Clinical trial NCT01620281: The Efficacy of the no!no!Back for Chronic Low Back Pain
Official title: The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Chronic Low Back Pain
Keywords: Back Pain
Lead sponsor: Radiancy
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain level after 3 weeks compared to baseline (before treatment)
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in functional health status by ODI
timeFrame: 3,6 weeks
measure: Subject satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mevasseret-Zion
country: Israel
facility: Koren Physiotherapy Institute
Study officials:
affiliation: Friedman Skin & Laser Center
name: Lilach Gavish, PhD
role: STUDY_DIRECTOR
affiliation: Friedman Skin & Laser Center
name: David J Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.