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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Passive Motion
Sponsored by
Radiancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New Heights Chiropractic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment Continuous Passive Motion

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Proprioception and Vestibular Function.
Gather information regarding: Balance and Fall Prevention using digital posturography
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)
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)
Change in Heart Rate Variability (and the Autonomic System)
Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).

Full Information

First Posted
December 11, 2013
Last Updated
June 28, 2015
Sponsor
Radiancy
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1. Study Identification

Unique Protocol Identification Number
NCT02155283
Brief Title
The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)
Acronym
LBP-2
Official Title
The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiancy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Continuous Passive Motion
Arm Type
Other
Arm Description
Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)
Intervention Type
Device
Intervention Name(s)
Continuous Passive Motion
Other Intervention Name(s)
Kyrobak
Intervention Description
Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Primary Outcome Measure Information:
Title
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in Proprioception and Vestibular Function.
Description
Gather information regarding: Balance and Fall Prevention using digital posturography
Time Frame
3 weeks, 4 weeks
Title
Change in Functional Health Status by ODI
Description
Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)
Time Frame
3 weeks, 4 weeks
Title
Change in Symmetry of Muscle Function on Either Side of the Spine
Description
Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)
Time Frame
3 weeks, 4 weeks
Title
Change in Heart Rate Variability (and the Autonomic System)
Description
Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).
Time Frame
3 weeks, 4 weeks
Other Pre-specified Outcome Measures:
Title
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)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven G Geanopulos, DC
Organizational Affiliation
New Heights Chiropractic
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Heights Chiropractic
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States

12. IPD Sharing Statement

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

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