ID

18602

Description

Functional Brain Imaging - Acupuncture and Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00070824

Link

https://clinicaltrials.gov/show/NCT00070824

Keywords

Versions (1)
  1. 11/11/16 11/11/16 -
Uploaded on

November 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00070824

English

Eligibility Osteoarthritis NCT00070824

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
seen in an outpatient clinical setting
Description

Clinical setting Outpatient

Data type

boolean

Alias
UMLS CUI [1,1]
C3176918
UMLS CUI [1,2]
C0029921
have active knee oa of >6 months including kellgren x-ray changes >2 from an x-ray report <12 months old or new x-ray interpretation
Description

Osteoarthritis, Knee | Kellgren-Lawrence score | X-ray Changes

Data type

boolean

Alias
UMLS CUI [1]
C0409959
UMLS CUI [2]
C3177117
UMLS CUI [3,1]
C0034571
UMLS CUI [3,2]
C0392747
moderate unilateral only pain (average >4/10 on a 0-10 likert scale) for more than 5 out of 7 days
Description

pain unilateral Moderate Frequency | Pain Rating Likert Scale Average

Data type

boolean

Alias
UMLS CUI [1,1]
C0747150
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0376249
UMLS CUI [2,1]
C3899970
UMLS CUI [2,2]
C1510992
have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
having had acupuncture before (must be acupuncture naïve)
Description

Acupuncture | Therapy naive Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0394664
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0686904
any history of claustrophobia that could affect the subject's ability to tolerate the f-mri study
Description

Claustrophobia Affecting participation fMRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0376335
hip or ankle disease by history or exam severe enough to cause pain >2/10 daily
Description

Disorder of hip Severe Causing Pain Frequency | Disorder of ankle Severe Causing Pain Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C1290862
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0030193
UMLS CUI [1,5]
C0376249
UMLS CUI [2,1]
C1290881
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0030193
UMLS CUI [2,5]
C0376249
bleeding disorder or current use of warfarin or heparin by patient history
Description

Blood Coagulation Disorders | Warfarin | Heparin

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.
Description

knee pain chronic Causes Primary | Chondromalacia Patellae | Tear of meniscus of knee | Ligament injury

Data type

boolean

Alias
UMLS CUI [1,1]
C0745571
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C0008475
UMLS CUI [3]
C0238218
UMLS CUI [4]
C0435001
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Similar models

Eligibility Osteoarthritis NCT00070824

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical setting Outpatient
Item
seen in an outpatient clinical setting
boolean
C3176918 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
Osteoarthritis, Knee | Kellgren-Lawrence score | X-ray Changes
Item
have active knee oa of >6 months including kellgren x-ray changes >2 from an x-ray report <12 months old or new x-ray interpretation
boolean
C0409959 (UMLS CUI [1])
C3177117 (UMLS CUI [2])
C0034571 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
pain unilateral Moderate Frequency | Pain Rating Likert Scale Average
Item
moderate unilateral only pain (average >4/10 on a 0-10 likert scale) for more than 5 out of 7 days
boolean
C0747150 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0376249 (UMLS CUI [1,3])
C3899970 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Protocol Compliance
Item
have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acupuncture | Therapy naive Patient need for
Item
having had acupuncture before (must be acupuncture naïve)
boolean
C0394664 (UMLS CUI [1])
C0919936 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Claustrophobia Affecting participation fMRI
Item
any history of claustrophobia that could affect the subject's ability to tolerate the f-mri study
boolean
C0008909 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0376335 (UMLS CUI [1,4])
Disorder of hip Severe Causing Pain Frequency | Disorder of ankle Severe Causing Pain Frequency
Item
hip or ankle disease by history or exam severe enough to cause pain >2/10 daily
boolean
C1290862 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,4])
C0376249 (UMLS CUI [1,5])
C1290881 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
C0376249 (UMLS CUI [2,5])
Blood Coagulation Disorders | Warfarin | Heparin
Item
bleeding disorder or current use of warfarin or heparin by patient history
boolean
C0005779 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
knee pain chronic Causes Primary | Chondromalacia Patellae | Tear of meniscus of knee | Ligament injury
Item
other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.
boolean
C0745571 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0008475 (UMLS CUI [2])
C0238218 (UMLS CUI [3])
C0435001 (UMLS CUI [4])
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