NCT00496886

Brief Summary

Fibromyalgia (FM) is a disabling chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points, specific places on the body that become painful with only slight pressure. Pain associated with FM cannot be explained medically, often leading to a delayed diagnosis and delayed treatment. The purpose of this study is to evaluate how the nervous system, specifically the brain, processes pain in women with FM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 2, 2015

Status Verified

February 1, 2013

Enrollment Period

4.2 years

First QC Date

July 5, 2007

Last Update Submit

October 1, 2015

Conditions

FibromyalgiaRheumatoid Arthritis

Keywords

PainNociception

Outcome Measures

Primary Outcomes (1)

  • Brain responses to pain

    The study determines brain responses to pain in both healthy participants and those with fibromyalgia under conditions designed to manipulate anticipation and attention.

    Single experimental session

Secondary Outcomes (2)

  • Physical activity

    one week

  • Brain white matter

    single experimental session

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community and primary care clinic samples.

You may qualify if:

  • Diagnosis of FM or RA OR healthy
  • Right-handed

You may not qualify if:

  • Diagnosis of depression
  • Using illegal drugs
  • Claustrophobic
  • Metal objects in body
  • Require cardiovascular, high-dose antidepressant, or certain analgesic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

FibromyalgiaArthritis, RheumatoidPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesArthritisJoint DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dane B. Cook, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

April 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

October 2, 2015

Record last verified: 2013-02

Locations

US(1)