Publications by authors named "Cristiane Carlesso"

2 Publications

  • Page 1 of 1

Responsiveness of Outcome Measures in Non-Surgical Patients with Lumbar Spinal Stenosis: A Secondary Analysis from a Randomized Controlled Trial.

Spine (Phila Pa 1976) 2020 Dec 30. Epub 2020 Dec 30.

aDepartment of Physical Therapy, University of Pittsburgh, Pittsburgh, PA 15203, USA bDC, PhD. Institute for Health Policy, Management and Evolution, University of Toronto, Mount Sinai Hospital, Toronto, Ontario, Canada.

Study Design: Secondary analysis from a randomized clinical trial on non-surgical interventions for patients with lumbar spinal stenosis (LSS).

Objective: To assess responsiveness of the Self-Paced Walking Test (SPWT), Swiss Spinal Stenosis Questionnaire (SSS) and Oswestry Disability Index (ODI) and determine their Minimal Clinically Important Differences (MCID) in non-surgical LSS patients.

Summary Of Background Data: Limited information is available about responsiveness of these tests in non-surgical LSS population.

Methods: A total of 180 participants completed the SPWT, SSS and ODI at baseline, 2 and 6 months. Responsiveness was assessed by distribution-based method, including effect size and standardized response mean, and anchor-based method, using the patient global index of change (PGIC) as the external anchor to distinguish responders and non-responders. Areas under the curve (AUC) were calculated along with MCIDs for "minimal" and "moderate improvement" subgroups.

Results: The following values represent 2- and 6-month analyses of each outcome measure, respectively. Standard effect sizes: 0.48 and 0.50 for SPWT, -0.42 and -0.36 for SSS, -0.29 and -0.25 for ODI. Spearman's correlation coefficients between PGIC and outcomes: 0.44 and 0.39 for SPWT, -0.53 and -0.55 for SSS, -0.46 and -0.54 for ODI. MCIDs for the "minimal improvement" subgroup: 375.9 and 319.3 meters for SPWT, -5.3 and -5.8 points for SSS, -9.3 and -10.8 points for ODI. AUCs: 0.68 to 0.76. MCIDs for the "moderate improvement" subgroup: 344.2 and 538.2 meters for SPWT, -5.5 and -7.5 points for SSS, -9.1 and -13.6 points for ODI. AUCs ranged from 0.68 to 0.76.

Conclusions: The SPWT, SSS and ODI are responsive outcome measures to assess non-surgical patients with LSS. This finding, along with the reported MCIDs, can help clinicians to monitor changes in their patients' walking and physical function over time and make clinical decisions. They also provide researchers with reference for future studies in LSS.

Level Of Evidence: 2.
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December 2020

Transcranial direct current stimulation for fatigue in patients with Sjogren's syndrome: A randomized, double-blind pilot study.

Brain Stimul 2021 Jan-Feb;14(1):141-151. Epub 2020 Dec 17.

Rheumatologist. Discipline of Emergency and Evidence-Based Medicine, EPM - UNIFESP, São Paulo, SP, Brazil.

Background: Transcranial direct-current stimulation (tDCS) has shown promise to decrease fatigue. However, it has never been examined in primary Sjogren Syndrome (pSS).

Objective: To assess the effect of a tDCS protocol on fatigue in patients with pSS.

Methods: This is a parallel, double-blind pilot study (NCT04119128). Women aged 18-65 years, with pSS, on stable pharmacological therapy, with complaints of fatigue for at least three months, and with scores >5 on Fatigue Severity Scale (FSS) were included. We randomized 36 participants to receive five consecutive or sham tDCS sessions, with an intensity of 2 mA, for 20 min/day.

Results: After five tDCS sessions, fatigue severity assessed by the FSS (primary outcome) demonstrated a mean group difference of -0.85 [95% confidence interval (CI) -1.57, -0.13; effect size 0.80] favouring the active group. The active group presented significantly greater reductions in fatigue as measured by the EULAR Sjögren's Syndrome Patient Reported Index after five tDCS sessions [mean group difference: 1.40; 95%CI -2.33, -0.48; effect size 1.04]. Although there were no between-group differences in the secondary outcomes of sleep, mood and anxiety, within-group comparisons evidenced a small but significant difference in the active group for pain and sleep. There were no significant cortisol changes. All reported adverse events were mild and transitory.

Conclusion: tDCS seems to be safe and reduce fatigue in pSS. A differential effect on pain and sleep may underlie its effects. Further studies are needed to optimise tDCS treatment strategies in pSS.
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December 2020