Trial reportNeuromodulation : journal of the International Neuromodulation Society2020
Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT).
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. Cited by 28 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
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.
- Spinal Cord Stimulation for Low Back Pain: A Systematic Review.Current pain and headache reports · 2025Pooled it
- Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021Pooled it
- To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.Neuromodulation : journal of the International Neuromodulation Society · 2021Trial
- Spinal Epidural Abscess During a Spinal Cord Stimulation Trial in Complete Spinal Cord Injury: A Case Report.A&A practice · 2026Article
- Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial to 12 months.Pain and therapy · 2026Article
- All-in-one spinal cord stimulation and its economic impact.Health economics review · 2026Article
- Closed-Loop Spinal Cord Stimulation in Chronic Pain Management: Mechanisms, Clinical Evidence, and Emerging Perspectives.Biomedicines · 2025Review
- 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
- Participant Perspectives on an Invasive Spinal Neuromodulation Study for Functional Sensorimotor and Autonomic Restoration in Chronic Thoracic Spinal Cord Injury: A Qualitative Case Series.Topics in spinal cord injury rehabilitation · 2025Article
- Preventing technique-related complications in spinal cord stimulation trials: The Dural Substitute Confetti technique. A retrospective monocentric analysis.Pain practice : the official journal of World Institute of Pain · 2025Article
- Spinal Cord Stimulation for Spinal Cord Injury-Related Pain: A Pilot Study.Brain sciences · 2024Article
- Epidural spread of surgical site infection from spinal cord stimulation trial.Pain management · 2024Article
- Cervical Spinal Cord Stimulation: A Review.Current pain and headache reports · 2024Review
- Optimizing Healthcare Expenditure for Spinal Cord Stimulation in Italy: The Value of Battery Longevity Improvement and a Direct-to-Implant Approach.Journal of health economics and outcomes research · 2024Article
- A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain.Pain management · 2024Review
- Large-scale real-world data on a multidisciplinary approach to spinal cord stimulation for persistent spinal pain syndromes: first evaluation of the Neuro-PainFrontiers in neuroscience · 2024Article
- Trial or not trial in the practice of spinal cord stimulation. That's the question.Interventional pain medicine · 2023Article
- Real-world outcomes of single-stage spinal cord stimulation in chronic pain patients: A multicentre, European case series.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
- Spinal cord stimulation for low back pain.The Cochrane database of systematic reviews · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 4 countries.
Funding
Abstract
introductionIn the PROMISE study, a multinational randomized controlled trial (RCT) of the effectiveness of spinal cord stimulation (SCS) with multicolumn surgical leads as a treatment of low back pain, clinicians followed their usual practice. An early, unplanned safety analysis revealed that the infection rate in Belgium (5/23), where trial duration was a median 21.5 days, was significantly higher than the 1/64 rate observed in the other study countries (median 5.8 days, p < 0.01). This report reviews infections observed in the PROMISE study after study completion. MATERIALS AND
methodsFor all infections related to SCS, we used descriptive statistics and tests of independent variables to analyze potentially contributing factors (age, sex, coexisting medical conditions, tobacco use, lead type, and trial duration) between subjects with infections versus those without. Cumulative incidence curves were created using the Kaplan-Meier method and compared between the two strata using a log-rank test.
resultsAmong nine (5.2%) infections in 174 subjects trialed, the only significant contributing factor to infection was trial duration: median 21 days (range 3-56) for those with infection vs. six days (1-41) for those without (p = 0.001; Wilcoxon rank-sum test). The cumulative incidence of infection for subjects trialed >10 days was 24.1% vs. 1.4% for subjects trialed ≤10 days (p < 0.001). After the protocol was amended to limit trial duration to 10 days, 14 infection-free trials were performed in Belgium.
conclusionsAlthough not part of the preplanned analysis, our observation supports the hypothesis of a cause-effect relationship between trial duration and the risk of infection and the conclusion that prolonged SCS trials should be avoided.
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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.