Trial reportPain medicine (Malden, Mass.)2026
Comparison of percutaneous 60-day peripheral nerve stimulation of the lumbar medial branches to usual care with standard interventional management for chronic low back pain-a multicenter pragmatic randomized controlled trial (RESET).
Trial report in Pain medicine (Malden, Mass.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04246281 (A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation), which is not on this map. Cited by 4 papers.
What it found
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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.
A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Who cites it
4 citing papers in PubMed.
- Durable Outcomes and Intervention Avoidance in Low Back Pain Up to 5 Years After Percutaneous 60-Day Peripheral Nerve Stimulation.Pain and therapy · 2026Article
- Sustained relief of chronic headache using percutaneous 60-day peripheral nerve stimulation treatment: 12-month results from a multicenter, prospective clinical study.Interventional pain medicine · 2026Article
- Observations from the RESET clinical trial: A post-hoc per protocol analysis of clinical outcomes with percutaneous 60-day medial branch PNS in chronic low back pain.Interventional pain medicine · 2026Article
- Not who we treat, but how we treat: Emphasizing treatment adherence in neuromodulation outcomes.Interventional pain medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
Abstract
objectiveManagement of refractory chronic low back pain (CLBP) includes a range of treatments (eg, physical therapy, injections, ablations, neurostimulation, surgery) with varying utilization and effectiveness. This pragmatic randomized controlled trial (RCT) evaluated the effectiveness of one treatment option, percutaneous 60-day peripheral nerve stimulation (PNS), compared to usual care with standard interventional management for CLBP.
methodsTwo hundred thirty patients with CLBP were randomized in a 1:1 ratio to Group 1 (percutaneous 60-day PNS) or Group 2 (physician-directed usual care with standard interventional management). The Primary Clinical Endpoint evaluated the proportion of participants with ≥50% reductions in CLBP at 3 months post-treatment compared to baseline.
resultsAt the Primary Endpoint, a greater proportion of participants receiving percutaneous 60-day PNS (55%; n = 112; 95% confidence interval [CI] = 45-65) experienced ≥50% pain relief compared to usual care with standard interventional management (26%; n = 110; 95% CI = 17-34; P < .001). Concordant with the Primary Endpoint, percutaneous 60-day PNS also produced greater improvements in patient-centric secondary endpoints, including disability, pain interference, health-related quality of life, and analgesic consumption. Reductions in pain and resulting improvements in function were sustained through 6 months with percutaneous 60-day PNS.
conclusionsThis prospective multicenter pragmatic RCT met its Primary Clinical Endpoint and found that more participants with CLBP reported pain relief at 3 months after receiving percutaneous 60-day PNS as compared to usual care with standard interventional management. Participants treated with 60-day PNS showed greater reductions in pain and more substantial improvements in functional outcomes through 6 months. CLINICALTRIALS.GOV: NCT04246281; Primary funding: Department of Defense (DoD), with additional funding needed to complete the study provided by the study's sponsor, SPR.The protocol is available on ClinicalTrials.gov. The statistical analysis plan and results will be made available within 12 months of the study's completion.
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