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NCT02034409 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
A Phase 1 study of Osteoarthritis, Degenerative, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 3
- Study locations
NCT02034409: Completed Phase 1 study of Osteoarthritis, Degenerative, sponsored by VA Office of Research and Development.
NCT02034409 is a Phase 1 study of Osteoarthritis, Degenerative that has completed, run by VA Office of Research and Development. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02034409, a Phase 1 study of Osteoarthritis, Degenerative, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
Primary Outcome
Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at l
Conditions Studied
Interventions
- DEVICE Sham Comparator
- DEVICE Pulsed Low Intensity Ultrasound
Study Locations (3)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Texas
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX - Dallas
Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-05-22 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 1 |
What the finished NCT02034409 record still lists
NCT02034409 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 1 condition, with Osteoarthritis, Degenerative appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.
NCT02034409 reports a single indexed study location in California, Texas, Utah.
Frequently Asked Questions
What is clinical trial NCT02034409 about?
NCT02034409 is a clinical study titled "A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis". The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
What is the current status of trial NCT02034409?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2015-05-22. Estimated completion is 2020-09-30.
What conditions does trial NCT02034409 study?
This clinical trial studies the following conditions: Osteoarthritis, Degenerative.
What interventions are being tested in trial NCT02034409?
The interventions under investigation include: Sham Comparator (DEVICE), Pulsed Low Intensity Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT02034409?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02034409 being conducted?
This trial has 3 study locations across California, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02034409's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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