Pain, quality of life, and function in chronic intractable leg pain were substantially improved with 10kHz spinal cord stimulation in a multicentre European study.

Abstract

Purpose: This prospective, single-arm, multicentre study evaluated the effectiveness of 10 kHz spinal cord stimulation (SCS) in relieving pain and improving function and quality of life in patients with chronic intractable leg pain in routine clinical practice.

Methods: Patients with leg pain refractory to conservative therapy and scoring ≥ 5 cm on a 10-cm visual analog scale (VAS) were enrolled at 12 centres. Those who achieved ≥ 50% leg pain relief during a temporary trial underwent permanent implantation and were followed for 12 months. Outcomes collected included the proportion of patients who achieved ≥ 50% reduction in leg pain VAS score, health-related quality-of-life (EQ-5D-5 L, functional disability [ODI]), opioid use, sleep quality (PSQ-3), global impression of change (GIC), and patient satisfaction.

Results: Of 121 patients trialed, 118 completed the trial and 95 proceeded to implant. At 3 months, 61/95 (64.2%) of all implanted patients were responders to therapy (≥ 50% VAS reduction), which remained stable at 64.2% through 12 months. EQ-5D-5 L, ODI, and PSQ-3 showed clinically important and sustained improvement over 12 months (repeated measures ANOVA, p < 0.001). Patients also reduced opioid dosage on average (p = 0.022). The safety profile was consistent with previous reports using 10 kHz SCS.

Conclusion: This study supports 10 kHz SCS as an effective and safe therapeutic option to reduce pain and disability while improving health-related quality of life in patients with chronic intractable leg pain. 10 kHz SCS appears to be effective in significantly improving the severe disability and poor quality of life experienced by patients with chronic intractable leg pain.

Study registered: ISRCTN Registry - ISRCTN11180496.