Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or … (NCT02609854) | Clinical Trial Compass
CompletedNot Applicable
Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions
United States65 participantsStarted 2015-11
Plain-language 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. 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brief Pain Inventory-Short Form (BPI-SF): Pain Severity