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 migraine is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. 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 chronic migraine. 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 greater occipital nerve block injection in treating chronic migraine. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or greater occipital nerve. After treatment, patients will be followed up for 2 years. Their NRS scores, attack frequency, attack duration, HIT-6 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 chronic migraine 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with migraine by at least two pain specialists or neurologists;
- •Disease duration of at least 3 months;
- •Age between 18 and 65 years;
- •Numerical Rating Scale (NRS) score ≥ 3 despite 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.;
- •Inability to use pain assessment scales;
- •Presence of local or systemic infection;
- •Pregnant or lactating patients.
研究组 & 干预措施
MTrPs injection group
MTrPs injection with triamcinolone acetonide.
干预措施: MTrPs Injection (Procedure)
Greater occipital nerve block group
Greater occipital nerve block with triamcinolone acetonide.
干预措施: Greater occipital nerve block group (Procedure)
结局指标
主要结局
NRS pain scores
时间窗: at the 4-weeks
The pain intensity of the migraine 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 2, 4, 8, 12, and 24 weeks)
- Attack frequency and duration(at the 2, 4, 8, 12, and 24 weeks)
- The Patient Global Impression of Change (PGIC) scale(at the 2, 4, 8, 12, and 24 weeks)
- 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