Trial reportPain2021
An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.
Trial report in Pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02577354 (ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain), which is not on this map. Cited by 41 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.
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
Who cites it
41 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- The Implementation of Persistent Spinal Pain Syndrome (PSPS): Mechanism-Based Recommendations.Pain practice : the official journal of World Institute of Pain · 2026Guideline
- Peripheral Nerve Stimulation for Low Back Pain: A Systematic Review.Current pain and headache reports · 2023Pooled it
- Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial.Neuromodulation : journal of the International Neuromodulation Society · 2023Trial
- Restorative neurostimulation of the lumbar multifidus muscles improves mobility, strength, pain and disability in patients with mechanical chronic low back pain.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 · 2026Article
- Real-world two-year durability of restorative neurostimulation for treatment of multifidus dysfunction in patients with chronic low back pain: an observational German cohort 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 · 2026Observational
- Paraspinal Muscle Fatty Infiltration as a Predictor of Intervertebral Disc Degeneration and Pain Severity in Chronic Low Back Pain.Pain research & management · 2026Article
- The effect of baseline spinal magnetic resonance imaging features on restorative neurostimulation efficacy in patients with chronic low back pain.Journal of spine surgery (Hong Kong) · 2025Article
- ISASS Recommendations and Coverage Criteria for Restorative Neurostimulation for Multifidus Dysfunction, Lumbar Region: Coverage Indications, Limitations, and/or Medical Necessity-An ISASS 2025 Guideline Update.International journal of spine surgery · 2025Article
- Multifidus Dysfunction and Chronic Low Back Pain: Systematic Review and Meta-analysis of the Supporting Data for Accurate Diagnosis and Successful Treatment Outcomes Associated With Restorative Neurostimulation.International journal of spine surgery · 2025Article
- Peripheral Nerve Stimulation for Low Back Pain: A Review of the Recent Literature.Current pain and headache reports · 2025Review
- Evidence of Multifidus Changes Post-Lumbar Radiofrequency Ablation: A Narrative Literature Review.Journal of clinical medicine · 2025Review
- Review of Guidelines for Implantable Peripheral Nerve Stimulation (PNS) in the Management of Chronic Pain.Current pain and headache reports · 2025Review
- ISSLS Prize in Basic Science 2025: Structural changes of muscle spindles in the multifidus muscle after intervertebral disk injury are resolved by targeted activation of the muscle.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 · 2025Article
- Application of restorative neurostimulation for chronic mechanical low back pain in an older population with 2-year follow up.Regional anesthesia and pain medicine · 2025Article
- Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction.Pain and therapy · 2025Article
- An Algorithmic Overview of Advanced Pain Therapies: A Narrative Review.Current pain and headache reports · 2025Review
- Consensus Guidelines for the Use of Peripheral Nerve Stimulation in the Treatment of Chronic Pain and Neurological Diseases: A Neuron Project from the American Society of Pain and Neuroscience.Journal of pain research · 2025Article
- A Call for Reckoning and Reform in Interventional Pain Medicine and Neuromodulation Research.Journal of pain research · 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
- Novel multimodal mechanical stimulation is superior to TENS to treat and prevent chronic low back pain: a randomized controlled trial.Frontiers in pain research (Lausanne, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
34 authors at 20 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
abstractChronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.
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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.