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Paddle leads for the treatment of nonsurgical back pain—The DISTINCT study.

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Title: Paddle leads for the treatment of nonsurgical back pain—The DISTINCT study.
Authors: Falowski, Steven, Dorsi, Michael J., Heros, Robert, Sales, Rafe, Tavel, Edward, Lansford, Todd, Weinand, Martin E., Baxi, Nrupen, Garber, Jason, Forage, James, Telfeian, Albert E., Souheil, Haddad, Gilligan, Christopher, Deer, Timothy, Levy, Robert, Jameson, Jessica, Moeschler, Susan, Duncan, Jonathan, Lim, Chi, Desai, Mehul
Source: Pain Practice. Jun2025, Vol. 25 Issue 5, p1-9. 9p.
Subjects: Research funding, Questionnaires, Artificial implants, Treatment effectiveness, Descriptive statistics, Medical device removal, Pain management, Neural stimulation, Pain catastrophizing, Patient satisfaction, Spinal cord, Lumbar pain, Electrodes
Abstract: Introduction: DISTINCT 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. Objective: To investigate the treatment effect of using BurstDR‐capable SCS in nonsurgical low back pain (NSLBP) patients with paddle leads. Methods: An 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). Results: Data 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. Conclusions: Passive 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. [ABSTRACT FROM AUTHOR]
Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Paddle leads for the treatment of nonsurgical back pain—The DISTINCT study.
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  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22Pain+Practice%22&quot;&gt;Pain Practice&lt;/searchLink&gt;. Jun2025, Vol. 25 Issue 5, p1-9. 9p.
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  Data: Introduction: DISTINCT 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. Objective: To investigate the treatment effect of using BurstDR‐capable SCS in nonsurgical low back pain (NSLBP) patients with paddle leads. Methods: An 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). Results: Data 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 &#177; 1.2 at baseline to 2.0 &#177; 1.6 and 2.2 &#177; 2.2, respectively (p &lt; 0.0001). Disability was substantially reduced (&gt; 20 points) from severe to mild at 6 and 12 months; ODI reduced from 54.4 &#177; 15.0 at baseline to 19.9 &#177; 14.1 and 22.1 &#177; 13.6, respectively (p &lt; 0.0001). Pain catastrophizing improved to reflect the average of a non‐chronic pain population; decreased from 27.6 &#177; 13.1 at baseline to 8.1 &#177; 8.2 and 7.8 &#177; 9.9 (p &lt; 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. Conclusions: Passive 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. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=185816366
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        Value: 10.1111/papr.70033
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