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临床试验/NCT03314285
NCT03314285已完成不适用

Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain

Alper Mengi2 个研究点 分布在 2 个国家目标入组 86 人开始时间: 2017年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Pittsburg Sleep Quality Scale

研究概览

简要总结

This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.

详细描述

It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (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

入选标准

  • Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
  • Patient's visual analogue scale score is 3 and over

排除标准

  • History of neurological deficit
  • History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
  • History of central or peripheral nervous system disorders
  • History of inflammatory neck pain
  • Pregnant or breast feeding
  • History of fibromyalgia disease
  • History of severe osteoporosis or osteomalacia
  • History of infectious, malignancy, and active psychiatric disease
  • Noncooperative
  • Patient has chronic pain in a region other than the neck region

结局指标

主要结局

Pittsburg Sleep Quality Scale

时间窗: 30 day

Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.The Pittsburgh Sleep Quality Scale is a 19-item self-rated questionnaire for evaluating subjective sleep quality the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.

次要结局

  • Pain Severity(7 day)
  • Demographic Data(30 day)

研究者

发起方
Alper Mengi
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Alper Mengi

Physiatrist, Medical Doctor

Gaziosmanpasa Research and Education Hospital

研究点 (2)

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