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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT03796832
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic and radiographic diagnosis of knee OA as per the American College of Rheumatology criteria (ie, aged≥50, knee pain on most days and osteophytes)
* Radiographic evidence of medial OA (ie, Kellgren Lawrence(KL) grade ≥2, ≥grade 1 medial joint space narrowing (JSN) (scale 0-3)\> lateral JSN, using a standardized atlas)
* Average knee pain on walking over the past week of ≥4 on a 11-point numeric rating scale (NRS; "0=no pain" to "10=worst pain imaginable")
* Ability to walk unaided
* Willing to comply with therapy prescriptions
* Sufficient understanding of the Dutch language
Exclusion Criteria:
* Current and previous (3 months) participation in exercise therapy
* Current and previous (3 months) use of customised footwear, minimalist shoes, insoles, braces and unable/unwilling to abandon during the study
* Knee surgery in either knee and/or injections (corticosteroids, hyaluronic acid) in the study knee (most painful knee or right knee if both equally painful) in the past 6 months
* Current or recent (4 weeks) use of oral corticosteroids
* Knee replacement or high tibial osteotomy surgery in the past, or planned during the study
* Inflammatory arthropathies
* Other muscular, joint, neurological or metabolic conditions affecting lower limb function and/or precluding safe regular participation in exercise therapy and walking
* Body mass index (BMI) of \>36 kg/m2 (due to difficulties performing gait analysis and MRI)
* Foot/ankle pain/pathologies at either side, and worse than knee pain complaints
* Contra-indications for radiography \& MRI
* Use of supplements (eg, glucosamine, chondroitin, curcuma derivates) or pain medication (NSAIDs, paracetamol) or other disease modifying or anti-bone resorptive drugs if participants were not on a stable dose for ≥2 months prior to entering the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03796832
Study Brief:
Protocol Section:
NCT03796832