Stimwave has announced initiation of a multicentre, randomised, double-blind, placebo-controlled clinical study of its wireless high frequency stimulator for the treatment of chronic, non-specific origin low back pain, the “Tsunami” study.
The study will compare a sham device to stimulation of spinal nerves at settings that are not perceived by the patient, thus allowing for a blinded patient experience. The study un-blinds the patients after 90 days, after which time the sham group devices are enabled to allow the sham participants to benefit from the therapy long-term. Overall pain scores utilising visual analogue score measurements are the primary endpoints. Quality of life, patients global impression of change and reduction in the use of opioids are the secondary endpoints.
Stimwave hopes 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, eliminating the need for more complicated surgical intervention and reducing the risks of infection and adverse events associated with implantable pulse generators. The device delivers “tonic” stimulation pulses, where the sensory and motor nerves react to the stimulation energy, producing a perceived tingling feeling. Optionally, the Stimwave platform includes the ability to programme various settings of pulse waveforms and high frequencies that eliminate the perception feeling, enabling, for the first time in pain management, the ability to perform a placebo randomised controlled-trial.
“The medical community at large has long awaited the ability to conduct placebo controlled trial 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,” says Adnan Al-Kaisy, director of the Pain Management and Neuromodulation Centre at Guy’s and St. Thomas’ Hospital NHS Trust, London, UK, and principal investigator of the trial.
The study will enrol a minimum of 45 patients throughout 2015 in centres throughout the UK, Netherlands, Switzerland and Belgium.