Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.
详细描述
BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal conditions, however no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS).
HYPOTHESIS
Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and functional disability compared with placebo in patients with chronic low back pain due to MPS.
STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized, double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to severe pain (VAS > 4) for more than 6 months, despite 6 weeks of conservative treatment with antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000 impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo. The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index, Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the temperature of the treated area will be evaluated with Thermography. The assessments will be apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more
- •Display pain of moderate to severe intensity: visual analogue scale (VAS)> 4
- •Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal
- •Authorize in writing the term of free and informed consent to participate in the study
- •Availability of frequent attendance at hospital
排除标准
- •Organic or psychological disorders that contraindication participation of patients in study
- •Metabolic, infectious, oncological or rheumatologic disorders
- •Fibromyalgia
- •Labor dispute
- •Indication for surgery in column
- •Contraindications to therapy of shock waves:
- •Coagulopathy and / or anticoagulant
- •Pregnancy
- •Acute infection in soft tissue or bone
- •Systemic Infections
- •Presence of ulcers at treatment sites
- •Presence of larger vessels or nerves at treatment sites
- •Polyneuropathies
- •Malignancies
- •Cardiac arrhythmias or use of pacemaker
结局指标
主要结局
Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo
时间窗: 12 weeks after the last session of shockwave
The outcome will be assessed by Visual Analogue Scale (VAS)
次要结局
未报告次要终点
研究者
Ricardo Kobayashi
Researcher and Collaborator of Pain Group
University of Sao Paulo