Trial reportNeuromodulation : journal of the International Neuromodulation Society2020
Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.
Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04735159 (Development of a Predictive Model of Effectiveness for the Implantation of Electrical Neurostimulators in Patients With Chronic Pain Using Imaging Biomarkers Extracted From Magnetic Resonance), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Development of a Predictive Model of Effectiveness for the Implantation of Electrical Neurostimulators in Patients With Chronic Pain Using Imaging Biomarkers Extracted From Magnetic Resonance
Who cites it
15 citing papers in PubMed.
- Towards Selective Trial Stimulation in Spinal Cord Stimulation: Clinical and Psychological Evidence for an Individualised Implantation Strategy.Journal of clinical medicine · 2026Review
- Psychometric and Molecular Profiling to Predict Outcomes of Spinal Cord Stimulation for Chronic Pain: A Pilot Study.Journal of pain research · 2026Article
- Consensus Guidelines from the American Society of Pain and Neuroscience for the Use of 60-Day Peripheral Nerve Stimulation Therapy. A NEURON Living Guideline Project.Journal of pain research · 2025Article
- Real-World Outcomes of Spinal Cord Stimulation: A Consecutive Institutional Experience with 505 Trials, Trial-to-Implant Ratio, Long-Term Efficacy, and Explantation Risk Factors.Journal of pain research · 2025Article
- Cervical Spinal Cord Stimulation for Failed Neck Surgery Syndrome.Current pain and headache reports · 2024Review
- Spinal Cord Stimulation for Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2024Review
- Trial or not trial in the practice of spinal cord stimulation. That's the question.Interventional pain medicine · 2023Article
- Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain.Regional anesthesia and pain medicine · 2023Review
- Non-Invasive Treatments for Failed Back Surgery Syndrome: A Systematic Review.Global spine journal · 2023Review
- Case report: The promising application of dynamic functional connectivity analysis on an individual with failed back surgery syndrome.Frontiers in neuroscience · 2022Article
- 60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief.Journal of pain research · 2022Article
- Article
- Cost-Effectiveness Model Shows Superiority of Wireless Spinal Cord Stimulation Implantation Without a Separate Trial.Neuromodulation : journal of the International Neuromodulation Society · 2021Article
- High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial.Pain practice : the official journal of World Institute of Pain · 2021Article
- A New Direction for Closed-Loop Spinal Cord Stimulation: Combining Contemporary Therapy Paradigms with Evoked Compound Action Potential Sensing.Journal of pain research · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
background"Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely.
objectiveTo evaluate fully implanted wireless SCS devices during a 30-day screening trial in subjects with chronic low back pain and leg pain and a history of lumbosacral spine surgery.
methodsIn a randomized controlled trial of single-stage wireless SCS using a wireless percutaneous system, 99 subjects received either 10 kHz high frequency stimulation (HFS) or lower frequency stimulation (LFS) below 1500 Hz (Bolash R, Creamer M, Rauck R, et al. Wireless high frequency spinal cord stimulation (10 kHz) compared to multi-waveform low frequency spinal cord stimulation in the management of chronic pain in failed back surgery syndrome subjects: preliminary results of a multicenter, prospective, randomized controlled study. Pain Med 2019, https://doi.org/10.1093/pm/pnz019). In this report, we assess the 30-day trial success rate (≥50% pain relief from baseline) and complications.
resultsThe overall trial success rate was 88% (87/99): 92% (46/50) for HFS and 84% (41/49) for LFS (NS). The trial success rate in the 64 subjects with predominant low back pain was 92% (59/64) vs. 80% (28/35) in those with leg pain ≥ low back pain (NS). During the screening trial, one infection occurred (1%) and one subject withdrew and was explanted (1%). Electrode migrations were seen on routine follow-up x-rays in 10 cases (10%).
conclusionUsing wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.