ID

30125

Descrição

Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00124462

Link

https://clinicaltrials.gov/show/NCT00124462

Palavras-chave

Versões (1)
  1. 14/05/2018 14/05/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de maio de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT00124462

Inglês

Eligibility Knee Osteoarthritis NCT00124462

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
trial participants must meet american college of rheumatology (acr) criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte. in addition, because the researchers are interested in recruiting persons with medial knee osteoarthritis, participants will need to have evidence of disease in this compartment on their radiographs, and not have lateral compartment or patellofemoral compartment disease. medial disease is based on definitions used in the researcher's previous publications as definite radiographic oa + at least grade 1 medial narrowing (0-3 scale) using an atlas from the osteoarthritis research society international.
Descrição

Degenerative polyarthritis | Knee pain | Knee stiff | Osteophyte Radiography | Degenerative polyarthritis Medial compartment of knee Radiography | Disease Lateral compartment of knee Absent | Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029408
UMLS CUI [2]
C0231749
UMLS CUI [3]
C0240129
UMLS CUI [4,1]
C1956089
UMLS CUI [4,2]
C0034571
UMLS CUI [5,1]
C0029408
UMLS CUI [5,2]
C0447799
UMLS CUI [5,3]
C0034571
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0447800
UMLS CUI [6,3]
C0332197
UMLS CUI [7]
C3846158
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals with clinical evidence of patellofemoral disease or knee pathology (other than medial compartment oa) likely to be causing their knee pain.
Descrição

Disorder of patellofemoral joint | Disorder of knee Causing Knee pain | Exception Degenerative polyarthritis Medial compartment of knee

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0409325
UMLS CUI [2,1]
C1290879
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0231749
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0029408
UMLS CUI [3,3]
C0447799
individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.
Descrição

Ambulation with walking aid | Cane | Crutches | Walkers | Wheelchair

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3695267
UMLS CUI [2]
C0006856
UMLS CUI [3]
C0010397
UMLS CUI [4]
C0043016
UMLS CUI [5]
C0043143
amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.
Descrição

Amputated foot | Major injury Foot | Lesions on foot | Skin sore on foot | Foot Ulcer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0576410
UMLS CUI [2,1]
C0332677
UMLS CUI [2,2]
C0016504
UMLS CUI [3]
C0744147
UMLS CUI [4]
C2231857
UMLS CUI [5]
C0085119
known neuropathy from diabetes or for other reasons.
Descrição

Neuropathy Due to Diabetes Mellitus | Neuropathy Due to Other Reason

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0442874
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3840932
past history of deep venous thrombosis.
Descrição

Deep Vein Thrombosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149871
pain emanating more from back or hip than from knee as determined by screening questionnaire
Descrição

Back Pain | Hip pain | Screening questionnaire

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004604
UMLS CUI [2]
C0019559
UMLS CUI [3]
C1134635
low pain score on womac, a widely used and well validated questionnaire to assess knee symptoms. to evaluate response, the researchers will require that patients have a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 for the womac pain scale in the eligible knee at pre-randomization phone call and visit, and at randomization visit. this will allow us to detect response to treatment if response occurs.
Descrição

Pain low Knee eligible | WOMAC scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C0022742
UMLS CUI [1,4]
C1548635
UMLS CUI [2]
C3472647
planning to move from area within 9 months of study screening
Descrição

Relocation of home Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
symptomatic comorbid disease limits walking more than knee pain (per screening questionnaire)
Descrição

Comorbidity Symptomatic Limiting Walking | Knee pain | Screening questionnaire

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0080331
UMLS CUI [2]
C0231749
UMLS CUI [3]
C1134635
receiving corticosteroid injections in the month prior to starting the trial. no other treatments will trigger exclusion, although for patients who have been on glucosamine +/or chondroitin +/or nonsteroidal anti-inflammatory drug (nsaid) the researchers will require that they must have taken these treatments for at least 2 months prior to onset of trial and to commit to not start a new treatment throughout the trial.
Descrição

Adrenal Cortex Hormones Injection | Glucosamine | Chondroitin | NSAIDs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1828121
UMLS CUI [2]
C0017718
UMLS CUI [3]
C0008454
UMLS CUI [4]
C0003211
bilateral total knee replacements (tkr) or plan for tkr in next 6 months for affected knee.
Descrição

Replacement of total knee joint Bilateral | Replacement of total knee joint Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2316964
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C2316964
UMLS CUI [2,2]
C1301732
known other causes of arthritis including rheumatoid arthritis (ra), systemic lupus erythematosus (sle), gout, psoriatic arthritis, pseudogout.
Descrição

Etiology Arthritis | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout | Arthritis, Psoriatic | Pseudogout

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0003864
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0018099
UMLS CUI [5]
C0003872
UMLS CUI [6]
C0033802
failure to pass 4 week run-in test.
Descrição

Run-in Test failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0231175
volunteers in a pre-contemplative state (persons who would not consider realignment therapy as a therapeutic option for their knee oa).
Descrição

Volunteers Precontemplation stage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3661466
UMLS CUI [1,2]
C1277197
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Similar models

Eligibility Knee Osteoarthritis NCT00124462

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Degenerative polyarthritis | Knee pain | Knee stiff | Osteophyte Radiography | Degenerative polyarthritis Medial compartment of knee Radiography | Disease Lateral compartment of knee Absent | Other Coding
Item
trial participants must meet american college of rheumatology (acr) criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte. in addition, because the researchers are interested in recruiting persons with medial knee osteoarthritis, participants will need to have evidence of disease in this compartment on their radiographs, and not have lateral compartment or patellofemoral compartment disease. medial disease is based on definitions used in the researcher's previous publications as definite radiographic oa + at least grade 1 medial narrowing (0-3 scale) using an atlas from the osteoarthritis research society international.
boolean
C0029408 (UMLS CUI [1])
C0231749 (UMLS CUI [2])
C0240129 (UMLS CUI [3])
C1956089 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
C0029408 (UMLS CUI [5,1])
C0447799 (UMLS CUI [5,2])
C0034571 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0447800 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C3846158 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Disorder of patellofemoral joint | Disorder of knee Causing Knee pain | Exception Degenerative polyarthritis Medial compartment of knee
Item
individuals with clinical evidence of patellofemoral disease or knee pathology (other than medial compartment oa) likely to be causing their knee pain.
boolean
C0409325 (UMLS CUI [1])
C1290879 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0231749 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0029408 (UMLS CUI [3,2])
C0447799 (UMLS CUI [3,3])
Ambulation with walking aid | Cane | Crutches | Walkers | Wheelchair
Item
individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.
boolean
C3695267 (UMLS CUI [1])
C0006856 (UMLS CUI [2])
C0010397 (UMLS CUI [3])
C0043016 (UMLS CUI [4])
C0043143 (UMLS CUI [5])
Amputated foot | Major injury Foot | Lesions on foot | Skin sore on foot | Foot Ulcer
Item
amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.
boolean
C0576410 (UMLS CUI [1])
C0332677 (UMLS CUI [2,1])
C0016504 (UMLS CUI [2,2])
C0744147 (UMLS CUI [3])
C2231857 (UMLS CUI [4])
C0085119 (UMLS CUI [5])
Neuropathy Due to Diabetes Mellitus | Neuropathy Due to Other Reason
Item
known neuropathy from diabetes or for other reasons.
boolean
C0442874 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0442874 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3840932 (UMLS CUI [2,3])
Deep Vein Thrombosis
Item
past history of deep venous thrombosis.
boolean
C0149871 (UMLS CUI [1])
Back Pain | Hip pain | Screening questionnaire
Item
pain emanating more from back or hip than from knee as determined by screening questionnaire
boolean
C0004604 (UMLS CUI [1])
C0019559 (UMLS CUI [2])
C1134635 (UMLS CUI [3])
Pain low Knee eligible | WOMAC scale
Item
low pain score on womac, a widely used and well validated questionnaire to assess knee symptoms. to evaluate response, the researchers will require that patients have a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 for the womac pain scale in the eligible knee at pre-randomization phone call and visit, and at randomization visit. this will allow us to detect response to treatment if response occurs.
boolean
C0030193 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C1548635 (UMLS CUI [1,4])
C3472647 (UMLS CUI [2])
Relocation of home Planned
Item
planning to move from area within 9 months of study screening
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Comorbidity Symptomatic Limiting Walking | Knee pain | Screening questionnaire
Item
symptomatic comorbid disease limits walking more than knee pain (per screening questionnaire)
boolean
C0009488 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0080331 (UMLS CUI [1,4])
C0231749 (UMLS CUI [2])
C1134635 (UMLS CUI [3])
Adrenal Cortex Hormones Injection | Glucosamine | Chondroitin | NSAIDs
Item
receiving corticosteroid injections in the month prior to starting the trial. no other treatments will trigger exclusion, although for patients who have been on glucosamine +/or chondroitin +/or nonsteroidal anti-inflammatory drug (nsaid) the researchers will require that they must have taken these treatments for at least 2 months prior to onset of trial and to commit to not start a new treatment throughout the trial.
boolean
C0001617 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0017718 (UMLS CUI [2])
C0008454 (UMLS CUI [3])
C0003211 (UMLS CUI [4])
Replacement of total knee joint Bilateral | Replacement of total knee joint Planned
Item
bilateral total knee replacements (tkr) or plan for tkr in next 6 months for affected knee.
boolean
C2316964 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C2316964 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Etiology Arthritis | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Gout | Arthritis, Psoriatic | Pseudogout
Item
known other causes of arthritis including rheumatoid arthritis (ra), systemic lupus erythematosus (sle), gout, psoriatic arthritis, pseudogout.
boolean
C0015127 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0018099 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0033802 (UMLS CUI [6])
Run-in Test failed
Item
failure to pass 4 week run-in test.
boolean
C3274438 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Volunteers Precontemplation stage
Item
volunteers in a pre-contemplative state (persons who would not consider realignment therapy as a therapeutic option for their knee oa).
boolean
C3661466 (UMLS CUI [1,1])
C1277197 (UMLS CUI [1,2])
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