Knee OsteoarthritisNCT02083861
Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial
A study testing Sam 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 measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in… 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?
- Sam Ultrasonic Diathermy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- 35-80 years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- 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
- Deemed appropriate by their physician or by the study site physician to participate
Who cannot join
- Cannot successfully demonstrate the ability to put on and take off the device
- Display 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.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Are non-ambulatory
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Show all 10Show fewer
- Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ZetrOZ Wearable Ultrasound Clinical Study
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.
Read the detailed description
This is an eight week study to clinically evaluate the effect of the low intensity long duration ultrasound (LITUS) device on symptoms of patients suffering from knee osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the study, baseline data will be collected as patients report pain scores (NRS) three times per day. During the following 6 weeks, patients will self-apply the wearable LITUS device to their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and range of motion assessment (JTech) will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.
Up to 93 subjects will be recruited from neighboring communities to the study site. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The sponsor and investigators are blinded as to which type of device each patient is assigned.
The study will be monitored by an external monitor and a data safety monitoring board (DSMB).
- Conditions
- Knee Osteoarthritis
- Being tested
- Sam Ultrasonic Diathermy Device
- Keywords
- osteoarthritis, arthritis, musculoskeletal, connective tissue disease, ultrasound, pain, mobility, heat, strength, ZetrOZ, LITUS, Sam, grade 1, grade 2
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis, Connective Tissue Diseases, Pain, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sam Ultrasonic Diathermy DeviceDevice
Also called ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS device
Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Active ultrasound device | Experimental | Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. Receives: Device: Sam Ultrasonic Diathermy Device |
| Placebo ultrasound device | Placebo comparator | Patients wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound. Receives: Device: Sam Ultrasonic Diathermy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion
The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.
Measured: Baseline, Week 6
Secondary outcomes (3)
Quality of Life (WOMAC) Change From Baseline
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index). WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400).
Measured: Baseline, Week 6
Range of Motion Change From Baseline in Treated Knee
JTech equipment was used to evaluate range of motion range of motion using an inclinometer (www.jtechmedical.com) in flexion and extension of the treated knee. 0 degrees is fully extended and 150 degrees is normal flexion. Positive flexion change indicates improvement in flexion. Negative extension indicates improvement in extension.
Measured: Baseline, Week 6
Muscle Strength Change From Baseline in Treated Knee
Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.
Measured: Baseline to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Ralph Ortiz, D.O., MPH, Principal investigator, Medical Pain Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083861
- Sponsor's protocol ID
- OA-03
- Other IDs
- 1R43MD008597-01
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2014
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.
PubMed 30326947
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZetrOZ Wearable Ultrasound Clinical Study
- ClinicalTrials.gov ID
- NCT02083861
- Acronym / sponsor ID
- OA-03
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, arthritis, musculoskeletal, connective tissue disease, ultrasound, pain, mobility, heat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 7 May 2018
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 measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.
Detailed description
This is an eight week study to clinically evaluate the effect of the low intensity long duration ultrasound (LITUS) device on symptoms of patients suffering from knee osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the study, baseline data will be collected as patients report pain scores (NRS) three times per day. During the following 6 weeks, patients will self-apply the wearable LITUS device to their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and range of motion assessment (JTech) will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.
Up to 93 subjects will be recruited from neighboring communities to the study site. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The sponsor and investigators are blinded as to which type of device each patient is assigned.
The study will be monitored by an external monitor and a data safety monitoring board (DSMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ultrasound device | Experimental | Device: Sam Ultrasonic Diathermy DevicePatients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. |
| Placebo ultrasound device | Placebo comparator | Device: Sam Ultrasonic Diathermy DevicePatients wear the Sam Ultrasonic Diathermy Device for 4 hours every day for 6 weeks. The placebo device appears and operates identically to the active device except that it does not emit ultrasound. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- 35-80 years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
Key exclusion criteria (10 listed)
- Cannot successfully demonstrate the ability to put on and take off the device
- Display 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.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Are non-ambulatory
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 |
|---|---|---|
| Sam Ultrasonic Diathermy DeviceAlso: ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS devicePatients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2. | Device | Active ultrasound device, Placebo ultrasound device |
Primary outcome
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion
Time frame: Baseline, Week 6
The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.
3 secondary outcomes
Quality of Life (WOMAC) Change From Baseline
Time frame: Baseline, Week 6
Range of Motion Change From Baseline in Treated Knee
Time frame: Baseline, Week 6
Muscle Strength Change From Baseline in Treated Knee
Time frame: Baseline to 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30326947Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Ralph Ortiz, D.O., MPH principal investigator
Medical Pain Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sam 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?
The sponsor lists 7 inclusion and 10 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 7 May 2018. 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?
Yes. Results are posted in the registry (first posted 7 May 2018). 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?
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083861, which also lists 1 linked publication.
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 7 May 2018.