ReActiv8 Therapy after Lower Lumbar Uninstrumented Spinal Surgery

The ReActiv8 System is indicated as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing. This study will be a single arm prospective study using two cohorts. Cohort 1 will be 30 patients who have mechanical low back pain (LBP) for > or equal to 12 months following a discectomy procedure in the L3/L4, L4/L5, or L5/S1 spinal levels. Cohort 2 will be 30 patients who have had chronic LBP > or equal to 12 months following a lumbar laminectomy in the L4 and/or L5 spinal levels. The study will consist of up to 60 patients implanted with ReActiv8, who are indicated for and agree to participation in this study. There is no pre-specified window from enrolment to ReActiv8 implant as the implant proceeds under normal standard of care and does not form part of this study. Participants who decline to be in the study will still have access to the ReActiv8 implant and will be followed up separately outside of the study as part of the International Spine Centre’s clinical care pathway. At the Baseline Visit, participants will come to the clinic to complete functional testing (touch toes, extend back, reach down leg to left and then to the right) with a physiotherapist and a series of Patient Reported Outcome Measures (PROMs) under the supervision of the principal investigator. The device implant will be completed as described by the implanting surgeon. The procedure to implant the device proceeds under normal standard of care and does not form part of this study. Participants will return for the Activation and Re-programming visits at approximately the 2-week timepoint and 45-day timepoint, in alignment with the standard of care follow-up visit schedule. The implanted ReActiv8 IPG is wirelessly programmed by the physician to meet their specific needs for 2 sessions per day for 30 minutes each. The implant analytics can be utilised to monitor adherence to the therapy. Participants will also return to the clinic at the follow-up visits specified per protocol (6, 12, and 24 months post-activation) to complete functional testing and a series of PROMs. Additional items such as adverse events and changes to LBP medication use will be collected. Each follow-up visit is anticipated to take one hour. Participants will be followed for 24 months post-activation.