[December 12, 2014] |
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Stimwave Announces Initiation of a Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Wireless High Frequency Stimulation for the Treatment of Chronic Non-Specific Low Back Pain
Stimwave Technologies Incorporated, a privately held medical device
manufacturer and research institute, today announced initiation of a
multi-center, randomized, double-blind, placebo-controlled clinical
study of its wireless high frequency stimulator for the treatment of
chronic, non-specific origin low back pain, the "TsunamiTM"
study.
The study is designed to compare a sham device to stimulation of spinal
nerves at settings that are not perceived by the patient, thus allowing
for a true, 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 utilizing visual analog score VAS measurements are
the primary endpoints. Quality of Life (QoL), Patients Global Impression
of Change (PGIC) and reduction in the use of opioids are the secondary
endpoints.
"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 truly blinded in order to finally enable accurate
measurement of the effetiveness of the therapy," said Stimwave Chairman
and Chief Executive Officer Laura Tyler Perryman. It is the hope that
the outcome of the study will provide proper evidence-based research to
encourage utilization 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 classically delivers what are
called "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 program
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 RCT.
"The medical community at large has long awaited the ability to conduct
placebo controlled 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," said Dr. 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 enroll a minimum of 45 patients throughout 2015 in
centers throughout United Kingdom, The Netherlands, Switzerland and
Belgium.
About Stimwave
Stimwave Technologies Incorporated is a privately held medical device
company engaged in the development, manufacture, and commercialization
of wirelessly powered, injectable, microtechnology neurostimulators,
providing patients with a convenient, safe, minimally invasive, and
highly cost-effective pain management solution that is easily
incorporated into their daily lives. Stimwave's goal is to evolve its
patented, cutting-edge platform into the default for neuromodulation,
increasing the accessibility for patients worldwide while lowering the
economic impact of pain management.
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