ArticleMayo Clinic proceedings. Innovations, quality & outcomes2022
High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial.
Article in Mayo Clinic proceedings. Innovations, quality & outcomes, 2022. 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 15 papers, 1 of them a synthesis that pooled it.
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.
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
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Emotional and psychosocial function after dorsal column spinal cord stimulator implantation: a systematic review and meta-analysis.Regional anesthesia and pain medicine · 2025Pooled it
- 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
- 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.Diabetes research and clinical practice · 2023Trial
- Comparative outcomes of spinal cord stimulation for neuropathic pain: peripheral nerve versus spinal cord lesions.Neurosurgical review · 2026Article
- Spinal Cord Stimulation in Painful Diabetic Neuropathy: Advances, Outcomes, and Future Directions.Biomedicines · 2025Review
- Can Spinal Cord Stimulation be Considered as a Frontier for Chronic Pain in Diabetic Foot?Pain and therapy · 2025Review
- Comparison of the efficacy of spinal cord stimulation and dorsal root ganglion stimulation in the treatment of painful diabetic peripheral neuropathy: a prospective, cohort-controlled study.Frontiers in neurology · 2024Article
- Spinal Cord Stimulation for Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2024Review
- A Systematic Guideline by the ASPN Workgroup on the Evidence, Education, and Treatment Algorithm for Painful Diabetic Neuropathy: SWEET.Journal of pain research · 2024Review
- Post-trial access to implantable neural devices: an exploratory international survey.BMJ surgery, interventions, & health technologies · 2024Article
- Treatment of Painful Diabetic Neuropathy with 10 kHz Spinal Cord Stimulation: Long-Term Improvements in Hemoglobin A1c, Weight, and Sleep Accompany Pain Relief for People with Type 2 Diabetes.Journal of pain research · 2024Article
- Current Neurostimulation Therapies for Chronic Pain Conditions.Current pain and headache reports · 2023Review
- A Brief Review on the Novel Therapies for Painful Diabetic Neuropathy.Current pain and headache reports · 2023Review
- Screening for diabetic peripheral neuropathy in resource-limited settings.Diabetology & metabolic syndrome · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
32 authors.
Funding
Abstract
Objective: To evaluate high-frequency (10-kHz) spinal cord stimulation (SCS) treatment in refractory painful diabetic neuropathy. Patients and Methods: A prospective, multicenter randomized controlled trial was conducted between Aug 28, 2017 and March 16, 2021, comparing conventional medical management (CMM) with 10-kHz SCS+CMM. The participants had hemoglobin A1c level of less than or equal to 10% and pain greater than or equal to 5 of 10 cm on visual analog scale, with painful diabetic neuropathy symptoms 12 months or more refractory to gabapentinoids and at least 1 other analgesic class. Assessments included measures of pain, neurologic function, and health-related quality of life (HRQoL) over 12 months with optional crossover at 6 months. Results: The participants were randomized 1:1 to CMM (n=103) or 10-kHz SCS+CMM (n=113). At 6 months, 77 of 95 (81%) CMM group participants opted for crossover, whereas none of the 10-kHz SCS group participants did so. At 12 months, the mean pain relief from baseline among participants implanted with 10-kHz SCS was 74.3% (95% CI, 70.1-78.5), and 121 of 142 (85%) participants were treatment responders (≥50% pain relief). Treatment with 10-kHz SCS improved HRQoL, including a mean improvement in the EuroQol 5-dimensional questionnaire index score of 0.136 (95% CI, 0.104-0.169). The participants also reported significantly less pain interference with sleep, mood, and daily activities. At 12 months, 131 of 142 (92%) participants were "satisfied" or "very satisfied" with the 10-kHz SCS treatment. Conclusion: The 10-kHz SCS treatment resulted in substantial pain relief and improvement in overall HRQoL 2.5- to 4.5-fold higher than the minimal clinically important difference. The outcomes were durable over 12 months and support 10-kHz SCS treatment in patients with refractory painful diabetic neuropathy. Trial registration: clincaltrials.gov Identifier: NCT03228420.
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