Mild to Moderate Chronic Low Back Pain Clinical Trial
— LBP-1Official title:
The no!no!Back Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study
| Verified date | August 2013 |
| Source | Radiancy |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Israeli Health Ministry Pharmaceutical Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | February 2013 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Koren Physiotherapy Institute | Mevasseret-Zion |
| Lead Sponsor | Collaborator |
|---|---|
| Radiancy |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |