Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- mean neck pain intensity of the last seven days
研究概览
简要总结
The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
详细描述
Objective
To evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
Study Design: Open single-centre randomized two-armed controlled trial. Setting: The study will be performed at a University out-patient clinic specialized in Integrative Medicine, with experience in the treatment of chronic pain.
Participants: 88 outpatients with chronic neck pain, who will be randomly allocated to two groups (tuina, or no intervention (control)).
Intervention: Patients receive either six tuina treatments within 3 weeks or no additional intervention.
Main outcome measure: The primary outcome is the mean neck pain intensity over the last seven days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst imaginable pain) after four 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
- None
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
- •female or male
- •18 to 60 years of age
- •clinical diagnosis "chronic neck pain", i.e. neck pain for at least 12 weeks
- •if additional back pain is reported, neck pain has to be predominant
- •intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)
- •ability to give oral and signed written informed consent
- •patient's mental and physical ability to participate in the trial
- •willingness to be randomized, to attend visits, to complete questionnaires
- •written and oral informed consent
排除标准
- •neck pain caused by a malignant disease
- •neck pain caused by trauma
- •rheumatic disorder
- •prior spinal column surgery
- •neurological symptoms, e.g. radicular symptoms because of a prolapsed vertebral disc
- •suspected osteoporosis
- •obesity with BMI ≥30 Kg/m2
- •known vascular anomaly such as aneurysm
- •regular intake of analgesics (>1x per week) because of a additional diseases
- •intake of centrally acting analgesics
- •current application for a benefit
- •pregnancy
- •severe acute and or chronic disease which does not allow participation in the therapy
- •other limitations which do not allow participation in the therapy
- •alcohol or substance abuse
- •tuina treatment during the six months before study entry
- •participation in another clinical trial during six months before the study and parallel to the study
- •anticipated new treatments which have a positive influence on the neck pain such as physiotherapy against neck pain, acupuncture, massage during the study
- •no sufficient German language skills
结局指标
主要结局
mean neck pain intensity of the last seven days
时间窗: 4 weeks
次要结局
- mean neck pain intensity of the last seven days(12 weeks)
- SF-12 health related quality of life(4 weeks, 12 weeks)
- Neck Pain and Disability Scale (NPDS)(4 weeks, 12 weeks)
- Costs(4 weeks, 12 weeks)
- Body efficacy expectation(4 weeks, 12 weeks)
- number of serious adverse events(4 weeks, 12 weeks)
- Neck Disability Index (NDI)(4 weeks, 12 weeks)
- medication intake(4 weeks, 12 weeks)
- adverse reactions(4 weeks, 12 weeks)
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany