Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial
ZetrOZ Wearable Ultrasound Clinical Study
2 other identifiers
interventional
93
1 country
1
Brief Summary
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Mar 2014
Shorter than P25 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
May 7, 2018
CompletedMay 7, 2018
April 1, 2018
7 months
March 7, 2014
February 27, 2017
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion
The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.
Baseline, Week 6
Secondary Outcomes (3)
Quality of Life (WOMAC) Change From Baseline
Baseline, Week 6
Range of Motion Change From Baseline in Treated Knee
Baseline, Week 6
Muscle Strength Change From Baseline in Treated Knee
Baseline to 6 Weeks
Study Arms (2)
Active ultrasound device
EXPERIMENTALPatients receive treatment from the Sam Ultrasonic Diathermy 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 ultrasound device
PLACEBO COMPARATORPatients wear the Sam Ultrasonic Diathermy 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 apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
Eligibility Criteria
You may qualify if:
- Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
- years of age
- Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment
- Report that knee pain negatively affects quality of life
- Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
- Deemed appropriate by their physician or by the study site physician to participate
You may not qualify if:
- Cannot successfully demonstrate the ability to put on and take off the device
- Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions.
- Have severe OA or have little to no cartilage in the knee
- Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
- Are non-ambulatory
- Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
- Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
- Currently taking steroids
- Have contraindication to radiograph
- Have a secondary cause of arthritis (metabolic or inflammatory)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Pain Consultants
Dryden, New York, 13053, United States
Related Publications (1)
Draper DO, Klyve D, Ortiz R, Best TM. Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. 2018 Oct 16;13(1):257. doi: 10.1186/s13018-018-0965-0.
PMID: 30326947DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small number of patients enrolled in range of motion and strength study may have limited statistical analysis. Future studies should include larger sample sizes.
Results Point of Contact
- Title
- Dr. Ralph Ortiz
- Organization
- Pain Management Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Ortiz, D.O., MPH
Medical Pain Consultants
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 11, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
May 7, 2018
Results First Posted
May 7, 2018
Record last verified: 2018-04