The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
Outcome Measures
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) [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 Outcome Measures
- Change in Proprioception and Vestibular Function. [3 weeks, 4 weeks]
Gather information regarding: Balance and Fall Prevention using digital posturography
- Change in Functional Health Status by ODI [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)
- Change in Symmetry of Muscle Function on Either Side of the Spine [3 weeks, 4 weeks]
Gather information regarding: Symmetry of muscle function about the spine using static surface electromyography (SEMG)
- Change in Heart Rate Variability (and the Autonomic System) [3 weeks, 4 weeks]
Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV).
Other Outcome Measures
- 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) [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Heights Chiropractic | New York | New York | United States | 10033 |
Sponsors and Collaborators
- Radiancy
Investigators
- Principal Investigator: Steven G Geanopulos, DC, New Heights Chiropractic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LBP-2
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment Continuous Passive Motion |
|---|---|
| Arm/Group Description | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day |
| Period Title: Overall Study | |
| STARTED | 16 |
| COMPLETED | 9 |
| NOT COMPLETED | 7 |
Baseline Characteristics
| Arm/Group Title | Treatment Continuous Passive Motion |
|---|---|
| Arm/Group Description | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day |
| Overall Participants | 16 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
53.75
(14.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
8
50%
|
| Male |
8
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Completers per protocol |
| Arm/Group Title | Treatment Continuous Passive Motion |
|---|---|
| Arm/Group Description | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day |
| Measure Participants | 9 |
| Mean (Standard Deviation) [units on a scale] |
-2.87
(1.71)
|
| Title | Change in Proprioception and Vestibular Function. |
|---|---|
| Description | Gather information regarding: Balance and Fall Prevention using digital posturography |
| Time Frame | 3 weeks, 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Continuous Passive Motion |
|---|---|
| Arm/Group Description | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day |
| Measure Participants | 9 |
| Mean (Standard Deviation) [units on a scale] |
-2.61
(1.51)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment Continuous Passive Motion | |
| Arm/Group Description | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day | |
All Cause Mortality |
||
| Treatment Continuous Passive Motion | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Treatment Continuous Passive Motion | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Treatment Continuous Passive Motion | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Daniele Perl-Treves, Clinical Director |
|---|---|
| Organization | Radiancy Ltd |
| Phone | 972-97757556 |
| daniele@radiancy.com |
- LBP-2