Medical device manufacturer Stimwave Technologies has started a multi-centre, randomised, double-blind and placebo-controlled clinical trial of its wireless high frequency stimulator to treat chronic and non-specific origin lower back pain.
The trial, called the Tsunami study will compare a sham device to stimulation of spinal nerves at settings not perceived by the patient, allowing for a genuine, blinded patient experience.
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In 2015, 45 patients will be enrolled in the trial at centres throughout the UK, Netherlands, Switzerland and Belgium.
Stimwave Technologies said the trial unbinds patients after 90 days, after which time the sham group devices are enabled to allow participants to benefit from long-term therapy.
The trial’s primary endpoints are overall pain scores using visual analog score (VAS) measurements, while secondary endpoints include quality of life (QoL), patients global impression of change (PGIC) and reduction in the use of opioids.
Stimwave Technologies chairman Laura Tyler Perryman said: "The unique Stimwave technology platform allows, for the first time, a true scientific study of neuromodulation therapy that can have no observational bias, since all of the products are provided by the same manufacturer.
"It is the hope that the outcome of the study will provide proper evidence-based research to encourage utilisation of electroceutical devices to replace or reduce dependence on pain medications, and bring forth a new era in medicine with potentially fewer side effects than medications."
The Stimwave device is introduced through a needle procedure, reducing the need for complicated surgical intervention, as well as risks of infection and adverse events associated with implantable pulse generators.
Principal investigator of the trial Dr Adnan Al-Kaisy said: "The medical community at large has long awaited the ability to conduct placebo controlled randomised controlled trial (RCT) for the treatment of chronic axial lower back pain patients without prior back surgery.
"This technology platform allows for flexibility in treatment to conduct this research that will benefit the field of neuromodulation immensely."
