Low Back PainLBP-2NCT02155283
The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)
A study testing Continuous Passive Motion in people with Low Back Pain, run by Radiancy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Continuous Passive Motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
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.
Read the 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
- Being tested
- Continuous Passive Motion
- Keywords
- Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Passive MotionDevice
Also called Kyrobak
Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
| Study group | Role | What they receive |
|---|---|---|
| Treatment Continuous Passive Motion | Other | Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) Receives: Device: Continuous Passive Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (4)
Change in Proprioception and Vestibular Function.
Gather information regarding:
Balance and Fall Prevention using digital posturography
Measured: 3 weeks, 4 weeks
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)
Measured: 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)
Measured: 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).
Measured: 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiancy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven G Geanopulos, DC, Principal investigator, New Heights Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155283
- Sponsor's protocol ID
- LBP-2
- Acronym
- LBP-2
- Status last verified
- Jun 2014
- First submitted
- 11 Dec 2013
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kyrobak Continuous Passive Motion Device for the Treatment of Chronic Low Back Pain: A Pilot Study
- ClinicalTrials.gov ID
- NCT02155283
- Acronym / sponsor ID
- LBP-2 / LBP-2
- Conditions
- Low Back Pain
- Keywords
- Chronic Low Back Pain, Mild-to-Moderate Chronic Low Back Pain, Continuous Passive Motion Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- RadiancyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 27 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Continuous Passive Motion | Other | Device: Continuous Passive MotionSingle-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Passive MotionAlso: KyrobakDaily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day | Device | Treatment Continuous Passive Motion |
Primary outcome
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)
Time frame: 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.
4 secondary outcomes
Change in Proprioception and Vestibular Function.
Time frame: 3 weeks, 4 weeks
Change in Functional Health Status by ODI
Time frame: 3 weeks, 4 weeks
Change in Symmetry of Muscle Function on Either Side of the Spine
Time frame: 3 weeks, 4 weeks
Change in Heart Rate Variability (and the Autonomic System)
Time frame: 3 weeks, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven G Geanopulos, DC principal investigator
New Heights Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion in people with Low Back Pain, run by Radiancy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.