Musculoskeletal InjuryNCT05254470
Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
An observational study of Musculoskeletal Injury and Pain, Chronic, run by ZetrOZ, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Injury, Pain, Chronic, Pain, Acute
- What is being tested?
- Continuous Ultrasound
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Feb 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with work and sport related musculoskeletal injuries
Who may be able to join
- Work-related musculoskeletal injuries with limited improvement under traditional therapies
Who cannot join
- Healthy participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sport & Orthopaedic Physical Therapy
Fairfield, Connecticut, 06824
About this study
Official title: Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care
The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow.
Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.
Read the detailed description
ZetrOZ's SAM Ultrasound Device is a portable and wearable medical device which, when applied to various areas of the body, applies Low Intensity Therapeutic Ultrasound to deep tissues. The SAM device is currently used by a broad range of Athletic Trainers (ATs) in the United States to assist in the rehabilitation of injured athletes.
The purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care. This includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on SAM treatment augmenting conservative therapies.
- Conditions
- Musculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport Injury, Soft Tissue Injuries, Arm Injury
- Being tested
- Continuous Ultrasound
- Keywords
- Continuous Ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Soft Tissue Injury
- Medical subject headings
- Chronic Pain, Acute Pain, Soft Tissue Injuries, Arm Injuries, Back Pain, Tendon Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous UltrasoundDevice
3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device
| Study group | Role | What they receive |
|---|---|---|
| Pre-Low Intensity Continuous Ultrasound Treatment | Routine care for pain alleviation, range of motion and ability to return to work with traditional therapies from rehabilitation. | |
| Post-Low Intensity Continuous Ultrasound Treatment | Routine care of pain alleviation, range of motion and ability to return to work after treatment with low-intensity continuous ultrasound (LICUS) in conjunction with traditional therapies. Receives: Device: Continuous Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NRS) (0-10)
Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain.
Measured: 0 - 4 weeks
Secondary outcomes (1)
Global Health Improvement Score (GROC) (-7 to +7)
Quality of health care improvement satisfaction from intervention compared to conservative treatment
Measured: 0 - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rod Walters, EdD, Study director, Walters Sports Medicine Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254470
- Sponsor's protocol ID
- CS-02-2021
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Draper DO, Wells A, Wilk K. Efficacy of Sustained Acoustic Medicine as an Add-on to Traditional Therapy in Treating Sport-related Injuries : Case Reports. Glob J Orthop Res. 2020;2(4):545. Epub 2020 Sep 21.
PubMed 33043316Langer MD, Lewis GK Jr. Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Proc SPIE Int Soc Opt Eng. 2015 May;9467:94670I. doi: 10.1117/12.2178213.
PubMed 30078928Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.
PubMed 33408796Winkler SL, Urbisci AE, Best TM. Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2021 Dec 18;13(1):159. doi: 10.1186/s13102-021-00383-0.
PubMed 34922606Jarit P, Klyve D, Walters R. Long Duration Sonophoresis of Diclofenac to Augment Rehabilitation of Common Musculoskeletal Injuries. Glob J Orthop Res. 2023;4(2):584. Epub 2023 Jan 20.
PubMed 36865667
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care
- ClinicalTrials.gov ID
- NCT05254470
- Acronym / sponsor ID
- CS-02-2021
- Conditions
- Musculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport Injury, Soft Tissue Injuries, Arm Injury
- Keywords
- Continuous Ultrasound, Sustained Acoustic Medicine, Musculoskeletal Injuries, Low Intensity Contiguous Ultrasound, Pain, Soft Tissue Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 24 Feb 2022 (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.
The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow.
Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.
Detailed description
ZetrOZ's SAM Ultrasound Device is a portable and wearable medical device which, when applied to various areas of the body, applies Low Intensity Therapeutic Ultrasound to deep tissues. The SAM device is currently used by a broad range of Athletic Trainers (ATs) in the United States to assist in the rehabilitation of injured athletes.
The purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care. This includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on SAM treatment augmenting conservative therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Low Intensity Continuous Ultrasound Treatment | – | –Routine care for pain alleviation, range of motion and ability to return to work with traditional therapies from rehabilitation. |
| Post-Low Intensity Continuous Ultrasound Treatment | – | Device: Continuous UltrasoundRoutine care of pain alleviation, range of motion and ability to return to work after treatment with low-intensity continuous ultrasound (LICUS) in conjunction with traditional therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with work and sport related musculoskeletal injuries
Key inclusion criteria (1 listed)
- Work-related musculoskeletal injuries with limited improvement under traditional therapies
Key exclusion criteria (1 listed)
- Healthy participant
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 |
|---|---|---|
| Continuous Ultrasound3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device | Device | Post-Low Intensity Continuous Ultrasound Treatment |
Primary outcome
Numeric Pain Rating Scale (NRS) (0-10)
Time frame: 0 - 4 weeks
Change in pain severity over the time of treatment, 0 being lowest, and 10 being the worst pain.
1 secondary outcome
Global Health Improvement Score (GROC) (-7 to +7)
Time frame: 0 - 4 weeks
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 24 Feb 2022.
- Background: PubMed 33043316Draper DO, Wells A, Wilk K. Efficacy of Sustained Acoustic Medicine as an Add-on to Traditional Therapy in Treating Sport-related Injuries : Case Reports. Glob J Orthop Res. 2020;2(4):545. Epub 2020 Sep 21.
- Background: PubMed 30078928Langer MD, Lewis GK Jr. Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Proc SPIE Int Soc Opt Eng. 2015 May;9467:94670I. doi: 10.1117/12.2178213.
- Background: PubMed 33408796Madzia A, Agrawal C, Jarit P, Petterson S, Plancher K, Ortiz R. Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. Open Orthop J. 2020;14:176-185. doi: 10.2174/1874325002014010176. Epub 2020 Dec 18.
- Background: PubMed 34922606Winkler SL, Urbisci AE, Best TM. Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2021 Dec 18;13(1):159. doi: 10.1186/s13102-021-00383-0.
- Derived from this study: PubMed 36865667Jarit P, Klyve D, Walters R. Long Duration Sonophoresis of Diclofenac to Augment Rehabilitation of Common Musculoskeletal Injuries. Glob J Orthop Res. 2023;4(2):584. Epub 2023 Jan 20.
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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.
Rod Walters, EdD study director
Walters Sports Medicine Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury and Pain, Chronic, 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 1 inclusion and 1 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 24 Feb 2022. 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. 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?
Numeric Pain Rating Scale (NRS) (0-10) (time frame: 0 - 4 weeks). 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 NCT05254470, which also lists 5 linked publications.
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 24 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.