A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

NCT02034409 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-10-18

Study results available
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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.

Conditions

  • Osteoarthritis, Degenerative

Interventions

DEVICE

Pulsed Low Intensity Ultrasound

20 minutes daily for 48 weeks

DEVICE

Sham Comparator

20 minutes daily for 48 weeks

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Daniel O Clegg, MD · VA Salt Lake City Health Care System, Salt Lake City, UT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-22
Primary Completion
2020-06-01
Completion
2020-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034409 on ClinicalTrials.gov