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临床试验/NCT00819624
NCT00819624已完成不适用

A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients

Pfizer16 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
185
试验地点
16
主要终点
Daily questions about pain asked using a telephone based system and a hand held diary

研究概览

简要总结

The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fibromyalgia using ACR diagnosis

排除标准

  • Other confounding disease including other inflammatory disease, pain and depression

结局指标

主要结局

Daily questions about pain asked using a telephone based system and a hand held diary

时间窗: 4 weeks

Daily questions about sleep asked using a telephone based system and a hand held diary

时间窗: 4 weeks

Daily questions about fatigue asked hand held electronic diary

时间窗: 2 weeks

Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use

时间窗: 4 weeks

次要结局

  • Questionaires about sleep, mood and fibromyalgia severity(4 weeks)

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (16)

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