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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Implantation of SCS electrodes and stimulator according to clinical standards
Southmead hospital
Bristol, United Kingdom
Guy's St. Thomas Hospital
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Evaluate the change in pain intensity between baseline, trial and long-term follow up evaluations using Visual Analog Scale (VAS) assessments.
Golden standard self-evaluation of pain intensity
Time frame: 3, 6 and 12 months
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