NCT01774734已完成不适用
Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from Baseline in Visual analog scale (VAS) at three-month interval
研究概览
简要总结
- Chronic neck pain is common in general population.
- High health care source expenditure
- Multiple therapeutic approaches available with limited evidence
- Previous studies showed active strengthening exercise improved pain (VAS) and functional performance (NDI)
- Muscle strengthening exercise with biofeedback technique showed more long-lasting effect in patients with chronic neck pain
- The investigators hypothesize that daily use of the neck strength exerciser (NSE), combined biofeedback technique with muscle strengthening exercise posture adjustment, in addition to traditional physiotherapy, could have more long-lasting and prominent effect on pain and functional improvement in patients with chronic neck pain.
详细描述
- A randomized single-blinded trial to compare the effect of combined home-based NSE with physiotherapy could be more effective to treat people with chronic neck pain
- The NSE is a simple equipment that is easy to learn and safe to apply as home-based program
- The NSE will apply to the patients in the NSE group for 6 weeks, and we will compare the target variables to see if it brings better improvement by correction of maladaptive habitual posture and daily postural muscle exercise
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, ≧20 yr.
- •Constantly or frequently occurring neck pain for more than 3 months in the last 1 year.
- •Motivated and willing to participate in rehabilitation therapy
- •Sign written informed consent.
排除标准
- •Neck or shoulder surgery.
- •Clinical evidence of cervical radiculopathy or myelopathy.
- •History of disk disease, degenerative joint disease, fracture, or dislocation in the cervical vertebrae.
- •Severe pathological change in the cervical vertebrae, including inflammatory rheumatic disease and tumor.
- •History of poor diet, hypothyroidism, or other severe systemic disorders.
- •Cognitive deficit and severe psychiatric illness.
结局指标
主要结局
Change from Baseline in Visual analog scale (VAS) at three-month interval
时间窗: day 0; day 42; 12 weeks
a 10-point horizontal line with 0 represented the expressions "no pain at all, and 10 represented "the most intense pain imaginable"
次要结局
- Cervical active ROM(day 0; day 42; 12 weeks)
- Amount of sick leave(day 42; 12 weeks)
- Patient global assessment (PGA)(day 0; day 42; 12 weeks)
- Effect of the intervention on the neck pain(day 42; 12 weeks)
- Neck Disability Index (NDI)(day 0; day 42; 12 weeks)
- Amount of analgesics(day 42; 12 weeks)
研究者
研究点 (1)
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