FibromyalgiaEarly Phase 1NCT00857740
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
A Early Phase 1 study testing Education in people with Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2009to Jun 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnose fibromyalgia
- Widespread pain
- Dutch speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education about the neurophysiology of pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffuse noxious inhibitory control
Measured: baseline, 14 days and 3 months follow-up
Secondary outcomes (1)
pain pressure thresholds
Measured: baseline, 14 days and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Investigators
- Jessica Van Oosterwijck, Doctoranda, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857740
- Sponsor's protocol ID
- BUN B14320084324
- Status last verified
- Mar 2009
- First submitted
- 6 Mar 2009
- Last updated
- 8 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
- ClinicalTrials.gov ID
- NCT00857740
- Acronym / sponsor ID
- BUN B14320084324
- Conditions
- Fibromyalgia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnose fibromyalgia
- Widespread pain
- Dutch speaking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducation about the neurophysiology of pain | Behavioural | – |
Primary outcome
Diffuse noxious inhibitory control
Time frame: baseline, 14 days and 3 months follow-up
1 secondary outcome
pain pressure thresholds
Time frame: baseline, 14 days and 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Van Oosterwijck, Doctoranda principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Education in people with Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffuse noxious inhibitory control (time frame: baseline, 14 days and 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.