ID

40785

Descripción

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

Palabras clave

Versiones (1)
  1. 13/5/20 13/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02197962

Inglés

Eligibility Knee Osteoarthritis NCT02197962

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Primary osteoarthritis of knee

Tipo de datos

boolean

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

Pain intensity Visual Analog Pain Scale

Tipo de datos

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);
Descripción

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

Tipo de datos

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;
Descripción

Age

Tipo de datos

boolean

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

Adrenal Cortex Hormones Absent

Tipo de datos

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;
Descripción

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

Tipo de datos

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;
Descripción

Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent

Tipo de datos

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);
Descripción

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

Tipo de datos

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;
Descripción

Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site

Tipo de datos

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;
Descripción

Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related

Tipo de datos

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;
Descripción

Fibromyalgia Absent

Tipo de datos

boolean

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

Absence Hematological Disease Severe

Tipo de datos

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;
Descripción

Absence Mental disorders Severe | Psychiatric assessment Required

Tipo de datos

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
Descripción

Compliance behavior Follow-up

Tipo de datos

boolean

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

Exclusion Criteria

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

Informed Consent Withdrawn

Tipo de datos

boolean

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

Eligibility Knee Osteoarthritis NCT02197962

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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