FibromyalgiaPhase 4NCT01261650
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
A Phase 4 study testing transcranial direct current stimulation in people with Fibromyalgia, run by Karl Landsteiner Institute of Remobilization and Functional Health at 1 site in Austria.
Trial summary
Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2010to not given
- Phase
- Phase 4
- 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
- All sexes
- Adult, Older adult
Who may be able to join
- Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
- Symptoms have been present at a similar level for at least 3 months
- Stable medication for at least 2 months
- visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
- The patient does not have a disorder that would otherwise explain the pain
Who cannot join
- Alcohol/substance abuse
- Pregnancy
- Neuropsychiatric disorders
- Metal implants near stimulation area
- Cardiac pace maker
- Local injuries
Show all 10Show fewer
- Inflammatory rheumatic disease
- Acute tumor
- Acute fracture
- Well-defined neuropathic induced pain
Trial locations and contacts
1 site in 1 country.
Austria1 site
Karl Landsteiner Institute of Remobilisation and Functional Health
Vienna, State of Vienna, 1100
About this study
Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.
- Conditions
- Fibromyalgia
- Being tested
- transcranial direct current stimulation, sham treatment
- Keywords
- widespread chronic pain, transcranial direct current stimulation, fibromyalgia
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Active comparator | transcranial direct current stimulation of the primary motor cortex Receives: Device: transcranial direct current stimulation |
| sham treatment | Sham comparator | Not described Receives: Device: sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoge Scale
Measured: Difference Baseline - after treatment
Secondary outcomes (7)
Quality of Life - SF-36
Measured: baseline / after treatment / 1 , 2, 3 months after treatment
Fibromyalgia Impact Questionaire
Measured: baseline / after treatment / 1,2,3, months after treatment
IL-10 ELISA
Measured: baseline / after treatment / 1,2,3, months after treatment
Visual analog scale
Measured: 1,2,3 months after treatment
IL-6 ELISA
Measured: baseline / after treatment / 1,2,3, months after treatment
IL-4 ELISA
Measured: baseline / after treatment / 1,2,3, months after treatment
TNF-alpha ELISA
Measured: baseline / after treatment / 1,2,3, months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
Why it stopped: There could not be enough patients recruited
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Institute of Remobilization and Functional Health
- Sponsor type
- University, hospital or other
- Investigators
- Michael Quittan, PhD, Principal investigator, Karl Landsteiner Institute of Remobilisation and functional Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261650
- Sponsor's protocol ID
- FIBRO 1
- Status last verified
- Jul 2014
- First submitted
- 14 Dec 2010
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT01261650
- Acronym / sponsor ID
- FIBRO 1
- Conditions
- Fibromyalgia
- Keywords
- widespread chronic pain, transcranial direct current stimulation, fibromyalgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There could not be enough patients recruited
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karl Landsteiner Institute of Remobilization and Functional HealthUniversity, hospital or other
- Study start
- Dec 2010
- First posted
- 16 Dec 2010 (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.
Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Active comparator | Device: transcranial direct current stimulationtranscranial direct current stimulation of the primary motor cortex |
| sham treatment | Sham comparator | Device: sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
- Symptoms have been present at a similar level for at least 3 months
- Stable medication for at least 2 months
- visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
- The patient does not have a disorder that would otherwise explain the pain
Key exclusion criteria (10 listed)
- Alcohol/substance abuse
- Pregnancy
- Neuropsychiatric disorders
- Metal implants near stimulation area
- Cardiac pace maker
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 |
|---|---|---|
| transcranial direct current stimulation | Device | transcranial direct current stimulation |
| sham treatment | Device | sham treatment |
Primary outcome
Visual Analoge Scale
Time frame: Difference Baseline - after treatment
7 secondary outcomes
Quality of Life - SF-36
Time frame: baseline / after treatment / 1 , 2, 3 months after treatment
Fibromyalgia Impact Questionaire
Time frame: baseline / after treatment / 1,2,3, months after treatment
IL-10 ELISA
Time frame: baseline / after treatment / 1,2,3, months after treatment
Visual analog scale
Time frame: 1,2,3 months after treatment
IL-6 ELISA
Time frame: baseline / after treatment / 1,2,3, months after treatment
IL-4 ELISA
Time frame: baseline / after treatment / 1,2,3, months after treatment
TNF-alpha ELISA
Time frame: baseline / after treatment / 1,2,3, months after treatment
Results and safety
The study was stopped early (reason given: There could not be enough patients recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
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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.
Michael Quittan, PhD principal investigator
Karl Landsteiner Institute of Remobilisation and functional Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transcranial direct current stimulation in people with Fibromyalgia, run by Karl Landsteiner Institute of Remobilization and Functional Health at 1 site in Austria.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Jul 2014. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: There could not be enough patients recruited). 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?
Visual Analoge Scale (time frame: Difference Baseline - after treatment). 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 3 Jul 2014.