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ID

40785

Description

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

Link

https://clinicaltrials.gov/show/NCT02197962

Keywords

Versions (1)
  1. 5/13/20 5/13/20 -
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May 13, 2020

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License

Creative Commons BY 4.0
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    Eligibility Knee Osteoarthritis NCT02197962

    English

    Eligibility Knee Osteoarthritis NCT02197962

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Primary osteoarthritis of knee

    Data type

    boolean

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

    Pain intensity Visual Analog Pain Scale

    Data type

    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);
    Description

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

    Data type

    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;
    Description

    Age

    Data type

    boolean

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

    Adrenal Cortex Hormones Absent

    Data type

    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;
    Description

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

    Data type

    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;
    Description

    Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent

    Data type

    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);
    Description

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

    Data type

    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;
    Description

    Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site

    Data type

    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;
    Description

    Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related

    Data type

    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;
    Description

    Fibromyalgia Absent

    Data type

    boolean

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

    Absence Hematological Disease Severe

    Data type

    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;
    Description

    Absence Mental disorders Severe | Psychiatric assessment Required

    Data type

    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
    Description

    Compliance behavior Follow-up

    Data type

    boolean

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

    Exclusion Criteria

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

    Informed Consent Withdrawn

    Data type

    boolean

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

    Eligibility Knee Osteoarthritis NCT02197962

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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