Long Duration Therapeutic Ultrasound on Tendon Injuries
1 other identifier
interventional
13
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 31, 2017
January 1, 2017
9 months
January 12, 2015
January 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Baseline, Week 7
Secondary Outcomes (4)
Pressure point sensitivity as measured through algometry
Baseline, Week 7
Change in pain during functional testing as measured by VAS
Baseline, Week 7
Change in strength of limb through dynamometry
Baseline, Week 7
Quality of life and functioning through limb-specific standardized questionnaires
Baseline, Week 7
Study Arms (2)
Therapeutic ultrasound device
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Patients receive "sham" therapeutic ultrasound daily for 4 hours.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZetrOZ, Inc.lead
Study Sites (2)
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Zetroz, Inc
Trumbull, Connecticut, 06611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George K Lewis, PhD
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 16, 2015
Study Start
December 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
January 31, 2017
Record last verified: 2017-01