ID

40749

Beschreibung

Randomized Trial in knEe Osteoarthritis Using Low Intensity Ultrasound - Evaluating Feasibility (RELIEF); ODM derived from: https://clinicaltrials.gov/show/NCT01623804

Link

https://clinicaltrials.gov/show/NCT01623804

Stichworte

Versionen (2)
  1. 07.05.20 07.05.20 -
  2. 08.05.20 08.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Mai 2020

DOI

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Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01623804

Englisch

Eligibility Knee Osteoarthritis NCT01623804

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
over 40 years of age;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
have medial tibiofemoral compartment knee oa;
Beschreibung

Knee Osteoarthritis Medial compartment femorotibial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0447799
UMLS CUI [1,3]
C0447795
have mild to moderate medial compartment radiographic oa severity (determined by the attending surgeon and/or advanced practice physiotherapist on the basis of a standing x-ray or mri scan depending upon which is available at initial consult);
Beschreibung

Osteoarthritis Mild Medial compartment of knee | Osteoarthritis Moderate Medial compartment of knee | X-ray of knee, standing | MRI scan Standing position

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C0447799
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C0447799
UMLS CUI [3]
C3861234
UMLS CUI [4,1]
C0024485
UMLS CUI [4,2]
C0231472
have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, vnrs) in one knee which is aggravated by activity and eased with rest;
Beschreibung

Knee pain Stable Pain severity - verbal numeric rating

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C3533077
limited pain from other lower extremity joints; and
Beschreibung

Pain Limited Lower extremity joint

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0584731
no change in first line pain medication in the past 2 months and willingness to forego alterations in pain medication for the duration of the study unless deemed medically necessary.
Beschreibung

Analgesics First line treatment unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002771
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0442739
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of traumatic oa or previous surgical intervention in the knee or knee effusion;
Beschreibung

Post traumatic osteoarthritis | Operative procedure on knee | Knee joint effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C2894027
UMLS CUI [2]
C0187769
UMLS CUI [3]
C0343166
intra-articular injection of the knee in the previous 6 months;
Beschreibung

Knee injection Intraarticular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0187946
UMLS CUI [1,2]
C1522204
received ultrasound treatment for knee oa within the past 6 months;
Beschreibung

Ultrasound Therapy Knee Osteoarthritis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041620
UMLS CUI [1,2]
C0409959
body weight changed ≥ 5% in the past 2 months;
Beschreibung

Body Weight Changed Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0872291
level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months);
Beschreibung

Organ function Insufficient | Intermittent Claudication | Peripheral Neuropathy Severe | Proliferative retinopathy | Heart Disease Unstable | Lung disease Unstable | Cerebrovascular accident Disabling | Chronic pain | Arthritis Knee Other | Bone fracture

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0231180
UMLS CUI [2]
C0021775
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0339467
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0024115
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0038454
UMLS CUI [7,2]
C4061999
UMLS CUI [8]
C0150055
UMLS CUI [9,1]
C0003864
UMLS CUI [9,2]
C0022742
UMLS CUI [9,3]
C0205394
UMLS CUI [10]
C0016658
conditions listed as precautions or unknown safety risks for using the exogen express ultrasound device (pregnant or nursing women, individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at the medial joint line of the knee, taking steroids/anti-coagulants, prescription non-steroidal anti-inflammatory, calcium channel blocker or applying the exogen express in close proximity to someone wearing a cardiac pacemaker);
Beschreibung

Condition Precaution Ultrasound device | Condition Safety Risk Ultrasound device | Pregnancy | Breast Feeding | Thrombophlebitis | Vascular insufficiency | Skin sensation disturbance | Paralysis Sensory | Open wound Medial knee joint line | Steroids | Anticoagulants | Anti-Inflammatory Agents, Non-Steroidal | Calcium Channel Blockers | Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1882442
UMLS CUI [1,3]
C1875843
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0036043
UMLS CUI [2,3]
C0035647
UMLS CUI [2,4]
C1875843
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5]
C0040046
UMLS CUI [6]
C0232352
UMLS CUI [7]
C0012766
UMLS CUI [8,1]
C0522224
UMLS CUI [8,2]
C0445254
UMLS CUI [9,1]
C0332798
UMLS CUI [9,2]
C0446570
UMLS CUI [10]
C0038317
UMLS CUI [11]
C0003280
UMLS CUI [12]
C0003211
UMLS CUI [13]
C0006684
UMLS CUI [14]
C0030163
unable to read, write and/or understand english;
Beschreibung

Lacking Able to read English Language | Lacking Able to write English Language | Comprehension English Language Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0584993
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
UMLS CUI [3,3]
C1299582
other illness or reasons judged by the participant, clinicians or researchers to make participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting in difficulty comprehending and complying with instructions, caregiving demands/lack of social support for participation);
Beschreibung

Other medical condition Study Subject Participation Status Unfavorable | Factor Study Subject Participation Status Unfavorable | Relocation of home Planned | Travel Planned | Cognitive deficits Impairing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
UMLS CUI [3,1]
C2699029
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0040802
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0338656
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C0525058
unwillingness to sign informed consent; or
Beschreibung

Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
participation in a competing study.
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Ähnliche Modelle

Eligibility Knee Osteoarthritis NCT01623804

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
over 40 years of age;
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis Medial compartment femorotibial
Item
have medial tibiofemoral compartment knee oa;
boolean
C0409959 (UMLS CUI [1,1])
C0447799 (UMLS CUI [1,2])
C0447795 (UMLS CUI [1,3])
Osteoarthritis Mild Medial compartment of knee | Osteoarthritis Moderate Medial compartment of knee | X-ray of knee, standing | MRI scan Standing position
Item
have mild to moderate medial compartment radiographic oa severity (determined by the attending surgeon and/or advanced practice physiotherapist on the basis of a standing x-ray or mri scan depending upon which is available at initial consult);
boolean
C0029408 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0447799 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0447799 (UMLS CUI [2,3])
C3861234 (UMLS CUI [3])
C0024485 (UMLS CUI [4,1])
C0231472 (UMLS CUI [4,2])
Knee pain Stable Pain severity - verbal numeric rating
Item
have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, vnrs) in one knee which is aggravated by activity and eased with rest;
boolean
C0231749 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C3533077 (UMLS CUI [1,3])
Pain Limited Lower extremity joint
Item
limited pain from other lower extremity joints; and
boolean
C0030193 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0584731 (UMLS CUI [1,3])
Analgesics First line treatment unchanged
Item
no change in first line pain medication in the past 2 months and willingness to forego alterations in pain medication for the duration of the study unless deemed medically necessary.
boolean
C0002771 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Post traumatic osteoarthritis | Operative procedure on knee | Knee joint effusion
Item
history of traumatic oa or previous surgical intervention in the knee or knee effusion;
boolean
C2894027 (UMLS CUI [1])
C0187769 (UMLS CUI [2])
C0343166 (UMLS CUI [3])
Knee injection Intraarticular
Item
intra-articular injection of the knee in the previous 6 months;
boolean
C0187946 (UMLS CUI [1,1])
C1522204 (UMLS CUI [1,2])
Ultrasound Therapy Knee Osteoarthritis
Item
received ultrasound treatment for knee oa within the past 6 months;
boolean
C0041620 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
Body Weight Changed Percentage Timespan
Item
body weight changed ≥ 5% in the past 2 months;
boolean
C0005910 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0872291 (UMLS CUI [1,4])
Organ function Insufficient | Intermittent Claudication | Peripheral Neuropathy Severe | Proliferative retinopathy | Heart Disease Unstable | Lung disease Unstable | Cerebrovascular accident Disabling | Chronic pain | Arthritis Knee Other | Bone fracture
Item
level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months);
boolean
C0678852 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C0021775 (UMLS CUI [2])
C0031117 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0339467 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0024115 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0038454 (UMLS CUI [7,1])
C4061999 (UMLS CUI [7,2])
C0150055 (UMLS CUI [8])
C0003864 (UMLS CUI [9,1])
C0022742 (UMLS CUI [9,2])
C0205394 (UMLS CUI [9,3])
C0016658 (UMLS CUI [10])
Condition Precaution Ultrasound device | Condition Safety Risk Ultrasound device | Pregnancy | Breast Feeding | Thrombophlebitis | Vascular insufficiency | Skin sensation disturbance | Paralysis Sensory | Open wound Medial knee joint line | Steroids | Anticoagulants | Anti-Inflammatory Agents, Non-Steroidal | Calcium Channel Blockers | Artificial cardiac pacemaker
Item
conditions listed as precautions or unknown safety risks for using the exogen express ultrasound device (pregnant or nursing women, individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at the medial joint line of the knee, taking steroids/anti-coagulants, prescription non-steroidal anti-inflammatory, calcium channel blocker or applying the exogen express in close proximity to someone wearing a cardiac pacemaker);
boolean
C0348080 (UMLS CUI [1,1])
C1882442 (UMLS CUI [1,2])
C1875843 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0036043 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C1875843 (UMLS CUI [2,4])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0040046 (UMLS CUI [5])
C0232352 (UMLS CUI [6])
C0012766 (UMLS CUI [7])
C0522224 (UMLS CUI [8,1])
C0445254 (UMLS CUI [8,2])
C0332798 (UMLS CUI [9,1])
C0446570 (UMLS CUI [9,2])
C0038317 (UMLS CUI [10])
C0003280 (UMLS CUI [11])
C0003211 (UMLS CUI [12])
C0006684 (UMLS CUI [13])
C0030163 (UMLS CUI [14])
Lacking Able to read English Language | Lacking Able to write English Language | Comprehension English Language Unable
Item
unable to read, write and/or understand english;
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0584993 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Other medical condition Study Subject Participation Status Unfavorable | Factor Study Subject Participation Status Unfavorable | Relocation of home Planned | Travel Planned | Cognitive deficits Impairing Protocol Compliance
Item
other illness or reasons judged by the participant, clinicians or researchers to make participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting in difficulty comprehending and complying with instructions, caregiving demands/lack of social support for participation);
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
C2699029 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0040802 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0338656 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Informed Consent Unwilling
Item
unwillingness to sign informed consent; or
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial
Item
participation in a competing study.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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