ID

31299

Description

Exploring Massage Benefits for Arthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00970008

Link

https://clinicaltrials.gov/show/NCT00970008

Keywords

Versions (1)
  1. 8/10/18 8/10/18 -
Copyright Holder

See clinicaltrials.gov

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August 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00970008

English

Eligibility Osteoarthritis of the Knee NCT00970008

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
35 years of age or greater.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written confirmation of oa of the knee as provided by the participant's physician.
Description

Knee Osteoarthritis Confirmed by Physician

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0031831
radiographically-established oa of the knee.
Description

Knee Osteoarthritis Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0034571
pre-randomization score of 40 to 90 on the visual analog pain scale (0-100 mm scale).
Description

Visual Analog Pain Scale

Data type

boolean

Alias
UMLS CUI [1]
C0042815
patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
Description

Bilateral primary osteoarthritis of knee | Index Knee Affected Severe

Data type

boolean

Alias
UMLS CUI [1]
C2893930
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0205082
american college of rheumatology defined oa of the knee:
Description

Knee Osteoarthritis Definition

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0679227
1. knee pain
Description

Knee pain

Data type

boolean

Alias
UMLS CUI [1]
C0231749
2. satisfaction of at least five of the following nine criteria:
Description

Criteria Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
1. age greater than 50 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. stiffness < 30 minutes
Description

Stiffness Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0427008
UMLS CUI [1,2]
C0449238
3. crepitus
Description

Crepitus

Data type

boolean

Alias
UMLS CUI [1]
C0277964
4. bony tenderness
Description

Bone tenderness

Data type

boolean

Alias
UMLS CUI [1]
C0238807
5. bony enlargement
Description

Bony joint enlargement

Data type

boolean

Alias
UMLS CUI [1]
C0221610
6. no palpable warmth
Description

Joint warmth Palpation Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0240095
UMLS CUI [1,2]
C0030247
UMLS CUI [1,3]
C1272705
7. esr < 40 mm/hr
Description

Erythrocyte sedimentation rate measurement

Data type

boolean

Alias
UMLS CUI [1]
C1176468
8. rheumatoid factor (rf) < 1:40
Description

Rheumatoid Factor Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201660
exclusion criteria: (no exclusion criterion may be present)
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
Description

Rheumatoid Arthritis | Fibromyalgia | Pseudogout Recurrent | Pseudogout

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0016053
UMLS CUI [3,1]
C0033802
UMLS CUI [3,2]
C2945760
UMLS CUI [4]
C0033802
presence of cancer or other serious medical conditions.
Description

Malignant Neoplasms | Other medical condition Serious

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
signs or history of kidney or liver failure.
Description

Signs Kidney Failure | Signs Liver Failure | Kidney Failure | Liver Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0035078
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0085605
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0085605
presence of asthma requiring the use of corticosteroid treatment.
Description

Asthma Requirement Steroid therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0149783
use of oral corticosteroids within the past four weeks.
Description

Adrenal Cortex Hormones Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
use of intra-articular knee depo-corticosteroids with the past three months.
Description

Knee Intraarticular injection of corticosteroids Depot Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0022742
UMLS CUI [1,2]
C2064783
UMLS CUI [1,3]
C0086129
use of intra-articular hyaluronate with the past six months.
Description

Hyaluronate Intraarticular

Data type

boolean

Alias
UMLS CUI [1,1]
C0178695
UMLS CUI [1,2]
C1522204
arthroscopic surgery of the knee within the past year.
Description

Arthroscopic Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0750934
significant injury to the knee within the past six months.
Description

Knee Injury

Data type

boolean

Alias
UMLS CUI [1]
C0022744
presence of a rash or open wound over the knee.
Description

Knee rash | Open wound of knee

Data type

boolean

Alias
UMLS CUI [1]
C0240126
UMLS CUI [2]
C0347570
unable to satisfy the treatment and follow-up requirements.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
unable to provide written informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
currently receiving massage therapy on a regular basis (at least twice a month).
Description

Massage Therapy Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C3536731
UMLS CUI [1,2]
C0205272
knee replacement of study knee (ok if the knee not being studied has been replaced).
Description

Knee Replacement Index Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0022742
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Similar models

Eligibility Osteoarthritis of the Knee NCT00970008

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
35 years of age or greater.
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis Confirmed by Physician
Item
written confirmation of oa of the knee as provided by the participant's physician.
boolean
C0409959 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
Knee Osteoarthritis Radiography
Item
radiographically-established oa of the knee.
boolean
C0409959 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Visual Analog Pain Scale
Item
pre-randomization score of 40 to 90 on the visual analog pain scale (0-100 mm scale).
boolean
C0042815 (UMLS CUI [1])
Bilateral primary osteoarthritis of knee | Index Knee Affected Severe
Item
patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
boolean
C2893930 (UMLS CUI [1])
C2986546 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
Knee Osteoarthritis Definition
Item
american college of rheumatology defined oa of the knee:
boolean
C0409959 (UMLS CUI [1,1])
C0679227 (UMLS CUI [1,2])
Knee pain
Item
1. knee pain
boolean
C0231749 (UMLS CUI [1])
Criteria Quantity Fulfill
Item
2. satisfaction of at least five of the following nine criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
1. age greater than 50 years
boolean
C0001779 (UMLS CUI [1])
Stiffness Duration
Item
2. stiffness < 30 minutes
boolean
C0427008 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Crepitus
Item
3. crepitus
boolean
C0277964 (UMLS CUI [1])
Bone tenderness
Item
4. bony tenderness
boolean
C0238807 (UMLS CUI [1])
Bony joint enlargement
Item
5. bony enlargement
boolean
C0221610 (UMLS CUI [1])
Joint warmth Palpation Unsuccessful
Item
6. no palpable warmth
boolean
C0240095 (UMLS CUI [1,1])
C0030247 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Erythrocyte sedimentation rate measurement
Item
7. esr < 40 mm/hr
boolean
C1176468 (UMLS CUI [1])
Rheumatoid Factor Measurement
Item
8. rheumatoid factor (rf) < 1:40
boolean
C0201660 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria: (no exclusion criterion may be present)
boolean
C0680251 (UMLS CUI [1])
Rheumatoid Arthritis | Fibromyalgia | Pseudogout Recurrent | Pseudogout
Item
presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
boolean
C0003873 (UMLS CUI [1])
C0016053 (UMLS CUI [2])
C0033802 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0033802 (UMLS CUI [4])
Malignant Neoplasms | Other medical condition Serious
Item
presence of cancer or other serious medical conditions.
boolean
C0006826 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Signs Kidney Failure | Signs Liver Failure | Kidney Failure | Liver Failure
Item
signs or history of kidney or liver failure.
boolean
C0311392 (UMLS CUI [1,1])
C0035078 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0085605 (UMLS CUI [2,2])
C0035078 (UMLS CUI [3])
C0085605 (UMLS CUI [4])
Asthma Requirement Steroid therapy
Item
presence of asthma requiring the use of corticosteroid treatment.
boolean
C0004096 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
Adrenal Cortex Hormones Oral
Item
use of oral corticosteroids within the past four weeks.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Knee Intraarticular injection of corticosteroids Depot Preparations
Item
use of intra-articular knee depo-corticosteroids with the past three months.
boolean
C0022742 (UMLS CUI [1,1])
C2064783 (UMLS CUI [1,2])
C0086129 (UMLS CUI [1,3])
Hyaluronate Intraarticular
Item
use of intra-articular hyaluronate with the past six months.
boolean
C0178695 (UMLS CUI [1,1])
C1522204 (UMLS CUI [1,2])
Arthroscopic Surgical Procedures
Item
arthroscopic surgery of the knee within the past year.
boolean
C0750934 (UMLS CUI [1])
Knee Injury
Item
significant injury to the knee within the past six months.
boolean
C0022744 (UMLS CUI [1])
Knee rash | Open wound of knee
Item
presence of a rash or open wound over the knee.
boolean
C0240126 (UMLS CUI [1])
C0347570 (UMLS CUI [2])
Protocol Compliance Unable
Item
unable to satisfy the treatment and follow-up requirements.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Informed Consent Unable
Item
unable to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Massage Therapy Regular
Item
currently receiving massage therapy on a regular basis (at least twice a month).
boolean
C3536731 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Knee Replacement Index Knee
Item
knee replacement of study knee (ok if the knee not being studied has been replaced).
boolean
C0086511 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
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