- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04050254
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Toledo
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Talavera De La Reina, Toledo, Spania, 45600
- Hospital General Nuestra Señora del Prado
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Kontroll
Ingen behandling.
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Eksperimentell: Real tDCS + exercise
Transcranial direct current stimulation combined with therapeutic exercise
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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.
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.
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Sham-komparator: Sham tDCS + exercise
Sham transcranial direct current stimulation combined with therapeutic exercise
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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.
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
Tidsramme: Baseline; immediately after intervention; 1-month after intervention
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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). |
Baseline; immediately after intervention; 1-month after intervention
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Change in pain intensity from baseline to post-treatment
Tidsramme: Baseline; immediately after intervention; 1-month after intervention
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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
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Baseline; immediately after intervention; 1-month after intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Fibromyalgi påvirker livskvaliteten
Tidsramme: Grunnlinje; umiddelbart etter intervensjon; 1 måned etter intervensjon
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Det vil bli målt med versjonen tilpasset den spanske av Fibromyalgia Impact Questionnaire (FIQ).
Skalaen går fra 0 til 100.
Høyere verdier representerer et dårligere resultat.
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Grunnlinje; umiddelbart etter intervensjon; 1 måned etter intervensjon
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Anxiety
Tidsramme: Baseline; immediately after intervention; 1-month after intervention
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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.
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Baseline; immediately after intervention; 1-month after intervention
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Pain catastrophizing
Tidsramme: Baseline; immediately after intervention; 1-month after intervention
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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.
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Baseline; immediately after intervention; 1-month after intervention
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Depression
Tidsramme: Baseline; immediately after intervention; 1-month after intervention
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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.
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Baseline; immediately after intervention; 1-month after intervention
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Blinding
Tidsramme: Immediately after intervention
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Blinding of subjects and researchers will be assessed using the James Index.
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Immediately after intervention
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- tDCS+ET-Fibromyalgia
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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University of ManitobaFullført
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University of Southern CaliforniaFullførtSukkersykeForente stater
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