Long Duration Therapeutic Ultrasound on Tendon Injuries
Tendon Injuries, Musculoskeletal Pain
About this trial
This is an interventional treatment trial for Tendon Injuries focused on measuring tendinopathy, ultrasound, pain, heat, strength, LITUS, long duration, therapeutic ultrasound, tendonopathy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Arthritis in the treatment area
- Carpal tunnel syndrome (if subject has elbow tendinitis)
Sites / Locations
- Clinical Research Consulting
- Zetroz, Inc
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Therapeutic ultrasound device
Placebo therapeutic ultrasound device
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.
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.