Trial reportDiabetes research and clinical practice2023
Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial.
Trial report in Diabetes research and clinical practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03228420 (A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Spinal Cord Stimulation for Painful Diabetic Neuropathy: A Systematic Review and Meta-Analysis of High- and Low-Frequency Modalities.Pain research & management · 2026Pooled it
- Clinical applications of invasive spinal cord stimulation in neurological disorders: a narrative review.Frontiers in neurology · 2026Pooled it
- [Practical guideline on the prevention and management of diabetic foot in China (Ⅰ)].Zhonghua shao shang yu chuang mian xiu fu za zhi · 2025Guideline
- Long-term efficacy of 10 kHz spinal cord stimulation in managing painful diabetic neuropathy: A post-study survey.Pain practice : the official journal of World Institute of Pain · 2025Trial
- Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients.Journal of pain research · 2024Trial
- Neuromodulation for Pain and Fatigue in Hereditary and Acquired Neuromuscular Conditions: A Narrative Review.Current pain and headache reports · 2026Review
- Molecular and Cellular Mechanisms of Spinal Cord Stimulation: Linking Dorsal Horn Circuits, Glia, and ECAP-Guided Therapy.International journal of molecular sciences · 2026Review
- From Pain Relief to Multidimensional Outcomes: A Structured Narrative Review of Success Language in a PubMed/MEDLINE Spinal Cord Stimulation Corpus.Journal of clinical medicine · 2026Review
- Long-Term Effectiveness of Spinal Cord Stimulation Beyond 24 Months: A PRISMA-ScR-Informed Scoping Review.Journal of clinical medicine · 2026Review
- Peripheral Neuropathy: A Phenotype-Driven Review for Diagnosis and Management.Revista de neurologia · 2026Review
- Spooky action at a distance: neuromodulation, physiologic distress signals, and limb preservation.Burns & trauma · 2026Review
- Long-term relief of refractory trigeminal neuropathy using high-frequency spinal cord stimulation at the cervicomedullary junction: a 6-year follow-up case report.Frontiers in neuroscience · 2026Article
- Mechanical cues as immunomodulators in neuroinflammation-driven spinal sensitization: analgesic mechanisms and therapeutic strategies.Frontiers in immunology · 2026Review
- Spinal Cord Stimulation in Painful Diabetic Neuropathy: Advances, Outcomes, and Future Directions.Biomedicines · 2025Review
- Article
- Spinal cord stimulation for the treatment of painful diabetic neuropathy and risk of major adverse cardiovascular events, mortality, amputation, infection and suicide: a retrospective cohort study.EClinicalMedicine · 2025Article
- Can Spinal Cord Stimulation be Considered as a Frontier for Chronic Pain in Diabetic Foot?Pain and therapy · 2025Review
- Effects of Spinal Cord Stimulation in Patients with Small Fiber and Associated Comorbidities from Neuropathy After Multiple Etiologies.Journal of clinical medicine · 2025Article
- Practical guidelines for the prevention and management of diabetic foot disease in China.Burns & trauma · 2025Article
- Mechanisms and clinical progress of spinal cord stimulation in refractory chronic pain: an overview.Frontiers in neurology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
34 authors at 17 institutions in 2 countries.
Funding
Abstract
aimsTo evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN).
methodsThe SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding.
resultsAt 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection.
conclusionsOver 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN.
trial registrationClincalTrials.gov Identifier, NCT03228420.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.