Osteo Arthritis KneeNCT03800927
Long-Duration Ultrasound for Knee Osteoarthritis
A study testing Long duration ultrasound in people with Osteo Arthritis Knee, run by ZetrOZ, Inc. at 2 sites in United States.
Trial summary
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Long duration ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2017to 1 Jun 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are you between 18 and 80 years of age (inclusive)?
- Can you speak, read, and write in English?
- Do you have knee pain that has lasted at least 3 months?
- Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
- Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
- Are you willing to document usage of any medications during the study period?
- Do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation [TENS], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services)
- On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? Pain must be ≥4 for the subject to be enrolled in this study. This criterion will be assessed by self-report at Visit 1.
Who cannot join
- Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
- Are you pregnant?
- Are you a prisoner?
- Are you non-ambulatory (unable to walk)?
- Do you have a pacemaker?
- Do you have a malignancy in the treatment area?
Show all 12Show fewer
- Do you have an active infection, open sores, or wounds in the treatment area?
- Do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia?
- Do you have a known neuropathy (disease of the brain or spinal nerves)?
- Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?
- Do you have peripheral artery disease?
- Does the subject 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?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Pain Consultants
Dryden, New York, 13053
Orthopedic Foundation
Stamford, Connecticut, 06905
About this study
Official title: Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Long duration ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long duration ultrasoundDevice
Low-intensity long duration ultrasound treatment
| Study group | Role | What they receive |
|---|---|---|
| Sham Ultrasound Device | Placebo comparator | No ultrasound treatment Receives: Device: Long duration ultrasound |
| Active Ultrasound Device | Active comparator | Active treatment Receives: Device: Long duration ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Units on a Numeric Rating Scale (NRS)
NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line
Measured: Average of first week (start of study) to average measure at 24 weeks (end of study)
Secondary outcomes (3)
Function
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in the scores. 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: First week (start of study) to 24 weeks (end of study)
Strengthen
Strength measurement with force meter (Newtons)
Measured: First week (start of study) to 24 weeks (end of study)
Range of motion
Range of Motion measurement with motion machine (Degrees)
Measured: First week (start of study) to 24 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Jan 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Crossover
- Model description
- Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Ortiz, MPH, DO, Study director, Medical Pain Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800927
- Sponsor's protocol ID
- OA-04
- Status last verified
- Jun 2023
- First submitted
- 15 Dec 2018
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Week Long-Duration Ultrasound for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03800927
- Acronym / sponsor ID
- OA-04
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 11 Jan 2019 (actual)
- 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.
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive active and sham devices for the first 12-weeks. Responders to treatment will continue with 12 weeks of additional active treatment.
| Arm | Type | Receives |
|---|---|---|
| Sham Ultrasound Device | Placebo comparator | Device: Long duration ultrasoundNo ultrasound treatment |
| Active Ultrasound Device | Active comparator | Device: Long duration ultrasoundActive treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are you between 18 and 80 years of age (inclusive)?
- Can you speak, read, and write in English?
- Do you have knee pain that has lasted at least 3 months?
- Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
- Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
Key exclusion criteria (12 listed)
- Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
- Are you pregnant?
- Are you a prisoner?
- Are you non-ambulatory (unable to walk)?
- Do you have a pacemaker?
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 |
|---|---|---|
| Long duration ultrasoundLow-intensity long duration ultrasound treatment | Device | Active Ultrasound Device, Sham Ultrasound Device |
Primary outcome
Change in Pain Units on a Numeric Rating Scale (NRS)
Time frame: Average of first week (start of study) to average measure at 24 weeks (end of study)
NRS on the scale of 1 - 10, 1 being minimum and 10 being maximum, Change was calculate from base line
3 secondary outcomes
Function
Time frame: First week (start of study) to 24 weeks (end of study)
Strengthen
Time frame: First week (start of study) to 24 weeks (end of study)
Range of motion
Time frame: First week (start of study) to 24 weeks (end of study)
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 26 Jun 2023.
- Class II Medical DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ralph Ortiz, MPH, DO study director
Medical Pain Consultants
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long duration ultrasound in people with Osteo Arthritis Knee, run by ZetrOZ, Inc. at 2 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 8 inclusion and 12 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 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?
Change in Pain Units on a Numeric Rating Scale (NRS) (time frame: Average of first week (start of study) to average measure at 24 weeks (end of study)). 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 26 Jun 2023.