Knee OsteoarthritisNCT01993693
Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis
A study testing Ultrasonic Diathermy Device in people with Knee Osteoarthritis, run by ZetrOZ, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound device to reduce pain and increase mobility for subjects with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ultrasonic Diathermy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2014
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Individual will be included if they:
- Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months,
- are between 35-65 years of age
- report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
- report mobility limitations because of their knee pain
- are currently not taking any prescription pain medication other than nonsteroidal antiinflammatory drugs (NSAIDs). All pain medication taken during the study should be documented.
- are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
- are deemed appropriate by their physician to participate.
Individuals will be excluded if they:
- cannot successfully demonstrate the ability to put on and take off the device
- are cognitively impaired
- have bone-on-bone crepitus
- have severe OA or patients with little to no cartilage on the knee
- have knee replacement or other surgical intervention
- take variable prescription medication
- are non-ambulatory
- participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- are currently taking neuropathic medications (ie: Neurontin, Lyrica or Topamax) and/or antidepressants (ie: Amitriptyline).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wearable Therapeutic Ultrasound Study
The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound device to reduce pain and increase mobility for subjects with knee osteoarthritis.
Read the detailed description
Up to 50 million people in the U.S. suffer from some form of chronic pain, and 60% of these Americans are under 65 and have limited mobility because of knee or hip Osteoarthritis (OA). Pharmaceuticals currently dominate the treatment options due to widespread insurance coverage and convenience. However, there are a myriad of public health problems associated with analgesic use, including costs, untoward side effects, and addiction potential with opioid analgesics.
Ultrasound therapy for pain and healing has been approved by the U.S. FDA and has been in use around the globe for the last 60 years. Traditionally, ultrasound-mediated pain treatment has been delivered in clinics and has been limited to short and confined periods of 5-15 min at acoustic intensities from 1-4 W/cm2 over a course of weeks to months. Over the past decade, research has increasingly focused on lower-intensity therapeutic ultrasound (30-1000 mW/cm2) delivered over extended 1-8 hr periods. (mW = milliwatt) Recent animal studies using low-intensity therapeutic ultrasound (LITUS) have demonstrated successful inflammation reduction, reduced cartilage degeneration, and tendon and fracture healing. It is believed that using a lower-intensity ultrasonic treatment regimen over extended treatment periods works with the body's natural healing process and minimizes acoustic insult as compared with traditional, higher intensity treatments. This study proposes to evaluate clinically the first wearable low intensity ultrasound system for noninvasive treatment of arthritis pain. This technology has the potential to measurably increase the quality of life for millions of people who suffer from osteoarthritis pain by providing a safe, effective, and easy-to-use treatment.
The pilot study will test the versatile ultrasound therapy system in a clinical study that will enroll up to 60 patients with mobility-impairing knee OA. The goal of the study is to establish statistically significant data that daily 4 hour LITUS treatment decreases participant pain (Visual Analog Scale [VAS]) and improves patient mobility (measured by an accelerometer worn by each participant) over placebo devices.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ultrasonic Diathermy Device, Sham Ultrasonic Diathermy Device
- Keywords
- knee, pain, osteoarthritis, ultrasound
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Diathermy DeviceDevice
Also called sam
The Ultrasonic Diathermy Device provides low intensity therapeutic ultrasound to musculoskeletal tissues and joints for the purpose of pain relief, relief of muscle spasm, treatment of joint contraction, and local increase of circulation. The device is FDA-cleared for up to 4 hours of continuous use per treatment. It is a stationary hands-free device.
Sham Ultrasonic Diathermy DeviceDevice
Also called Sham
Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Diathermy Device | Experimental | Therapeutic ultrasound used daily. Receives: Device: Ultrasonic Diathermy Device |
| Sham Ultrasonic Diathermy Device | Placebo comparator | Sham device that does not deliver ultrasound Receives: Device: Sham Ultrasonic Diathermy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be recorded using the Visual Analogue Scale (VAS).
Measured: Pain will be recorded twice a day, immediately before application of the device and then immediately after the 4 hour treatment.
Secondary outcomes (1)
Mobility
Mobility will be measured using an actigraph that will be worn on the subject's wrist 24 hours a day.
Measured: Mobility will be recorded logged every 5 minutes, up to 24 hours a day, by the actigraph that the subject is wearing on their wrist.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- State University of New York - Upstate Medical University
- Responsible party
- Sponsor
- Investigators
- Timothy A. Damron, MD, Principal investigator, SUNY Upstate Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993693
- Sponsor's protocol ID
- OA-02
- Other IDs
- 2012-1
- Status last verified
- Jun 2014
- First submitted
- 24 Oct 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Therapeutic Ultrasound Study
- ClinicalTrials.gov ID
- NCT01993693
- Acronym / sponsor ID
- OA-02
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, pain, osteoarthritis, ultrasound
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Collaborators
- State University of New York - Upstate Medical University
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Nov 2013 (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.
The purpose of this study is to evaluate the ability of a wearable therapeutic ultrasound device to reduce pain and increase mobility for subjects with knee osteoarthritis.
Detailed description
Up to 50 million people in the U.S. suffer from some form of chronic pain, and 60% of these Americans are under 65 and have limited mobility because of knee or hip Osteoarthritis (OA). Pharmaceuticals currently dominate the treatment options due to widespread insurance coverage and convenience. However, there are a myriad of public health problems associated with analgesic use, including costs, untoward side effects, and addiction potential with opioid analgesics.
Ultrasound therapy for pain and healing has been approved by the U.S. FDA and has been in use around the globe for the last 60 years. Traditionally, ultrasound-mediated pain treatment has been delivered in clinics and has been limited to short and confined periods of 5-15 min at acoustic intensities from 1-4 W/cm2 over a course of weeks to months. Over the past decade, research has increasingly focused on lower-intensity therapeutic ultrasound (30-1000 mW/cm2) delivered over extended 1-8 hr periods. (mW = milliwatt) Recent animal studies using low-intensity therapeutic ultrasound (LITUS) have demonstrated successful inflammation reduction, reduced cartilage degeneration, and tendon and fracture healing. It is believed that using a lower-intensity ultrasonic treatment regimen over extended treatment periods works with the body's natural healing process and minimizes acoustic insult as compared with traditional, higher intensity treatments. This study proposes to evaluate clinically the first wearable low intensity ultrasound system for noninvasive treatment of arthritis pain. This technology has the potential to measurably increase the quality of life for millions of people who suffer from osteoarthritis pain by providing a safe, effective, and easy-to-use treatment.
The pilot study will test the versatile ultrasound therapy system in a clinical study that will enroll up to 60 patients with mobility-impairing knee OA. The goal of the study is to establish statistically significant data that daily 4 hour LITUS treatment decreases participant pain (Visual Analog Scale [VAS]) and improves patient mobility (measured by an accelerometer worn by each participant) over placebo devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Diathermy Device | Experimental | Device: Ultrasonic Diathermy DeviceTherapeutic ultrasound used daily. |
| Sham Ultrasonic Diathermy Device | Placebo comparator | Device: Sham Ultrasonic Diathermy DeviceSham device that does not deliver ultrasound |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ultrasonic Diathermy DeviceAlso: samThe Ultrasonic Diathermy Device provides low intensity therapeutic ultrasound to musculoskeletal tissues and joints for the purpose of pain relief, relief of muscle spasm, treatment of joint contraction, and local increase of circulation. The device is FDA-cleared for up to 4 hours of continuous use per treatment. It is a stationary hands-free device. | Device | Ultrasonic Diathermy Device |
| Sham Ultrasonic Diathermy DeviceAlso: ShamSham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound | Device | Sham Ultrasonic Diathermy Device |
Primary outcome
Pain
Time frame: Pain will be recorded twice a day, immediately before application of the device and then immediately after the 4 hour treatment.
Pain will be recorded using the Visual Analogue Scale (VAS).
1 secondary outcome
Mobility
Time frame: Mobility will be recorded logged every 5 minutes, up to 24 hours a day, by the actigraph that the subject is wearing on their wrist.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
Timothy A. Damron, MD principal investigator
SUNY Upstate Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Diathermy Device in people with Knee Osteoarthritis, run by ZetrOZ, Inc. 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?
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: stopped early, as of the sponsor's last update on 18 Nov 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Pain (time frame: Pain will be recorded twice a day, immediately before application of the device and then immediately after the 4 hour treatment.). 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 18 Nov 2015.