FibromyalgiaPhase 2/3NCT02358902
Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
A Phase 2/3 study testing tDCS and active intervention of aerobic exercise in people with Fibromyalgia, run by University of Sao Paulo General Hospital.
Trial summary
This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- tDCS and active intervention of aerobic exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2014
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Fibromyalgia according to the American College of Rheumatology
- Have completed high school
- Age between 18 and 65 years old
Who cannot join
- Were on medication for pain control for less than two months
- In treatment of depression for less than two months
- Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope
- Pregnant women and infants
- Possessing metallic implant in the brain
- In use of illicit drugs
- That were in some kind of physical treatment for less than two months
About this study
This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.
Read the detailed description
The average between the analyzed values was 1.20, with a standard deviation of 0.84, taking into account a type I error of 5%, a type II error of 10% and a power of 80%. From the sample calculation was found an n = 10 for each group. The sample is amplified in order to avoid possible effects of dropout ending with a n = 15 in each group with a total N = 45.
Randomization was performed by a blinded therapist using sealed envelopes for each individual. The subjects will be divided into three intervention groups: tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group, in which will receive active intervention of aerobic exercise training and active tDCS intervention. AE group, which will receive active intervention of aerobic exercise and placebo tDCS. And tDCS group, which will receive placebo AE and active intervention for tDCS.
Participants will be blinded to the intervention groups as well as therapists involved in the evaluation process.
The evaluation methods were carried out one week before the beginning of the intervention (baseline) for all variables. After the first week of intervention (neuromodulatory period) was performed ratings for level of cortical excitability (T1), and after the end of the one month period of intervention for all variables (T2). Follow-up evaluations were conducted one month (T3) and two months (T4) after the end of the intervention period."
- Conditions
- Fibromyalgia
- Being tested
- tDCS, active intervention of aerobic exercise, placebo tDCS, placebo AE
- Keywords
- Transcranial Direct Current Stimulation, Exercise, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
tDCS - DC stimulator, Neurocom, Germany
active intervention of aerobic exerciseProcedure or surgery
different types of aerobic exercise
placebo tDCSDevice
only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)
placebo AEProcedure or surgery
the procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention Receives: Device: tDCS; Procedure: active intervention of aerobic exercise |
| Group B | Experimental | AE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany) Receives: Procedure: active intervention of aerobic exercise; Device: placebo tDCS |
| Group C | Experimental | tDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany) Receives: Device: tDCS; Procedure: placebo AE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Numeric Scale (VNS)
Pain intensity is measured using a scale from 0 to 10. A straight 10 cm line is displayed for the subject enumerated from zero to 10, where zero represents no pain and 10 the worst pain possible. Subjects should mark the number that most represents the symptom of pain at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.
Measured: Up to 2 months
Secondary outcomes (1)
Change in Visual Numeric Scale for Anxiety
This scale has a straight 10 cm enumerated from zero to 10, where zero represents not anxious and 10 the most anxious possible. Subjects should mark the number that most represents the anxiety level at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nove de Julho
- Responsible party
- Sponsor
- Investigators
- Marcel Simis, MD PhD, Study chair, Institute of Physical Medicine and Rehabilitation, Clinicas Hospital, Faculty of Medicine, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358902
- Sponsor's protocol ID
- 08603612.0.0000.5511
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.
PubMed 17133529
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02358902
- Acronym / sponsor ID
- 08603612.0.0000.5511
- Conditions
- Fibromyalgia
- Keywords
- Transcranial Direct Current Stimulation, Exercise, Fibromyalgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Nove de Julho
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Feb 2015 (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.
This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.
Detailed description
The average between the analyzed values was 1.20, with a standard deviation of 0.84, taking into account a type I error of 5%, a type II error of 10% and a power of 80%. From the sample calculation was found an n = 10 for each group. The sample is amplified in order to avoid possible effects of dropout ending with a n = 15 in each group with a total N = 45.
Randomization was performed by a blinded therapist using sealed envelopes for each individual. The subjects will be divided into three intervention groups: tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group, in which will receive active intervention of aerobic exercise training and active tDCS intervention. AE group, which will receive active intervention of aerobic exercise and placebo tDCS. And tDCS group, which will receive placebo AE and active intervention for tDCS.
Participants will be blinded to the intervention groups as well as therapists involved in the evaluation process.
The evaluation methods were carried out one week before the beginning of the intervention (baseline) for all variables. After the first week of intervention (neuromodulatory period) was performed ratings for level of cortical excitability (T1), and after the end of the one month period of intervention for all variables (T2). Follow-up evaluations were conducted one month (T3) and two months (T4) after the end of the intervention period."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: tDCS, Procedure: active intervention of aerobic exercisetDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group in which will receive active intervention of aerobic exercise training and active tDCS intervention |
| Group B | Experimental | Procedure: active intervention of aerobic exercise, Device: placebo tDCSAE group which will receive active intervention of aerobic exercise and placebo tDCS (tDCS - DC stimulator, Neurocom, Germany) |
| Group C | Experimental | Device: tDCS, Procedure: placebo AEtDCS group which will receive placebo AE and active intervention for tDCS (tDCS - DC stimulator, Neurocom, Germany) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Fibromyalgia according to the American College of Rheumatology
- Have completed high school
- Age between 18 and 65 years old
Key exclusion criteria (7 listed)
- Were on medication for pain control for less than two months
- In treatment of depression for less than two months
- Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope
- Pregnant women and infants
- Possessing metallic implant in the brain
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 |
|---|---|---|
| tDCStDCS - DC stimulator, Neurocom, Germany | Device | Group A, Group C |
| active intervention of aerobic exercisedifferent types of aerobic exercise | Procedure or surgery | Group A, Group B |
| placebo tDCSonly 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany) | Device | Group B |
| placebo AEthe procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill | Procedure or surgery | Group C |
Primary outcome
Change in Visual Numeric Scale (VNS)
Time frame: Up to 2 months
Pain intensity is measured using a scale from 0 to 10. A straight 10 cm line is displayed for the subject enumerated from zero to 10, where zero represents no pain and 10 the worst pain possible. Subjects should mark the number that most represents the symptom of pain at the moment. Outcome will be measured 24 hours after each intervention session, after 1 month of the end of protocol and 2 months after the end of protocol for evaluation of long term effects.
1 secondary outcome
Change in Visual Numeric Scale for Anxiety
Time frame: Up to 2 months
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 9 Feb 2015.
- Results publication: PubMed 17133529Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.
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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.
Marcel Simis, MD PhD study chair
Institute of Physical Medicine and Rehabilitation, Clinicas Hospital, Faculty of Medicine, University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tDCS and active intervention of aerobic exercise in people with Fibromyalgia, run by University of Sao Paulo General Hospital.
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 7 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in Visual Numeric Scale (VNS) (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358902, which also lists 1 linked publication.
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 9 Feb 2015.