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ID

39603

Description

Splinting to Treat Hand Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01249391

Link

https://clinicaltrials.gov/show/NCT01249391

Keywords

Versions (1)
  1. 2/2/20 2/2/20 -
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See clinicaltrials.gov

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February 2, 2020

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Creative Commons BY 4.0
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    Eligibility Hand Osteoarthritis NCT01249391

    English

    Eligibility Hand Osteoarthritis NCT01249391

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged 18 - 90
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    definite diagnosis of ipj osteoarthritis (american college of rheumatology criteria for oa)
    Description

    Interphalangeal osteoarthritis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0263779
    a previous radiograph of the hands with changes consistent with oa
    Description

    Radiography of hand | Change Consistent with Osteoarthritis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0203244
    UMLS CUI [2,1]
    C0392747
    UMLS CUI [2,2]
    C0332290
    UMLS CUI [2,3]
    C0029408
    either, intervention group: at least 2 'affected' ipjs (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological oa associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on xray)
    Description

    Intervention Group | Interphalangeal joint Symptomatic Quantity | Average Severity of Pain Numeric Pain Scale | Osteoarthritis Diagnostic radiologic examination | Radial deviation Joint Degree Quantity | Ulnar deviation Joint Degree Quantity | Clinical examination | Radiology

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2986530
    UMLS CUI [2,1]
    C0016125
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3,1]
    C3641836
    UMLS CUI [3,2]
    C1518471
    UMLS CUI [4,1]
    C0029408
    UMLS CUI [4,2]
    C0043299
    UMLS CUI [5,1]
    C0449751
    UMLS CUI [5,2]
    C0022417
    UMLS CUI [5,3]
    C0449286
    UMLS CUI [5,4]
    C1265611
    UMLS CUI [6,1]
    C0449752
    UMLS CUI [6,2]
    C0022417
    UMLS CUI [6,3]
    C0449286
    UMLS CUI [6,4]
    C1265611
    UMLS CUI [7]
    C1456356
    UMLS CUI [8]
    C0034571
    or control group: at least 1 'affected' ipj (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological oa associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on x-ray)
    Description

    Control Group | Interphalangeal joint Symptomatic Quantity | Average Severity of Pain Numeric Pain Scale | Osteoarthritis Diagnostic radiologic examination | Radial deviation Joint Degree Quantity | Ulnar deviation Joint Degree Quantity | Clinical examination | Radiology

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009932
    UMLS CUI [2,1]
    C0016125
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3,1]
    C3641836
    UMLS CUI [3,2]
    C1518471
    UMLS CUI [4,1]
    C0029408
    UMLS CUI [4,2]
    C0043299
    UMLS CUI [5,1]
    C0449751
    UMLS CUI [5,2]
    C0022417
    UMLS CUI [5,3]
    C0449286
    UMLS CUI [5,4]
    C1265611
    UMLS CUI [6,1]
    C0449752
    UMLS CUI [6,2]
    C0022417
    UMLS CUI [6,3]
    C0449286
    UMLS CUI [6,4]
    C1265611
    UMLS CUI [7]
    C1456356
    UMLS CUI [8]
    C0034571
    stable oral therapy for month prior to study entry e.g. nsaids
    Description

    Therapy Oral Stable | Anti-Inflammatory Agents, Non-Steroidal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1527415
    UMLS CUI [1,3]
    C0205360
    UMLS CUI [2]
    C0003211
    capable of providing written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    contraindication to splinting e.g. allergy to materials
    Description

    Medical contraindication Splinting | Hypersensitivity Materials

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C2014585
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0520510
    planned surgery during study period
    Description

    Operative Surgical Procedure Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C1301732
    oral, intramuscular or intraarticular steroids within 3 months of study entry
    Description

    Steroids Oral | Steroids Intramuscular | Steroids Intraarticular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038317
    UMLS CUI [1,2]
    C1527415
    UMLS CUI [2,1]
    C0038317
    UMLS CUI [2,2]
    C1556154
    UMLS CUI [3,1]
    C0038317
    UMLS CUI [3,2]
    C1522204
    intraarticular hyaluronans to any nominated ip joints within 6 months of study entry
    Description

    Hyaluronic Acid Intraarticular Interphalangeal joint

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020196
    UMLS CUI [1,2]
    C1522204
    UMLS CUI [1,3]
    C0016125
    not resident in uk
    Description

    Residence Except UK

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0237096
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0041700
    pregnancy
    Description

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    other inflammatory arthritis
    Description

    Arthritis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003864
    history of psoriasis
    Description

    Psoriasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033860
    participation in other intervention trials
    Description

    Study Subject Participation Status | Interventional Study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C3274035
    patients with any uncontrolled or severe medical problems which in the opinion of the investigator makes them unsuitable for study participation
    Description

    Medical Problem Uncontrolled | Medical Problem Severe | Study Subject Participation Status Inappropriate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1254481
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C1254481
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3,1]
    C2348568
    UMLS CUI [3,2]
    C1548788
    unable to give informed written consent in english
    Description

    Informed Consent English Language Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0376245
    UMLS CUI [1,3]
    C1299582
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    Similar models

    Eligibility Hand Osteoarthritis NCT01249391

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    aged 18 - 90
    boolean
    C0001779 (UMLS CUI [1])
    Interphalangeal osteoarthritis
    Item
    definite diagnosis of ipj osteoarthritis (american college of rheumatology criteria for oa)
    boolean
    C0263779 (UMLS CUI [1])
    Radiography of hand | Change Consistent with Osteoarthritis
    Item
    a previous radiograph of the hands with changes consistent with oa
    boolean
    C0203244 (UMLS CUI [1])
    C0392747 (UMLS CUI [2,1])
    C0332290 (UMLS CUI [2,2])
    C0029408 (UMLS CUI [2,3])
    Intervention Group | Interphalangeal joint Symptomatic Quantity | Average Severity of Pain Numeric Pain Scale | Osteoarthritis Diagnostic radiologic examination | Radial deviation Joint Degree Quantity | Ulnar deviation Joint Degree Quantity | Clinical examination | Radiology
    Item
    either, intervention group: at least 2 'affected' ipjs (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological oa associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on xray)
    boolean
    C2986530 (UMLS CUI [1])
    C0016125 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C3641836 (UMLS CUI [3,1])
    C1518471 (UMLS CUI [3,2])
    C0029408 (UMLS CUI [4,1])
    C0043299 (UMLS CUI [4,2])
    C0449751 (UMLS CUI [5,1])
    C0022417 (UMLS CUI [5,2])
    C0449286 (UMLS CUI [5,3])
    C1265611 (UMLS CUI [5,4])
    C0449752 (UMLS CUI [6,1])
    C0022417 (UMLS CUI [6,2])
    C0449286 (UMLS CUI [6,3])
    C1265611 (UMLS CUI [6,4])
    C1456356 (UMLS CUI [7])
    C0034571 (UMLS CUI [8])
    Control Group | Interphalangeal joint Symptomatic Quantity | Average Severity of Pain Numeric Pain Scale | Osteoarthritis Diagnostic radiologic examination | Radial deviation Joint Degree Quantity | Ulnar deviation Joint Degree Quantity | Clinical examination | Radiology
    Item
    or control group: at least 1 'affected' ipj (symptomatic (>2/10 average pain on 0-10 scale in past week) and radiological oa associated with 10 degrees of either radial or ulnar deviation of the joint evident clinically and on x-ray)
    boolean
    C0009932 (UMLS CUI [1])
    C0016125 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C3641836 (UMLS CUI [3,1])
    C1518471 (UMLS CUI [3,2])
    C0029408 (UMLS CUI [4,1])
    C0043299 (UMLS CUI [4,2])
    C0449751 (UMLS CUI [5,1])
    C0022417 (UMLS CUI [5,2])
    C0449286 (UMLS CUI [5,3])
    C1265611 (UMLS CUI [5,4])
    C0449752 (UMLS CUI [6,1])
    C0022417 (UMLS CUI [6,2])
    C0449286 (UMLS CUI [6,3])
    C1265611 (UMLS CUI [6,4])
    C1456356 (UMLS CUI [7])
    C0034571 (UMLS CUI [8])
    Therapy Oral Stable | Anti-Inflammatory Agents, Non-Steroidal
    Item
    stable oral therapy for month prior to study entry e.g. nsaids
    boolean
    C0087111 (UMLS CUI [1,1])
    C1527415 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    C0003211 (UMLS CUI [2])
    Informed Consent
    Item
    capable of providing written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Medical contraindication Splinting | Hypersensitivity Materials
    Item
    contraindication to splinting e.g. allergy to materials
    boolean
    C1301624 (UMLS CUI [1,1])
    C2014585 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0520510 (UMLS CUI [2,2])
    Operative Surgical Procedure Planned
    Item
    planned surgery during study period
    boolean
    C0543467 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Steroids Oral | Steroids Intramuscular | Steroids Intraarticular
    Item
    oral, intramuscular or intraarticular steroids within 3 months of study entry
    boolean
    C0038317 (UMLS CUI [1,1])
    C1527415 (UMLS CUI [1,2])
    C0038317 (UMLS CUI [2,1])
    C1556154 (UMLS CUI [2,2])
    C0038317 (UMLS CUI [3,1])
    C1522204 (UMLS CUI [3,2])
    Hyaluronic Acid Intraarticular Interphalangeal joint
    Item
    intraarticular hyaluronans to any nominated ip joints within 6 months of study entry
    boolean
    C0020196 (UMLS CUI [1,1])
    C1522204 (UMLS CUI [1,2])
    C0016125 (UMLS CUI [1,3])
    Residence Except UK
    Item
    not resident in uk
    boolean
    C0237096 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0041700 (UMLS CUI [1,3])
    Pregnancy
    Item
    pregnancy
    boolean
    C0032961 (UMLS CUI [1])
    Arthritis
    Item
    other inflammatory arthritis
    boolean
    C0003864 (UMLS CUI [1])
    Psoriasis
    Item
    history of psoriasis
    boolean
    C0033860 (UMLS CUI [1])
    Study Subject Participation Status | Interventional Study
    Item
    participation in other intervention trials
    boolean
    C2348568 (UMLS CUI [1])
    C3274035 (UMLS CUI [2])
    Medical Problem Uncontrolled | Medical Problem Severe | Study Subject Participation Status Inappropriate
    Item
    patients with any uncontrolled or severe medical problems which in the opinion of the investigator makes them unsuitable for study participation
    boolean
    C1254481 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1254481 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C2348568 (UMLS CUI [3,1])
    C1548788 (UMLS CUI [3,2])
    Informed Consent English Language Unable
    Item
    unable to give informed written consent in english
    boolean
    C0021430 (UMLS CUI [1,1])
    C0376245 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
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