A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of British Columbia
About this trial
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
Eligibility criteria
Qualifiers
medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
history of knee pain longer than 6 months
average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
pain in the same foot/feet as the painful knee(s)
Disqualifiers
radiographic evidence of more lateral tibiofemoral OA than medial
knee surgery or intra-articular injection within the previous 6 months
current or recent (within 6 months) corticosteroid use for any reason
presence of a systemic arthritic condition
Trial design
Treatments tested in this trial
- Lateral wedge insoles (LWIs)
- Lateral wedge plus custom arch support (LWAS)
Treatment groups
31 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of British Columbia
Lead sponsor
Western University
Collaborator
Dalhousie University
Collaborator
Source ClinicalTrials.gov