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ID

40785

Beskrivning

Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02197962

Länk

https://clinicaltrials.gov/show/NCT02197962

Nyckelord

  1. 2020-05-13 2020-05-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 maj 2020

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Knee Osteoarthritis NCT02197962

    Eligibility Knee Osteoarthritis NCT02197962

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    clinical and radiological diagnosis of primary knee diagnosis.
    Beskrivning

    Primary osteoarthritis of knee

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2893931
    pain intensity: visual analog scale (vas) ≥ 6;
    Beskrivning

    Pain intensity Visual Analog Pain Scale

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1320357
    UMLS CUI [1,2]
    C0042815
    one of more failures with conventional treatment (drugs, non-steroidal anti-inflammatory drugs - nsad, physiotherapy, stretching, acupuncture, orthosis and others);
    Beskrivning

    Conventional Treatment failed Number of occurrences | Pharmaceutical Preparations | Anti-Inflammatory Agents, Non-Steroidal | Physical therapy | Stretching | Acupuncture | Orthosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2945704
    UMLS CUI [1,2]
    C0231175
    UMLS CUI [1,3]
    C0449789
    UMLS CUI [2]
    C0013227
    UMLS CUI [3]
    C0003211
    UMLS CUI [4]
    C0949766
    UMLS CUI [5]
    C0600080
    UMLS CUI [6]
    C0394664
    UMLS CUI [7]
    C0006086
    age over 60 years;
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    no use of corticosteroids in the prior 48 hours;
    Beskrivning

    Adrenal Cortex Hormones Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001617
    UMLS CUI [1,2]
    C0332197
    no major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
    Beskrivning

    Absence Osteoarthritis of wrist Major | Absence Osteoarthritis of ankle Major | Absence Osteoarthritis Lower back

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0409955
    UMLS CUI [1,3]
    C0205164
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C0409931
    UMLS CUI [2,3]
    C0205164
    UMLS CUI [3,1]
    C0332197
    UMLS CUI [3,2]
    C0029408
    UMLS CUI [3,3]
    C0230102
    no clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
    Beskrivning

    Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0442874
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [2,1]
    C0700594
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0031117
    UMLS CUI [3,2]
    C0332197
    absence of systemic inflammatory disease (rheumatoid arthritis, reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
    Beskrivning

    Absence Inflammatory disorder Systemic | Rheumatoid Arthritis Absent | Reiter Syndrome Absent | Ankylosing spondylitis Absent | Generalized polyarthritis Absent | Malignant Neoplasm Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C1290884
    UMLS CUI [1,3]
    C0205373
    UMLS CUI [2,1]
    C0003873
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [3,1]
    C0035012
    UMLS CUI [3,2]
    C0332197
    UMLS CUI [4,1]
    C0038013
    UMLS CUI [4,2]
    C0332197
    UMLS CUI [5,1]
    C0234948
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [6,1]
    C0006826
    UMLS CUI [6,2]
    C0332197
    absence of infection or cancer at the application site;
    Beskrivning

    Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0009450
    UMLS CUI [1,3]
    C0229986
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C0006826
    UMLS CUI [2,3]
    C0229986
    absence of related endocrine and metabolic diseases;
    Beskrivning

    Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0014130
    UMLS CUI [1,3]
    C0439849
    UMLS CUI [2,1]
    C0332197
    UMLS CUI [2,2]
    C0025517
    UMLS CUI [2,3]
    C0439849
    absence of fibromyalgia, diagnosed after the american college of rheumatology, 1999;
    Beskrivning

    Fibromyalgia Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0016053
    UMLS CUI [1,2]
    C0332197
    absence of severe blood dyscrasias;
    Beskrivning

    Absence Hematological Disease Severe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0018939
    UMLS CUI [1,3]
    C0205082
    absence of severe psychiatric disturbances that requires psychiatric assessment;
    Beskrivning

    Absence Mental disorders Severe | Psychiatric assessment Required

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332197
    UMLS CUI [1,2]
    C0004936
    UMLS CUI [1,3]
    C0205082
    UMLS CUI [2,1]
    C0846574
    UMLS CUI [2,2]
    C1514873
    availability to comply with the clinic visits and follow up evaluations along the treatment
    Beskrivning

    Compliance behavior Follow-up

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C3274571
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who withdraw the informed consent form at any time
    Beskrivning

    Informed Consent Withdrawn

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2349954

    Similar models

    Eligibility Knee Osteoarthritis NCT02197962

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Primary osteoarthritis of knee
    Item
    clinical and radiological diagnosis of primary knee diagnosis.
    boolean
    C2893931 (UMLS CUI [1])
    Pain intensity Visual Analog Pain Scale
    Item
    pain intensity: visual analog scale (vas) ≥ 6;
    boolean
    C1320357 (UMLS CUI [1,1])
    C0042815 (UMLS CUI [1,2])
    Conventional Treatment failed Number of occurrences | Pharmaceutical Preparations | Anti-Inflammatory Agents, Non-Steroidal | Physical therapy | Stretching | Acupuncture | Orthosis
    Item
    one of more failures with conventional treatment (drugs, non-steroidal anti-inflammatory drugs - nsad, physiotherapy, stretching, acupuncture, orthosis and others);
    boolean
    C2945704 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C0449789 (UMLS CUI [1,3])
    C0013227 (UMLS CUI [2])
    C0003211 (UMLS CUI [3])
    C0949766 (UMLS CUI [4])
    C0600080 (UMLS CUI [5])
    C0394664 (UMLS CUI [6])
    C0006086 (UMLS CUI [7])
    Age
    Item
    age over 60 years;
    boolean
    C0001779 (UMLS CUI [1])
    Adrenal Cortex Hormones Absent
    Item
    no use of corticosteroids in the prior 48 hours;
    boolean
    C0001617 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Absence Osteoarthritis of wrist Major | Absence Osteoarthritis of ankle Major | Absence Osteoarthritis Lower back
    Item
    no major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0409955 (UMLS CUI [1,2])
    C0205164 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [2,1])
    C0409931 (UMLS CUI [2,2])
    C0205164 (UMLS CUI [2,3])
    C0332197 (UMLS CUI [3,1])
    C0029408 (UMLS CUI [3,2])
    C0230102 (UMLS CUI [3,3])
    Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent
    Item
    no clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0442874 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0700594 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0031117 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    Absence Inflammatory disorder Systemic | Rheumatoid Arthritis Absent | Reiter Syndrome Absent | Ankylosing spondylitis Absent | Generalized polyarthritis Absent | Malignant Neoplasm Absent
    Item
    absence of systemic inflammatory disease (rheumatoid arthritis, reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
    boolean
    C0332197 (UMLS CUI [1,1])
    C1290884 (UMLS CUI [1,2])
    C0205373 (UMLS CUI [1,3])
    C0003873 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C0035012 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0038013 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    C0234948 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0006826 (UMLS CUI [6,1])
    C0332197 (UMLS CUI [6,2])
    Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site
    Item
    absence of infection or cancer at the application site;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0009450 (UMLS CUI [1,2])
    C0229986 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [2,1])
    C0006826 (UMLS CUI [2,2])
    C0229986 (UMLS CUI [2,3])
    Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related
    Item
    absence of related endocrine and metabolic diseases;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0014130 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [2,1])
    C0025517 (UMLS CUI [2,2])
    C0439849 (UMLS CUI [2,3])
    Fibromyalgia Absent
    Item
    absence of fibromyalgia, diagnosed after the american college of rheumatology, 1999;
    boolean
    C0016053 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Absence Hematological Disease Severe
    Item
    absence of severe blood dyscrasias;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0018939 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    Absence Mental disorders Severe | Psychiatric assessment Required
    Item
    absence of severe psychiatric disturbances that requires psychiatric assessment;
    boolean
    C0332197 (UMLS CUI [1,1])
    C0004936 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    C0846574 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    Compliance behavior Follow-up
    Item
    availability to comply with the clinic visits and follow up evaluations along the treatment
    boolean
    C1321605 (UMLS CUI [1,1])
    C3274571 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Informed Consent Withdrawn
    Item
    patients who withdraw the informed consent form at any time
    boolean
    C0021430 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])

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