ID

24809

Description

An Intervention of Electrical Stimulation in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00500448

Link

https://clinicaltrials.gov/show/NCT00500448

Keywords

Versions (1)
  1. 8/18/17 8/18/17 -
Uploaded on

August 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00500448

English

Eligibility Osteoarthritis NCT00500448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all participants must be at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all participants must be female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
subjects must have radiographic osteoarthritis of grade 2 severity according to the kellgren and lawrence scale on the posterior-anterior semi-flexed view with definite osteophytes present in the medial and not lateral compartment.
Description

Osteoarthritis Kellgren-Lawrence score | Osteophytes Medial compartment of knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C3177117
UMLS CUI [2,1]
C1956089
UMLS CUI [2,2]
C0447799
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous adverse reaction to electrical stimulation
Description

Adverse reactions Electric stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0013786
inability to ambulate without the use of an assistive device (i.e cane, walker)
Description

Ambulate Assistive device Patient need for | Cane | Walker

Data type

boolean

Alias
UMLS CUI [1,1]
C4036205
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0006856
UMLS CUI [3]
C0043016
patients who have undergone a total knee arthroplasty
Description

Knee Replacement Arthroplasty

Data type

boolean

Alias
UMLS CUI [1]
C0086511
patients who have torn any knee ligament (acl, pcl, mcl, lcl)
Description

Anterior Cruciate Ligament Tear | Rupture of posterior cruciate ligament | Rupture of medial collateral ligament of knee | Rupture of lateral collateral ligament of knee

Data type

boolean

Alias
UMLS CUI [1]
C0409312
UMLS CUI [2]
C0409316
UMLS CUI [3]
C0409320
UMLS CUI [4]
C0435133
enrollees who have a demand-type cardiac pacemaker or are pregnant
Description

Artificial cardiac pacemaker | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0032961
history of tibial osteotomy surgery
Description

Osteotomy of tibia

Data type

boolean

Alias
UMLS CUI [1]
C0187826
significant peripheral or central nervous system disease
Description

Peripheral Neuropathy | CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0007682
concurrent clinically active arthritis of the hip, ankle, hindfoot or midfoot in either limb
Description

Coxitis | Ankle arthritis Lower limb Either | Hindfoot Arthritis Lower limb Either | Midfoot Arthritis Lower limb Either

Data type

boolean

Alias
UMLS CUI [1]
C0263776
UMLS CUI [2,1]
C0238650
UMLS CUI [2,2]
C0023216
UMLS CUI [2,3]
C3844638
UMLS CUI [3,1]
C0230459
UMLS CUI [3,2]
C0003864
UMLS CUI [3,3]
C0023216
UMLS CUI [3,4]
C3844638
UMLS CUI [4,1]
C0932074
UMLS CUI [4,2]
C0003864
UMLS CUI [4,3]
C0023216
UMLS CUI [4,4]
C3844638
concurrent bilateral radiographic evidence of tibiofemoral osteoarthritis
Description

Osteoarthritis Tibiofemoral joint Bilateral Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0447795
UMLS CUI [1,3]
C0238767
UMLS CUI [1,4]
C0034571
enrollees who are concurrently undergoing physical therapy for pain or oa
Description

Physical therapy Pain | Physical therapy Osteoarthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0949766
UMLS CUI [1,2]
C0030193
UMLS CUI [2,1]
C0949766
UMLS CUI [2,2]
C0029408
enrollees who are taking cox-2 inhibitors or are receiving corticosteroid injections
Description

COX-2 Inhibitors | Adrenal Cortex Hormones Injection

Data type

boolean

Alias
UMLS CUI [1]
C1257954
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1828121
subjects will be allowed to take buffered aspirin and naproxen sodium while enrolled in the study
Description

Buffered aspirin allowed | Naproxen sodium allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0718687
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0546873
UMLS CUI [2,2]
C0683607
enrollees who have a body mass index of greater than 40 (morbidly obese)
Description

Body mass index | Obesity, Morbid

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0028756
enrollees who have a car > .95 (e.g. patients whose quadriceps are uninhibited)
Description

Activation Central Ratio | Quadriceps uninhibited

Data type

boolean

Alias
UMLS CUI [1,1]
C1879547
UMLS CUI [1,2]
C0205099
UMLS CUI [1,3]
C0456603
UMLS CUI [2,1]
C0224440
UMLS CUI [2,2]
C2188186
enrollees who have previously undergone quadriceps nmes therapy
Description

Quadriceps Neuromuscular Electrical Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C0224440
UMLS CUI [1,2]
C2985393
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Similar models

Eligibility Osteoarthritis NCT00500448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
all participants must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender
Item
all participants must be female
boolean
C0079399 (UMLS CUI [1])
Osteoarthritis Kellgren-Lawrence score | Osteophytes Medial compartment of knee
Item
subjects must have radiographic osteoarthritis of grade 2 severity according to the kellgren and lawrence scale on the posterior-anterior semi-flexed view with definite osteophytes present in the medial and not lateral compartment.
boolean
C0029408 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C1956089 (UMLS CUI [2,1])
C0447799 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Adverse reactions Electric stimulation
Item
previous adverse reaction to electrical stimulation
boolean
C0559546 (UMLS CUI [1,1])
C0013786 (UMLS CUI [1,2])
Ambulate Assistive device Patient need for | Cane | Walker
Item
inability to ambulate without the use of an assistive device (i.e cane, walker)
boolean
C4036205 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0006856 (UMLS CUI [2])
C0043016 (UMLS CUI [3])
Knee Replacement Arthroplasty
Item
patients who have undergone a total knee arthroplasty
boolean
C0086511 (UMLS CUI [1])
Anterior Cruciate Ligament Tear | Rupture of posterior cruciate ligament | Rupture of medial collateral ligament of knee | Rupture of lateral collateral ligament of knee
Item
patients who have torn any knee ligament (acl, pcl, mcl, lcl)
boolean
C0409312 (UMLS CUI [1])
C0409316 (UMLS CUI [2])
C0409320 (UMLS CUI [3])
C0435133 (UMLS CUI [4])
Artificial cardiac pacemaker | Pregnancy
Item
enrollees who have a demand-type cardiac pacemaker or are pregnant
boolean
C0030163 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Osteotomy of tibia
Item
history of tibial osteotomy surgery
boolean
C0187826 (UMLS CUI [1])
Peripheral Neuropathy | CNS disorder
Item
significant peripheral or central nervous system disease
boolean
C0031117 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
Coxitis | Ankle arthritis Lower limb Either | Hindfoot Arthritis Lower limb Either | Midfoot Arthritis Lower limb Either
Item
concurrent clinically active arthritis of the hip, ankle, hindfoot or midfoot in either limb
boolean
C0263776 (UMLS CUI [1])
C0238650 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C3844638 (UMLS CUI [2,3])
C0230459 (UMLS CUI [3,1])
C0003864 (UMLS CUI [3,2])
C0023216 (UMLS CUI [3,3])
C3844638 (UMLS CUI [3,4])
C0932074 (UMLS CUI [4,1])
C0003864 (UMLS CUI [4,2])
C0023216 (UMLS CUI [4,3])
C3844638 (UMLS CUI [4,4])
Osteoarthritis Tibiofemoral joint Bilateral Radiography
Item
concurrent bilateral radiographic evidence of tibiofemoral osteoarthritis
boolean
C0029408 (UMLS CUI [1,1])
C0447795 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0034571 (UMLS CUI [1,4])
Physical therapy Pain | Physical therapy Osteoarthritis
Item
enrollees who are concurrently undergoing physical therapy for pain or oa
boolean
C0949766 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0949766 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
COX-2 Inhibitors | Adrenal Cortex Hormones Injection
Item
enrollees who are taking cox-2 inhibitors or are receiving corticosteroid injections
boolean
C1257954 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Buffered aspirin allowed | Naproxen sodium allowed
Item
subjects will be allowed to take buffered aspirin and naproxen sodium while enrolled in the study
boolean
C0718687 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0546873 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Body mass index | Obesity, Morbid
Item
enrollees who have a body mass index of greater than 40 (morbidly obese)
boolean
C1305855 (UMLS CUI [1])
C0028756 (UMLS CUI [2])
Activation Central Ratio | Quadriceps uninhibited
Item
enrollees who have a car > .95 (e.g. patients whose quadriceps are uninhibited)
boolean
C1879547 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
C0224440 (UMLS CUI [2,1])
C2188186 (UMLS CUI [2,2])
Quadriceps Neuromuscular Electrical Stimulation
Item
enrollees who have previously undergone quadriceps nmes therapy
boolean
C0224440 (UMLS CUI [1,1])
C2985393 (UMLS CUI [1,2])
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