Marcelo Riberto

A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury

Abstract Past evidence has shown that motor cortical stimulation with invasive and non‐invasive brain stimulation is effective to relieve central pain. Here we aimed to study the effects of another, very safe technique of non‐invasive brain stimulation – transcranial direct current stimulation (tDCS) – on pain control in patients with central pain due to traumatic spinal cord injury. Patients were randomized to receive sham or active motor tDCS (2 mA, 20 min for 5 consecutive days). A blinded evaluator rated the pain using the visual analogue scale for pain, Clinician Global Impression and Patient Global Assessment. Safety was assessed with a neuropsychological battery and confounders with the evaluation of depression and anxiety changes. There was a significant pain improvement after active anodal stimulation of the motor cortex, but not after sham stimulation. These results were not confounded by depression or anxiety changes. Furthermore, cognitive performance was not significantly changed throughout the trial in both treatment groups. The results of our study suggest that this new approach of cortical stimulation can be effective to control pain in patients with spinal cord lesion. We discuss potential mechanisms for pain amelioration after tDCS, such as a secondary modulation of thalamic nuclei activity.

A sham stimulation-controlled trial of rTMS of the unaffected hemisphere in stroke patients

The authors investigated the use of slow-frequency repetitive transcranial magnetic stimulation (rTMS) to the unaffected hemisphere to decrease interhemispheric inhibition of the lesioned hemisphere and improve motor function in patients within 12 months of a stroke. Patients showed a significant decrease in simple and choice reaction time and improved performance of the Purdue Pegboard test with their affected hand after rTMS of the motor cortex in the intact hemisphere as compared with sham rTMS.

Validação da versão brasileira da Medida de Independência Funcional

Introduction: the Brazilian version of the Functional Independence Measure (FIM) was developed in the 2000. Studies of validity is still required in order corroborate its use in rehabilitation assessment of Brazilian individuals, since local peculiarities may determine differences in the data provided by such instrument. Objectives: the aim of this study is test construct validity of the FIM by checking its convergent validity in groups of patients with impairments expected to develop specific levels of disability. Methods: Medical charts of 150 SCI and 103 hemiplegic patients from 2 rehabilitation centers in Sao Paulo provided data about demographic characteristics, clinical and functional features. The level of disability was evaluated by the Functional Independence Measure. Traumatic SCI patients were classified according to the level of injury as cervical, thoracic and lumbar or below. Hemiplegic patients were classified according to the side of motor impairment as right, left or bilateral.

Reprodutibilidade da versäo brasileira da medida de independência funcional

A versao brasileira da Medida de Independencia Funcional (MIF) foi desenvolvida por meio de um processo de traducao para o portugues do Brasil por equipe medica bilingue familiarizada com o instrumento e tradutor profissional, seguido de traducao reversa para o ingles por tradutor independente. Nao foram identificados problemas de equivalencia cultural quando a versao obtida foi apresentada a um conjunto de 25 profissionais de saude treinados no seu uso. Oito centros de reabilitacao participaram da captacao de dados para a obtencao de medidas de reprodutibilidade. Todos os pacientes adultos com historia de pelo menos 4 meses de acidente vascular cerebral, consultados no periodo entre dezembro de 1999 e janeiro de 2000, foram avaliados por dois avaliadores treinados na aplicacao da MIF, de forma independente, e reavaliados por apenas um desses examinadores apos uma semana (teste/reteste). Uma amostra de 164 pacientes foi examinada e os valores de kappa para concordância em cada um dos itens da MIF variaram entre dois observadores de 0,50 (alimentacao) a 0,64 (controle da urina) e no teste/ reteste entre 0,61 (vestir abaixo da cintura) a 0,77 (transferencia para o vaso sanitario). As subescalas da MIF apresentaram no teste/reteste boa correlacao (Pearson: 0,91 – 0,98; ICC: 0,91 – 0,98); a reprodutibilidade interobservadores tambem foi boa (Pearson: 0,87 – 0,98; ICC: 0,87 – 0,98). Analise de variância mostra boa concordância entre as medias dos resultados de dois avaliadores na primeira avaliacao e na medida apos uma semana. Concluimos que a versao brasileira da MIF tem boa equivalencia cultural e boa reprodutibilidade.

Translation and Cross-Cultural Adaptation of the Brazilian Version of the International Knee Documentation Committee Subjective Knee Form: Validity and Reproducibility

Background: The perception of improvement by a patient has assumed a central role in functional evaluation after a variety of knee problems. One of the instruments most used in clinical research is the International Knee Documentation Committee (IKDC) Subjective Knee Form because its psychometric properties are considered to be excellent. Nonetheless, this questionnaire was originally developed for use in the English language. Therefore, to use this questionnaire in the Brazilian population, it is essential to translate and validate it. Purpose: The aim of this study was to translate the IKDC Subjective Knee Form into a Brazilian version and to test its validity and reproducibility. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: The translation of the original IKDC Subjective Knee Form into a Brazilian version was accomplished in accordance with the American Orthopaedic Society for Sports Medicine guidelines and was tested in 32 patients with knee pathologic conditions to develop the first Brazilian version. To test validity and reproducibility, 117 patients with several knee complaints completed the Brazilian IKDC Subjective Knee Form, the Short Form 36 (SF-36), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lysholm score. From these patients, 85 were retested within a week to achieve reproducibility. The validation was addressed by correlating the Brazilian IKDC Subjective Knee Form to the other outcome measures. The reproducibility was tested by measuring internal consistency, test-retest reliability, and agreement. Results: The Brazilian IKDC Subjective Knee Form was highly related to the physical component summary of the SF-36, the Lysholm score, and the WOMAC, and weakly related to the mental component summary of SF-36 (r = .79, .89, .85, and .51, respectively). The internal consistency was strong, with a Cronbach α value of .928 and .935 in the test and retest assessment, respectively. The test-retest reliability proved to be excellent, with a high value of the intraclass correlation coefficient (.988), as well as the agreement, demonstrated by the low differences between the means of the test and retest, and the short limit of agreement, observed in the Altman-Bland and survival-agreement plots. Conclusion: The results of this study provide evidence that the Brazilian IKDC Subjective Knee Form has psychometric properties similar to the original version. In addition, it was a reliable evaluation instrument for patients with knee-related problems.

Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group.

Fregni F, Imamura M, Chien HF, Lew HL, Boggio P, Kaptchuk TJ, Riberto M, Hsing WT, Battistella LR, Furlan A: Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: A report of the International Placebo Symposium Working Group.Compared with other specialties, the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments. The best way to change this disadvantage is through a well conducted clinical research, such as standard placebo- or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in physical and rehabilitation medicine that ultimately translates to better clinical care. To address the challenges for the use of placebo in physical and rehabilitation medicine and randomized clinical trials and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in physical and rehabilitation medicine, (2) challenges for the use of placebo in physical and rehabilitation medicine, (3) bioethics, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group.

Translation and Cross-cultural Adaptation of the Lower Extremity Functional Scale Into a Brazilian Portuguese Version and Validation on Patients With Knee Injuries

STUDY DESIGN Clinical measurement. OBJECTIVE To translate and culturally adapt the Lower Extremity Functional Scale (LEFS) into a Brazilian Portuguese version, and to test the construct and content validity and reliability of this version in patients with knee injuries. BACKGROUND There is no Brazilian Portuguese version of an instrument to assess the function of the lower extremity after orthopaedic injury. METHODS The translation of the original English version of the LEFS into a Brazilian Portuguese version was accomplished using standard guidelines and tested in 31 patients with knee injuries. Subsequently, 87 patients with a variety of knee disorders completed the Brazilian Portuguese LEFS, the Medical Outcomes Study 36-Item Short-Form Health Survey, the Western Ontario and McMaster Universities Osteoarthritis Index, and the International Knee Documentation Committee Subjective Knee Evaluation Form and a visual analog scale for pain. All patients were retested within 2 days to determine reliability of these measures. Validation was assessed by determining the level of association between the Brazilian Portuguese LEFS and the other outcome measures. Reliability was documented by calculating internal consistency, test-retest reliability, and standard error of measurement. RESULTS The Brazilian Portuguese LEFS had a high level of association with the physical component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.82), the Western Ontario and McMaster Universities Osteoarthritis Index (r = 0.87), the International Knee Documentation Committee Subjective Knee Evaluation Form (r = 0.82), and the pain visual analog scale (r = -0.60) (all, P<.05). The Brazilian Portuguese LEFS had a low level of association with the mental component of the Medical Outcomes Study 36-Item Short-Form Health Survey (r = 0.38, P<.05). The internal consistency (Cronbach α = .952) and test-retest reliability (intraclass correlation coefficient = 0.957) of the Brazilian Portuguese version of the LEFS were high. The standard error of measurement was low (3.6) and the agreement was considered high, demonstrated by the small differences between test and retest and the narrow limit of agreement, as observed in Bland-Altman and survival-agreement plots. CONCLUSION The translation of the LEFS into a Brazilian Portuguese version was successful in preserving the semantic and measurement properties of the original version and was shown to be valid and reliable in a Brazilian population with knee injuries.

Efficacy of Transcranial Direct Current Stimulation Coupled with a Multidisciplinary Rehabilitation Program for the Treatment of Fibromyalgia

Pain control in fibromyalgia patients is limited no matter the therapeutic regimens used. Recent data have shown that daily sessions of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with fibromyalgia (FM) are associated with reduction of pain perception. Objective: We aimed to test whether active tDCS, as compared with sham tDCS, combined with multidisciplinary rehabilitation is associated with significant clinical gains in fibromyalgia. Design: This was a randomized, double-blinded controlled trial. Subjects: 23 patients were randomized to receive weekly sessions of multidisciplinary rehabilitation approach combined with sham or anodal tDCS of M1. Patients were evaluated for pain with VAS and for quality of life with SF-36, fibromyalgia pain questionnaire and health assessment questionnaire by a blinded rater before and after the 4 month period of rehabilitation. Results: Patients tolerated tDCS treatment well, without adverse effects. Patients who received active treatment had a significantly greater reduction of SF-36 pain domain scores (F(2,21)=6.57; p=0.006) and a tendency of higher improvement in Fibromyalgia Impact Questionnaire (FIQ) scores after (p=0.056) as compared with sham tDCS/standard treatment, but no differences were observed in the other domains. Conclusions: Although active tDCS was associated with superior results in one domain (SF-36 pain domain), the lack of significance in the other domains does not fully support this strategy (weekly tDCS) combined with a multidisciplinary approach.

Functional mobility and balance in community-dwelling elderly submitted to multisensory versus strength exercises

It is well documented that aging impairs balance and functional mobility. The objective of this study was to compare the efficacy of multisensory versus strength exercises on these parameters. We performed a simple blinded randomized controlled trial with 46 community-dwelling elderly allocated to strength ([GST], N = 23, 70.2-years-old ± 4.8 years) or multisensory ([GMS], N = 23, 68.8-years-old ± 5.9 years) exercises twice a week for 12 weeks. Subjects were evaluated by blinded raters using the timed ‘up and go’ test (TUG), the Guralnik test battery, and a force platform. By the end of the treatment, the GMS group showed a significant improvement in TUG (9.1 ± 1.9 seconds (s) to 8.0 ± 1.0 s, P = 0.002); Guralnik test battery (10.6 ± 1.2 to 11.3 ± 0.8 P = 0.009); lateromedial (6.1 ± 11.7 cm to 3.1 ± 1.6 cm, P = 0.02) and anteroposterior displacement (4.7 ± 4.2 cm to 3.4 ± 1.0 cm, P = 0.03), which were not observed in the GST group. These results reproduce previous findings in the literature and mean that the stimulus to sensibility results in better achievements for the control of balance and dynamic activities. Multisensory exercises were shown to be more efficacious than strength exercises to improve functional mobility.

Comparison of multisensory and strength training for postural control in the elderly

Objective The objective of this study was to analyze the efficacy of multisensory versus muscle strengthening to improve postural control in healthy community-dwelling elderly. Participants We performed a single-blinded study with 46 community-dwelling elderly allocated to strength (GS, n = 23; 70.18 ± 4.8 years 22 women and 1 man) and multisensory exercises groups (GM, n = 23; 68.8 ± 5.9 years; 22 women and 1 man) for 12 weeks. Methods We performed isokinetic evaluations of muscle groups in the ankle and foot including dorsiflexors, plantar flexors, inversion, and eversion. The oscillation of the center of pressure was assessed with a force platform. Results The GM group presented a reduction in the oscillation (66.8 ± 273.4 cm2 to 11.1 ± 11.6 cm2; P = 0.02), which was not observed in the GS group. The GM group showed better results for the peak torque and work than the GS group, but without statistical significance. Conclusion Although the GM group presented better results, it is not possible to state that one exercise regimen proved more efficacious than the other in improving balance control.