SynthesisNeuromodulation : journal of the International Neuromodulation Society2020
Randomized Placebo-/Sham-Controlled Trials of Spinal Cord Stimulation: A Systematic Review and Methodological Appraisal.
Synthesis 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. Cited by 25 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease.Journal of Parkinson's disease · 2023Pooled it
- Auricular Vagus Neuromodulation-A Systematic Review on Quality of Evidence and Clinical Effects.Frontiers in neuroscience · 2021Pooled it
- ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial.Regional anesthesia and pain medicine · 2024Trial
- Trial
- Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study).Medicina (Kaunas, Lithuania) · 2021Trial
- Contemporary and Emerging Therapies in the Management of Refractory Angina: A Clinical Review.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Review
- Electromagnetic neuromodulation for chronic pain: historical context, contemporary modalities, and evidence gaps.Frontiers in pain research (Lausanne, Switzerland) · 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
- 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
- Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension.EClinicalMedicine · 2024Review
- Reporting guidelines for protocols of randomised controlled trials of implantable neurostimulation devices: the SPIRIT-iNeurostim extension.EClinicalMedicine · 2024Review
- Transcutaneous spinal cord stimulation neuromodulates pre- and postsynaptic inhibition in the control of spinal spasticity.Cell reports. Medicine · 2024Article
- Sham controls in device trials for chronic pain - tricky in practice-a review article.Contemporary clinical trials communications · 2023Review
- Trial or not trial in the practice of spinal cord stimulation. That's the question.Interventional pain medicine · 2023Article
- Spinal cord stimulation for refractory pericarditis: a case report and a review of the mechanism of action.Frontiers in pain research (Lausanne, Switzerland) · 2023Article
- Spinal Cord Stimulation in Chronic Low Back Pain Syndrome: Mechanisms of Modulation, Technical Features and Clinical Application.Healthcare (Basel, Switzerland) · 2022Review
- The Added Value of Intraoperative Hypnosis during Spinal Cord Stimulation Lead Implantation under Awake Anesthesia in Patients Presenting with Refractory Chronic Pain.Medicina (Kaunas, Lithuania) · 2022Article
- The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study.Journal of clinical medicine · 2022Article
- Association of Spinal Cord Stimulator Implantation With Persistent Opioid Use in Patients With Postlaminectomy Syndrome.JAMA network open · 2022Article
- Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model - A Narrative Review.Journal of pain research · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe recent availability of paraesthesia/sensation free spinal cord stimulation (SCS) modalities allow the design of clinical trials of SCS using placebo/sham controls and blinding of patients, clinicians, and researchers. The aims of this study were to: 1) systematically review the current evidence base of randomized controlled trials (RCTs) of SCS placebo/sham trials and 2) to undertake a methodological critique of their methods. Based on this critique, we developed a checklist for the design and reporting of future RCTs of SCS. MATERIALS AND
methodsElectronic data bases were searched from inception until January 2019 for RCTs of SCS using a placebo/sham control. RCTs with only an active comparator arm were excluded. The results are presented as a narrative synthesis.
resultsSearches identified 12 eligible RCTs. SCS modalities included paraesthesia stimulation, subthreshold, burst, and high-frequency SCS and were mainly conducted in patients with failed back surgery syndrome, complex regional pain syndrome, and refractory angina. The quality and transparency of reporting of the methods of placebo stimulation, blinding of patients, clinicians, and researchers varied markedly across studies.
conclusionsTo date the methods of placebo/sham control and blinding in RCTs have been poorly reported, leading to concerns about the validity and replicability of the findings. Important aspects that need to be clearly reported in the design of placebo-/sham-controlled RCTs of SCS include the transparent reporting of stimulation programming parameters, patient position during perception threshold measurement, management of the patient handheld programmer, frequency of recharging, and assessment of the fidelity of blinding.
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.