ID

40766

Beschreibung

Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis: Double Blinded, Randomized Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01877278

Link

https://clinicaltrials.gov/show/NCT01877278

Stichworte

Versionen (1)
  1. 09.05.20 09.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Mai 2020

DOI

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Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01877278

Englisch

Eligibility Knee Osteoarthritis NCT01877278

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of primary oa of the knee according to the acr criteria, including radiologic evidence of oa
Beschreibung

Primary osteoarthritis of knee | Osteoarthritis Radiology

Datentyp

boolean

Alias
UMLS CUI [1]
C2893931
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0043299
age >40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
symptomatic disease for at least 6 months prior to enrollment
Beschreibung

Disease Symptomatic Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0449238
persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (nsaid), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (vas) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
Beschreibung

Pain Persistent | Standard therapy Maximum Tolerated Dose | Acetaminophen U/day | Anti-Inflammatory Agents, Non-Steroidal | Pain daily mean Visual Analog Pain Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0752079
UMLS CUI [3,1]
C0000970
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0003211
UMLS CUI [5,1]
C3845611
UMLS CUI [5,2]
C0444504
UMLS CUI [5,3]
C0042815
ability to attend followup appointments
Beschreibung

Compliance behavior Follow-up

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary causes of oa
Beschreibung

Secondary osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C2732281
local or systemic infection
Beschreibung

Local infection | Sepsis

Datentyp

boolean

Alias
UMLS CUI [1]
C1400591
UMLS CUI [2]
C0243026
diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
systemic arthritis
Beschreibung

Arthritis Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205373
allergy to anesthetic agent or contrast material
Beschreibung

Anesthetic allergy | Contrast media allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0741020
UMLS CUI [2]
C0570562
coagulopathy
Beschreibung

Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
anticoagulant therapy
Beschreibung

Anticoagulant therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0150457
had previous ia steroid injection
Beschreibung

Intraarticular steroid injection

Datentyp

boolean

Alias
UMLS CUI [1]
C2064783
avascular necrosis of bone
Beschreibung

Avascular necrosis of bone

Datentyp

boolean

Alias
UMLS CUI [1]
C0027543
patients who are on specific oa pharmacological therapy (nsaids, opioids) for more than 2 weeks prior enrollment
Beschreibung

Pharmacotherapy Specific Osteoarthritis | NSAIDs | Opioids

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0029408
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0242402
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT01877278

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Primary osteoarthritis of knee | Osteoarthritis Radiology
Item
a diagnosis of primary oa of the knee according to the acr criteria, including radiologic evidence of oa
boolean
C2893931 (UMLS CUI [1])
C0029408 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Age
Item
age >40 years
boolean
C0001779 (UMLS CUI [1])
Disease Symptomatic Duration
Item
symptomatic disease for at least 6 months prior to enrollment
boolean
C0012634 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Pain Persistent | Standard therapy Maximum Tolerated Dose | Acetaminophen U/day | Anti-Inflammatory Agents, Non-Steroidal | Pain daily mean Visual Analog Pain Scale
Item
persistent pain despite receiving the maximum tolerated doses of conventional medical therapy, including acetaminophen (4 gm/day) and/or a nonsteroidal antiinflammatory drug (nsaid), with persistent pain defined as a minimum mean score of 25 mm on the visual analog scales (vas) for global pain (0-100-mm range for each) daily pain during the month prior to study enrollment
boolean
C0030193 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0000970 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0003211 (UMLS CUI [4])
C3845611 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
C0042815 (UMLS CUI [5,3])
Compliance behavior Follow-up
Item
ability to attend followup appointments
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Secondary osteoarthritis
Item
secondary causes of oa
boolean
C2732281 (UMLS CUI [1])
Local infection | Sepsis
Item
local or systemic infection
boolean
C1400591 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Arthritis Systemic
Item
systemic arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Anesthetic allergy | Contrast media allergy
Item
allergy to anesthetic agent or contrast material
boolean
C0741020 (UMLS CUI [1])
C0570562 (UMLS CUI [2])
Blood Coagulation Disorders
Item
coagulopathy
boolean
C0005779 (UMLS CUI [1])
Anticoagulant therapy
Item
anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
Intraarticular steroid injection
Item
had previous ia steroid injection
boolean
C2064783 (UMLS CUI [1])
Avascular necrosis of bone
Item
avascular necrosis of bone
boolean
C0027543 (UMLS CUI [1])
Pharmacotherapy Specific Osteoarthritis | NSAIDs | Opioids
Item
patients who are on specific oa pharmacological therapy (nsaids, opioids) for more than 2 weeks prior enrollment
boolean
C0013216 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0029408 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
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