The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2) (LBP-2)

The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Continuous Passive Motion

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10033
      • New Heights Chiropractic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Continuous Passive Motion; Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)	Device: Continuous Passive Motion; Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day; Other Names: Kyrobak

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)	Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proprioception and Vestibular Function.	Gather information regarding: Balance and Fall Prevention using digital posturography	3 weeks, 4 weeks
Change in Functional Health Status by ODI	Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)	3 weeks, 4 weeks
Change in Symmetry of Muscle Function on Either Side of the Spine	Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)	3 weeks, 4 weeks
Change in Heart Rate Variability (and the Autonomic System)	Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).	3 weeks, 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.	4 weeks

Collaborators and Investigators

• Sponsor: Radiancy
• Investigators: Principal Investigator: Steven G Geanopulos, DC, New Heights Chiropractic

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): July 27, 2015
• Last Update Submitted That Met QC Criteria: June 28, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Low Back Pain; Mild-to-Moderate Chronic Low Back Pain; Continuous Passive Motion Devices
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LBP-2