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

N/ACompletedNCT00819624

Pfizer185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

185

Conditions

Fibromyalgia

Interventions

Interactive Voice Response System (IVRS)OTHER

Telephone based system

Personal Digital Assisstant (PDA)OTHER

Electronic Hand Held diary

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fibromyalgia using ACR diagnosis Exclusion Criteria: * Other confounding disease including other inflammatory disease, pain and depression

Locations (15)

Pfizer Investigational Site

Roseville, California, United States

Pfizer Investigational Site

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

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

Time frame: 4 weeks

Daily questions about fatigue asked hand held electronic diary

Time frame: 2 weeks

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

Time frame: 4 weeks

Secondary Outcomes

Questionaires about sleep, mood and fibromyalgia severity

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.