TendinopathyNCT02466308
Long Duration Therapeutic Ultrasound for Tendon Healing
A study testing SAM Ultrasound Diathermy Device in people with Tendinopathy and Tendinitis, run by ZetrOZ, Inc. at 1 site in United States.
Trial summary
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy, Tendinitis, Tendinosis
- What is being tested?
- SAM Ultrasound Diathermy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18-65 years of age, inclusive
- Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
- Body mass index (BMI) less than or equal to 30.0
- Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period.
Who cannot join
- History or current diagnosis of tendon tear in treated tendon
- Known neuropathy
- Type I or Type II diabetes mellitus
- Had surgery in target treatment area within 6 months
- Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety
- Refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided
Show all 9Show fewer
- Refuse to discontinue all other interventional treatment modalities (e.g., transcutaneous electrical nerve stimulation, other ultrasound therapy, etc.)
- Have had a local corticosteroid or platelet-rich plasma injection within the past 3 months
- Have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) 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 enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
- Conditions
- Tendinopathy, Tendinitis, Tendinosis
- Being tested
- SAM Ultrasound Diathermy Device
- Keywords
- sustained acoustic medicine, therapeutic ultrasound, SAM, LITUS
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM Ultrasound Diathermy DeviceDevice
Also called sustained acoustic medicine, SAM
| Study group | Role | What they receive |
|---|---|---|
| SAM Ultrasound Diathermy Device | Experimental | SAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks Receives: Device: SAM Ultrasound Diathermy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Numeric Rating Scale; NRS)
Measured: Change from Baseline to Week 6
Secondary outcomes (4)
Pain (NRS): 50% response rate
Measured: Week 6
Pain (NRS) during treatment session
Measured: Pre-treatment to Post-treatment (4 hours)
Grip Strength (dynamometer)
Measured: Change from Baseline to Week 6
Treatment Compliance (subject-reported use of device compared to protocol)
Measured: weekly through Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466308
- Sponsor's protocol ID
- TN-01
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Best TM, Moore B, Jarit P, Moorman CT, Lewis GK. Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy. Phys Sportsmed. 2015 Nov;43(4):366-74. doi: 10.1080/00913847.2015.1095617. Epub 2015 Oct 15.
PubMed 26468991
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Duration Therapeutic Ultrasound for Tendon Healing
- ClinicalTrials.gov ID
- NCT02466308
- Acronym / sponsor ID
- TN-01
- Conditions
- Tendinopathy, Tendinitis, Tendinosis
- Keywords
- sustained acoustic medicine, therapeutic ultrasound, SAM, LITUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jun 2015 (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.
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) 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 enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAM Ultrasound Diathermy Device | Experimental | Device: SAM Ultrasound Diathermy DeviceSAM (sam Professional System) 3 MHz ultrasound diathermy device: 4 hours/day, at least 5 days per week, for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- 18-65 years of age, inclusive
- Diagnosis of tendinitis in the elbow (lateral or medial epicondyle), Achilles tendon, or patellar tendon based on examination of medical history and confirmed by physical examination including either manual movements of the injured limb, e.g., a positive Mill's Test for elbow tendinitis, or local tenderness upon palpation of the tendon;
- Body mass index (BMI) less than or equal to 30.0
- Not taking NSAIDs or prescription pain medications for their tendinitis, and agree to document all pain medication use during the study period.
Key exclusion criteria (9 listed)
- History or current diagnosis of tendon tear in treated tendon
- Known neuropathy
- Type I or Type II diabetes mellitus
- Had surgery in target treatment area within 6 months
- Refuse to agree to not increase current use or initiate new use of pain medication during the trial unless medically necessary to ensure patient safety
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 Ultrasound Diathermy DeviceAlso: sustained acoustic medicine, SAM | Device | SAM Ultrasound Diathermy Device |
Primary outcome
Pain (Numeric Rating Scale; NRS)
Time frame: Change from Baseline to Week 6
4 secondary outcomes
Pain (NRS): 50% response rate
Time frame: Week 6
Pain (NRS) during treatment session
Time frame: Pre-treatment to Post-treatment (4 hours)
Grip Strength (dynamometer)
Time frame: Change from Baseline to Week 6
Treatment Compliance (subject-reported use of device compared to protocol)
Time frame: weekly through Week 6
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 31 Jan 2017.
- Derived from this study: PubMed 26468991Best TM, Moore B, Jarit P, Moorman CT, Lewis GK. Sustained acoustic medicine: wearable, long duration ultrasonic therapy for the treatment of tendinopathy. Phys Sportsmed. 2015 Nov;43(4):366-74. doi: 10.1080/00913847.2015.1095617. Epub 2015 Oct 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound Diathermy Device in people with Tendinopathy and Tendinitis, 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 5 inclusion and 9 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 31 Jan 2017. 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?
Pain (Numeric Rating Scale; NRS) (time frame: Change from Baseline to 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 NCT02466308, 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 31 Jan 2017.