ID

12007

Description

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.

Link

https://clinicaltrials.gov/show/NCT02034409

Keywords

Versions (1)
  1. 9/1/15 9/1/15 -
Uploaded on

September 1, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Degenerative NCT02034409

English

Eligibility Osteoarthritis, Degenerative NCT02034409

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

40 years of age or older

Data type

boolean

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

Clinical symptoms of osteoarthritis for at least 6 months

Data type

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
Description

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

Data type

boolean

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

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

Data type

boolean

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

American Rheumatism Association Functional Class I, II, or III

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

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
Description

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

Data type

boolean

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

Spine or hip pain of significant magnitude

Data type

boolean

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

History of significant ligament or meniscal injury of the index joint

Data type

boolean

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

Arthroscopy of the index knee within 6 months of study entry

Data type

boolean

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

Unable to undergo MRI of the knee

Data type

boolean

Alias
UMLS CUI [1]
C0412714
Pregnancy or lactation
Description

Pregnancy or lactation

Data type

boolean

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

Corticosteroid treatment within 1 to 3 months prior to study entry

Data type

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
Description

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

Data type

boolean

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

therapy; exclude

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

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

Unlikely to comply with study requirements

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Osteoarthritis, Degenerative NCT02034409

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