
Neuromodulation
Kallewaard JW et al (2024): RCT evaluating DTM™ SCS for PSPS Type 1 – 24 month results.
European randomized controlled trial evaluating Differential Target Multiplexed™ spinal cord stimulation and conventional medical management in subjects with persistent back pain ineligible for spine surgery: 24-month results
Authors | Kallewaard JW, Billet B, Van Paesschen R, et al. |
Journal | European Journal of Pain |
Published date | November 2024 |
Medtronic summary | This publication describes a prospective, multicenter, open-label, randomized controlled trial testing DTM™ spinal cord stimulation (SCS) against conventional medical management (CMM) in patients with chronic low back pain (CLBP) who have not had prior back surgery and are ineligible for spine surgery (persistent spinal pain syndrome [PSPS] Type 1). Patients were required to have a diagnosis of neuropathic CLBP with or without leg pain, have no previous lumbar spinal surgery, and not be eligible for spine surgery. The primary endpoint was the responder rate (percentage of subjects with at least 50% reduction in pain) at six months. Secondary analyses included pain levels (back and leg pain), disability, quality of life, patient satisfaction, and patient global impression of change. An optional crossover was allowed after the six-month follow-up, and data were collected up to two years. A total of 112 participants were randomized to DTM™ SCS (n = 55) and CMM (n = 57). Pain etiology included (number of patients, DTM™ SCS/CMM): degenerative disc disease (42/41), lumbar facet-mediated pain (14/18), radiculopathy (12/17), mild/moderate spinal stenosis (9/6), internal disc disruption/annular tear (9/11), spondylosis (7/6), and spondylolisthesis (2/3). The back pain responder rate (defined as a ≥ 50% reduction in back pain) for DTM™ SCS at six months was 85.1%, while the corresponding responder rate for CMM was 3.6% (modified intent to treat population, p < 0.0001). After the six-month follow-up, 50 of 55 patients in the CMM group crossed over to the SCS group. Per protocol, the back pain responder rates for DTM™ SCS and the crossover patients to DTM™ SCS were 95.0% and 97.4%, respectively, at the two-year follow-up. Eight serious adverse events occurred in seven participants; six events were implant-site infections which required system explant (two trial leads; four device removals), and two events occurred in a single patient (postdural puncture headache and transient sensory and motor deficit in the left leg, which was ongoing at the end of the study). A total of 28 adverse events occurred in 29.1% of patients in the DTM™ SCS arm; no adverse events occurred in the CMM arm prior to crossover. Thirty percent of the patients who crossed over from CMM to DTM™ SCS experienced 23 study-related adverse events. DTM™ SCS provided sustained pain reduction in patients with CLBP classified as PSPS Type 1. Improvements in quality of life and functional outcomes were also reported. Safety was consistent with the safety profile of previous SCS studies.
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Disclosure:
This publication involves uses of Medtronic spinal cord stimulation (SCS) therapy that are not approved by the U.S. Food and Drug Administration (FDA) and safety and effectiveness of Medtronic SCS systems for the unapproved uses have not been established.
Inclusion criteria for the study includes patients with neuropathic chronic low back pain (CLBP) with or without leg pain who had no prior lumbar spinal surgeries and who were not eligible for spine surgery. This inclusion criteria is broader than the indicated conditions specified in Medtronic SCS labeling. Medtronic SCS systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs — including unilateral or bilateral pain associated with certain conditions. Among the approved conditions are “radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome (FBS) or herniated disk” and “Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions.” A majority (77%) of patients in the study had DDD, but 23% had other etiologies including lumbar facet-mediated pain, radiculopathy, spinal stenosis, internal disc disruption/annular tear, spondylosis, and spondylolisthesis. Medtronic SCS is not approved for lumbar facet-mediated pain or pain related to spinal stenosis, internal disc disruption/annular tear, spondylosis, or spondylolisthesis.
Contraindications for Medtronic SCS include diathermy; energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death. Adverse events may include paralysis, infection, device malfunction or migration, pain at implant site, and other surgical risks.
Medtronic does not market its products for off-label uses and makes no representations regarding safety, effectiveness, and performance without the required market authorizations for use.
View the FDA-required labeling.
SGX International was the sponsor of the study described in the publication. Medtronic acquired the study data after the study had been completed and closed and was not involved in the design of the study, data analysis, or authorship of the manuscript. Several authors received payment from Medtronic or had a conflict of interest with Medtronic noted in the publication: Jan W. Kallewaard, Bart Billet, Isaac Peña, Pablo López, Carlos Tornero, David L. Cedeño, and Ricardo Vallejo.
Full citation: Kallewaard JW, Billet B, Van Paesschen R, et al. European randomized controlled trial evaluating differential target multiplexed spinal cord stimulation and conventional medical management in subjects with persistent back pain ineligible for spine surgery: 24-month results. Eur J Pain. 2024;28(10):1745–1761.