Low Back Pain
Conditions
Keywords
Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices
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.
Interventions
Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
Sponsors
Radiancy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment Continuous Passive Motion |
|---|---|
| Age, Continuous | 53.75 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 3 weeks
Population: Completers per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Continuous Passive Motion | Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) | -2.87 units on a scale | Standard Deviation 1.71 |
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)
Time frame: 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).
Time frame: 3 weeks, 4 weeks
Secondary
Change in Proprioception and Vestibular Function.
Gather information regarding: Balance and Fall Prevention using digital posturography
Time frame: 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)
Time frame: 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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Continuous Passive Motion | 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) | -2.61 units on a scale | Standard Deviation 1.51 |