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| Do knee braces or foot insoles help pain and function in patients with knee osteoarthritis? |
| Source of record | UK Trials |
| ISRCTN | ISRCTN93462890 |
| Date ISRCTN assigned | 03/03/2008 |
| Local reference number(s) | N/A |
| Public title | Do knee braces or foot insoles help pain and function in patients with knee osteoarthritis? |
| Scientific title | Biomechanical assessment of medial compartment knee osteoarthritis before and after surgery |
| Acronym | N/A |
| Disease/condition/study domain | Knee osteoarthritis |
| Study hypothesis | 1. There is no significant difference in the knee kinematics or kinetics in patients with medial compartment knee osteoarthritis when wearing the valgus knee brace or lateral wedged insole 2. There is no significant difference in the clinical outcome scores in patients with medial compartment knee osteoarthritis when wearing the valgus knee brace or lateral wedged insole 3. There is no significant difference in the knee kinematics or kinetics or clinical scores between the two treatments (valgus knee braces and lateral wedged insoles) |
| Design/methodology | Randomised controlled crossover trial |
| Research ethics review | 1. Stockport Local Research Committee. Date of approval: 01/12/2003 (ref: 03/12/2363) 2. Salford and Trafford Local Research Ethics Committee (ref: 03/12/2363) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female between 45 and 75 years of age 2. Medial compartment knee osteoarthritis symptoms 3. Diagnosis confirmed on radiographs 4. Able to walk and stand on one leg for about three seconds |
| Participants - exclusion criteria | 1. Previous knee pain or any other musculo-skeletal conditions 2. Currently wears orthoses of any description prescribed by a podiatrist or orthotist 3. Tricompartmental knee osteoarthritis and/or clinical evidence of patellofemoral disease or knee pathology (other than medial compartment osteoarthritis) likely to be causing their knee pain 4. Unable to walk unsupported or stand on affected leg for 3 seconds 5. Severe coexisting medical morbidities |
| Patient information material | |
| Anticipated start date | 01/03/2003 |
| Anticipated end date | 01/10/2006 |
| Status of trial | Completed |
| Target number of participants | 28 |
| Interventions | Arm 1: A valgus knee brace which is classed as a direct orthotic Arm 2: A lateral wedged insole which is classed as an indirect orthotic Cross-over: Two week intervention period and a two-week wash-out period to account for carry-over effects from the first treatment. |
| Primary outcome measure(s) | 1. Knee adduction moment 2. Knee kinematics and kinetics These outcomes were assessed at the following timepoints: T1: Baseline assessment and start of wear of intervention 1 T2. Two weeks following wear of intervention 1 T3. Two weeks after no treatment to deal with carry over effects, and start of intervention 2 T4. Two weeks following wear of intervention 2 |
| Secondary outcome measure(s) | 1. Western Ontario and McMaster Osteoarthritis Index (WOMAC), Pain and Function Subscales 2. Knee Pain Visual Analogue Scale (VAS) (0 = no pain, 10 = extreme pain) These outcomes were assessed at the following timepoints: T1: Baseline assessment and start of wear of intervention 1 T2. Two weeks following wear of intervention 1 T3. Two weeks after no treatment to deal with carry over effects, and start of intervention 2 T4. Two weeks following wear of intervention 2 |
| Sources of funding | University of Salford (UK) |
| Sponsor name | University of Salford (UK) |
| Sponsor details | Allerton Building Frederick Road Campus Salford United Kingdom M6 6PU |
| Sponsor telephone | +44 (0)161 295 2295 |
| Sponsor fax | +44 (0)161 295 2668 |
| Sponsor email | r.k.jones@salford.ac.uk |
| Sponsor website | http://www.salford.ac.uk |
| Contact name | Mr Richard Jones |
| Contact details | Room PO18 Brian Blatchford Building University of Salford Salford United Kingdom M6 6PU |
| Contact telephone | +44 (0)161 295 2295 |
| Contact fax | +44 (0)161 295 2668 |
| Contact email | r.k.jones@salford.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN93462890 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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