The Efficacy of the no!no!Back for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study

Conditions
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Mild to Moderate Chronic Low Back Pain

Intervention / Treatment
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* Device: no!no!Back


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18 or more 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 etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome). Pregnant or lactating 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 tumour 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 Current or future litigation for low back pain Prolonged use of corticosteroids 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
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate treatment (IT)<br>Subjects from this group will receive the device immediately. Subjects will be instructed to treat themselves daily for 3 weeks, in up to three 10-minutes sessions. All subjects will receive a diary to record details of the daily use of the device (time of day, position of legs, and number of daily uses), degree of pain, a weekly ODI questionnaire, and record of any back/pain related events. After 3 weeks the subjects from the IT group will return the device and at 6 weeks they will visit again for the final evaluation. | Device: no!no!Back<br>* Self treatments daily for 3 weeks, in up to three 10-minutes sessions<br>|
| Other: Waiting List Control (WLC)<br>The WLC group will go through the same evaluations at the same time intervals but will begin treatments 3 weeks later during which they will fill the diary daily but not use the device. | Device: no!no!Back<br>* Self treatments daily for 3 weeks, in up to three 10-minutes sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level after 3 weeks compared to baseline (before treatment) | Pain level will be scored by the subject using a numerical rating scone on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional health status by ODI | Functional health status will be determined by the ODI questionnaire filled by the subject (10 multi-choice questions, takes 5 minutes to answer). | 3,6 weeks | 
| Subject satisfaction | The subject will be verbally asked to grade his/her overall satisfaction according to the satisfaction assessment scale based on a 5-point Likert scale detailed in Table 3 where 0 represents very unsatisfied and 4 represents very satisfied. In addition the subject will fill a questionnaire. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain