The CRISP study is looking at patients with chronic back pain. They were implanted with two leads; one using paraesthesia mapping (PM) and the other using the anatomic midline-based (AM) procedure. Stimulation contacts were programmed using the standard mapping procedure for the PM lead, and contacts overlapping the T9-T10 junction were utilised for the AM lead. During the trial patients evaluated the AM and PM leads in a random order.
The need for intraoperative mapping in paraesthesia free spinal cord stimulation (SCS) is unknown. In this study, the therapeutic efficacy of BurstDR SCS delivered using leads implanted with the conventional paraesthesia mapping approach to leads implanted with the anatomic midline-based approach was compared. The result were presented by Adnan Al-Kaisy, Guy’s & St. Thomas’ NHS Foundation Trust, London, United Kingdom at the World Congress of the World Institute of Pain (WIP; 9–12 May 2018, Dublin, Ireland).
Twenty-eight patients (mean age = 50.8±10.2 years) successfully completed the trial so far (total 33 planned enrolments = 60). Pain relief at trial was 67% in the AM and 64% in the PM arms (p<0.0001) with no significant differences between the two approaches (p=0.69). Pain relief at three months was sustained at 63% for the AM and 68% for the PM. Quality of life was significantly improved and disability reduced with both AM and PM leads (p<0.0001) with no difference between the two approaches (p=0.32 and p=0.64 respectively). At the end of the trial preference between leads was divided evenly between AM (13) and PM (15) leads.
Preliminary results of the CRISP study suggest that intraoperative paraesthesia mapping may not be required for BurstDR trials, and anatomical midline-based placements have the potential to provide similar clinical outcomes.