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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Continuous Passive Motion | Other | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Passive Motion | Device | Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven G Geanopulos, DC | New Heights Chiropractic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Heights Chiropractic | New York | New York | 10033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Continuous Passive Motion | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Continuous Passive Motion | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Completers per protocol | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Continuous Passive Motion | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniele Perl-Treves, Clinical Director | Radiancy Ltd | 972-97757556 | daniele@radiancy.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Proprioception and Vestibular Function. | Gather information regarding: Balance and Fall Prevention using digital posturography | Not Posted | 3 weeks, 4 weeks |
| Secondary | 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) | Not Posted | 3 weeks, 4 weeks |
| Secondary | 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) | Not Posted | 3 weeks, 4 weeks |
| Secondary | Change in Heart Rate Variability (and the Autonomic System) | Gather information regarding: Autonomic nervous system activity by measuring heart rate variability (HRV). | Not Posted | 3 weeks, 4 weeks |
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |