NCT00857740

Brief Summary

The purpose of this study is to investigate whether education about the neurophysiology of pain is able to improve central pain inhibition in patients with Fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2009

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

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 8, 2010

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

March 6, 2009

Last Update Submit

July 7, 2010

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Diffuse noxious inhibitory control

    baseline, 14 days and 3 months follow-up

Secondary Outcomes (1)

  • pain pressure thresholds

    baseline, 14 days and 3 months follow-up

Interventions

EducationBEHAVIORAL

Education about the neurophysiology of pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnose fibromyalgia
  • Widespread pain
  • Dutch speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1500, Belgium

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jessica Van Oosterwijck, Doctoranda

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 8, 2010

Record last verified: 2009-03

Locations

BE(1)