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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Continuous Passive Motion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18 or older Level of pain - mild to moderate low back pain (≤5 NRS pain) Chronic - symptoms must have been present for at least 12 weeks or more. Location - lower tip of scapula to back of pelvis Etiology - non-specific 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Continuous Passive Motion<br>Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) | Device: Continuous Passive Motion<br>* Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day<br>* Other names: Kyrobak;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) | 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. | 3 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices