The Effect of Single Thoracic Manipulation Combined With Special Massage Technique on Mechanical Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pain level at rest
研究概览
简要总结
This study aims to compare the immediate effects of using a single thoracic manipulation combined with special massage technique (RT technique) and single thoracic manipulation alone on pain level at rest, cervical range of motion, upper limb neurodynamic test, neck disability, and adverse effects in chronic mechanical neck pain patients.
详细描述
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The subjects will be recruited through posted advertisements, and announcements, to find the patients who meet the criteria of mechanical neck pain that is the pain provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature. The subjects will be screened by screening questionnaire, and then will be examined by a physiotherapist. All subjects will be required to sign an inform consent before participating to the study
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The sample size was calculated by using the averaged of pain level at rest after treatment from the single thoracic manipulation combined with special massage group and single thoracic manipulation group, after the preliminary procedure that will be conducted with ten subjects per each group. After that, the variance was calculated by using the equation σ2 = (n1-1)s12 + (n2-1)s22/(n1+n2)-2 and the result will be used for calculate the sample size. A drop out rate will be set as 20%. The effect size (∆), the significant level of lower than 0.05 (Zα(0.05) = 1.96) and a power of test at 90 percent (Zβ(0.2)=1.28) was used to calculate in the equation as follow: n/group = "2(Zα + Zβ)2σ2" /"∆2"
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They have neck pain on posterior neck or shoulder, which is the area from superior nuchal line to spinous process of 1st thoracic vertebrae, with mechanical characteristics consisting of the symptoms provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature (Martı´nez-Segura et al., 2006).
- •They have symptoms for at least 3 months in duration.
- •They have pain level at rest at least mild level (from 3 score or greater) measured by Visual Analog Scale (Jensen et al., 2003).
- •They have a baseline Neck Disability Index (NDI) Thai version score of 10% or greater (Suvarnnato et al., 2013).
排除标准
- •The subjects will be excluded from current study if they have the following conditions including:
- •Cervical radiculopathy or myelopathy
- •History of whiplash injury within 6 weeks of examination
- •History of cervical surgery or thoracic surgery
- •History of cervical or thoracic injuries including fracture or dislocation
- •Fibromyalgia syndrome
- •The serious spinal conditions including spinal osteoporosis, spinal tuberculosis, and tumors
- •History of treated by spinal manipulation within 2 months before participating in the study
- •The diseases that are contra-indication to receive a spinal manipulation, such as hypertension, heart disease and meningitis
结局指标
主要结局
Pain level at rest
时间窗: Change from baseline at 3 weeks
A Visual Analog Scale (VAS) will be used for recording level of pain at rest.
次要结局
- Adverse effects(Change from baseline at 3 weeks)
- The Neck Disability Index Thai version (NDI-TH)(Change from baseline at 3 weeks)
- Cervical Range of Motion (CROM)(Change from baseline at 3 weeks)
- Upper limb tension test 1 (ULTT1)(Change from baseline at 3 weeks)
研究者
RAWIPORN PITHAK
Principle Investigator
Khon Kaen University