Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial

  • Sam Eldabe (Creator)
  • Ashish P. Gulve (Creator)
  • Simon Thomson (Creator)
  • Ganesan Baranidharan (Creator)
  • Rui V. Duarte (Creator)
  • Susan Jowett (Creator)
  • Harbinder Sandhu (Creator)
  • Raymond Chadwick (Contributor)
  • Morag E. Brookes (Creator)
  • Anisah Tariq (Creator)
  • Jenny Earle (Creator)
  • Jill Bell (Creator)
  • Anu Kansal (Creator)
  • Shelley Rhodes (Creator)
  • Rod Taylor (Creator)



Abstract Background The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. Methods/design The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital); Basildon and Thurrock University Hospitals NHS Foundation Trust; and Leeds Teaching Hospitals NHS Trust. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. Allocation will be stratified by centre and minimised on patient age (≥ 65 or 
Date made available16 Nov 2018

Cite this