Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laterally wedged shoe insoles | Experimental | Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months |
|
| Flat control insoles | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laterally wedged shoe insoles | Device | Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months |
|
| Measure | Description | 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 |
| Measure | Description | 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. | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kim Bennell, PhD | University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne | Melbourne | Victoria | 3010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21593096 | Derived | Bennell KL, Bowles KA, Payne C, Cicuttini F, Williamson E, Forbes A, Hanna F, Davies-Tuck M, Harris A, Hinman RS. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ. 2011 May 18;342:d2912. doi: 10.1136/bmj.d2912. | |
| 17892539 | Derived | Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control insole group | Device | Flat control insoles worn inside the shoes daily for 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 |