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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • There is only limited published literature (1 randomised controlled trial [RCT] and 3 small case series) on neurostimulation of lumbar muscles with short-term follow-up.

    • The RCT compared therapeutic stimulation with low-level stimulation sham control.

    • There are no studies comparing this treatment with current standard of care.

    • The feasibility study (Deckers 2015) used standard spinal cord stimulator leads from other manufacturers. The frequent lead migrations observed in this study led to the development of the ReActiv8 lead with exclusive distal fixation tines.

    • ReActiv8-A Study (Deckers 2017)was performed using the ReActiv8 lead and a "lateral" surgical approach for the first 47 subjects. To mitigate the risk of lead conductor fractures associated with the lateral approach, the lead trajectory was modified to the 'midline approach'.