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Completed

NCT Number: NCT02155283

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Heights Chiropractic

New York, 10033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Passive Motion

Device

Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day

Other names: Kyrobak

Primary outcomes

  1. Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Change in Proprioception and Vestibular Function.

    Time frame: 3 weeks, 4 weeks

    Gather information regarding:

    Balance and Fall Prevention using digital posturography

  2. Change in Functional Health Status by ODI

    Time frame: 3 weeks, 4 weeks

    Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)

  3. Change in Symmetry of Muscle Function on Either Side of the Spine

    Time frame: 3 weeks, 4 weeks

    Gather information regarding:

    Symmetry of muscle function about the spine using static surface electromyography (SEMG)

  4. Change in Heart Rate Variability (and the Autonomic System)

    Time frame: 3 weeks, 4 weeks

    Gather information regarding:

    Autonomic nervous system activity by measuring heart rate variability (HRV).

Other outcomes

  1. 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)

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Radiancy

Industry

Registry information

Official study title

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

Acronym: LBP-2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 4, 2014
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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