VICENTE HENNEMANN
Centro de Fisioterapia Hennemann, Porto Alegre, Brazil
FLAVIA BARRETO GARCEZ
Division of Geriatrics, University of Sao Paulo Medical School, Brazil
GABRIELA SANTOS REVILLA
Clinical Research Unit - Department of Infectious and Tropical Diseases, Hospital Nacional Dos de Mayo, Historia de la Medicina Peruana Park. Lima, Perú
ENRICO FRITSCHE
BIH Center for Regenerative Therapies (BCRT), Charité Universitätsmedizin Berlin, 13353 Berlin, Germany
XIMENA STECHER
Radiology Department, Clinica Alemana de Santiago Chile; Facultad de Medicina Clinica Alemana Universidad del Desarrollo
MARIA RÖNNEFARTH
Department of Neurology, Charité Universitätsmedizin Berlin, 10117 Berlin, Germany
JÚLIA SCHIRMER SALDANHA
Post-graduation Program in Medicine: Medical Sciences, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain & Neuromodulation, HCPA, Porto Alegre, Brazil
THENRAL SOCRATES
University Hospital Basel, Department of Internal Medicine-Outpatient Clinic Basel, Switzerland
GIANCARLO FATOBENE
Hospital Sírio-Libanês, São Paulo, Brazil; Hospital das Clínicas, University of São Paulo, Brazil
DALIYA ABUBAKAR
Clinical Research- MRC, Hamad Medical Corporation (Doha, Qatar)
NATALIA ANGELUZZI CUNHA
Pharmacy & Biochemistry Department- Universidade de São Paulo Medical Information Specialist at PPD, São Paulo - Brazil
ABDULJABBAR ALHAMMOUD
Orthopedics Department, Hamad Medical Corporation, Doha, Qatar
FLAVIA ROCHA PAES
Oncocentro, grupo Oncoclinicas do Brasil. Belo Horizonte, Brasil
MARCO CASTILLO AYARZA
Universidad San Martín de Porres. Lima, Peru
SALVADOR PASTOR-IDOATE
Clinic University Hospital. Valladolid, Spain; IOBA, Eye Institute, University of Valladolid, Spain
MOHAMMED SOHA
Principle and Practice of Clinical Research Program, Harvard T.H.Chan school of Public Health, Boston, Massachusetts, United States
JOSE C. VALLE
University of Costa Rica, Caja Costarricense Seguro Social
LUCAS CAMARGO
Lusíada University Center (UNILUS), Santos, Brazil
SHAZA EL SONOSI
Consultant Nephrology/Medicine at Hamad medical corporation Doha, Qatar
ANDREA GOMEZ
Principle and Practice of Clinical Research Program, Harvard T.H.Chan school of Public Health, Boston, Massachusetts, United States
ANELISA COUTINHO
Principle and Practice of Clinical Research Program, Harvard T.H.Chan school of Public Health, Boston, Massachusetts, United States
DANTE DUARTE
Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, 79 13th St, Charlestown, MA 02129, Boston, United States
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.
