Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.
详细描述
The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic.
Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS
排除标准
- •Presence of any cervical radiculopathy or a history of degenerative conditions
- •Presence of any cervical surgery or trauma in the past year,
- •History of injection for the treatment of MAS in the last 6 months,
- •Cognitive disorder,
- •Rheumatological disease, fibromyalgia,
- •History of metabolic diseases such as hypothyroidism and diabetes mellitus
研究组 & 干预措施
Local anesthetic injection
Patients will be injected with lidocaine and given upper trapezius muscle stretching exercises. Lidocaine injection 2cc 2% will be administered to all patients using a 26 gauge, 0.45x13 mm disposable sterile needle to the affected trigger point.
干预措施: Lidocaine 2% Injectable Solution (Drug)
Local anesthetic injection
Patients will be injected with lidocaine and given upper trapezius muscle stretching exercises. Lidocaine injection 2cc 2% will be administered to all patients using a 26 gauge, 0.45x13 mm disposable sterile needle to the affected trigger point.
干预措施: stretching exercise (Other)
Ozone injection
Ozone injection will be performed on patients and upper trapezius muscle stretching exercises will be given. 8 cc of oxygen/ozone gas at a concentration of 15 µg/mL will be injected into the trigger point.
干预措施: Ozone (Drug)
Ozone injection
Ozone injection will be performed on patients and upper trapezius muscle stretching exercises will be given. 8 cc of oxygen/ozone gas at a concentration of 15 µg/mL will be injected into the trigger point.
干预措施: stretching exercise (Other)
Stretching exercise
Patients will be given a home program that includes upper trapezius muscle stretching exercises. Upper trapezius stretching exercises will be performed twice a day for at least 15 seconds, ten sets each time, for three weeks, with one hand on the patient's back and the other hand holding the side of the head and tilting it to the side until a slight tension is felt. The exercises will be explained in the text, visual and verbal forms with the exercise form.
干预措施: stretching exercise (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from baseline VAS at the 1st week after the treatment.
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
次要结局
- Neck Disability Index (NDI)(Change from baseline VAS at the 1st week after the treatment.)
- Range of motion (ROM)(Change from baseline VAS at the 1st week after the treatment.)
研究者
Hakan Alkan
Clinical Professor
Pamukkale University