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The Effect of tDCS in the Preoperative Period of Hallux Valgus Surgical Treatment

14. juli 2017 opdateret af: Hospital de Clinicas de Porto Alegre
This is a clinical trial that intend to determine if transcranial direct current stimulation (tDCS) is effective in the treatment of postoperative pain and in the anxiety level in the preoperative period of hallux valgus surgical treatment

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Introduction: Forefoot deformities are important cause of feet pain and discomfort and affect around 80% of general population, predominantly in female population. Among teenagers and adults´ common forefoot deformities is hallux valgus. To achieve the deformity heal, surgical treatment is needed. The transcranial direct current stimulation (tDCS) is a non invasive technic, that aims for the central nervous system modulation for pain control, which can become a therapeutic option for postoperative pain. Experimental studies have shown that tDCS has reverted the hyperalgesia induced by chronic stress and articular inflammatory pain, has reduced total knee arthroplasty postoperative opioid consumption and a single 20 minutes session has shown reduction in endoscopic procedures opioid consumption, safety and minimal adverse effects. However, the tDCS effect in preoperative hyperalgesia has not been explored yet in sensitized patients, neither in anxiety and postoperative rehabilitation of patients submitted to hallux valgus surgical correction. In this study, it was chosen to use tDCS to stimulate cerebral cortex due to its efficacy in painful syndromes, for being a non invasive, low cost and easy-to-apply technic in comparison to other neurostimulation technics and especially, for its potential to counter-regulate the mal adaptive neuroplastic alterations associated to chronic pain. Objective: to evaluate the effect of tDCS compared to tDCS-sham in the pain control (visual analog scale score, pain threshold and the descendent modulator system), perioperative anxiety, postoperative analgesic drug consumption and in the rehabilitation of patients with arthralgia of the first metatarsophalangeal articulation submitted to hallux valgus surgical correction. Method: it is a randomized, blinded, placebo-sham controlled clinical trial which includes 40 female patients, between 18 and 70 years old, candidates to hallux valgus surgical treatment by combined Chevron + Akin osteotomy due to arthralgia of the first metatarsophalangeal articulation. The patients will be randomized and divided into two groups that will be treated with two tDCS or tDCS-sham sessions of 20 minutes each in preoperative period. Expected results: This study will evaluate the effect of tDCS as a treatment option to postoperative pain and perioperative anxiety of patients submitted to hallux valgus surgical correction. In case of proven efficacy, this technic can become a low cost, easy access, safe and effective treatment option for these patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 91430-000
        • Hospital Independência

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • indication of hallux valgus surgical treatment because of arthralgia of the first metatarsophalangeal joint,
  • capability of writing and understanding the Portuguese language

Exclusion Criteria:

  • diabetic neuropathy,
  • history of intense or frequent headache,
  • chronic dermatologic disease,
  • previous adverse effects to treatment with tDCS, seizures,
  • severe cranial trauma with alteration of the cranial anatomy,
  • metallic intracranial implants or pacemaker,
  • non-compensated psychiatric disease,
  • non-collaborative patients,
  • history of neurologic,
  • oncologic disease,
  • heart, renal or hepatic failure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active tDCS
Active tDCS will be applied in the head of the patients in 20 minute sessions, twice. First session will be applied in the night before and the second session, in the morning before the surgical procedure. The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area, and it will use a 2 mA current
Enhed: Aktiv tDCS
Stimuleringen vil blive administreret med et par overfladeelektroder, belagt med svamp, gennemblødt i saltvand. En batteridrevet konstantstrømstimulator vil blive brugt til dette formål (tDCS-enhed). Stimuleringen udføres ved at placere den anodiske elektrode i den primære motoriske cortex (M1) og den katodiske i det kontralaterale supraorbitale område, og den vil bruge en 2 mA (milliampere) strøm.
Andre navne:
  • transkraniel jævnstrømsstimulering (tDCS)
Sham-komparator: Sham tDCS
The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
Enhed: Sham tDCS
The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after stimulation starts (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session
Andre navne:
  • Sham transcranial direct current stimulation (Sham tDCS)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in pain scores assessed with the visual analogue scale
Tidsramme: Once Daily. It starts in the day before surgical treatment (Day 0), and it is assessed every day until one week after the surgical procedure (total = 10 days)
Patients will be asked their worst pain level (assessed by the Visual Analogue Scale) with 2 different scores: worst daily pain including movement period and pain in rest period. It will also be assessed a pain score for the moment before and another for the moment right after each tDCS session (Day 0 and Day 1). The outcome assessor will visit the patient once daily during the hospital stay (an expected average of 2 days) and will call the patient once daily after discharge. Patients will also be asked to daily write down the analgesic drug intake after hospital discharge and the outcome assessor will review nursery notes during hospital stay for drug intake. Total evaluations: 10 days
Once Daily. It starts in the day before surgical treatment (Day 0), and it is assessed every day until one week after the surgical procedure (total = 10 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preoperative Anxiety level
Tidsramme: Initial contact (before any tDCS session - Day 0) and the moment before the surgical procedure (Day 1)
Anxiety level will be assessed by State-Trait Anxiety Inventory (STAI), adapted to Brazilian Portuguese Language. It will be assessed before the first session of tDCS (on initial contact with the patient - Day 0), and in the moment right before going to the surgical room in the next day (Day 1). Total = 2 evaluations
Initial contact (before any tDCS session - Day 0) and the moment before the surgical procedure (Day 1)
Change in the temperature pain threshold
Tidsramme: Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
It will be assessed by the Quantitative Sensory Test (QST) in the dominant (right) forearm and in the leg ipsilateral to the foot that will be treated. The heat pain tolerance, the pain threshold to the heat and the temperature defined as pain 6/10 by the participant will be determined. The temperature starts at 32°C, and it heats at a 1.0 °C/sec rate and cools down after a button is pressed or whenever it reaches the max temperature of 52°C. The participant will be asked to press down the button at the first sensation of pain to determine the pain threshold; to press down the button whenever she can not stand the heat anymore for the pain tolerance determination and, for last, to press down the button at the temperature she fells pain equivalent to 6/10 in the numeric scale of pain. The pain threshold and the temperature of pain 6/10 will be determined by the arithmetic mean of 3 evaluations each.
Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
Change in effect of the descendent modulator system of pain
Tidsramme: Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
It will be assessed by the Conditioned Pain Modulation test (CPM). A nociceptive tonic conditioning stimulus - immersion of the non-dominant hand in cold water (0°C for 1 minute) - will be applied concomitant to the progressive thermal stimulus in the dominant forearm as applied in the QST pattern until it reaches the 6/10 pain temperature previously determined by the participant. It will be tested in the day before the surgical treatment (before the first session of tDCS), and after the spinal anesthesia recovery in immediate postoperative period. Total of 2 test days.
Day before the surgical treatment (Day 0), and in the moment after the spinal anesthesia recovery in immediate postoperative period (Day 1).
Change in serum biomarkers level: The brain derived neurotrophic factor (BDNF), S100B, nerve growth factor (NGF) and enolase
Tidsramme: The day before the surgical treatment (Day 0), in the moment before the spinal anestesia (Day 1) and a week after the surgical procedure (Day 9)
A blood sample will be collected to measure each plasma biomarker in the day before the surgical treatment (Day 0), in the moment before the spinal anesthesia (Day 1) and a week after the surgical procedure (Day 9). Total = 3 evaluations
The day before the surgical treatment (Day 0), in the moment before the spinal anestesia (Day 1) and a week after the surgical procedure (Day 9)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Effects
Tidsramme: At the end of each tDCS session (Day 0 and Day 1)
At the end of each tDCS session, the incidence of any adverse effects - paresthesia, headache, dizziness, nausea, neck pain, burns, redness or pain in the scalp, insomnia, abrupt humor changes and lack of concentration - will be questioned to the participant. Total = 2 evaluations
At the end of each tDCS session (Day 0 and Day 1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clinicas de Porto Alegre

Samarbejdspartnere

Hospital Independencia

Efterforskere

  • Ledende efterforsker: Wolnei Caumo, MD, PhD, Hospital de Clínicas de Porto Alegre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2014

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

22. januar 2015

Først indsendt, der opfyldte QC-kriterier

5. februar 2015

Først opslået (Skøn)

10. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14-0643

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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