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Treatment of Neck and Upper Limb Pain Using BurstDR (De Ridder) Stimulation — NU-BURST  

Neck Pain Clinical Trial

Official title:
Treatment of Neck and Upper (NU) Limb Pain Using BurstDR Stimulation

Clinical Trial Summary

This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back

Clinical Trial Description

Subjects diagnosed with chronic intractable neck pain with or without radiation down to arm/shoulder/upper back will be considered for inclusion in this study. After baseline evaluation, subjects will undergo a SCS trial using the Abbott Invisible Trial system. At the end of the SCS trial, subjects experiencing at least 50% pain relief, according to average neck VAS (calculated by the average of last 3 days on the pain diary), will be considered for permanent implant and further participation in the study. Pain intensity, quality of life, disability, headache severity, sleep quality, patient satisfaction, anxiety, depression, stimulation sensation and medication usage assessments will be performed at baseline, after SCS trial and at the 3, 6 and 12 month follow up visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03159169
Study type Interventional
Source Abbott Medical Devices
Contact Lalit Venkatesan, Ph.D.
Phone +19723098522
Email LVenkatesan@sjm.com
Status Recruiting
Phase N/A
Start date May 15, 2018
Completion date August 2022
View Details
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