Boston Scientific has started patient enrollment in the Evidence clinical trial, which compares the therapeutic effectiveness and cost effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome (FBSS).
The Evidence trial is a randomized, controlled trial enrolling 132 patients at 20 sites worldwide. Patients in the SCS arm of the trial will receive the Boston Scientific Precision Plus Spinal Cord Stimulator System.
Boston said that 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 Precision Plus Spinal Cord Stimulator System delivers electrical signals that travel along nerve fibers through the spinal cord to the brain. The System masks pain signals by delivering doses of electricity to change pain signals into signals that the brain interprets as a pleasant sensation called paresthesia.
Boston Scientific said that the System is indicated for use as an aid in the management of chronic pain in the trunk and/or limbs, including unilateral or bilateral pain associated with FBSS and intractable lower back and leg pain.
Michael Onuscheck, senior vice president and president of neuromodulation division at Boston Scientific, said: “The Evidence trial is the first multi-center, randomized, controlled trial to include rechargeable SCS devices like the Precision Plus System. We are pleased to sponsor this groundbreaking trial, which will help physicians better understand the treatment options available to patients with FBSS.”
Richard North, neurosurgeon at The Sandra and Malcolm Berman Brain and Spine Institute in Baltimore, and principal investigator of the trial, said: “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. Following the positive, single-center trial we conducted at Johns Hopkins, the Evidence multi-center trial will provide important data on the comparative effectiveness of SCS versus surgical spine reoperation in the management of chronic pain in FBSS patients.”
Boston Scientific is a developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.