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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment (IT) | Experimental | 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. |
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| Waiting List Control (WLC) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no!no!Back | Device | Self treatments daily for 3 weeks, in up to three 10-minutes sessions |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilach Gavish, PhD | Friedman Skin & Laser Center | Study Director |
| David J Friedman, MD | Friedman Skin & Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koren Physiotherapy Institute | Mevaseret Zion | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25280603 | Derived | Gavish L, Barzilay Y, Koren C, Stern A, Weinrauch L, Friedman DJ. Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study. Physiotherapy. 2015 Mar;101(1):75-81. doi: 10.1016/j.physio.2014.06.003. Epub 2014 Jul 28. |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |