Spinal cord stimulation promising therapy for managing diabetic neuropathy pain;JAMA

Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. Nonpharmacological PDN treatment with spinal cord stimulation (SCS) devices was first reported in 1996. Observational data suggest high-frequency (10-kHz) SCS provides substantial pain relief for patients with PDN without generating paresthesias required for other types of SCS. Previous results support 10-kHz SCS as a superior treatment compared with low-frequency SCS for chronic low back and leg pain and effective for nonsurgical low back pain, upper limb and axial neck pain, and neuropathic limb pain while reducing opioid dosages.

Researchers undertook the current study 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 analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (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. At 6-month follow-up, 187 patients were evaluated.

The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months.

Data analysis revealed some important facts.

• Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively.
• The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001).
• Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months.
• For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months.
• Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).

"The Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain (SENZA-PDN) RCT²⁹ extends observations from low-frequency SCS studies in, to our knowledge, the largest RCT to date to test the hypothesis that 10-kHz SCS combined with conventional medical management (CMM) provides meaningful pain relief compared with CMM alone for patients with refractory PDN. Evidence-based treatment guidelines should contemplate positioning of 10-kHz SCS in the continuum of care. Follow-up of this study population will continue for 24 months and establish potential durability of this treatment beyond 6 months. Patients experienced substantial, sustained pain relief as well as clinically assessed improvements in neurological function and improved health-related quality of life. In practice, patients with PDN with inadequate response to conventional treatments should be considered for 10-kHz SCS."the team concluded.

For full article follow the link: doi:10.1001/jamaneurol.2021.0538

Primary source: JAMA