Pain medicine

5-year longitudinal follow-up of patients treated for chronic mechanical low back pain using restorative neurostimulation

Reg Anesth Pain MedPublished Prospective postmarket clinical follow-up study

Authors' conclusion

Restorative neurostimulation provides robust, sustained improvements in pain, function, and quality of life in patients with CLBP associated with multifidus dysfunction.

Study context

Population
Patients with chronic mechanical low back pain (CLBP) associated with multifidus dysfunction, five UK sites34 (81%) completed 5-year follow-up
Participants
42 patients
Outcome
Clinical outcomes: pain (NRS), disability (ODI), health-related quality of life (EQ-5D-5L)
Follow-up
5 years
Methodological detailsopen-label, multicentre (five UK sites), single-group
  • Open-label
  • Multicentre (five UK sites)
  • Single-group

Main finding

As reported in the abstract

Pain, disability and quality of life, baseline to 5 years

Minimally clinically important change in either pain or disability

82%

Pain remitters (Numerical Rating Scale (NRS) ≤3)

62%

Observational data: associations, not effects.

Further findings

Device usage (therapy utilization, implantable device logs) · 5 years

Device usage averaged 1106 hours over 5 years, with reductions in usage over time
Lower usage associated with non-response; causality could not be determined

Original publication

5-year longitudinal follow-up of patients treated for chronic mechanical low back pain using restorative neurostimulation. Reg Anesth Pain Med. Published 14 August 2025. doi:10.1136/rapm-2025-106899

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