROCEDURE

Patients in the intra-articular injection group will receive an intra-articular shoulder 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).

MTrPs injection group

MTrPs injection with triamcinolone acetonide.

Group Type: EXPERIMENTAL

MTrPs Injection

Intervention Type: 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.

Interventions

Joint Cavity Injection

Patients in the intra-articular injection group will receive an intra-articular shoulder 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).

Intervention Type: PROCEDURE

MTrPs Injection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of shoulder 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.

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.;
• 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director, Department of Pain Management, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Luo

Role: CONTACT

13611326978@163.com

+86 13611326978

Facility Contacts

Fang Luo

Role: primary

13611326978@163.com

+86 13611326978

Other Identifiers

KY2025-317-02-03

Identifier Type: -

Identifier Source: org_study_id