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

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.

To investigate the treatment effect of using BurstDR-capable SCS in nonsurgical low back pain (NSLBP) patients with paddle leads.

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).

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.

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.