ID

40785

Descrição

Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02197962

Link

https://clinicaltrials.gov/show/NCT02197962

Palavras-chave

Versões (1)
  1. 13/05/2020 13/05/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de maio de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02197962

Inglês

Eligibility Knee Osteoarthritis NCT02197962

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical and radiological diagnosis of primary knee diagnosis.
Descrição

Primary osteoarthritis of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2893931
pain intensity: visual analog scale (vas) ≥ 6;
Descrição

Pain intensity Visual Analog Pain Scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0042815
one of more failures with conventional treatment (drugs, non-steroidal anti-inflammatory drugs - nsad, physiotherapy, stretching, acupuncture, orthosis and others);
Descrição

Conventional Treatment failed Number of occurrences | Pharmaceutical Preparations | Anti-Inflammatory Agents, Non-Steroidal | Physical therapy | Stretching | Acupuncture | Orthosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2945704
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0449789
UMLS CUI [2]
C0013227
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0949766
UMLS CUI [5]
C0600080
UMLS CUI [6]
C0394664
UMLS CUI [7]
C0006086
age over 60 years;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
no use of corticosteroids in the prior 48 hours;
Descrição

Adrenal Cortex Hormones Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0332197
no major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
Descrição

Absence Osteoarthritis of wrist Major | Absence Osteoarthritis of ankle Major | Absence Osteoarthritis Lower back

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0409955
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0409931
UMLS CUI [2,3]
C0205164
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0029408
UMLS CUI [3,3]
C0230102
no clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
Descrição

Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0442874
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0700594
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C0332197
absence of systemic inflammatory disease (rheumatoid arthritis, reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
Descrição

Absence Inflammatory disorder Systemic | Rheumatoid Arthritis Absent | Reiter Syndrome Absent | Ankylosing spondylitis Absent | Generalized polyarthritis Absent | Malignant Neoplasm Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1290884
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035012
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0038013
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0234948
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0332197
absence of infection or cancer at the application site;
Descrição

Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0229986
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0229986
absence of related endocrine and metabolic diseases;
Descrição

Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0014130
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0025517
UMLS CUI [2,3]
C0439849
absence of fibromyalgia, diagnosed after the american college of rheumatology, 1999;
Descrição

Fibromyalgia Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0016053
UMLS CUI [1,2]
C0332197
absence of severe blood dyscrasias;
Descrição

Absence Hematological Disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0018939
UMLS CUI [1,3]
C0205082
absence of severe psychiatric disturbances that requires psychiatric assessment;
Descrição

Absence Mental disorders Severe | Psychiatric assessment Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0004936
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0846574
UMLS CUI [2,2]
C1514873
availability to comply with the clinic visits and follow up evaluations along the treatment
Descrição

Compliance behavior Follow-up

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who withdraw the informed consent form at any time
Descrição

Informed Consent Withdrawn

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2349954
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Similar models

Eligibility Knee Osteoarthritis NCT02197962

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Primary osteoarthritis of knee
Item
clinical and radiological diagnosis of primary knee diagnosis.
boolean
C2893931 (UMLS CUI [1])
Pain intensity Visual Analog Pain Scale
Item
pain intensity: visual analog scale (vas) ≥ 6;
boolean
C1320357 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Conventional Treatment failed Number of occurrences | Pharmaceutical Preparations | Anti-Inflammatory Agents, Non-Steroidal | Physical therapy | Stretching | Acupuncture | Orthosis
Item
one of more failures with conventional treatment (drugs, non-steroidal anti-inflammatory drugs - nsad, physiotherapy, stretching, acupuncture, orthosis and others);
boolean
C2945704 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0449789 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0949766 (UMLS CUI [4])
C0600080 (UMLS CUI [5])
C0394664 (UMLS CUI [6])
C0006086 (UMLS CUI [7])
Age
Item
age over 60 years;
boolean
C0001779 (UMLS CUI [1])
Adrenal Cortex Hormones Absent
Item
no use of corticosteroids in the prior 48 hours;
boolean
C0001617 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Osteoarthritis of wrist Major | Absence Osteoarthritis of ankle Major | Absence Osteoarthritis Lower back
Item
no major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
boolean
C0332197 (UMLS CUI [1,1])
C0409955 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0409931 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0029408 (UMLS CUI [3,2])
C0230102 (UMLS CUI [3,3])
Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent
Item
no clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
boolean
C0332197 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0700594 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0031117 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Absence Inflammatory disorder Systemic | Rheumatoid Arthritis Absent | Reiter Syndrome Absent | Ankylosing spondylitis Absent | Generalized polyarthritis Absent | Malignant Neoplasm Absent
Item
absence of systemic inflammatory disease (rheumatoid arthritis, reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
boolean
C0332197 (UMLS CUI [1,1])
C1290884 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035012 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0038013 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0234948 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site
Item
absence of infection or cancer at the application site;
boolean
C0332197 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0229986 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0229986 (UMLS CUI [2,3])
Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related
Item
absence of related endocrine and metabolic diseases;
boolean
C0332197 (UMLS CUI [1,1])
C0014130 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0025517 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Fibromyalgia Absent
Item
absence of fibromyalgia, diagnosed after the american college of rheumatology, 1999;
boolean
C0016053 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Hematological Disease Severe
Item
absence of severe blood dyscrasias;
boolean
C0332197 (UMLS CUI [1,1])
C0018939 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Absence Mental disorders Severe | Psychiatric assessment Required
Item
absence of severe psychiatric disturbances that requires psychiatric assessment;
boolean
C0332197 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0846574 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Compliance behavior Follow-up
Item
availability to comply with the clinic visits and follow up evaluations along the treatment
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Withdrawn
Item
patients who withdraw the informed consent form at any time
boolean
C0021430 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
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