Extracorporeal Shockwave Therapy vs Mesotherapy in the Treatment of Myofascial Pain Syndrome: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Extent of pain: Numeric Rating Scale (NRS 0-10)
研究概览
简要总结
Myofascial Pain Syndrome (MPS) is a disorder of the musculoskeletal system manifested by referred pain associated with functional limitation, muscle contractures, and possible neuralgic manifestations; this condition is characterized by the presence of "trigger points". The goal of this case-control study was to compare the effects and benefits of treatment with ESWT vs Mesotherapy in myofascial pain syndrome. The main question it aims to answer is: what is the best rehabilitation project-program between ESWT and mesotherapy for patients with myofascial syndrome? A case-control study was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" A.O.U.P. "P. Giaccone" of Palermo from February 2022 to Dicember2023. Patients were randomized into 2 groups: in group "A", No. 5 sessions of focal ESWT were given weekly; in group "B", No. 5 sessions of Mesotherapy with administration of Thiocolchicoside fl 4mg/2ml and Mepivacaine fl 10mg/1ml were given weekly. Patients in group "A" and group "B" were evaluated at baseline (T0), after 5 sessions (T1) and one month after the end of treatment (T2). Researchers will compare patients treated with ESWT and patients performing mesotherapy to see if there are real differences in terms of pain reduction and improved quality of life.
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
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-65 years
- •Diagnosis of myofascial syndrome
- •NRS at T0 ≥ 4
- •Written informed consent
排除标准
- •Pregnant patients
- •Patients with malignancies already diagnosed or in the process of diagnostic definition
- •Coagulation disorders and/or therapy with anticoagulants
- •Skin lesions and/or local infections
- •Contraindications and/or allergies to the active ingredients of Mesotherapy.
结局指标
主要结局
Extent of pain: Numeric Rating Scale (NRS 0-10)
时间窗: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.
Intensity o f pain: Pressure pain threshold (PPT 1-4)
时间窗: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
PPT is defined as the minimum force applied to induce pain in the patient with myofascial pain syndrome. It has a score between 0 and 4; a score of 4 indicates maximum pain.
次要结局
- Quality of life: Short Form Health Survey 36 (0-100)(At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).)
- Autonomy in activities of daily living: Barthel Index (BI 0-100)(At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).)
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo