ArticleNeuromodulation : journal of the International Neuromodulation Society2021
Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain.
Article in Neuromodulation : journal of the International Neuromodulation Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- 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
- 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
- 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 for Patients with Mechanical Chronic Low Back Pain and Impaired Neuromuscular Control of the Lumbar Spine | A New Treatment Paradigm.Journal of pain research · 2025Review
- Correlating Evoked Electromyography and Anatomic Factors During Spinal Cord Stimulation Implantation With Short-Term Outcomes.Neuromodulation : journal of the International Neuromodulation Society · 2024Article
- Psychophysiological biomarkers to assess the effectiveness of surface electromyography biofeedback as an alternative therapy to reduce chronic low back pain: protocol for a randomised controlled trial.BMJ open sport & exercise medicine · 2024Article
- Article
- Multifidus dysfunction and restorative neurostimulation: a scoping review.Pain medicine (Malden, Mass.) · 2023Article
- International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability.International journal of spine surgery · 2023Article
- ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol).Pain and therapy · 2023Article
- Article
- Restorative Neurostimulation: A Clinical Guide for Therapy Adoption.Journal of pain research · 2022Review
- Non-Spinal Neuromodulation of the Lumbar Medial Branch Nerve for Chronic Axial Low Back Pain: A Narrative Review.Frontiers in pain research (Lausanne, Switzerland) · 2022Review
- The Added Value of Subcutaneous Peripheral Nerve Field Stimulation Combined with SCS, as Salvage Therapy, for Refractory Low Back Pain Component in Persistent Spinal Pain Syndrome Implanted Patients: A Randomized Controlled Study (CUMPNS Study) Based on 3D-Mapping Composite Pain Assessment.Journal of clinical medicine · 2021Article
Corrections and comments
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Authors and funding
15 authors at 7 institutions in 4 countries.
Funding
Abstract
objectivesThe purpose of the ongoing follow-up of ReActiv8-A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four-year outcomes of this trial. MATERIALS AND
methodsReActiv8-A is a prospective, single-arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30-min stimulation-sessions twice daily. Annual follow-up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ-5D). Background on mechanisms, trial design, and one-year outcomes were previously described.
resultsAt baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ-5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. Patients completing year 4 follow-up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ-5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment.
conclusionsIn participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality-of-life are clinically meaningful and durable through four years.
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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.