ID

36242

Description

Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02083861

Link

https://clinicaltrials.gov/show/NCT02083861

Keywords

Versions (1)
  1. 4/23/19 4/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02083861

English

Eligibility Knee Osteoarthritis NCT02083861

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate | Other Coding | Osteophytes Diagnostic radiologic examination | Narrowed joint space Diagnostic radiologic examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C1956089
UMLS CUI [4,2]
C0043299
UMLS CUI [5,1]
C1859695
UMLS CUI [5,2]
C0043299
fulfill the american college of rheumatology clinical and radiological diagnostic criteria for knee oa
Description

Osteoarthritis, Knee

Data type

boolean

Alias
UMLS CUI [1]
C0409959
35-80 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
report a frequent pain score between 3-7 (vas range: 0-10) during the week preceding enrollment
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
report that knee pain negatively affects quality of life
Description

Knee pain Limiting Quality of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0034380
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
Description

Use of Ultrasound gel Approved

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0361557
UMLS CUI [1,3]
C0205540
deemed appropriate by their physician or by the study site physician to participate
Description

Study Subject Participation Status Appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cannot successfully demonstrate the ability to put on and take off the device
Description

Use of Medical Device Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0025080
UMLS CUI [1,3]
C1299582
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.
Description

Condition Study Subject Participation Status Unacceptable | Comprehension Instructions Unable | Adherence Instructions Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1883420
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2051542
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2051542
UMLS CUI [3,3]
C1299582
have severe oa or have little to no cartilage in the knee
Description

Osteoarthritis Severe | Articular cartilage of knee joint Little | Articular cartilage of knee joint Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0582925
UMLS CUI [2,2]
C0700321
UMLS CUI [3,1]
C0582925
UMLS CUI [3,2]
C0332268
have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
Description

Knee Replacement | Surgical intervention | Hyaluronidase injection Knee affected

Data type

boolean

Alias
UMLS CUI [1]
C0086511
UMLS CUI [2]
C0549433
UMLS CUI [3,1]
C4283365
UMLS CUI [3,2]
C0022742
UMLS CUI [3,3]
C1314939
are non-ambulatory
Description

Non-ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0560046
participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
modify their medications during the course of the study (medications and doses must remain constant throughout the study)
Description

Modification Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C3840684
UMLS CUI [1,2]
C0013227
currently taking steroids
Description

Taking steroids

Data type

boolean

Alias
UMLS CUI [1]
C2054177
have contraindication to radiograph
Description

Medical contraindication Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0034571
have a secondary cause of arthritis (metabolic or inflammatory)
Description

Cause Secondary Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0003864
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Similar models

Eligibility Knee Osteoarthritis NCT02083861

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Mild | Knee Osteoarthritis Moderate | Other Coding | Osteophytes Diagnostic radiologic examination | Narrowed joint space Diagnostic radiologic examination
Item
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
boolean
C0409959 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0409959 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C1956089 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
C1859695 (UMLS CUI [5,1])
C0043299 (UMLS CUI [5,2])
Osteoarthritis, Knee
Item
fulfill the american college of rheumatology clinical and radiological diagnostic criteria for knee oa
boolean
C0409959 (UMLS CUI [1])
Age
Item
35-80 years of age
boolean
C0001779 (UMLS CUI [1])
Visual Analog Pain Scale
Item
report a frequent pain score between 3-7 (vas range: 0-10) during the week preceding enrollment
boolean
C0042815 (UMLS CUI [1])
Knee pain Limiting Quality of life
Item
report that knee pain negatively affects quality of life
boolean
C0231749 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0034380 (UMLS CUI [1,3])
Use of Ultrasound gel Approved
Item
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
boolean
C1524063 (UMLS CUI [1,1])
C0361557 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
Study Subject Participation Status Appropriate
Item
deemed appropriate by their physician or by the study site physician to participate
boolean
C2348568 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Use of Medical Device Unable
Item
cannot successfully demonstrate the ability to put on and take off the device
boolean
C1524063 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Condition Study Subject Participation Status Unacceptable | Comprehension Instructions Unable | Adherence Instructions Unable
Item
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.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C2051542 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1510802 (UMLS CUI [3,1])
C2051542 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Osteoarthritis Severe | Articular cartilage of knee joint Little | Articular cartilage of knee joint Lacking
Item
have severe oa or have little to no cartilage in the knee
boolean
C0029408 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0582925 (UMLS CUI [2,1])
C0700321 (UMLS CUI [2,2])
C0582925 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Knee Replacement | Surgical intervention | Hyaluronidase injection Knee affected
Item
have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
boolean
C0086511 (UMLS CUI [1])
C0549433 (UMLS CUI [2])
C4283365 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
Non-ambulatory
Item
are non-ambulatory
boolean
C0560046 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Modification Pharmaceutical Preparations
Item
modify their medications during the course of the study (medications and doses must remain constant throughout the study)
boolean
C3840684 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Taking steroids
Item
currently taking steroids
boolean
C2054177 (UMLS CUI [1])
Medical contraindication Radiography
Item
have contraindication to radiograph
boolean
C1301624 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Cause Secondary Arthritis
Item
have a secondary cause of arthritis (metabolic or inflammatory)
boolean
C0015127 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
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