Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
MTrPs Injection
Procedure/SurgeryEach 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) Injection
Procedure/SurgeryPatients 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.
Treatment groups
238 Participants
are divided into 2 treatment groupsGroup A: Joint cavity injection groupActive comparator 1 intervention
Group B: MTrPs injection groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at the 4-weeksSecondary outcomes
1
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.
Time frame
at the weeks 2, 4, 8, 12, and 242
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.
Time frame
At the weeks 2, 4, 8, 12 and 243
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."
Time frame
at the weeks 2, 4, 8, 12, and 244
Knee performance
including nee flexion, extension deficit, maximal flexion, and total range of motion
Time frame
at baseline and at the weeks 4, 12, and 24Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Renmin Hospital of Wuhan University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Beijing Aerospace General Hospital
Collaborator
Beijing Jianjia Rehabilitation Hospital
Collaborator
Yangyuan Youyi Hospital
Collaborator
Source ClinicalTrials.gov