An interventional study of Therapeutic ultrasound and Placebo therapeutic ultrasound in Tendon Injuries and Musculoskeletal Pain, sponsored by ZetrOZ, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by ZetrOZ, Inc. · Not applicable, Interventional, and Treatment
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.
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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 13 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →ZetrOZ, Inc. is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Therapeutic ultrasound
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.
Device: Placebo therapeutic ultrasound
Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Also known as: Therapeutic ultrasound (active), wearable ultrasound device, long duration ultrasound, LITUS device, long duration low intensity device
Patients receive "sham" therapeutic ultrasound daily for 4 hours.
Change in pain on the visual analog scale (VAS) from baseline to study conclusion
Time frame: Baseline, Week 7
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
This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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ZetrOZ, Inc.