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


Although nonsurgical treatments, including physical therapy, chiropractic care, nonopioid and opioid medications, injections, and medial branch rhizotomy, provide modest relief and improved function for some, they are ineffective or provide only transient relief for many.

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. Dr Willem Volkschenk, Dr Marc Russo along with a group of other experts, conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centres to determine the safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms.

The findings and safety outcomes from this study may be compelling enough to affect regulatory approvals and clinical practice, especially for patients in whom available treatment options are not effective.

Read the complete research paper here.

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