The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Neck Pain
研究概览
简要总结
Ozone (O2-O3) has been used as a supportive therapy in various musculoskeletal diseases such as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder pathologies.The aim of this study is to investigate the effectiveness of ozone (O2-O3) injection applied to the trigger point in the treatment of myofascial pain syndrome.
详细描述
The study was designed as a prospective, randomized, controlled trial. Fourty six people who met the inclusion criteria will randomized into two groups of 23 people. The first group will be designated as ozone therapy group and patients in the second group will be designated as the lidocaine injection group. Patients will be evaluated with visuel analog scale (10cm-VAS), Neck Disability Index (NDI), Pain Score (PS) and neck lateral flexion measurement before and after treatment at 4 and 12 weeks.
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
- Single (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 myofascial pain syndrome according to the criteria defined by Simons et al.
- •aged between18-65
- •having typical myofascial pain symptoms for at least 3 months
排除标准
- •presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration
- •presence of a history of neck trauma or surgery in the last year
- •presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months
- •presence of cognitive impairment, malignant hypertension, G6PDH (Glucose 6- Phosphate Dehydrogenase) deficiency, Graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value <50,000 / microliter), cerebrovascular disease in which bleeding is active
- •presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy.
- •presence of pregnancy and breastfeeding
结局指标
主要结局
Neck Pain
时间窗: baseline, change from baseline VAS at 4 and 12 weeks after injection
Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
次要结局
- Pain Scor (PS)(baseline, change from baseline PS at 4 and 12 weeks after injection)
- Range of Motion (ROM) of the neck(baseline, change from baseline ROM at 4 and 12 weeks after injection)
- Neck Disability Index (NDI)(baseline, change from baseline NDI at 4 and 12 after injection)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital