Status:
COMPLETED
Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Universiteit Antwerpen
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a chronic degenerative joint disease and leading cause of musculoskeletal pain and disability worldwide. The high rates of knee replacement surgery worldwide emphasize the need ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03796832
Start Date
January 28 2019
End Date
June 1 2022
Last Update
October 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ghent University, Department of Rehabilitation Sciences
Ghent, Belgium, 9000