Mild to Moderate Chronic Low Back Pain
Conditions
Keywords
Back Pain
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.
Interventions
DEVICEno!no!Back
Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Sponsors
Radiancy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level after 3 weeks compared to baseline (before treatment) | 3 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional health status by ODI | 3,6 weeks | Functional health status will be determined by the ODI questionnaire filled by the subject (10 multi-choice questions, takes 5 minutes to answer). |
| Subject satisfaction | 6 weeks | 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. |
Countries
Israel
Outcome results
None listed