Effect of Anodal Transcranial Direct Current Stimulation Combined with Exercise in Adults with Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

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VICENTE HENNEMANN
FLAVIA BARRETO GARCEZ
GABRIELA SANTOS REVILLA
ENRICO FRITSCHE
XIMENA STECHER
MARIA RÖNNEFARTH
JÚLIA SCHIRMER SALDANHA
THENRAL SOCRATES
GIANCARLO FATOBENE
DALIYA ABUBAKAR
NATALIA ANGELUZZI CUNHA
ABDULJABBAR ALHAMMOUD
FLAVIA ROCHA PAES
MARCO CASTILLO AYARZA
SALVADOR PASTOR-IDOATE
MOHAMMED SOHA
JOSE C. VALLE
LUCAS CAMARGO
SHAZA EL SONOSI
ANDREA GOMEZ
ANELISA COUTINHO
DANTE DUARTE

Abstract

Background:Chronic Low back pain (LBP) is a prevalent disease associated with significant disability and high costs to society. Although exercise protocols have proven benefit to relief pain symptoms, their effectiveness are often limited. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, has shown promising results on reducing pain scores in different conditions. However, there is still weak evidence of its clinical impact on chronic LBP.


Objective:To evaluate the efficacy of tDCS plus exercise (standard of care) compared to sham-tDCS plus exercise in adults with chronic non-specific LBP.


Methods:We propose a single-center, randomized, double-blind, placebo-controlled, phase II trial, with parallel design, including 97 patients aged 18-65 years with > 12 weeks of LBP and a baseline pain score of ≥ 3 in theVisual Analogue Scale (VAS).Participants will be randomized by blocks to one of the treatment arms (active-tDCS + exercise or sham-tDCS + exercise), with 4 weeks of intervention. Our main outcome will be pain as assessed by VAS. Secondary outcomes will be: (1) functional disability (Roland Morris Disability Questionnaire); (2) quality of life (SF-36); (3) parameters related to pain mechanisms (endogenous pain inhibition and facilitation, and central sensitization). Follow-up assessments will be performed at 1 and 3 months after the intervention period.


Conclusions: The proposed study will contribute to previous literature by testing an innovative and non-invasive technique to treat chronic LBP. Despite potential methodological challenges, the analyses of clinical and neurophysiological markers will bring valuable information to the understanding of this burdensome condition.

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How to Cite
HENNEMANN, V., GARCEZ, F. B., REVILLA, G. S., FRITSCHE, E., STECHER, X., RÖNNEFARTH, M., SALDANHA, J. S., SOCRATES, T., FATOBENE, G., ABUBAKAR, D., CUNHA, N. A., ALHAMMOUD, A., PAES, F. R., AYARZA, M. C., PASTOR-IDOATE, S., SOHA, M., VALLE, J. C., CAMARGO, L., EL SONOSI, S., GOMEZ, A., COUTINHO, A., & DUARTE, D. (2019). Effect of Anodal Transcranial Direct Current Stimulation Combined with Exercise in Adults with Chronic Non-specific Low Back Pain: A Randomized Controlled Trial. Principles and Practice of Clinical Research, 5(2), 58-66. Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/89
Section
Study Design

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