The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients who have low back pain due to specific and known causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome (radiating nerve pain from the spine such as sciatica), cauda equinal syndrome (serious neurological disorder where the spinal nerve roots are compressed which can cause).
Weight in excess of 265 lbs. (120.4 kg)
Pregnant or breastfeeding
Recent history of violent trauma
History of previous back surgery
Constant progressive, non-mechanical pain (no relief with bed rest)
Chronic pain other than low back pain
Past medical history of malignant tumor
Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
Mental disorder that would lead to difficulty in questionnaire completion
Any litigation for low back pain
Prolonged use of corticosteroids (i.e. used for 3 months or more)
Present use of prescription pain medication (i.e. Percocet®, Oxycodone, Vicodin®, etc.)
Physical disability that prevents the subject to lie down/get up
Drug abuse, immunosuppression, HIV
Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.

Arm && Interventions

Group	Intervention	Description
Treatment Continuous Passive Motion	Continuous Passive Motion	Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)

Primary Outcome Measures

Name	Time	Method
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)	3 weeks	Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.

Secondary Outcome Measures

Name	Time	Method
Change in Functional Health Status by ODI	3 weeks, 4 weeks	Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)
Change in Proprioception and Vestibular Function.	3 weeks, 4 weeks	Gather information regarding: Balance and Fall Prevention using digital posturography
Change in Symmetry of Muscle Function on Either Side of the Spine	3 weeks, 4 weeks	Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)
Change in Heart Rate Variability (and the Autonomic System)	3 weeks, 4 weeks	Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).