Medtronic initiates landmark study of neurostimulation therapy for failed back surgery syndrome


Medtronic has announced the start of PROMISE, a prospective, randomised study of multicolumn implantable lead stimulation for predominant low back pain.

According to a company release, this is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5 multicolumn surgical leads plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.

“Chronic pain is a clinically challenging and often debilitating condition for which oral medications may provide insufficient relief,” said Bart Edmiston, principal investigator for the PROMISE study at The Neuroscience Center in Ocean Springs, Mississippi, USA, which enrolled the study’s first patient on 8 January. “The PROMISE study will add to the growing body of evidence supporting Medtronic neurostimulation therapy, a well-established therapeutic approach, for the patients worldwide who continue to experience low back pain following back surgery.”

PROMISE is a prospective, randomised, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from predominant chronic low back pain due to FBSS at 30 centres in the USA, Canada and Europe (Belgium, France, Germany, Spain, The Netherlands and the UK). It is the first large-scale, randomised, controlled clinical trial designed to assess the value of SCS for predominant low back pain with leg pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.

“Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study,” said Philippe Rigoard, the study’s global principal investigator, who started enrolling patients on 14 January at Poitiers University Hospital in Poitiers, France. “If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS.”

PROMISE participants will be randomised 1:1 to receive treatment with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50% reduction in low back-pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group. Health care utilisation data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS.