Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Chronic Musculoskeletal Pain(CMP), Chronic Migraine and Cervicogenic Headache
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- NRS pain scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Joint cavity injection group
Joint cavity injection with triamcinolone acetonide
干预措施: Joint Cavity Injection (Procedure)
MTrPs injection group
MTrPs injection with triamcinolone acetonide.
干预措施: MTrPs Injection (Procedure)
结局指标
主要结局
NRS pain scores
时间窗: at the 4-weeks
The pain intensity of the knee will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
次要结局
- 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)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital