- Joined
- Nov 21, 1998
- Messages
- 12,577
- Reaction score
- 6,989
Once you see the results, you literally can't un-see them.
Neuromodulation. 2023 Aug 28;S1094-7159(23)00712-2.
doi: 10.1016/j.neurom.2023.07.009. Online ahead of print.
Affiliations expand
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.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Neuromodulation. 2023 Aug 28;S1094-7159(23)00712-2.
doi: 10.1016/j.neurom.2023.07.009. Online ahead of print.
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 31Affiliations expand
- PMID: 37642628
- DOI: 10.1016/j.neurom.2023.07.009
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.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
