Trial reportPain2019
Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.
Trial report in Pain, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01697358 (Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain), which is not on this map. Cited by 60 papers, 8 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.
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Who cites it
60 citing papers in PubMed, 8 syntheses or guidelines pooled it, 144 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
- Does rehabilitation improve work participation in patients with chronic spinal pain after spinal surgery: a systematic review.Journal of rehabilitation medicine · 2025Pooled it
- The effectiveness of spinal cord stimulation combined with physiotherapy in the management of chronic pain in adults: a systematic review.Frontiers in pain research (Lausanne, Switzerland) · 2025Pooled it
- Spinal Cord Stimulation vs Medical Management for Chronic Back and Leg Pain: A Systematic Review and Network Meta-Analysis.JAMA network open · 2024Pooled it
- Comparison of clinical outcomes associated with spinal cord stimulation (SCS) or conventional medical management (CMM) for chronic pain: a systematic review and meta-analysis.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 · 2023Pooled it
- Spinal Cord Stimulation Meets Them All: An Effective Treatment for Different Pain Conditions. Our Experience and Literature Review.Acta neurochirurgica. Supplement · 2023Pooled it
- Pooled it
- Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021Pooled it
- 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
- Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.Pain practice : the official journal of World Institute of Pain · 2021Trial
- Postoperative Infections Associated With Prolonged Spinal Cord Stimulation Trial Duration (PROMISE RCT).Neuromodulation : journal of the International Neuromodulation Society · 2020Trial
- Structural and Functional Treatment of Persistent Spinal Pain Syndrome Type 2: A Fibrosis-Stratified Network Meta-Analysis of Epidural Adhesiolysis and Neuromodulation.Journal of clinical medicine · 2026Review
- The Spinal Cord Stimulation Trial Success Score (STSS): A Narrative Review and Evidence-Informed Conceptual Framework for Structured Candidate Assessment.Journal of clinical medicine · 2026Review
- Differential target multiplexed SCS (DTM SCS): a rational hypothesis.Pain medicine (Malden, Mass.) · 2026Review
- Spinal Cord Stimulation Alleviates Neuropathic Pain Involves Regulation of the CaCellular and molecular neurobiology · 2026Article
- 2024 Japan Society for Stereotactic and Functional Neurosurgery Guidelines for Stereotactic and Functional Neurosurgery.Neurologia medico-chirurgica · 2026Article
- Functional Recovery Following Spinal Cord Stimulation in a Patient Utilizing Prospera Spinal Cord Stimulation System with Multiphase Stimulation.Orthopedic reviews · 2026Article
- A systematic review of evidence comparing spinal cord stimulation to sham or conservative medical management in the treatment of persistent spinal pain syndrome - Type 2.Interventional pain medicine · 2025Review
- Multifidus Fat Infiltration in Patients with Persistent Spinal Pain Syndrome Type II Treated with Spinal Cord Stimulation: A Preliminary Report.Journal of clinical medicine · 2025Article
- Treatment modalities for patients with Persistent Spinal Pain Syndrome Type II: A systematic review and network meta-analysis.Communications medicine · 2025Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.
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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.