Trial reportPain practice : the official journal of World Institute of Pain2025
Paddle leads for the treatment of nonsurgical back pain-The DISTINCT study.
Trial report in Pain practice : the official journal of World Institute of Pain, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The trial behind it
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Who cites it
2 citing papers in PubMed.
- Paddle leads for the treatment of nonsurgical back pain-The DISTINCT study.Pain practice : the official journal of World Institute of Pain · 2025Trial
- Passive recharge burst spinal cord stimulation for the treatment of refractory nonsurgical low back pain: 24-month results from a prospective randomized controlled trial and predictors of success.North American Spine Society journal · 2026Article
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Authors and funding
23 authors.
Funding
Abstract
introductionDISTINCT is a randomized controlled trial evaluating passive recharge burst SCS compared with CMM in improving pain and pain-related physical function in patients suffering from chronic back pain without prior lumbar surgery, and for whom corrective surgery is not an option. Sub-analyses of outcome measures are presented for a subset implanted with paddle leads at both 6 and 12 months.
objectiveTo investigate the treatment effect of using BurstDR-capable SCS in nonsurgical low back pain (NSLBP) patients with paddle leads.
methodsAn independent board-certified spine surgeon reviewed each case, confirming a lack of corrective surgical options. Out of 29 sites and 115 implants, 10 sites implanted 50 patients with paddle leads. Primary and secondary endpoints assessed improvements in low back pain intensity (NRS), low back pain-related disability (ODI), pain catastrophizing (PCS), and patient global impression of change (PGIC).
resultsData for patients with NSLBP and implanted with paddle leads are available for 47 and 44 patients at 6 and 12 months, respectively. Patients reported significant reductions in pain relief at 6 and 12 months, decreasing from 7.8 ± 1.2 at baseline to 2.0 ± 1.6 and 2.2 ± 2.2, respectively (p < 0.0001). Disability was substantially reduced (> 20 points) from severe to mild at 6 and 12 months; ODI reduced from 54.4 ± 15.0 at baseline to 19.9 ± 14.1 and 22.1 ± 13.6, respectively (p < 0.0001). Pain catastrophizing improved to reflect the average of a non-chronic pain population; decreased from 27.6 ± 13.1 at baseline to 8.1 ± 8.2 and 7.8 ± 9.9 (p < 0.0001). 93.2% of patients reported a moderately better-much-improved outcome on PGIC. Ten complications occurred in 9 patients, 3 being severe device-related events. Two explants were required; one due to infection and one due to persistent pain at the IPG site, and one lead-related event was resolved by surgical repositioning.
conclusionsPassive recharge burst using paddle leads provides substantial relief to patients suffering from severe, debilitating, NSLBP. Patients report significant improvements in pain, function, and pain-related emotional distress. In addition, the rate of adverse events is low, supporting a favorable safety profile.
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