Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT02234895
Eligibility Criteria:
Inclusion Criteria:
i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Exclusion Criteria:
i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
ii) knee surgery or intra-articular corticosteroid injection within the previous six months
iii) current or recent (within 4 weeks) oral corticosteroid use
iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months
v) ankle/foot pathology or pain that precludes the use of orthotics
vi) current use of foot orthotics
vii) use of footwear unable to accommodate an orthotic
viii) unable to walk without a gait aid
ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02234895
Study Brief:
Protocol Section:
NCT02234895