ID

36242

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02083861

Nyckelord

Versioner (1)
  1. 2019-04-23 2019-04-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02083861

Engelsk

Eligibility Knee Osteoarthritis NCT02083861

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

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

Datatyp

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
Beskrivning

Osteoarthritis, Knee

Datatyp

boolean

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

Age

Datatyp

boolean

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

Visual Analog Pain Scale

Datatyp

boolean

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

Knee pain Limiting Quality of life

Datatyp

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
Beskrivning

Use of Ultrasound gel Approved

Datatyp

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
Beskrivning

Study Subject Participation Status Appropriate

Datatyp

boolean

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

Exclusion Criteria

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

Use of Medical Device Unable

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Knee Replacement | Surgical intervention | Hyaluronidase injection Knee affected

Datatyp

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
Beskrivning

Non-ambulatory

Datatyp

boolean

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

Study Subject Participation Status | Investigational New Drugs

Datatyp

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)
Beskrivning

Modification Pharmaceutical Preparations

Datatyp

boolean

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

Taking steroids

Datatyp

boolean

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

Medical contraindication Radiography

Datatyp

boolean

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

Cause Secondary Arthritis

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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