Chronic Low Back Pain (CLBP)NCT02609854
Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
A study testing Sustained Acoustic Medicine (SAM) in people with Chronic Low Back Pain (CLBP) and Intervertebral Disc Displacement, run by ZetrOZ, Inc. at 3 sites in United States.
Trial summary
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Intervertebral Disc Displacement
- What is being tested?
- Sustained Acoustic Medicine (SAM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Chronic low back pain, may be secondary to herniated nucleus pulposus (HNP) or other causes
- 18-60 years of age, inclusive
- Has Numeric Rating Scale (NRS) pain severity score of at least 4 for a minimum 5 days over the 1 week Baseline Period prior to being randomized to treatment
- Pain lasting >3 months
- Has MRI from within 2 months prior to Screening (If no recent MRI is available, then subject must agree to have MRI performed prior to randomization of treatment)
- If pain is secondary to HNP: MRI within the last 2 months demonstrating the presence of a herniated disc; herniated disc is laterally located and not centrally located; herniated disc is not sequestered
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- Has the presence of radicular pain as assessed by a health care practitioner
- Is willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
- Is maintained on a stable pain management regimen, which may include opioid and/or non-opioid analgesic medications, but must be willing to keep dosage(s) stable through the study period; any dose adjustments that the investigator feels are required during the study period must be discussed with the study sponsor; and the use of any medications must be documented in the subject's Medication Log.
- Be willing to discontinue any other interventional treatment modalities on the lower back during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).
Who cannot join
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Has arthritis, bone spurs, stenosis, fusions, or implants near the treatment area.
- Is pregnant.
- Is a prisoner.
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- Is non-ambulatory (unable to walk).
- Has a pacemaker.
- Has a malignancy in the treatment area.
- Has an active infection, open sores, or wounds in the treatment area.
- Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
- Has a known neuropathy (disease of the brain or spinal nerves).
- Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
- Has peripheral artery disease.
- Has BMI ≥30
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Osteopathic Medical Arts
Chapel Hill, North Carolina, 27514
Medical Pain Consultants
Dryden, New York, 13053
Weber State University
Ogden, Utah, 84408
About this study
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.
- Being tested
- Sustained Acoustic Medicine (SAM), Sham Device
- Keywords
- herniated disc, sustained acoustic medicine, ultrasound, CLBP
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Acoustic Medicine (SAM)Device
Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day.
Sham DeviceDevice
Inactive ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| Sham Sustained Acoustic Medicine Device | Experimental | Sham Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks. Receives: Device: Sham Device |
| 3 MHz Sustained Acoustic Medicine Device | Experimental | 3 MHz Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks. Receives: Device: Sustained Acoustic Medicine (SAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory-Short Form (BPI-SF): Pain Severity
Measured: Change from Baseline to Week 8
Secondary outcomes (4)
BPI-SF: Pain Interference
Measured: Change from Baseline to Week 8
Oswestry Disability Index
Measured: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Flexion
Measured: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Extension
Measured: Change from Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609854
- Sponsor's protocol ID
- BP-01
- Status last verified
- Jan 2017
- First submitted
- 17 Nov 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
- ClinicalTrials.gov ID
- NCT02609854
- Acronym / sponsor ID
- BP-01
- Keywords
- herniated disc, sustained acoustic medicine, ultrasound, CLBP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Sustained Acoustic Medicine Device | Experimental | Device: Sham DeviceSham Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks. |
| 3 MHz Sustained Acoustic Medicine Device | Experimental | Device: Sustained Acoustic Medicine (SAM)3 MHz Sustained Acoustic Medicine device - the device is to be used 4 hours/day, ≥4 days per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Diagnosis of Chronic low back pain, may be secondary to herniated nucleus pulposus (HNP) or other causes
- 18-60 years of age, inclusive
- Has Numeric Rating Scale (NRS) pain severity score of at least 4 for a minimum 5 days over the 1 week Baseline Period prior to being randomized to treatment
- Pain lasting >3 months
- Has MRI from within 2 months prior to Screening (If no recent MRI is available, then subject must agree to have MRI performed prior to randomization of treatment)
Key exclusion criteria (15 listed)
- Cannot successfully demonstrate the ability to put on and take off the device.
- Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Has arthritis, bone spurs, stenosis, fusions, or implants near the treatment area.
- Is pregnant.
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 |
|---|---|---|
| Sustained Acoustic Medicine (SAM)Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day. | Device | 3 MHz Sustained Acoustic Medicine Device |
| Sham DeviceInactive ultrasound device | Device | Sham Sustained Acoustic Medicine Device |
Primary outcome
Brief Pain Inventory-Short Form (BPI-SF): Pain Severity
Time frame: Change from Baseline to Week 8
4 secondary outcomes
BPI-SF: Pain Interference
Time frame: Change from Baseline to Week 8
Oswestry Disability Index
Time frame: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Flexion
Time frame: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Extension
Time frame: Change from Baseline to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Acoustic Medicine (SAM) in people with Chronic Low Back Pain (CLBP) and Intervertebral Disc Displacement, run by ZetrOZ, Inc. at 3 sites 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 10 inclusion and 15 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Pain Inventory-Short Form (BPI-SF): Pain Severity (time frame: Change from Baseline to Week 8). 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 31 Jan 2017.