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Randomized Controlled Trial
. 2023 Oct;26(7):1387-1399.
doi: 10.1016/j.neurom.2023.07.009. Epub 2023 Aug 28.

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial

Timothy Deer  1 , Christopher Gilligan  2 , Steven Falowski  3 , Mehul Desai  4 , Julie Pilitsis  5 , Jessica Jameson  6 , Susan Moeschler  7 , Robert Heros  8 , Edward Tavel  9 , Anne Christopher  10 , Denis Patterson  11 , Sayed Wahezi  12 , Jacqueline Weisbein  13 , Ajay Antony  14 , Robert Funk  15 , Mohab Ibrahim  16 , Chi Lim  17 , Derron Wilson  18 , Michael Fishell  19 , Keith Scarfo  20 , David Dickerson  21 , Edward Braun  22 , Patrick Buchanan  23 , Robert M Levy  24 , Nathan Miller  25 , Jonathan Duncan  26 , Jijun Xu  27 , Kenneth Candido  28 , Scott Kreiner  29 , Marie E Fahey  30 , James Yue  31
Affiliations
Randomized Controlled Trial

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial

Timothy Deer et al. Neuromodulation. 2023 Oct.

Abstract

Objective: Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery.

Methods and materials: Patients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function.

Results: Intention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a <one-point change in the CMM arm. Three serious and 14 non-serious device- or procedure-related events were reported.

Conclusions: This study found substantial improvement at six months in back pain, back pain-related disability, pain-related emotional suffering, PGIC, pain interference, and physical function in a population with severe, debilitating back pain for more than a decade. These improvements were reported in conjunction with reduced opioid use, injection, and ablation therapy.

Clinical trial registration: The Clinicaltrials.gov registration number for the study is NCT04479787.

Keywords: composite outcomes; persistent spinal pain syndrome; refractory chronic low back pain; spinal cord stimulation.

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Conflict of interest statement

Conflict of Interest David Dickerson has a consulting relationship with Abbott Labs, Versos Medical, Biotronik, SPR Therapeutics, Pfizer, Nalu, and Myovant Biosciences. Robert M. Levy is an unpaid consultant for Abbott, Nalu, Biotronik and Saluda Medical. Robert M. Levy has stock options with Nalu and Saluda. Jacqueline Weisbein has consulting agreements with Abbott, Versos, Saluda, Biotronik and SI Bone. She has received payment or honoraria for lectures, presentations, speaking bureaus or educational events from Abbott and Saluda. Jacqueline Weisbein has received grants from Medtronic, Saluda, and SI Bone. Marie E. Fahey is an employee of Abbott. Denis Patterson has consulting agreements with Abbott, AIS, Allergan, Amgen, Pajunk Medical, Saluda, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Spark Biomedical, and Versos and has received honoraria from Abbott, Allergan, Amgen, Vertos, CornerLoc, Lundbeck, and Saluda. He also has stock or stock options with CornerLoc. Julie Pilitsis has received grant support from Medtronic, Boston Scientific, and Abbott. Timothy Deer has consulting agreements with Abbott, Saluda, Nalu, and SPR Therapeutics and has received grant support from Saluda, Nalu, and SPR Therapeutics. Timothy Deer has stocks or stock options with Saluda, Nalu, and SPR Therapeutics. Steven Falowski has consulting agreements with Medtronic, Abbott, Saluda, Vertos, CornerLoc, Mainstay Medical, Relievant, and Avanos and has received grant support from Abbott, Mainstay, Medtronic, Vertiflex, CornerLoc, Saluda, Nalu, and Biotronik. He also has stocks or stock options with SPR Therapeutics, Saluda and Stimgenics. Ajay Antony has consulting agreements with Abbott, Boston Scientific, Saluda, Versos, PainTEQ, and Avanos and serves on an advisory board for Boston Scientific, Abbott, and Saluda. Patrick Buchanan reports consulting fees from Abbott and PainTEQ. Mehul Desai reports consulting fees from Abbott, SPR Therapeutics and Nalu Medical and stock or stock options from SPR Therapeutics, Synerfuse, Virdio, and VYRSA. Chris Gilligan reports consulting fees from Mainstay Medical, Persica, Saluda, and Iliad Lifesciences and stock or stock options from Mainstay Medical. Robert Heros reports consulting fees from Abbott, Mainstay Medical, Saluda Medical, Biotronik, and Boston Scientific and support for attending meetings from Mainstay Medical and participated on a data safety monitoring board/advisory board for Biotronik. Jessica Jameson reports consulting fees from Boston Scientific, Nevro, Saluda, Abbott, and SI Bone and payment or honoraria from Nevro, Boston Scientific, Saluda, Abbott, and Medtronic. Chi Lim reports consulting fees from Synthes, Medtronic, Abbott, Implanet, Kyocera, and Met One. Derron Wilson reports consulting fees from Abbott, Boston Scientific and Biotronik and payment or honoraria for lectures, or educational events from Abbott and has received travel support from Abbott, Biotronik, and Boston Scientific. Derron Wilson has participated on advisory boards for Abbott and Biotronik. James J. Yue reports consulting income and grant support from Abbott. Susan Moeschler, Jijun Xu, Edward Braun, Kenneth Candido, Anne Christopher, Jonathan Duncan, Michael Fishell, Robert Funk, Mohab Ibrahim, Scott Kreiner, Nathan Miller, Keith-Austin Scarfo, Edward Tavel, and Sayed Wahezi reported no conflict of interest.

Figures

Figure 1.
Figure 1.
Consort diagram for 269 subjects randomized and disposition through the six-month follow-up visit. One patient was enrolled, but the patient was never randomized. Patient withdrawal by sponsor request was due to contract and budgeting difficulties. Patients who failed to meet the inclusion and exclusion criteria after randomization were withdrawn after the occurrence of a monitoring visit that uncovered medical conditions that should have excluded the patient. The patient excluded after three months was excluded before the six-month primary end point.
Figure 2.
Figure 2.
Individual pain relief for all subjects with six-month data. Phase 1 represents data from the first 200 randomized subjects for end-point analysis; phase 2 (blue) represents the next 69 randomized with outcome data.
Figure 3.
Figure 3.
A composite end point evaluated pain relief (NRS) or functional improvement (ODI). Venn diagram shows 78% of subjects with SCS reported meaningful improvements on both. The end-point analysis reported a 91% responded rate after six months of passive recharge burst therapy.
Figure 4.
Figure 4.
Improvements on ODI are shown for all subjects with six-month data. Blue represents a substantial improvement defined by ≥20-point improvement. MCID is defined as a 13-point improvement.
Figure 5.
Figure 5.
Line plots show all secondary end-point measures that show greater improvements on a continuous scale after SCS (blue) than with CMM (red). Panels a–e represent NRS, ODI, PCS, PROMIS-29 pain interference, and PROMIS-29 physical function instruments, respectively. Hypothesis testing was conducted for the secondary end-point analysis. All baseline-to-six-month change values are statistically significant (p < 0.05).
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References

    1. Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–2037. - PubMed
    1. Shmagel A, Foley R, Ibrahim H. Epidemiology of chronic low back pain in US adults: data from the 2009–2010 national health and nutrition examination survey. Arthritis Care Res (Hoboken). 2016;68:1688–1694. - PMC - PubMed
    1. Spears CA, Hodges SE, Kiyani M, et al. Health care resource utilization and management of chronic, refractory low back pain in the United States. Spine (Phila Pa 1976). 2020;45:E1333–E1341. - PMC - PubMed
    1. Petersen EA, Schatman ME, Sayed D, Deer T. Persistent spinal pain syndrome: new terminology for a New Era. J Pain Res. 2021;14:1627–1630. - PMC - PubMed
    1. Kreiner DS, Matz P, Bono CM, et al. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. 2020;20:998–1024. - PubMed

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