Do knee braces or foot insoles help pain and function in patients with knee osteoarthritis?
| ISRCTN | ISRCTN93462890 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93462890 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/02/2008
- Registration date
- 03/03/2008
- Last edited
- 04/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Jones
Scientific
Scientific
Room PO18
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
| Phone | +44 (0)161 295 2295 |
|---|---|
| r.k.jones@salford.ac.uk |
Study information
| Study design | Randomised controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Biomechanical assessment of medial compartment knee osteoarthritis before and after surgery |
| Study objectives | 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) |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | Knee osteoarthritis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/03/2003 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 28 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Room PO18
Salford
M6 6PU
United Kingdom
M6 6PU
United Kingdom
Sponsor information
University of Salford (UK)
University/education
University/education
Allerton Building
Frederick Road Campus
Salford
M6 6PU
England
United Kingdom
| Phone | +44 (0)161 295 2295 |
|---|---|
| r.k.jones@salford.ac.uk | |
| Website | http://www.salford.ac.uk |
"ROR" |
https://ror.org/01tmqtf75 |
Funders
Funder type
University/education
University of Salford (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
