None listed
Conditions
Brief summary
Knee osteoarthritis (OA) affects many older people and is a major public health problem. Afflicted individuals suffer from knee pain and physical dysfunction that impacts dramatically on quality of life. Osteoarthritis has no cure and often gets worse over time. Non-toxic treatments that reduce symptoms and assist patient self-management over the long-term are needed. Increased joint loading (force across the knee) is central to pain development and increased risk of disease progression in people with knee OA. The type of shoes a person wears can increase or decrease their knee load depending on the shoe design features. This randomised controlled trial will test the efficacy of modified shoes (designed to unload the knee joint) for reducing symptoms and improving physical function in people with knee OA.
Interventions
Intervention: modified walking shoes (that are denser/more rigid on the outside (laterally) compared to the inside (medially)) designed to unload the knee joint of people with knee osteoarthritis- Gel Melbourne OA shoes (Asics). Participants will be instructed to wear their allocated shoes every day for six months, for at least 4 hours per day. Shoe wear will be monitored by use of log-books and pedometers.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged>50; Knee pain on most days of the last month; Kellgren & Lawrence Grade 2 or above radiographic changes Presence of medial osteoarthritis on x-ray (grade 1 medial osteophytes AND grade 1 medial joint space narrowing, as defined by a standard radiographic atlas); Minimum average knee pain score of 4 on an 11-point numerical rating scale
Exclusion criteria
Predominant lateral tibiofemoral osteoarthritis on x-ray (lateral osteophytes (joint space narrowing) greater than medial); Intra-articular corticosteroid injection or knee surgery to either knee within past 3 months; Systemic arthritic conditions; History of knee joint replacement or high tibial osteotomy or plan for surgery to either knee in next 6 months; Other muscular, joint or neurological condition affecting lower limb function; Current or previous 6 months use of shoe insert, knee or ankle brace or customised shoes prescribed by a health professional; Unable to walk unaided; Body mass index> 36 kg/m2 (due to difficulties in biomechanical gait analysis); Ankle/foot pathology/pain on either side
Outcome results
None listed