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THE FOCUSSM WORKFLOW PNS FOR BACK PAIN

BEST PRACTICE GUIDANCE

recommended and STANDARDISED approach

The FocusSM workflow is a recommended and standardised approach for physicians interested in applying subcutaneous PNS in patients with chronic, intractable back pain.

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BASED ON EVIDENCE...AND EXPERT PHYSICIAN OPINION

PNS for back pain: based on evidence

Ideal patient* presents with:

PNS for back pain
  • Defined, focal back pain located below the rib cage and above the iliac crest
  • Worst pain about the size of 1–2 business cards (1 card = 55 mm x 85 mm)
  • Significant back pain (e.g., ≥5 on a 0–10 scale)
  • No or insignificant leg pain that is sufficiently managed conservatively
  • Disability on ODI no worse than a category score of severe
  • No severe or untreated depression
  • At least a moderate level of quality of life

Implant procedure

PNS for back pain
  • 1–2 percutaneous leads1 subcutaneously on a cranial-caudal axis in the centre of maximal pain
  • Avoid lead placement directly in areas of allodynia2
  • Ensure optimal paraesthesia coverage

Programming

PNS for back pain
  • Start trial with one programme per lead using one anode and one cathode
  • 40 Hz and 210 μs
  • Soft start/stop at 4 sec
  • Adjust amplitude to comfort
  • Allow a sufficient trial period duration to evaluate outcomes. Higher patient usage of PNS therapy correlated to better outcomes3

DOWNLOAD the Studies

html PNS: Innovation in Back Pain (.html)

Learn more about the SubQStim Clinical Study as well as the FocusSM workflow

Download the case study here
html Focus PNS Workflow FAQ (.html)

Learn which FocusSM workflow guideline is backed up by which specific evidence

Download the Guidelines

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INFORMATION

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1

Select lead for broadest paraesthesia coverage.

2

Consider implanting leads directly outside/bracketing the area.

3

Results from post-hoc analyses of the SubQStim Study, PNFS Prospective Study, SubQ study and expert clinician review and input from the PNS Advisory Board.

  • Eldabe SS, Taylor RS, Goossens S, et al. Randomized Controlled Trial of Subcutaneous Nerve Stimulation for Back Pain Due to Failed Back Surgery Syndrome: The SubQStim Study. Neuromodulation 2018; E-pub ahead of print. DOI:10.1111/ner.12784.
  • Kloimstein H, Likar R, Kern M, et al. Peripheral Nerve Field Stimulation (PNFS) in Chronic Low Back Pain: A Prospective Multicenter Study. Neuromodulation. 2013;17(2):180-187.
  • Tinsley J, Luyet PP, Kern M et al. Predictors analysis of a prospective multicentre study on peripheral nerve field stimulation (PNFS) for chronic low back pain (CLBP): Results from the Austrian PNS Registry. Presented at the 9th World Congress of the World Institute of Pain, Dublin, Ireland, May 9-12, 2018. Abstract # WIP18-0273.
  • Van Gorp E-JJAA, Teernstra OPM, Gultuna I, et al. Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial. Neuromodulation. 2016;19(2):171-178.

The FocusSM workflow is guidance only and physicians should use their medical judgment and product labelling to optimise therapy for individual patients, which may require discontinuation or modification of the workflow.

* Neurostimulation for Peripheral Nerve Stimulation (PNS) using percutaneous leads - A Medtronic PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the posterior trunk.

See the device/therapy manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events, If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.