A randomized sham-controlled clinical trial for refractory mechanical chronic low back pain


An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.

Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and the prognosis is unfavourable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centres to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms ( identifier: NCT02577354).

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