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    Interventional procedure overview of neurostimulation of lumbar muscles for refractory non-specific chronic low back pain

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    Additional information considered by IPAC

    Professional experts' opinions

    Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate. Three professional expert questionnaires for neurostimulation of lumbar muscles for refractory non-specific chronic low back pain was submitted and can be found on the NICE website.

    Patient commentators' opinions

    Twenty-two commentaries from patients who have had this procedure were discussed by the committee. The patient commentators' views on the procedure were consistent with the published evidence and the opinions of the professional experts.

    Company engagement

    A structured information request was sent to 1 company who manufacture a potentially relevant device for use in this procedure. NICE received 1 completed submission. This was considered by the IP team and any relevant points have been taken into consideration when preparing this overview.

    Issues for consideration by IPAC

    Ongoing studies

    • NCT02577354: ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B). international multicentre prospective randomised blinded controlled trial with one-way crossover (appropriate stimulation eeliciting multifidus contractions versus sub-threshold stimulation, 30 minutes twice a day sessions); n=204; patients in control arm crossed over to treatment arm after primary outcome assessment; primary outcomes: comparison of responder rates for low back pain VAS between treatment and control groups, device or procedure related adverse events. Study location: USA, Australia, Belgium, The Netherlands, UK. Study completion date December 2023.

    • NCT03255200: ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-C). observational cohort study, n=50, primary outcomes: rates of low back pain, adverse events; location: Germany. Study completion date December 2023, status: recruiting.

    • NCT01985230: Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain (post marketing clinical follow-up [PMCF] -ReActiv8-A continuation study). Interventional single group assignment, n=96, primary outcome: low back pain assessed on NRS, adverse events at 90 days; study location: Australia, Belgium, UK (8 sites). Study completion date December 2024; status: active.