FibromyalgiaNCT01506817
Dynamic Contrast Enhanced (DCE)-MRI in Fibromyalgia
An observational study of Fibromyalgia, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The primary objective of the current pilot study is to analyze MRI contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Dynamic contrast-enhanced MRI of the hands
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Sep 2012
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with fibromyalgia recruited from Department of Rheumatology, Frederiksberg Hospital. Inclusion in the study will be based on clinical assessment by a specialist in rheumatology and member of the research team. Patients fulfilling the 1990-ACR criteria for fibromyalgia and with pain in the hands as a prominent clinical feature will be referred for DCE-MRI as part of the diagnostic workup. Healthy controls will be recruited by advertisement at www.forsøgsperson.dk or in the daily press and included in the project based on written, informed consent.
Who may be able to join
- Age above 18
- Fibromyalgia according to the 1990-ACR research criteria
- Pain in the hands as a prominent clinical feature
Who cannot join
- Other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
- Renal impairment
- Contraindications for MRI
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Frederiksberg University Hospital
Frederiksberg, 2000
About this study
Official title: Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study
The primary objective of the current pilot study is to analyze MRI contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic arthritis.
Hypothesis:
Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g. superficial soft tissues and /or muscle with patterns distinct from those of inflammatory joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.
Read the detailed description
Systematic, diagnostic studies applying DCE-MRI have never been performed in patients with fibromyalgia. However, characteristic contrast-enhancement patterns different from those seen in patients with rheumatoid arthritis and psoriatic arthritis have been observed in a small sample of fibromyalgia patients referred for DCE-MRI of the hands for differential diagnostic purposes at department of radiology, Frederiksberg Hospital. In these patients enhancement parameters indicative of vasodilatation and diffuse hyperperfusion involving subcutaneous tissues and muscles of the hands and fingers were found, whereas no synovial inflammation in joints or tendons could be demonstrated in the majority of these patients. Whether these observations are part of a "normal" physiological perfusion in healthy individual or a potential novel marker of disease activity remains to be studied.
If a pathological imaging pattern indicative of superficial soft tissue or muscle inflammation/hyper perfusion can be demonstrated it will have far-reaching implications for future research related to this patient population. Not only may this line of research contribute to a better neurobiological understanding of fibromyalgia and the neurobiological link between inflammation and pain modulation, but also to the development of more objective examination methods, which will make diagnosing more reliable and less subjective. Further, a better understanding of the neurobiology and phenomenological manifestations of fibromyalgia may have critical treatment implications
- Conditions
- Fibromyalgia
- Being tested
- Dynamic contrast-enhanced MRI of the hands
- Keywords
- fibromyalgia, DCE-MRI, neurogenic inflammation, contrast-enhancement patterns
- Medical subject headings
- Fibromyalgia, Neurogenic Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast-enhanced MRI of the handsProcedure or surgery
The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil. Total imaging time varies between 30-35 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | patients with fibromyalgia fulfilling the 1990-ACR research criteria and with pain in the hands as a prominent clinical feature Receives: Procedure: Dynamic contrast-enhanced MRI of the hands | |
| Controls | healthy aged matched pain-free controls Receives: Procedure: Dynamic contrast-enhanced MRI of the hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study.
The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oak Foundation
- Responsible party
- Principal investigator, Henning Bliddal, Frederiksberg University Hospital
- Investigators
- Mikael Boesen, MD,PhD, Principal investigator, The Parker Institute and Department of Radiology, Frederiksberg Hospital DenmarkHenning Bliddal, Professor, DMSci, Study director, The Parker Institute, Frederiksberg Hospital DenmarkKirstine Amris, MD, Principal investigator, The Parker Institute and Department of Rheumatology, Frederiksberg Hospital DenmarkPeter Taylor, Professor, MA, PhD, Principal investigator, Kennedy Institute of Rheumatology, University of Oxford, England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506817
- Sponsor's protocol ID
- HB-030112
- Status last verified
- Jan 2012
- First submitted
- 3 Jan 2012
- Last updated
- 10 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Enhanced MRI of the Hands in Patients With Fibromyalgia. A Pilot Study
- ClinicalTrials.gov ID
- NCT01506817
- Acronym / sponsor ID
- HB-030112
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, DCE-MRI, neurogenic inflammation, contrast-enhancement patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Collaborators
- Oak Foundation
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 10 Jan 2012 (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 primary objective of the current pilot study is to analyze MRI contrast-enhancement patterns in the hands of patients with fibromyalgia as compared to the findings in healthy controls. Further, to compare enhancement patterns obtained in fibromyalgia patients with those described in inflammatory joint disorders, i.e. rheumatoid arthritis and psoriatic arthritis.
Hypothesis:
Dynamic contrast-enhanced MRI (DCE-MRI) of the hands in patients with fibromyalgia reveals pathological imaging patterns indicative of diffuse non-arthrogenic inflammation of e.g. superficial soft tissues and /or muscle with patterns distinct from those of inflammatory joint disorders e.g. rheumatoid arthritis and psoriatic arthritis.
Detailed description
Systematic, diagnostic studies applying DCE-MRI have never been performed in patients with fibromyalgia. However, characteristic contrast-enhancement patterns different from those seen in patients with rheumatoid arthritis and psoriatic arthritis have been observed in a small sample of fibromyalgia patients referred for DCE-MRI of the hands for differential diagnostic purposes at department of radiology, Frederiksberg Hospital. In these patients enhancement parameters indicative of vasodilatation and diffuse hyperperfusion involving subcutaneous tissues and muscles of the hands and fingers were found, whereas no synovial inflammation in joints or tendons could be demonstrated in the majority of these patients. Whether these observations are part of a "normal" physiological perfusion in healthy individual or a potential novel marker of disease activity remains to be studied.
If a pathological imaging pattern indicative of superficial soft tissue or muscle inflammation/hyper perfusion can be demonstrated it will have far-reaching implications for future research related to this patient population. Not only may this line of research contribute to a better neurobiological understanding of fibromyalgia and the neurobiological link between inflammation and pain modulation, but also to the development of more objective examination methods, which will make diagnosing more reliable and less subjective. Further, a better understanding of the neurobiology and phenomenological manifestations of fibromyalgia may have critical treatment implications
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Procedure: Dynamic contrast-enhanced MRI of the handspatients with fibromyalgia fulfilling the 1990-ACR research criteria and with pain in the hands as a prominent clinical feature |
| Controls | – | Procedure: Dynamic contrast-enhanced MRI of the handshealthy aged matched pain-free controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fibromyalgia recruited from Department of Rheumatology, Frederiksberg Hospital. Inclusion in the study will be based on clinical assessment by a specialist in rheumatology and member of the research team. Patients fulfilling the 1990-ACR criteria for fibromyalgia and with pain in the hands as a prominent clinical feature will be referred for DCE-MRI as part of the diagnostic workup. Healthy controls will be recruited by advertisement at www.forsøgsperson.dk or in the daily press and included in the project based on written, informed consent.
Key inclusion criteria (3 listed)
- Age above 18
- Fibromyalgia according to the 1990-ACR research criteria
- Pain in the hands as a prominent clinical feature
Key exclusion criteria (3 listed)
- Other know medical condition capable of causing patients symptoms (e.g. uncontrolled inflammatory/autoimmune disorder, uncontrolled endocrine disorder, malignancy)
- Renal impairment
- Contraindications for MRI
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 |
|---|---|---|
| Dynamic contrast-enhanced MRI of the handsThe hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil. Total imaging time varies between 30-35 minutes. | Procedure or surgery | Controls, Fibromyalgia |
Primary outcome
Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study.
Time frame: at baseline
The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
- Related InfoLink provided by the sponsor.
Related trials for Fibromyalgia
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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.
Mikael Boesen, MD,PhD principal investigator
The Parker Institute and Department of Radiology, Frederiksberg Hospital Denmark
Henning Bliddal, Professor, DMSci study director
The Parker Institute, Frederiksberg Hospital Denmark
Kirstine Amris, MD principal investigator
The Parker Institute and Department of Rheumatology, Frederiksberg Hospital Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Frederiksberg University Hospital at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Jan 2012. 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 Denmark. 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.
Are results available for this study?
Results are not available in the source record.
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?
Imaging patterns obtained at DCE-MRI using the software program DYNAMIKA (www.imageanalysis.org.uk) of the dominant hand as evaluated by a specialist in radiology will be the primary outcome of the study. (time frame: at baseline). 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 10 Jan 2012.