Tendon InjuriesNCT02340273
Long Duration Therapeutic Ultrasound on Tendon Injuries
A study testing Therapeutic ultrasound in people with Tendon Injuries and Musculoskeletal Pain, run by ZetrOZ, Inc. at 2 sites in United States.
Trial summary
Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendon Injuries, Musculoskeletal Pain
- What is being tested?
- Therapeutic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Sep 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles), patella, or Achilles tendon based on physical examination by a healthcare practitioner and medical history. Physical examination must include one of the following: assessment of pain during manual movements of the injured limb (e.g. a positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness upon palpation over the tendon
- Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week preceding study screening
- Between 18 and 70 years of age
- Willing and able to self-administer the study device to the treatment area daily
- Have access to a mobile phone or camera to take a picture of the treatment area immediately after use of the device
- Body Mass Index (BMI) is less than or equal to 34.0
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- Agree to document all pain medications and associated dosages during participation in the study.
- If taking prescription pain medication, agree to keep dosage constant (unchanged) during participation in the study.
- Agree not to use any topical solution such as analgesic cream or ointment on the treatment area during participation in the study
Who cannot join
- Subjects that cannot speak, read or write English
- History or current diagnosis of tendinosis or a tendon tear
- Known neuropathy (nerve damage that affects the treatment area)
- Surgery in the treatment area within the last 6 months
- Non-ambulatory (unable to walk)
- Prisoner
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- Pregnant
- Have a pacemaker
- Malignancy in the treatment area
- Refuse to discontinue all other interventional treatment modalities (i.e. transcutaneous electrical nerve stimulation (TENS), electrical stimulation, or other ultrasound therapy) during the study
- Local corticosteroid or platelet-rich plasma (PRP) injection within the past 3 months
- Clinically significant or unstable medical or psychological conditions that would compromise participation in the study
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- Involved in any injury-related litigation in the treatment area
- Open sores or wounds in the treatment area that would prevent use of the device
- Arthritis in the treatment area
- Carpal tunnel syndrome (if subject has elbow tendinitis)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Research Consulting
Milford, Connecticut, 06460
Zetroz, Inc
Trumbull, Connecticut, 06611
About this study
Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.
Read the detailed description
The ability of long duration therapeutic ultrasound to reduce pain, increase strength, and improve quality of life for patients with tendon injury [e.g. tendinopathy of the elbow (medial or lateral], Achilles tendon, or patellar tendon) will be assessed. During the 7-week protocol, participants will receive 4 continuous hours of therapy daily.
For the first week, baseline data will be collected as participants report pain scores (VAS) in the morning, noon, and night. During the next 6 weeks, participants will self-apply the device each day and record their pain score (VAS) before and treatment; and record their pain score (VAS) while performing specified movements designed to evaluate tendon rehabilitation. At bi-weekly site visits, strength measurements will be performed on the injured and uninjured limb. Participants will also complete a standardized questionnaire to assess disability due to the specific tendon injury at baseline and study conclusion.
- Conditions
- Tendon Injuries, Musculoskeletal Pain
- Being tested
- Therapeutic ultrasound, Placebo therapeutic ultrasound
- Keywords
- tendinopathy, ultrasound, pain, heat, strength, LITUS, long duration, therapeutic ultrasound, tendonopathy
- Medical subject headings
- Tendon Injuries, Musculoskeletal Pain, Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasoundDevice
Also called Therapeutic ultrasound (active), wearable ultrasound device, long duration ultrasound, LITUS device
Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Placebo therapeutic ultrasoundDevice
Patients receive "sham" therapeutic ultrasound daily for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic ultrasound device | Experimental | Patients receive treatment from the long duration therapeutic ultrasound 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: Therapeutic ultrasound |
| Placebo therapeutic ultrasound device | Placebo comparator | Patients receive the "sham" long duration therapeutic ultrasound 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: Placebo therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Measured: Baseline, Week 7
Secondary outcomes (4)
Pressure point sensitivity as measured through algometry
Measured: Baseline, Week 7
Change in pain during functional testing as measured by VAS
Measured: Baseline, Week 7
Change in strength of limb through dynamometry
Measured: Baseline, Week 7
Quality of life and functioning through limb-specific standardized questionnaires
Measured: Baseline, Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K Lewis, PhD, Principal investigator, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340273
- Sponsor's protocol ID
- TN-02 (ZetrOZ-20140923)
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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 on Tendon Injuries
- ClinicalTrials.gov ID
- NCT02340273
- Acronym / sponsor ID
- TN-02 (ZetrOZ-20140923)
- Conditions
- Tendon Injuries, Musculoskeletal Pain
- Keywords
- tendinopathy, ultrasound, pain, heat, strength, LITUS, long duration, therapeutic ultrasound
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Jan 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.
Human clinical trial to measure the effect of long duration therapeutic ultrasound on tendon injuries. The hypothesis is that use of long duration ultrasound will relieve pain, increase tendon strength, and improve quality of life for patients with tendon injury.
Detailed description
The ability of long duration therapeutic ultrasound to reduce pain, increase strength, and improve quality of life for patients with tendon injury [e.g. tendinopathy of the elbow (medial or lateral], Achilles tendon, or patellar tendon) will be assessed. During the 7-week protocol, participants will receive 4 continuous hours of therapy daily.
For the first week, baseline data will be collected as participants report pain scores (VAS) in the morning, noon, and night. During the next 6 weeks, participants will self-apply the device each day and record their pain score (VAS) before and treatment; and record their pain score (VAS) while performing specified movements designed to evaluate tendon rehabilitation. At bi-weekly site visits, strength measurements will be performed on the injured and uninjured limb. Participants will also complete a standardized questionnaire to assess disability due to the specific tendon injury at baseline and study conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic ultrasound device | Experimental | Device: Therapeutic ultrasoundPatients receive treatment from the long duration therapeutic ultrasound 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 therapeutic ultrasound device | Placebo comparator | Device: Placebo therapeutic ultrasoundPatients receive the "sham" long duration therapeutic ultrasound 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
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has been diagnosed with tendinitis in the elbow (medial or lateral epicondyles), patella, or Achilles tendon based on physical examination by a healthcare practitioner and medical history. Physical examination must include one of the following: assessment of pain during manual movements of the injured limb (e.g. a positive Mill's Test [Wadsworth, 1987] for elbow tendinitis), or local tenderness upon palpation over the tendon
- Experience tendon pain greater than 1 (using the VAS scale of 0-10) during the week preceding study screening
- Between 18 and 70 years of age
- Willing and able to self-administer the study device to the treatment area daily
- Have access to a mobile phone or camera to take a picture of the treatment area immediately after use of the device
Key exclusion criteria (17 listed)
- Subjects that cannot speak, read or write English
- History or current diagnosis of tendinosis or a tendon tear
- Known neuropathy (nerve damage that affects the treatment area)
- Surgery in the treatment area within the last 6 months
- Non-ambulatory (unable to walk)
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 |
|---|---|---|
| Therapeutic ultrasoundAlso: Therapeutic ultrasound (active), wearable ultrasound device, long duration ultrasound, LITUS devicePatients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2. | Device | Therapeutic ultrasound device |
| Placebo therapeutic ultrasoundPatients receive "sham" therapeutic ultrasound daily for 4 hours. | Device | Placebo therapeutic ultrasound device |
Primary outcome
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Time frame: Baseline, Week 7
4 secondary outcomes
Pressure point sensitivity as measured through algometry
Time frame: Baseline, Week 7
Change in pain during functional testing as measured by VAS
Time frame: Baseline, Week 7
Change in strength of limb through dynamometry
Time frame: Baseline, Week 7
Quality of life and functioning through limb-specific standardized questionnaires
Time frame: Baseline, Week 7
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 31 Jan 2017.
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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.
George K Lewis, PhD principal investigator
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultrasound in people with Tendon Injuries and Musculoskeletal Pain, 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 9 inclusion and 17 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: stopped early, 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 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 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?
Change in pain on the visual analog scale (VAS) from baseline to study conclusion (time frame: Baseline, Week 7). 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 31 Jan 2017.