Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2018
Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT.
Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01609972 (Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation), which is not on this map. Cited by 38 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.
Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain as Compared to Commercially Available SCS Devices
Who cites it
38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Emotional and psychosocial function after dorsal column spinal cord stimulator implantation: a systematic review and meta-analysis.Regional anesthesia and pain medicine · 2025Pooled it
- Spinal Cord Stimulation for Low Back Pain: A Systematic Review.Current pain and headache reports · 2025Pooled it
- 10-kHz High-Frequency Spinal Cord Stimulation for Adults With Chronic Noncancer Pain: A Health Technology Assessment.Ontario health technology assessment series · 2020Pooled it
- 10 kHz Spinal Cord Stimulation for the Treatment of Failed Back Surgery Syndrome with Predominant Leg Pain: Results from a Prospective Study in Patients from the Dutch Healthcare System.Pain practice : the official journal of World Institute of Pain · 2021Trial
- High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Combined Neck and Arm Pain: Results From a Prospective Multicenter Study.Neurosurgery · 2020Trial
- 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
- Pain, quality of life, and function in chronic intractable leg pain were substantially improved with 10kHz spinal cord stimulation in a multicentre European study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025Observational
- Extreme pulse dosing of 10 kHz spinal cord stimulation: how low can you go?Frontiers in pain research (Lausanne, Switzerland) · 2025Article
- An Evidence-Based Consensus for the Use of Neurostimulation for the Treatment of Non-Surgical Low Back Pain: The NEURON Group.Journal of pain research · 2025Review
- Motor improvement and spasms recovery with high-frequency 10 kHz spinal cord stimulation in a patient with spastic tetraparesis: beyond pain relief.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- Spinal Cord Stimulation for Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2024Review
- Article
- Model-based analysis of subthreshold mechanisms of spinal cord stimulation for pain.Journal of neural engineering · 2023Article
- Measures of sleep disturbance are not routinely captured in trials for chronic low back pain: a systematic scoping review of 282 trials.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023Article
- Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2023Review
- Inactivation of spinal cord stimulator implanted pulse generators after elective surgery: an under-recognized problem.Spinal cord series and cases · 2023Article
- Problems With O'Connell et al, "Implanted Spinal Neuromodulation Interventions for Chronic Pain in Adults" (Cochrane Review).Neuromodulation : journal of the International Neuromodulation Society · 2023Article
- Dorsal root ganglion stimulation for treatment of chronic postsurgical pain secondary to triple neurectomy.Interventional pain medicine · 2023Article
- Research hotspots and trends on spinal cord stimulation for pain treatment: a two-decade bibliometric analysis.Frontiers in neuroscience · 2023Article
- The Area Deprivation Index Corresponds Effectively With Other Measures of Objective Socioeconomic Status in Adults With Chronic Low Back Pain.Journal of nursing measurement · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeChronic axial low-back pain is a debilitating disorder that impacts all aspects of an afflicted individual's life. Effective, durable treatments have historically been elusive. Interventional therapies, such as spinal cord stimulation (SCS), have shown limited efficacy at best. Recently, a novel treatment, 10 kHz SCS, has demonstrated superior pain relief compared with traditional SCS in a randomized controlled trial (RCT). In this manuscript, we report on the long-term improvements in quality of life (QoL) outcomes for subjects enrolled in this study.
methodsA prospective, multicenter, randomized controlled trial (SENZA-RCT) was conducted. Patients with both chronic back and leg pain were enrolled and randomized (1:1) into 10 kHz SCS or traditional SCS treatment groups. A total of 171 subjects received a permanent SCS device implant. QoL and functionality measures were collected up to 12 months. The device remote control utilization, which is an indication of patient interaction with the device for adjustments, was collected at 24-month post-implantation.
resultsAt 12 months, a higher proportion of 10 kHz SCS subjects had marked improvement of their disability (Oswestry Disability Index) to a "moderate" or "minimal" impact on their daily function versus the control group. The subjects also reported better improvement in the Global Assessment of Functioning, Clinician Global Impression of Change, Pittsburgh Sleep Quality Index, and short-form McGill Pain Questionnaire, compared to traditional SCS subjects. The 10 kHz SCS subjects also reported far higher rates of both driving and sleeping with their device turned on, as well as reduced reliance on their programmers to adjust therapy settings.
conclusionsIn addition to superior pain relief, 10 kHz SCS provides long-term improvements in quality of life and functionality for subjects with chronic low-back and leg pain.
trial registrationClinicalTrials.gov (NCT01609972).
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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.