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

NCT ID: NCT02155283

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Continuous Passive Motion

Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)

Group Type: OTHER

Continuous Passive Motion

Intervention Type: DEVICE

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

Interventions

Continuous Passive Motion

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

Intervention Type: DEVICE

Other Intervention Names

Kyrobak

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiancy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven G Geanopulos, DC

Role: PRINCIPAL_INVESTIGATOR

New Heights Chiropractic

Locations

New Heights Chiropractic

New York, New York, United States

Countries

United States

Other Identifiers

LBP-2

Identifier Type: -

Identifier Source: org_study_id