Effect of High-frequency Spinal Cord Stimulation in Patients
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The JAMA Neurology study suggests that patients with painful diabetic neuropathy with inadequate pain relief despite best available medical treatments should be considered for 10-kHz spinal cord stimulation.

The study was conducted to determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).

The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analog scale (VAS), body mass index of 45 or less, HbA1c of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At a 6-month follow-up, 187 patients were evaluated.

Of 216 randomized patients, 136 were male, and the mean (SD) age was 60.8 years. Additionally, the median duration of diabetes and peripheral neuropathies were 10.9 years and 5.6 years, respectively.

--The primary endpoint assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group and 75 of 95 patients in the 10-kHz SCS plus CMM group.

--Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group.

--For the CMM group, the mean pain VAS score was 7.0 cm at baseline and 6.9 cm at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm at baseline and 1.7 cm at 6 months.

--Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group and 52 of 84 in the 10-kHz SCS plus CMM group at 6 months.

In particular, substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN.

Source: https://jamanetwork.com/journals/jamaneurology/fullarticle/2777806
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