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

2017년 7월 14일 업데이트: 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

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
장치: 활성 tDCS
자극은 식염수에 적신 스폰지 코팅된 한 쌍의 표면 전극으로 관리됩니다. 이 목적을 위해 배터리로 구동되는 정전류 자극기가 사용됩니다(tDCS 장치). 자극은 양극 전극을 일차 운동 피질(M1)에, 음극 전극을 반대측 안와 상부 영역에 배치하여 수행되며 2mA(밀리암페어) 전류를 사용합니다.
다른 이름들:
  • 경두개 직류 자극(tDCS)
가짜 비교기: 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.
장치: 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
다른 이름들:
  • Sham transcranial direct current stimulation (Sham tDCS)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in pain scores assessed with the visual analogue scale
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Preoperative Anxiety level
기간: 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
기간: 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
기간: 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
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Adverse Effects
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospital de Clinicas de Porto Alegre

협력자

Hospital Independencia

수사관

  • 수석 연구원: Wolnei Caumo, MD, PhD, Hospital de Clínicas de Porto Alegre

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 12월 1일

기본 완료 (실제)

2015년 11월 1일

연구 완료 (실제)

2016년 6월 1일

연구 등록 날짜

최초 제출

2015년 1월 22일

QC 기준을 충족하는 최초 제출

2015년 2월 5일

처음 게시됨 (추정)

2015년 2월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 7월 14일

마지막으로 확인됨

2017년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 14-0643

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 통증에 대한 임상 시험

활성 tDCS에 대한 임상 시험

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위치

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