FibromyalgiaNCT04050254
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
A study testing Real tDCS and Therapeutic exercise in people with Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Real tDCS and Therapeutic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2019to 27 Mar 2020
- Phase
- Interventional
- 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
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Normal pain intensity of 4 or more points on a visual analog scale.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Who cannot join
- Pregnancy or breastfeeding.
- Metallic implants in the head.
- Tumor, trauma or surgery in the brain.
- Epilepsy or stroke.
- History of substance abuse in the last 6 months.
- Use of carbamazepine in the last 6 months.
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- Severe depression (Beck Depression Index II of 29 or more).
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
- Coexisting autoimmune pathology.
- Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
About this study
Official title: Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
The purpose of this study is to assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.
Read the detailed description
Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.
Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.
In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.
The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Real tDCS, Sham tDCS, Therapeutic exercise
- Keywords
- tDCS, Therapeutic exercise, Referred pain, Central sensitization
- Medical subject headings
- Fibromyalgia, Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSDevice
Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
Sham tDCSDevice
Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days. Sham tDCS will be applied for the same time than real tDCS.
Therapeutic exerciseDevice
The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days. The program will include exercises and will last 30-45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS + exercise | Experimental | Transcranial direct current stimulation combined with therapeutic exercise Receives: Device: Real tDCS; Device: Therapeutic exercise |
| Sham tDCS + exercise | Sham comparator | Sham transcranial direct current stimulation combined with therapeutic exercise Receives: Device: Sham tDCS; Device: Therapeutic exercise |
| Control | No intervention | No treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds.
After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark).
Measured: Baseline; immediately after intervention; 1-month after intervention
Change in pain intensity from baseline to post-treatment
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable
Measured: Baseline; immediately after intervention; 1-month after intervention
Secondary outcomes (4)
Fibromyalgia Impact Quality-of-Life
It will be measured with the version adapted to the Spanish of the Fibromyalgia Impact Questionnaire (FIQ). The scale ranges from 0 to 100. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Anxiety
The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used. The scale ranges from 0 to 60. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Pain catastrophizing
The Spanish version of the Pain Catastrophizing Scale (PCS) will be used. The scale ranges from 0 to 52. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Depression
The adaptation to the Spanish of Beck Depression Inventory II will be used. The scale ranges from 0 to 63. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start2 Sep 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050254
- Sponsor's protocol ID
- tDCS+ET-Fibromyalgia
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arroyo-Fernandez R, Avendano-Coy J, Velasco-Velasco R, Palomo-Carrion R, Bravo-Esteban E, Ferri-Morales A. Effectiveness of Transcranial Direct Current Stimulation Combined With Exercising in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1524-1532. doi: 10.1016/j.apmr.2022.02.020. Epub 2022 Mar 22.
PubMed 35331718
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04050254
- Acronym / sponsor ID
- tDCS+ET-Fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- tDCS, Therapeutic exercise, Referred pain, Central sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 8 Aug 2019 (actual)
- 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 assess the effects on pain of transcranial direct current stimulation combined with therapeutic exercise in fibromyalgia patients.
Detailed description
Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.
Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.
In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.
The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real tDCS + exercise | Experimental | Device: Real tDCS, Device: Therapeutic exerciseTranscranial direct current stimulation combined with therapeutic exercise |
| Sham tDCS + exercise | Sham comparator | Device: Sham tDCS, Device: Therapeutic exerciseSham transcranial direct current stimulation combined with therapeutic exercise |
| Control | No intervention | –No treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Normal pain intensity of 4 or more points on a visual analog scale.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding.
- Metallic implants in the head.
- Tumor, trauma or surgery in the brain.
- Epilepsy or stroke.
- History of substance abuse in the last 6 months.
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 |
|---|---|---|
| Real tDCSReal tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps. | Device | Real tDCS + exercise |
| Sham tDCSSham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days. Sham tDCS will be applied for the same time than real tDCS. | Device | Sham tDCS + exercise |
| Therapeutic exerciseThe therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days. The program will include exercises and will last 30-45 minutes. | Device | Real tDCS + exercise, Sham tDCS + exercise |
Primary outcome
Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
Time frame: Baseline; immediately after intervention; 1-month after intervention
A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark).
Change in pain intensity from baseline to post-treatment
Time frame: Baseline; immediately after intervention; 1-month after intervention
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable
4 secondary outcomes
Fibromyalgia Impact Quality-of-Life
Time frame: Baseline; immediately after intervention; 1-month after intervention
Anxiety
Time frame: Baseline; immediately after intervention; 1-month after intervention
Pain catastrophizing
Time frame: Baseline; immediately after intervention; 1-month after intervention
Depression
Time frame: Baseline; immediately after intervention; 1-month after intervention
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 11 Jun 2021.
- Derived from this study: PubMed 35331718Arroyo-Fernandez R, Avendano-Coy J, Velasco-Velasco R, Palomo-Carrion R, Bravo-Esteban E, Ferri-Morales A. Effectiveness of Transcranial Direct Current Stimulation Combined With Exercising in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1524-1532. doi: 10.1016/j.apmr.2022.02.020. Epub 2022 Mar 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS and Therapeutic exercise in people with Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.
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 11 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 11 Jun 2021. 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 Spain. 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.
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 referred pain area after suprathreshold pressure stimulation from baseline to post-treatment (time frame: Baseline; immediately after intervention; 1-month after intervention). The study lists 2 primary outcomes in all. 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 NCT04050254, 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 11 Jun 2021.