A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients
Not Applicable
Completed
- Conditions
- Fibromyalgia
- Interventions
- Other: Personal Digital Assisstant (PDA)Other: Interactive Voice Response System (IVRS)
- Registration Number
- NCT00819624
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
Inclusion Criteria
- Fibromyalgia using ACR diagnosis
Exclusion Criteria
- Other confounding disease including other inflammatory disease, pain and depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Personal Digital Assisstant Personal Digital Assisstant (PDA) - Interactive Voice Response System Interactive Voice Response System (IVRS) -
- Primary Outcome Measures
Name Time Method Daily questions about pain asked using a telephone based system and a hand held diary 4 weeks Daily questions about sleep asked using a telephone based system and a hand held diary 4 weeks Daily questions about fatigue asked hand held electronic diary 2 weeks Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use 4 weeks
- Secondary Outcome Measures
Name Time Method Questionaires about sleep, mood and fibromyalgia severity 4 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Spokane, Washington, United States