EVIDENCE is a randomised, controlled trial enrolling 132 patients at 20 sites worldwide. Patients in the stimulation arm of the trial will receive the Boston Scientific Precision Plus spinal cord stimulator system.
The trial will examine treatment response rates (leg pain relief with no request for the alternative therapy) at six and 24 months. Successful patient response is defined as having greater than or equal to 50% relief of pain in the lower extremities compared to pain levels prior to the intervention.
"The standard approach to patients who continue to have persistent back and leg pain after lumbosacral spine surgery has been to look for another surgical treatment," said Richard B North, neurosurgeon at The Sandra and Malcolm Berman Brain and Spine Institute in Baltimore, and Principal Investigator of the trial.
"Following the positive, single centre trial we conducted at Johns Hopkins, the EVIDENCE multicentre trial will provide important data on the comparative effectiveness of stimulation vs.csurgical spine re-operation in the management of chronic pain in patients."
"Ultimately, this study may provide support to shift stimulation earlier in the treatment paradigm for patients who suffer chronic pain resulting fromfailed back surgery," said Kumar."EVIDENCE may also demonstrate the cost-effectiveness of stimulation compared to re-operation."
"The EVIDENCE trial is the first multicentre, randomised, controlled trial to include rechargeable stimulation devices like the Precision Plus System," said Michael Onuscheck, senior vice president and president of Boston Scientific’s Neuromodulation Division. "We are pleased to sponsor this groundbreaking trial, which will help physicians better understand the treatment options available to patients with failed back surgery syndrome."
