N/A
N=16
The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02155283 ↗Enrolled (actual)
16
Serious AEs
—
Results posted
Jul 2015
Primary outcome: Primary: Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) — -2.87 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Passive Motion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiancy
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) |
-2.87 | — |
| SECONDARY Change in Proprioception and Vestibular Function. |
— | — |
| SECONDARY Change in Functional Health Status by ODI |
— | — |
| SECONDARY Change in Symmetry of Muscle Function on Either Side of the Spine |
— | — |
| SECONDARY Change in Heart Rate Variability (and the Autonomic System) |
— | — |
Summary
The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive motion home-use device in relieving low back pain, improving proprioception (balance and fall prevention) and improving the symmetry of muscle function on either side of the spine.
Eligibility Criteria
Inclusion Criteria
- Male or female, age 18 or older
- 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 causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome (radiating nerve pain from the spine such as sciatica), cauda equinal syndrome (serious neurological disorder where the spinal nerve roots are compressed which can cause).
- Weight in excess of 265 lbs. (120.4 kg)
- Pregnant or breastfeeding
- 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 tumor
- 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
- Any litigation for low back pain
- Prolonged use of corticosteroids (i.e. used for 3 months or more)
- Present use of prescription pain medication (i.e. Percocet®, Oxycodone, Vicodin®, etc.)
- 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.
Data sourced from ClinicalTrials.gov (NCT02155283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.