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 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2020

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License

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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