Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial

Research output: Contribution to journalArticlepeer-review


  • Sam Eldabe
  • Rui V Duarte
  • Ashish Gulve
  • Simon Thomson
  • Ganesan Baranidharan
  • Rachel Houten
  • Harbinder Sandhu
  • Raymond Chadwick
  • Morag Brookes
  • Anu Kansal
  • Jenny Earle
  • Jill Bell
  • Jennifer Robinson
  • Sarah Walker
  • Shelley Rhodes
  • Rod Taylor

Colleges, School and Institutes


Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at three centres in United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at six-months follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51). Mean NRS pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6-months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% CI: -1.2 to 0.9, p=0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25). The mean incremental cost-effectiveness ratio of TG versus NTG was £78,895 per additional quality-adjusted life-year (QALY) gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening trial strategy provides superior patient outcomes or is cost-effective compared to a no trial screening approach.


Original languageEnglish
Pages (from-to)2820-2829
Number of pages10
Issue number12
Early online date29 Jun 2020
Publication statusPublished - Dec 2020


  • randomised controlled trial, screening trial, spinal cord stimulation, neuropathic pain, cost-effectiveness