ID

12007

Beskrivning

A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02034409. Principal Investigator: Daniel O Clegg, MD VA Salt Lake City Health Care System, Salt Lake City, UT.

Länk

https://clinicaltrials.gov/show/NCT02034409

Nyckelord

  1. 2015-09-01 2015-09-01 -
Uppladdad den

1 september 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Osteoarthritis, Degenerative NCT02034409

Eligibility Osteoarthritis, Degenerative NCT02034409

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
40 years of age or older
Beskrivning

40 years of age or older

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Clinical symptoms of osteoarthritis for at least 6 months
Beskrivning

Clinical symptoms of osteoarthritis for at least 6 months

Datatyp

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0029408
Pain in the index knee on motion or weight bearing for the majority of days during the month before screening
Beskrivning

Pain in the index knee on motion or weight bearing for the majority of days during the month before screening

Datatyp

boolean

Alias
UMLS CUI [1]
C0231749
Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria
Beskrivning

Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
American Rheumatism Association Functional Class I, II, or III
Beskrivning

American Rheumatism Association Functional Class I, II, or III

Datatyp

boolean

Alias
UMLS CUI [1]
C0035435
UMLS CUI [2]
C0008902
Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception
Beskrivning

Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy
Beskrivning

Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy

Datatyp

boolean

Alias
UMLS CUI [1]
C0205420
UMLS CUI [2]
C0012634
Spine or hip pain of significant magnitude
Beskrivning

Spine or hip pain of significant magnitude

Datatyp

boolean

Alias
UMLS CUI [1]
C0019559
History of significant ligament or meniscal injury of the index joint
Beskrivning

History of significant ligament or meniscal injury of the index joint

Datatyp

boolean

Alias
UMLS CUI [1]
C0435001
Arthroscopy of the index knee within 6 months of study entry
Beskrivning

Arthroscopy of the index knee within 6 months of study entry

Datatyp

boolean

Alias
UMLS CUI [1]
C1304878
Unable to undergo MRI of the knee
Beskrivning

Unable to undergo MRI of the knee

Datatyp

boolean

Alias
UMLS CUI [1]
C0412714
Pregnancy or lactation
Beskrivning

Pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
Corticosteroid treatment within 1 to 3 months prior to study entry
Beskrivning

Corticosteroid treatment within 1 to 3 months prior to study entry

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0087111
Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry
Beskrivning

Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry

Datatyp

boolean

Alias
UMLS CUI [1]
C0021488
Use of excluded therapy(ies) prior to study entry
Beskrivning

therapy; exclude

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0332196
Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives
Beskrivning

Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0003191
Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry
Beskrivning

Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry

Datatyp

boolean

Alias
UMLS CUI [1]
C0017720
UMLS CUI [2]
C0087111
Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry
Beskrivning

Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry

Datatyp

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0087111
Initiation of any other medical or physical therapy, or muscle conditioning program, within 2 months prior to or during the study
Beskrivning

Initiation of any other medical or physical therapy, or muscle conditioning program, within 2 months prior to or during the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0949766
Unlikely to comply with study requirements
Beskrivning

Unlikely to comply with study requirements

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605

Similar models

Eligibility Osteoarthritis, Degenerative NCT02034409

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
40 years of age or older
boolean
C0001779 (UMLS CUI [1])
symptoms ;Degenerative polyarthritis
Item
Clinical symptoms of osteoarthritis for at least 6 months
boolean
C1457887 (UMLS CUI [1])
C0029408 (UMLS CUI [2])
Knee pain
Item
Pain in the index knee on motion or weight bearing for the majority of days during the month before screening
boolean
C0231749 (UMLS CUI [1])
Diagnosis
Item
Clinical diagnosis of primary osteoarthritis of the knee based on clinical and radiographic criteria
boolean
C0011900 (UMLS CUI [1])
Rheumatism; Classification
Item
American Rheumatism Association Functional Class I, II, or III
boolean
C0035435 (UMLS CUI [1])
C0008902 (UMLS CUI [2])
contraception
Item
Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Concurrent; disease
Item
Concurrent medical/arthritis condition(s), or any other illness per the opinion of the investigator, that could interfere with the evaluation of pain or efficacy
boolean
C0205420 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
Hip pain
Item
Spine or hip pain of significant magnitude
boolean
C0019559 (UMLS CUI [1])
Ligament injury
Item
History of significant ligament or meniscal injury of the index joint
boolean
C0435001 (UMLS CUI [1])
Arthroscopy of knee
Item
Arthroscopy of the index knee within 6 months of study entry
boolean
C1304878 (UMLS CUI [1])
MRI of the knee
Item
Unable to undergo MRI of the knee
boolean
C0412714 (UMLS CUI [1])
pregnancy
Item
Pregnancy or lactation
boolean
C0549206 (UMLS CUI [1])
corticosteroid; treatment
Item
Corticosteroid treatment within 1 to 3 months prior to study entry
boolean
C0001617 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Intra-articular injection
Item
Intra-articular injection of hyaluronic acid or congeners to the index knee within 6 months of study entry
boolean
C0021488 (UMLS CUI [1])
therapy; exclude
Item
Use of excluded therapy(ies) prior to study entry
boolean
C0087111 (UMLS CUI [1])
C0332196 (UMLS CUI [2])
Antirheumatic Agents
Item
Use of disease modifying anti-rheumatic medications and chronic tetracycline or its derivatives
boolean
C0003191 (UMLS CUI [1])
Glucosamine Sulfate; treatement
Item
Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment, within 1 month of study entry
boolean
C0017720 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
osteoarthritis; treatment
Item
Use of any medical therapy, complementary or alternative regimens for the treatment of osteoarthritis within 7 days prior to study entry
boolean
C0029408 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
physical therapy
Item
Initiation of any other medical or physical therapy, or muscle conditioning program, within 2 months prior to or during the study
boolean
C0949766 (UMLS CUI [1])
compliance
Item
Unlikely to comply with study requirements
boolean
C1321605 (UMLS CUI [1])

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