Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
研究概览
简要总结
The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort.
详细描述
50 inpatients with neck discomfort(NRS>4) will be randomly allocated to 2 groups. The experimental group was treated with functional cervical pillow and the control group was treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at baseline, 3 day, per weeks until the duration of admission. Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D will also be collected. The applicants will also get thru the diagnosis of range of motion by X-ray(flexion, neutral, extension of their neck position)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to a Korean Medicine hospital
- •Age between 18 and 69
- •NRS score of >4 on the day of the intervention
- •Voluntary participation with written consent given to study consent form, including cervical x-ray
排除标准
- •Diagnosis of serious disease(s) which are possible causes of neck pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda-equina compression, etc.
- •Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- •Progressive neurologic deficit(s) or concurrent severe neurological symptoms
- •Previously using any kind of functional pillow
研究组 & 干预措施
Functional pillow
cervical pillow, designed functionally to decrease neck pain and help to ensure the right support of the cervical curve, was applied to patients' posterior neck area.
干预措施: Functional pillow (Device)
General pillow
Applicants Randomly allocated to this group were issued by placebo-general pillow. There is not any specific intervention for their neck discomfort except for that.
干预措施: Placebo general pillow (Device)
结局指标
主要结局
Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
时间窗: At baseline, 3 day, week 1, 2, 3, 4 following intervention
The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning
次要结局
- Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)(At baseline, week 4 following intervention)
- Change from baseline in radiological angle on Range of motion(ROM)(At baseline, week 4)
- Change from baseline in Satisfaction levels on present status of him/her(At baseline, 3 day, week 1, 2, 3, 4 following intervention)
- Change from baseline in functional impairment on Neck Disability Index(NDI)(At baseline, week 2, 4 following intervention)
- Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)(At baseline, week 2, 4 following intervention)
研究者
In-Hyuk Ha
Dr
Jaseng Hospital of Korean Medicine