Clinical trial NCT00819624: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia methodology pain sleep fatigue
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: Inclusion Criteria:

* Fibromyalgia using ACR diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Daily questions about pain asked using a telephone based system and a hand held diary
timeFrame: 4 weeks
measure: Daily questions about sleep asked using a telephone based system and a hand held diary
timeFrame: 4 weeks
measure: Daily questions about fatigue asked hand held electronic diary
timeFrame: 2 weeks
measure: Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
timeFrame: 4 weeks
Secondary outcomes:
measure: Questionaires about sleep, mood and fibromyalgia severity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Pfizer Investigational Site
state: California
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: