A randomised, patient-assessor blinded, sham-controlled trial of external non-invasive peripheral nerve stimulation for chronic neuropathic pain following peripheral nerve injury (EN-PENS trial): study protocol for a randomised controlled trial

This study aims to assess the effectiveness of external non-invasive peripheral nerve stimulation (EN-PENS) for chronic neuropathic pain after peripheral nerve injury. EN-PENS involves placing a pen-shaped electrode on the skin for self-administration and may relieve localized neuropathic pain. The trial will compare EN-PENS treatment against a control treatment in patients with moderate to severe neuropathic pain.

• 1
  The primary outcome is average 24-h pain intensity recorded on an 11-point numerical rating scale, averaged over the last 7 days of treatment.
• 2
  The study will also evaluate the impact of EN-PENS on quality of life and day-to-day function.
• 3
  The results will inform the potential treatment efficacy and cost-effectiveness of EN-PENS for neuropathic pain.