ID

40785

Description

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

Keywords

Versions (1)
  1. 5/13/20 5/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 13, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT02197962

English

Eligibility Knee Osteoarthritis NCT02197962

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Primary osteoarthritis of knee

Data type

boolean

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

Pain intensity Visual Analog Pain Scale

Data type

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);
Description

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

Data type

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;
Description

Age

Data type

boolean

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

Adrenal Cortex Hormones Absent

Data type

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;
Description

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

Data type

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;
Description

Absence Neuropathy Related | Radiculopathy Absent | Peripheral Neuropathy Absent

Data type

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);
Description

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

Data type

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;
Description

Absence Communicable Disease Application site | Absence Malignant Neoplasm Application site

Data type

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;
Description

Absence Endocrine System Diseases Related | Absence Metabolic Diseases Related

Data type

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;
Description

Fibromyalgia Absent

Data type

boolean

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

Absence Hematological Disease Severe

Data type

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;
Description

Absence Mental disorders Severe | Psychiatric assessment Required

Data type

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
Description

Compliance behavior Follow-up

Data type

boolean

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

Exclusion Criteria

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

Informed Consent Withdrawn

Data type

boolean

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

Eligibility Knee Osteoarthritis NCT02197962

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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