ID

31331

Description

A Functional Magnetic Resonance Imaging (fMRI) Study of Expectancy on Acupuncture Treatment Outcomes in Knee Osteoarthritis (OA); ODM derived from: https://clinicaltrials.gov/show/NCT01040754

Link

https://clinicaltrials.gov/show/NCT01040754

Keywords

Versions (1)
  1. 8/13/18 8/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoarthritis, Knee NCT01040754

English

Eligibility Osteoarthritis, Knee NCT01040754

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
volunteers 40-70 years of age.
Description

Volunteer | Age

Data type

boolean

Alias
UMLS CUI [1]
C1997894
UMLS CUI [2]
C0001779
meet the classification criteria of the american college of rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months, as determined by the referring physician.
Description

Osteoarthritis of right knee Duration | Osteoarthritis of left knee Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3862651
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C3862659
UMLS CUI [2,2]
C0449238
radiographic evidence of grade 2 or 3 knee oa using the kellgren-lawrence scale.
Description

Knee Osteoarthritis Kellgren-Lawrence score Radiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C3177117
UMLS CUI [1,3]
C0034571
ability to read and understand english; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Description

Able to read English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any interventional procedure for knee pain, including corticosteroid injections (within 2 months) to the knee.
Description

Intervention Knee pain | Adrenal Cortex Hormones Injection Knee

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0231749
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C0022742
prior acupuncture treatment for any condition. because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.
Description

Acupuncture

Data type

boolean

Alias
UMLS CUI [1]
C0394664
the intent to undergo surgery during the time of involvement in the study.
Description

Operative Surgical Procedure intended

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1283828
presence of any illness or medication use that is judged to interfere with the trial. for example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; diabetes due to the increased possibility of sensitivity to heat pain; and use of opiate medications and other substances of abuse that may influence the patient's experience of analgesia. (due to the potential risk that prescription or non-prescription medication use can confound our results, we may perform a urine toxicology screen to verify patient's medication status during session 1.)
Description

Illness Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial | Skin irritation Knee | Psoriasis | Blood Coagulation Disorders | Anticoagulants | Medical contraindication Acupuncture | Diabetes Mellitus | Increased Sensitivy Heat Pain | Opiates Influence Analgesia | Illicit medication use Influence Analgesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0152030
UMLS CUI [3,2]
C0022742
UMLS CUI [4]
C0033860
UMLS CUI [5]
C0005779
UMLS CUI [6]
C0003280
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0394664
UMLS CUI [8]
C0011849
UMLS CUI [9,1]
C2346484
UMLS CUI [9,2]
C0018837
UMLS CUI [9,3]
C0030193
UMLS CUI [10,1]
C0376196
UMLS CUI [10,2]
C4054723
UMLS CUI [10,3]
C3202977
UMLS CUI [11,1]
C0281875
UMLS CUI [11,2]
C4054723
UMLS CUI [11,3]
C3202977
knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, oa of ipsilateral hip, diagnosis of rheumatoid arthritis (ra).
Description

Knee pain Cause Other | Inflammation | Malignant Neoplasms | Pain Disorder Other | Pain in lower limb | Osteoarthritis of hip Ipsilateral | Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C0021368
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0391976
UMLS CUI [4,2]
C0205394
UMLS CUI [5]
C0023222
UMLS CUI [6,1]
C0029410
UMLS CUI [6,2]
C0441989
UMLS CUI [7]
C0003873
non-ambulatory status.
Description

Lacking Able to walk

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia.
Description

Heart Disease Study Subject Participation Status Excluded | Respiration Disorder Study Subject Participation Status Excluded | Nervous system disorder Study Subject Participation Status Excluded | Asthma | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0008909
presence of any contraindications to fmri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Description

Medical contraindication fMRI | Artificial cardiac pacemaker | Metallic implant | Claustrophobia | Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0376335
UMLS CUI [2]
C0030163
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0008909
UMLS CUI [5]
C0032961
instability of pain rating within session 1 or session 2 of experiment one or visit 1 of experiment two.
Description

Pain Rating Instability

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0871208
UMLS CUI [1,3]
C1444783
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Similar models

Eligibility Osteoarthritis, Knee NCT01040754

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Volunteer | Age
Item
volunteers 40-70 years of age.
boolean
C1997894 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Osteoarthritis of right knee Duration | Osteoarthritis of left knee Duration
Item
meet the classification criteria of the american college of rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months, as determined by the referring physician.
boolean
C3862651 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3862659 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Knee Osteoarthritis Kellgren-Lawrence score Radiography
Item
radiographic evidence of grade 2 or 3 knee oa using the kellgren-lawrence scale.
boolean
C0409959 (UMLS CUI [1,1])
C3177117 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
Able to read English Language | Comprehension English Language
Item
ability to read and understand english; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Intervention Knee pain | Adrenal Cortex Hormones Injection Knee
Item
any interventional procedure for knee pain, including corticosteroid injections (within 2 months) to the knee.
boolean
C0184661 (UMLS CUI [1,1])
C0231749 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Acupuncture
Item
prior acupuncture treatment for any condition. because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy.
boolean
C0394664 (UMLS CUI [1])
Operative Surgical Procedure intended
Item
the intent to undergo surgery during the time of involvement in the study.
boolean
C0543467 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Illness Interferes with Clinical Trial | Pharmaceutical Preparations Interfere with Clinical Trial | Skin irritation Knee | Psoriasis | Blood Coagulation Disorders | Anticoagulants | Medical contraindication Acupuncture | Diabetes Mellitus | Increased Sensitivy Heat Pain | Opiates Influence Analgesia | Illicit medication use Influence Analgesia
Item
presence of any illness or medication use that is judged to interfere with the trial. for example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; diabetes due to the increased possibility of sensitivity to heat pain; and use of opiate medications and other substances of abuse that may influence the patient's experience of analgesia. (due to the potential risk that prescription or non-prescription medication use can confound our results, we may perform a urine toxicology screen to verify patient's medication status during session 1.)
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0152030 (UMLS CUI [3,1])
C0022742 (UMLS CUI [3,2])
C0033860 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C0003280 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0394664 (UMLS CUI [7,2])
C0011849 (UMLS CUI [8])
C2346484 (UMLS CUI [9,1])
C0018837 (UMLS CUI [9,2])
C0030193 (UMLS CUI [9,3])
C0376196 (UMLS CUI [10,1])
C4054723 (UMLS CUI [10,2])
C3202977 (UMLS CUI [10,3])
C0281875 (UMLS CUI [11,1])
C4054723 (UMLS CUI [11,2])
C3202977 (UMLS CUI [11,3])
Knee pain Cause Other | Inflammation | Malignant Neoplasms | Pain Disorder Other | Pain in lower limb | Osteoarthritis of hip Ipsilateral | Rheumatoid Arthritis
Item
knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, oa of ipsilateral hip, diagnosis of rheumatoid arthritis (ra).
boolean
C0231749 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0021368 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0391976 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0023222 (UMLS CUI [5])
C0029410 (UMLS CUI [6,1])
C0441989 (UMLS CUI [6,2])
C0003873 (UMLS CUI [7])
Lacking Able to walk
Item
non-ambulatory status.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
Heart Disease Study Subject Participation Status Excluded | Respiration Disorder Study Subject Participation Status Excluded | Nervous system disorder Study Subject Participation Status Excluded | Asthma | Claustrophobia
Item
history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia.
boolean
C0018799 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0004096 (UMLS CUI [4])
C0008909 (UMLS CUI [5])
Medical contraindication fMRI | Artificial cardiac pacemaker | Metallic implant | Claustrophobia | Pregnancy
Item
presence of any contraindications to fmri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
boolean
C1301624 (UMLS CUI [1,1])
C0376335 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
C0032961 (UMLS CUI [5])
Pain Rating Instability
Item
instability of pain rating within session 1 or session 2 of experiment one or visit 1 of experiment two.
boolean
C0030193 (UMLS CUI [1,1])
C0871208 (UMLS CUI [1,2])
C1444783 (UMLS CUI [1,3])
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