Mild to Moderate Chronic Low Back Pain Clinical Trial
Official title:
The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study
This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive motion device in relieving of mild to moderate non-specific low back pain.
The no!no!Back is an electrically operated, continuous passive motion device including a
platform that performs angular oscillations. The device is intended to be used at home as an
accessory for relieving of mild to moderate low back pain (LBP).
This study is designed to determine the efficacy of daily use home use with the no!no!Back
device during 3 weeks and to assess the sustained effect 3 weeks later. Up to 30 subjects
will be randomized to either an immediate treatment (IT) group that will receive the
no!no!Back device at the baseline visit, or to the wait-list control (WLC) group that will
receive the device 3 weeks later. The evaluation will include level of pain using the
numerical rating scale (NRS), functional health status by Oswestry disability index (ODI),
and subject satisfaction.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment