ID

17169

Description

Is Botox Effective in Relieving Pain From Knee Osteoarthritis?; ODM derived from: https://clinicaltrials.gov/show/NCT00279903

Link

https://clinicaltrials.gov/show/NCT00279903

Keywords

Versions (1)
  1. 8/29/16 8/29/16 -
Uploaded on

August 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT00279903

English

Eligibility Osteoarthritis, Knee NCT00279903

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a history of knee joint pain for greater than 6 months.
Description

Knee joint pain

Data type

boolean

Alias
UMLS CUI [1]
C0231749
2. medial or lateral tibiofemoral joint line tenderness.
Description

Medial or lateral tibiofemoral joint line tenderness

Data type

boolean

Alias
UMLS CUI [1]
C0576135
UMLS CUI [2]
C0576136
3. unilateral knee pain 6/10 or greater, on average, on the visual analog scale (vas), that interferes with function most days per week.
Description

Visual analog pain scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
4. prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy (quadriceps strengthening).
Description

Failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0438286
UMLS CUI [1,2]
C0000970
UMLS CUI [2,1]
C0438286
UMLS CUI [2,2]
C0003211
UMLS CUI [3,1]
C0438286
UMLS CUI [3,2]
C0949766
5. kellgren grade ii or iii radiographic changes of osteoarthritis.
Description

Kellgren radiographic changes

Data type

boolean

Alias
UMLS CUI [1]
C3177117
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age less than 40 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. anticoagulation with warfarin or heparin.
Description

Anticoagulation with warfarin or heparin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0019134
3. known allergy or sensitivity to any of the components of the study medications.
Description

Allergy to study medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
4. body mass index greater than 35.
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
5. previous major reconstructive surgery on the affected knee.
Description

Reconstructive surgery on the affected knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0524865
UMLS CUI [1,2]
C0022742
6. previous arthroscopic surgery on the affected knee in the past 12 months.
Description

Arthroscopic surgery on the affected knee

Data type

boolean

Alias
UMLS CUI [1]
C1304878
7. history of crystal induced arthropathy.
Description

Crystal induced arthropathy

Data type

boolean

Alias
UMLS CUI [1]
C0152087
8. use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.
Description

aminoglycoside antibiotics, curare-like agents; neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy

Data type

boolean

Alias
UMLS CUI [1]
C0003233
UMLS CUI [2]
C0010464
UMLS CUI [3]
C0027868
UMLS CUI [4]
C0026896
UMLS CUI [5]
C0002736
UMLS CUI [6]
C0026848
9. history of or evidence of active rheumatologic disease, diabetes, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders.
Description

active rheumatologic disease, diabetes, severe peripheral neuropathy, cardiac or respiratory disease; other serious diseases, including psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0031117
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0009488
10. evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
Description

Substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
11. females who are pregnant, breastfeeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Description

Pregnant or breastfeeding or planning a pregnancy; contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C2081645
UMLS CUI [4]
C0700589
12. intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular knee hyaluronic acid injection in the past 6 months.
Description

Intra-articular (knee) or systemic steroids; intra-articular knee hyaluronic acid injection

Data type

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2]
C2825233
UMLS CUI [3,1]
C0020196
UMLS CUI [3,2]
C0021488
13. patients who rate their average daily pain as less than 6 on a 10 point vas scale at the screening visit.
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
14. concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Osteoarthritis, Knee NCT00279903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Knee joint pain
Item
1. a history of knee joint pain for greater than 6 months.
boolean
C0231749 (UMLS CUI [1])
Medial or lateral tibiofemoral joint line tenderness
Item
2. medial or lateral tibiofemoral joint line tenderness.
boolean
C0576135 (UMLS CUI [1])
C0576136 (UMLS CUI [2])
Visual analog pain scale
Item
3. unilateral knee pain 6/10 or greater, on average, on the visual analog scale (vas), that interferes with function most days per week.
boolean
C0042815 (UMLS CUI [1])
Failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy
Item
4. prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy (quadriceps strengthening).
boolean
C0438286 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C0438286 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0438286 (UMLS CUI [3,1])
C0949766 (UMLS CUI [3,2])
Kellgren radiographic changes
Item
5. kellgren grade ii or iii radiographic changes of osteoarthritis.
boolean
C3177117 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age less than 40 years.
boolean
C0001779 (UMLS CUI [1])
Anticoagulation with warfarin or heparin
Item
2. anticoagulation with warfarin or heparin.
boolean
C0043031 (UMLS CUI [1])
C0019134 (UMLS CUI [2])
Allergy to study medication
Item
3. known allergy or sensitivity to any of the components of the study medications.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
BMI
Item
4. body mass index greater than 35.
boolean
C1305855 (UMLS CUI [1])
Reconstructive surgery on the affected knee
Item
5. previous major reconstructive surgery on the affected knee.
boolean
C0524865 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
Arthroscopic surgery on the affected knee
Item
6. previous arthroscopic surgery on the affected knee in the past 12 months.
boolean
C1304878 (UMLS CUI [1])
Crystal induced arthropathy
Item
7. history of crystal induced arthropathy.
boolean
C0152087 (UMLS CUI [1])
aminoglycoside antibiotics, curare-like agents; neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy
Item
8. use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.
boolean
C0003233 (UMLS CUI [1])
C0010464 (UMLS CUI [2])
C0027868 (UMLS CUI [3])
C0026896 (UMLS CUI [4])
C0002736 (UMLS CUI [5])
C0026848 (UMLS CUI [6])
active rheumatologic disease, diabetes, severe peripheral neuropathy, cardiac or respiratory disease; other serious diseases, including psychiatric disorders
Item
9. history of or evidence of active rheumatologic disease, diabetes, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders.
boolean
C0035435 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0009488 (UMLS CUI [7])
Substance abuse
Item
10. evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
boolean
C0038586 (UMLS CUI [1])
Pregnant or breastfeeding or planning a pregnancy; contraception
Item
11. females who are pregnant, breastfeeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C2081645 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Intra-articular (knee) or systemic steroids; intra-articular knee hyaluronic acid injection
Item
12. intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular knee hyaluronic acid injection in the past 6 months.
boolean
C2064783 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C0020196 (UMLS CUI [3,1])
C0021488 (UMLS CUI [3,2])
Visual Analog Pain Scale
Item
13. patients who rate their average daily pain as less than 6 on a 10 point vas scale at the screening visit.
boolean
C0042815 (UMLS CUI [1])
Study Subject Participation Status
Item
14. concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
boolean
C2348568 (UMLS CUI [1])
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