João Eduardo Daud Amadera

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation

Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.

Sample Size Calculation in Physical Medicine and Rehabilitation: A Systematic Review of Reporting, Characteristics, and Results in Randomized Controlled Trials

OBJECTIVE To assess systematically the reporting of sample size calculation in randomized controlled trials (RCTs) in 5 leading journals in the field of physical medicine and rehabilitation (PM&R). DATA SOURCES The data source was full reports of RCTs in 5 leading PM&R journals (Journal of Rehabilitation Medicine, Archives of Physical Medicine and Rehabilitation, American Journal of Physical Medicine and Rehabilitation, Clinical Rehabilitation, and Disability and Rehabilitation) between January and December of 1998 and 2008. Articles were identified in Medline. STUDY SELECTION A total of 111 articles met our inclusion criteria, which include RCTs of human studies in the 5 selected journals. DATA EXTRACTION Sample size calculation reporting and trial characteristics were collected for each trial by independent investigators. DATA SYNTHESIS In 2008, 57.3% of articles reported sample size calculation as compared with only 3.4% in 1998. The parameters that were commonly used were a power of 80% and alpha of 5%. Articles often failed to report effect size or effect estimates for sample size calculation. Studies reporting sample size calculation were more likely to describe the main outcome and to have a sample size greater than 50 subjects. The study outcome (positive vs negative) was not associated with the likelihood of sample size reporting. Trial characteristics of the 2 periods (1998 vs 2008) were similar except that in 1998 there were more negative studies compared with 2008. CONCLUSIONS Although sample size calculation reporting has improved dramatically in 10 years and is comparable with other fields in medicine, it is still not adequate given current publication guidelines.

The teaching of acupuncture in the University of São Paulo School of Medicine, Brazil

OBJECTIVE Since being introduced as an elective discipline (non-obligatory) in the second semester of 2002, acupuncture has been taught in the University of São Paulo School of Medicine. We conducted this study to verify interest and acceptance among under graduate medical students and to discern a positive influence contributing to improving their skills. METHODS The study was conducted from 2002 to 2007 using descriptive statistical methods. RESULTS The average number of students who concluded the discipline is 24.9 students per semester with an average number of medical students per semester of 87.5 (28% of all medical students in the 7th and 8th semesters). After a semester of basic training in acupuncture, only eight students per group are promoted (after selection) to the Medical Academic League of Acupuncture which lasts for two years. Every semester, all eight vacancies are filled. Among the students who concluded the course, 98% described course quality as good or very good, 85% considered themselves at least partially able to use acupuncture and 79% stated that the course influenced them in their medical education. CONCLUSION There is a genuine interest to learn acupuncture, almost 30% of all students volunteer for a brief training in acupuncture while some of them choose additional training of two years due to the importance of acupuncture as part of professional skills. Results indicate that acupuncture should be included as an elective discipline for medical students.

Generalized pruritus as an unusual side effect after epidural injection with dexamethasone.

A 51‐year‐old man with lumbar radiculopathy underwent a right L5 transforaminal epidural steroid injection with dexamethasone. One minute after the injection, the patient experienced severe pruritus and burning, which began in the groin and then spread throughout his body. The symptoms resolved completely after 1 minute, and the patient was discharged without any complications. Although there are a small number of publications reporting perineal pruritus after intravenous administration of dexamethasone, to our knowledge there is no report of a generalized reaction to an epidural dexamethasone injection such as the one described here.

Nonsurgical Treatment (Indications, Limitations, Outcomes): Injections

This chapter discusses various injection procedures performed in the process of treatment of painful hip conditions. The different causes of hip pain are described including intra-articular, extra-articular, and referred pain to the hip.

Poster 402 Comparison of Radiation Exposure Using Two Types of Shield Protection During Spinal Interventions

detection during needle positioning of transforaminal epidural steroid injections (TFESI) with dexamethasone and the occurrence of perineal pruritus. Design: A prospective, single-arm, observational epidemiological study. Setting: Spine center affiliated with a rehabilitation hospital. Participants: 150 consecutive subjects who underwent 284 TFESIs for management of radicular and axial spinal pain. Interventions: Cervical, lumbar and sacral TFESI with dexamethasone. Main Outcome Measures: Signs of vascular penetration during needle positioning at the neural foramen were observed using 4 different methods: the presence of blood at the needle hub after stylet removal (flash); blood aspiration; visualization of intravascular flow with contrast injection under live fluoroscopy; and visualization of intravascular flow using digital subtraction technology. Subsequently, the needle was repositioned and dexamethasone injection was performed after no sign of vascular penetration was noted. Within 5 minutes of the injection, the development of perineal pruritus was observed and correlated with any sign of vascular penetration during positioning. Results: Two hundred eighty four procedures were performed, 53 (18.66%) cervical, 144 (50.7%) lumbar and 87 (30.63%) sacral. Sixty eight procedures (23.94%) had signs of intravascular needle placement, and 216 procedures (76.06%) had no signs of vascular flow detection. For the subjects who had signs of vascular penetration during needle positioning, 10.29% had perineal pruritus, while for subjects who didn’t have any sign of vascular penetration only 1.39% had pruritus (P .0022) OR: 8.14 (CI: 2.04-32.45). Pruritus was observed in 2.08% of lumbar and 8.05% of sacral procedures OR 4.11 (CI: 1.03-16.34). In our sample no subjects who underwent cervical TFESI reported pruritis. Conclusions: The occurrence of signs of vascular penetration during needle introduction correlates with a higher chance of perineal pruritus after TFESI. This might be related to unrecognized intravascular injection leading to systemic absorption of dexamethasone.

Poster 401 Correlation Between Vascular Penetration During Needle Positioning and Perineal Pruritus in Transforaminal Epidural Injections With Dexamethasone

50Hz. Motor stimulation confirmed appropriate muscle twitch (2Hz). pRFA was performed at 42 degrees C for 120 seconds. 20 mg of triamcinolone acetate and 3mL of 1% lidocaine was then injected at both sites. Setting: Tertiary care VA hospital. Results or Clinical Course: The patient reported reduction in pain (90 mm to 20 mm on visual analog scale) for 12 days after procedure. He underwent 3 additional sessions, one month apart, with prolonged relief after each treatment. By the fourth procedure, he reported 90% pain relief for greater than 3 months. Discussion: Previous trials using pRFA for chronic shoulder pain have included treatment of the suprascapular nerve alone. This approach includes pRFA of both nerves as well as ultrasound guidance to improve chronic shoulder pain. Conclusions: pRFA of axillary and suprascapular nerves may offer improved pain relief in comparison to suprascapular technique alone. Further studies are indicated to compare differences between these two approaches.

Poster 400 Immediate and Acute Complications Following Transforaminal Epidural Steroid Injections With Dexamethasone

50Hz. Motor stimulation confirmed appropriate muscle twitch (2Hz). pRFA was performed at 42 degrees C for 120 seconds. 20 mg of triamcinolone acetate and 3mL of 1% lidocaine was then injected at both sites. Setting: Tertiary care VA hospital. Results or Clinical Course: The patient reported reduction in pain (90 mm to 20 mm on visual analog scale) for 12 days after procedure. He underwent 3 additional sessions, one month apart, with prolonged relief after each treatment. By the fourth procedure, he reported 90% pain relief for greater than 3 months. Discussion: Previous trials using pRFA for chronic shoulder pain have included treatment of the suprascapular nerve alone. This approach includes pRFA of both nerves as well as ultrasound guidance to improve chronic shoulder pain. Conclusions: pRFA of axillary and suprascapular nerves may offer improved pain relief in comparison to suprascapular technique alone. Further studies are indicated to compare differences between these two approaches.

Poster 306 Vascular Flow Detection During Transforaminal Epidural Steroid Injections

Examination Survey (2003-2004). Interventions: The statistics package R 2.11, SAS 9.2, and custom SAS macros were used for exploratory, complex survey analyses, and model selection by using CDC data. Main Outcome Measures: 7-day measurements were made on single-axis ActiGraph AM-7164, summarized into per-minute intensities. Summary measures of activity were computed based on percentile, interval, and thresholds. Demographics, anthropometrics, social history, and medical comorbidities were investigated as predictors. Results: Estimates are significant at P .05, all confidence intervals were at 95% and were adjusted for other confounders. Subjects older than 65 years old demonstrated a third lower peak activity (9530) compared with the 16-25 age group (15,109). Female subjects recorded 19 more minutes (range, 8.3-29.1 minutes) in nonstationary light activity (0-500) per day compared with male subjects. Body mass index (BMI) was negatively associated with higher physical activity intensities. Mean minutes per day of at-least-moderate-intensity activity ( 1000) is 121, 109, 96, and 91 for BMI 20-25, 25-30, 30-35, and 35, respectively. Stationary-to-light activity (0-500) decreases by 11, 13, 24, and 36 minutes per day, respectively. Peak activity intensity and 90th percentile intensity for current smokers are decreased by 3.7% and 14%, respectively. Diabetes, congestive heart failure, chronic obstructive pulmonary disease, and stroke were associated with a increased number of minutes per day, with no recorded activity (intensity of 0), at 31 (15-47), 33 (12-54), 34 (6.5-61), and 54 (24-84) minutes, respectively. Diabetics on insulin recorded 18 fewer minutes per day in moderate ranges of intensity (500-1500). Conclusions: This is the first study to uniquely quantify the negative effect of increased age, smoking, increased BMI, insulindependent diabetes, cardiopulmonary disease, and stroke on daily physical activity.

Poster 307 Perineal Pruritus After Transforaminal Epidural Injections With Dexamethasone

Disclosures: A. A. Shrikhande, none. Objective: There is a lack of consensus on effective protocols after failure of epidural injection of corticosteroids, facet blocks and spinal surgery for the management of back pain with radiculopathy. Muscle tendon injections to painful muscles are suggested as an option for the treatment of chronic back pain with radiculopathy. Design: A retrospective review was conducted at a comprehensive pain treatment center from 2008 until 2010 was conducted on patients who presented with persistent spinal pain after receiving epidural injection of corticosteroids, facet blocks, and/or spinal surgery. Patients’ muscles were assessed as a source of pain by using an electrical stimulus–driven muscle pain detection device, and injections were directed to the entire muscle by using only lidocaine for comfort. Results: Of 97 patients, 69 were available for follow-up interview by telephone at an average follow-up time of 14.9 months from the onset of pain. Of the patients, 73.9% (51/69) reported continued pain relief at the time of the follow-up interview, with an average of 48.4% 37.6% reduction in pain intensity. The standardized Brief Pain Inventory (BPI) scale was used to compare pain severity and daily interference before and after treatment with muscle tendon injections. The BPI pain severity score decreased from 5.6 1.7 to 3.7 2.6 after treatment (P .001), and the interference score decreased from 6.0 1.9 to 3.2 2.7 after treatment (P .001). When analyzing patients specifically with radicular symptoms (n 40), the BPI pain severity score decreased from 5.9 1.6 to 4.0 2.5 after treatment (P .001) and the BPI interference score decreased from 6.1 1.6 to 3.5 2.7 after treatment (P .001). Conclusions: When there is a failure of epidural injection of corticosteroids, facet blocks, and spinal surgery for the management of back pain with radiculopathy, muscle tendon injections provide significant lasting relief.