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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819624

Enrollment

185

Registered

2009-01-09

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

fibromyalgia methodology pain sleep fatigue

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.

Interventions

OTHERInteractive Voice Response System (IVRS)

Telephone based system

OTHERPersonal Digital Assisstant (PDA)

Electronic Hand Held diary

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Fibromyalgia using ACR diagnosis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Questionaires about sleep, mood and fibromyalgia severity	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026