Clinical trial NCT02155283: The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)
Official title: The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic Low Back Pain
Mild-to-Moderate Chronic Low Back Pain
Continuous Passive Motion Devices
Lead sponsor: Radiancy
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The Kyrobak is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The Kyrobak is used at home as an aid to relieve mild-to-moderate low back pain.

The study is designed to evaluate the efficacy of daily home use of the Kyrobak for 3 weeks and to assess the sustained efficacy 1 week later.

The evaluation will include the level of pain using the numerical rating scale (NRS), Digital Posturography, Heart Rate Variability (HRV), Static Surface Electromyography (SEMG), a condition-specific low back pain disability status by the Oswestry Disability Index (ODI) and subject satisfaction.

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.

Primary outcomes:
measure: Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in Proprioception and Vestibular Function.
timeFrame: 3 weeks, 4 weeks
measure: Change in Functional Health Status by ODI
timeFrame: 3 weeks, 4 weeks
measure: Change in Symmetry of Muscle Function on Either Side of the Spine
timeFrame: 3 weeks, 4 weeks
measure: Change in Heart Rate Variability (and the Autonomic System)
timeFrame: 3 weeks, 4 weeks
Other outcomes:
measure: Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
timeFrame: 4 weeks
Locations:
city: New York
country: United States
facility: New Heights Chiropractic
state: New York
Study officials:
affiliation: New Heights Chiropractic
name: Steven G Geanopulos, DC
role: PRINCIPAL_INVESTIGATOR
References: