RESUMO
BACKGROUND: Chronic upper extremity pain (UEP) has complex etiologies and is often disabling. It has been shown that 10 kHz SCS can provide paresthesia-free and durable pain relief in multiple pain types and improve the quality of life of patients. OBJECTIVE: To gain additional evidence on the safety and effectiveness of 10 kHz SCS for the treatment of chronic UEP. STUDY DESIGN: It was a prospective, multicenter, and observational study. The study was registered on ClinicalTrials.gov prospectively (clinical trial identifier: NCT02703818). SETTING: Multicenter. PATIENTS INTERVENTION AND MAIN OUTCOMES: A total of 43 subjects with chronic UEP of ≥5 cm (on a 0-10 cm visual analog scale; VAS) underwent a trial of 10 kHz SCS, and subjects with ≥40% pain relief received a permanent implant. All subjects had upper limb pain at baseline, while some had concomitant shoulder or neck pain. Subject outcomes were assessed for 12 months, and the primary outcome was the responder rate (percentage of subjects experiencing ≥50% pain relief from baseline) at three months. RESULTS: Thirty-eight subjects successfully completed the trial (88.3% success rate), 33 received permanent implants (five withdrew consent), and 32 had device activation (per protocol population). There were no paresthesias or uncomfortable changes in stimulation related to changes in posture during the study and there were no neurological deficits. Responder rates at 12 months for upper limb, shoulder, and neck pain in per protocol population (N=32) were 78.1%, 85.2%, and 75.0%, respectively. At 12 months, 84.4% of subjects were satisfied or very satisfied with 10 kHz SCS, and 38.7% either reduced or eliminated opioid usage. CONCLUSION: This study further supports the effectiveness of 10 kHz SCS for chronic UEP treatment and documents the safety profile of the therapy. CLINICAL TRIAL IDENTIFIER: NCT02703818.
RESUMO
OBJECTIVES: To compare the corneal anterior chamber depth (ACD) adjusted by age and sex in normal and keratoconus eyes. METHODS: Scheimpflug photography with the Oculus Pentacam was used to measure the ACD of 162 normal and 41 keratoconus patients. RESULTS: Univariate analysis showed that the mean ACD of 162 normal subjects (3.18 +/- 0.32 mm) was borderline significantly less than in 41 keratoconus patients (3.28 +/- 0.40 mm; P=0.079). However, we found that sex (P=0.001) and age (P<0.001) are significantly related to ACD in all patients. Women with normal eyes had a significantly lower mean ACD (3.13 +/- 0.34 mm) than men (3.27 +/- 0.28 mm, P=0.008). Women with keratoconus eyes also had a lower mean ACD (3.16 +/- 0.39 mm) than men with keratoconus (3.42 +/- 0.36 mm, P=0.032). Bivariate regression showed that with each additional year of aging, the ACD was decreased by an average of 0.012 mm in a normal eye (P<0.001) and by 0.014 mm in a keratoconus eye (P<0.001). Regression analysis showed that sex (P=0.003), age (P<0.001), and keratoconus (P=0.003) are all significant variables for determining ACD. After adjusting for age and sex, keratoconus eyes had a significantly higher mean ACD (3.34 +/- 0.34 mm) than normal eyes (3.18 +/- 0.28 mm) (P=0.003). CONCLUSIONS: Sex, age, and keratoconus are all significant variables for ACD. After adjusting for age, keratoconus eyes of both genders had a significantly higher ACD than normal eyes of both genders. Women showed lower mean ACD than men in both normal and keratoconus eyes.
