Dataset Information

Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study.

ABSTRACT: 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.

SUBMITTER: Burgher A

PROVIDER: S-EPMC7667505 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study.

Burgher Abram A Kosek Peter P Surrett Steven S Rosen Steven M SM Bromberg Todd T Gulve Ashish A Kansal Anu A Wu Paul P McRoberts W Porter WP Udeshi Ashish A Esposito Michael M Gliner Bradford E BE Maneshi Mona M Rotte Anand A Subbaroyan Jeyakumar J

Journal of pain research 20201110

<h4>Background</h4>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.<h4>Objective</h4>To gain additional evidence on the safety and effectiveness of 10 kHz SCS for the treatment of chronic UEP.<h4>Study design</h4>It was a prospective, multicenter, and observational study. The study was registered on ClinicalTri ...[more]

PMID: 33204145

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Project description:BACKGROUND:Sonographers have reported a high occurrence of musculoskeletal pain for more than 25?years. Assessments of occupational risk factors have previously been based on cross-sectional surveys. The aim of this longitudinal study was to determine which factors at baseline that were associated with neck/shoulder and elbow/hand pain at follow-up. METHODS:A questionnaire was answered by 248 female sonographers at baseline and follow-up (85% of the original cohort). 208 were included in the analyses. Physical, visual, and psychosocial work-related conditions were assessed at baseline. Pain in two body regions (neck/shoulders and elbows/hands) was assessed at both baseline and follow up. RESULTS:Pain at baseline showed the strongest association with pain at follow-up in both body regions [prevalence ratio (PR) 2.04; 95% confidence interval (CI) 1.50-2.76], for neck/shoulders and (PR 3.45; CI 2.29-5.22) for elbows/hands. Neck/shoulder pain at follow-up was associated with inability of ergonomic adjustments at the ultrasound device (PR 1.25; CI 1.05-1.49), a high mechanical exposure index (PR 1.66; CI 1.09-2.52), and adverse visual conditions (PR 1.24; CI 1.00-1.54) at baseline. Moreover, among participants with no neck/shoulder pain at baseline, high job demands (PR 1.78; CI 1.01-3.12), and a high mechanical exposure index (PR 2.0; CI 0.98-4.14) predicted pain at follow-up. Pain in the elbows/hands at follow-up was associated with high sensory demands at baseline (PR 1.63; CI 1.08-2.45), and among participants without pain at baseline high sensory demands predicted elbow/hand pain at follow-up (PR 3.34; CI 1.53-7.31). CONCLUSION:Pain at baseline was the strongest predictor for pain at follow-up in both body regions. We also found several occupational factors at baseline that were associated with pain at follow-up: inability to adjust equipment, adverse visual conditions, a high MEI, high job demands and high sensory demands. These results point at a possibility to influence pain with better ergonomics.

Dataset Information

Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study.

Publications

Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study.

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