Low Back Pain Clinical Trial
Official title:
The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive motion home-use device in relieving low back pain, improving proprioception (balance and fall prevention) and improving the symmetry of muscle function on either side of the spine.
The Kyrobak is an electrically operated, continuous passive motion device including a
platform that performs angular oscillations. The Kyrobak is used at home as an aid to
relieve mild-to-moderate low back pain.
The study is designed to evaluate the efficacy of daily home use of the Kyrobak for 3 weeks
and to assess the sustained efficacy 1 week later.
The evaluation will include the level of pain using the numerical rating scale (NRS),
Digital Posturography, Heart Rate Variability (HRV), Static Surface Electromyography (SEMG),
a condition-specific low back pain disability status by the Oswestry Disability Index (ODI)
and subject satisfaction.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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