The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.
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
- Double (Participant, 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
- •Main complaint of Neck Pain for at least six (6) months;
- •Score of at least 10 points in NDI (Neck Disability Index);
- •Pain and / or restriction of cervical movements;
- •Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
- •The definition of the term Neck Pain follows the classification of TFNP.
排除标准
- •Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
- •History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
- •Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
- •Red flags contraindicating spinal manipulation.
研究组 & 干预措施
Spinal Manipulation
High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
干预措施: Spinal Manipulation (Other)
Spinal Manipulation
High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
干预措施: Pain Education (Other)
Pain Education
Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
干预措施: Pain Education (Other)
Pain Education
Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.
干预措施: Sham (Other)
结局指标
主要结局
Pain Intensity
时间窗: 4 weeks after randomization
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
次要结局
- Pressure Pain Threshold(4 weeks and 3 months after randomization)
- Health-related Quality of Life(4 weeks and 3 months after randomization)
- Cytokines(4 weeks after randomization)
- Disability(4 weeks and 3 months after randomization)
- Fear Avoidance Beliefs(4 weeks and 3 months after randomization)
- Kinesiophobia(4 weeks and 3 months after randomization)
- Pain Intensity(3 months after randomization)
研究者
Marcelo Anderson Bracht
Principal Investigator
Santa Catarina Federal University