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Project

The holistic response of patients with Failed Back Surgery Syndrome by Subthreshold Spinal Cord Stimulation compared to Best Medical Treatment, investigated by a Multicentric Randomized Controlled Trial. (FWOTM1050)

Despite the proven efficacy of standard Spinal Cord Stimulation
(SCS) over Best Medical Treatment (BMT) on the one hand and the
superiority of new subthreshold SCS paradigms compared to
standard SCS on the other hand, the efficacy of subthreshold SCS
compared to BMT has not yet been investigated. Additionally,
previous research only focused on pain relief (one-dimensional),
without taking functionality and participation into account. The novelty
of this project is to evaluate patients from a holistic point of view,
taking functioning, medication use, quality of life, and satisfaction into
account besides pain intensity. Therefore, the aim of this multicenter
randomized controlled trial is to evaluate whether subthreshold SCS
results in more clinical holistic responders in Failed Back Surgery
Syndrome patients directly compared to BMT. The primary objective
is to examine whether subthreshold SCS results in a higher
percentage of clinical holistic responders at 6 months, compared to
BMT. The secondary objective is to examine if subthreshold SCS
compared with BMT is having more efficacy in improving patients'
individual competencies for self-management, work status and
healthcare expenditure. The shift in primary outcome measurement
from a sole focus on pain intensity scores towards clinical holistic
responders is unconventional since we dare to go back to an
unanswered question of basic clinical knowledge with a new outcome
perspective and a potential high socio-economic value.
Date:1 Oct 2021 →  Today
Keywords:Spinal Cord Stimulation, holistic response, Failed Back Surgery Syndrome
Disciplines:Biostatistics, Pain medicine anaesthesiology, Rehabilitation, Occupational health and safety