The Efficacy of the no!no!Back for Chronic Low Back Pain
NCT ID: NCT01620281
Last Updated: 2013-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2012-06-30
2013-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate treatment (IT)
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.
no!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Waiting List Control (WLC)
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.
no!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Interventions
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no!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Radiancy
INDUSTRY
Responsible Party
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Principal Investigators
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Lilach Gavish, PhD
Role: STUDY_DIRECTOR
Friedman Skin & Laser Center
David J Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Friedman Skin & Laser Center
Locations
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Koren Physiotherapy Institute
Mevaseret Zion, , Israel
Countries
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References
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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.
Other Identifiers
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LBP-1
Identifier Type: -
Identifier Source: org_study_id