Do knee braces or foot insoles help pain and function in patients with knee osteoarthritis?

ISRCTN	ISRCTN93462890
DOI	https://doi.org/10.1186/ISRCTN93462890
Protocol serial number	N/A
Sponsor	University of Salford (UK)
Funder	University of Salford (UK)

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

Room PO18
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom

Phone	+44 (0)161 295 2295
Email	r.k.jones@salford.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled crossover trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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
Key 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
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Room PO18

Salford
M6 6PU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes