Osteoarthritis
Conditions
Brief summary
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.
Interventions
DEVICELaterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
DEVICEControl insole group
Flat control insoles worn inside the shoes daily for 12 months
Sponsors
National Health and Medical Research Council, Australia
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligibility will be confirmed by radiographic and clinical examination * People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale * varus knee malalignment on standing anteroposterior lower limb x-ray.
Exclusion criteria
* advanced radiographic knee OA (Kellgren and Lawrence stage 4 * knee surgery or intra-articular corticosteroid injection within 6 months * current or past (within 4 weeks) oral corticosteroid use * systemic arthritic conditions * history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy * any other muscular, joint or neurological condition affecting lower limb function * ankle/foot pathology or pain that precludes the use of insoles * use of foot orthotics within past 6 months and * use of footwear that does not accomodate an insole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain via a visual analogue scale | Measured at baseline and 12 months |
| Disease progression via MRI measurements of knee cartilage volume | Measured at baseline and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index | Measured at baseline and 12 months |
| Patient perceived response to treatment | Measured at baseline and 12 months. |
| Health-related quality-of-life (via SF-36, AQoL questionnaires) | Measured at baseline and 12 months |
| Recorded use of health care | Measured at baseline and 12 months |
Countries
Australia
Outcome results
None listed