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

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. 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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Osteoarthritis; Chronic Musculoskeletal Pain; Myofascial Trigger Points
• Intervention / Treatment: Procedure: MTrPs Injection; Procedure: Joint Cavity Injection

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTrPs injection group; MTrPs injection with triamcinolone acetonide.	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.
Active Comparator: Joint cavity injection group; Joint cavity injection with triamcinolone acetonide.	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain scores	The pain intensity of the shoulder will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.	at the 4-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	at the 2, 4, 8, 12, and 24 weeks
NRS pain scores	The pain intensity of the shoudler will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.	at the 2, 4, 8, 12, and 24 weeks
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 shoulder 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.	at the 2, 4, 8, 12, and 24 weeks
Adverse Reactions	Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection at the puncture site, and intra-articular infection.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY2025-317-02-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No