Age | Knee pain Moderate Osteoarthritis Related | Knee pain Severe Osteoarthritis Related
Item
male or female patients ≥37 years with moderate-to-severe oa related pain in one knee
boolean
C0001779 (UMLS CUI [1])
C0231749 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0029408 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0231749 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0029408 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Knee Osteoarthritis Symptomatic Class Functional | Knee Osteoarthritis Contralateral Symptomatic | Pain persistent Duration Pain intensity rating scale
Item
symptomatic oa of the index knee diagnosed with a functional capacity of ii or iii according to acr criteria classification note: patients with symptomatic contralateral knee oa with persistent pain ≤2 cm on a 0-10 cm pi-nrs for ≥2 months will be allowed to participate.
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0205245 (UMLS CUI [1,4])
C0409959 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0030193 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C1960637 (UMLS CUI [3,4])
Analgesics Dose unchanged Osteoarthritis
Item
unchanged dose of analgesic medication for oa for at least 4 weeks prior to screening and for the duration of the study
boolean
C0002771 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0029408 (UMLS CUI [1,4])
Protocol Compliance | Subject Diary Electronic Completion
Item
able and willing to complete all paper and e-diary assessments required by protocol
boolean
C0525058 (UMLS CUI [1])
C3890583 (UMLS CUI [2,1])
C0013850 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Joint Pain Interferes with Pain Joint Involved
Item
pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
boolean
C1963066 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C1314939 (UMLS CUI [1,5])
Skin layer Superficial Intact | Integrity At risk
Item
compromised integrity of the intact, superficial skin layer
boolean
C1282402 (UMLS CUI [1,1])
C0205124 (UMLS CUI [1,2])
C0205266 (UMLS CUI [1,3])
C1947912 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Kellgren-Lawrence score Radiography
Item
a grade 1 or 4 kellgren and lawrence score on radiographic examination
boolean
C3177117 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Knee Injury Causing Pain | Knee Injury Interferes with Daily activities | Knee Injury Interferes with Walking
Item
recent injury to either knee causing pain and interference with daily activities (eg. walking)
boolean
C0022744 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0022744 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0871707 (UMLS CUI [2,3])
C0022744 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0080331 (UMLS CUI [3,3])
Operative procedure on knee Causing Pain | Operative procedure on knee Interferes with Assessment Pain | Operative procedure on knee Interferes with Assessment Function | Operative procedure on knee Interferes with Assessment Quality of life
Item
recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and qol
boolean
C0187769 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C0187769 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0030193 (UMLS CUI [2,4])
C0187769 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C0031843 (UMLS CUI [3,4])
C0187769 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C0034380 (UMLS CUI [4,4])
Lidocaine allergy | ANESTHETIC ALLERGY LOCAL AMIDE TYPE | Hypersensitivity Product Component
Item
known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
boolean
C0570646 (UMLS CUI [1])
C0741021 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])