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Trial registered on ANZCTR


Registration number
ACTRN12605000503628
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
23/09/2005
Date last updated
11/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of shoes insoles on symptoms and disease progression in knee osteoarthritis
Scientific title
The effects of laterally wedged insoles on reducing knee pain and physical disability, and slowing disease progression in sufferers of knee osteoarthritis.
Secondary ID [1] 287864 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 628 0
Condition category
Condition code
Musculoskeletal 700 700 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Project Examiner will conduct preliminary screening over the phone. Participants will undergo examination by the Project Examiner and the Project Podiatrist to ensure they fulfil selection criteria. An x-ray will be performed to ensure varus knee joint malalignment. Baseline testing including assessment of knee pain and MRI measurements of knee cartilage volume will be performed on all subjects, following whoich the particpant will be randomised into one of two groups: (i) laterally wedged insoles or, (ii) control insoles. The intervention period will be 12 months after which participants will be reassessed.
Intervention code [1] 670 0
None
Comparator / control treatment
Control insoles.
Control group
Placebo

Outcomes
Primary outcome [1] 852 0
a) Knee pain via a visual analogue scale
Timepoint [1] 852 0
Measured at baseline and 12 months
Primary outcome [2] 853 0
b) Disease progression via MRI measurements of knee cartilage volume
Timepoint [2] 853 0
Measured at baseline and 12 months
Secondary outcome [1] 1693 0
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Timepoint [1] 1693 0
Measured at baseline and 12 months.
Secondary outcome [2] 1694 0
Patient perceived response to treatment
Timepoint [2] 1694 0
Measured at baseline and 12 months.
Secondary outcome [3] 1695 0
Health-related quality-of-life (via SF-36, AQoL questionnaires).
Timepoint [3] 1695 0
Measured at baseline and 12 months.
Secondary outcome [4] 1696 0
Recorded use of health care.
Timepoint [4] 1696 0
Measured at baseline and 12 months.

Eligibility
Key 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 will be included. Other inclusion criteria will be: (i) varus knee malalignment on standing anteroposterior lower limb x-ray.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) advanced radiographic knee OA (Kellgren and Lawrence stage 4; (ii) knee surgery or intra-articular corticosteroid injection within 6 months; (iii) current or past (within 4 weeks) oral corticosteroid use; (iv) systemic arthritic conditions; (v) history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy; (vi) any other muscular, joint or neurological condition affecting lower limb function; (vii) ankle/foot pathology or pain that precludes the use of insoles; (viii) use of foot orthotics within past 6 months and; (ix) use of footwear that does not accomodate an insole.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes kept in central location and opened at time of treatment by central administrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, according to a computer-generated random number list. Variable block sizes will be used with blocks stratified according to gender and severity of knee OA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 775 0
Government body
Name [1] 775 0
NHMRC project grant
Address [1] 775 0
NHMRC
Canberra, ACT
Australia
Country [1] 775 0
Australia
Primary sponsor type
Individual
Name
Prof Kim Bennell
Address
Department of Physiotherapy
University of Melbourne
Country
Australia
Secondary sponsor category [1] 637 0
Individual
Name [1] 637 0
Dr Rana Hinman
Address [1] 637 0
Department of Physiotherapy
University of Melbourne
Country [1] 637 0
Australia
Secondary sponsor category [2] 638 0
Individual
Name [2] 638 0
Mr Tim Wrigley
Address [2] 638 0
Department of Physiotherapy
University of Melbourne
Country [2] 638 0
Australia
Secondary sponsor category [3] 639 0
Individual
Name [3] 639 0
A/Prof Flavia Cicuttini
Address [3] 639 0
Monash University
Melbourne
Victoria
Country [3] 639 0
Australia
Secondary sponsor category [4] 640 0
Individual
Name [4] 640 0
Dr Craig Payne
Address [4] 640 0
La Trobe University
Bundoora
Victoria
Country [4] 640 0
Australia
Secondary sponsor category [5] 641 0
Individual
Name [5] 641 0
Mr Anthony Harris
Address [5] 641 0
Monash University
Melbourne
Victoria
Country [5] 641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293840 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 293840 0
University of Melbourne
Victoria
Ethics committee country [1] 293840 0
Australia
Date submitted for ethics approval [1] 293840 0
01/12/2004
Approval date [1] 293840 0
01/12/2004
Ethics approval number [1] 293840 0
050031

Summary
Brief summary
Knee osteoarthritis (OA) is a painful and costly condition. Wedged shoe insoles are a simple intervention that may reduce pain and slow disease progression in people with knee OA and bow legs. They are thought to work by changing the alignment of the knee, altering muscle activity and ultimately reducing load across the knee joint. This project will compare the effect of a lateral wedged insole and a flat insole to see whether the lateral wedges are a useful treatment for people with knee OA.

Participants will be screened over the phone first then will attend the Centre for Health, Exercise and Sports Medicine for further screening to assess their suitability. If they pass the screening, they will undergo baseline testing at the Centre which will take around 2 hours. They will complete questionnaires about their knee pain and function, quality of life, expectation of treatment benefit, physical activity levels and self motivation. Measurements will also be taken of walking, muscle strength, and foot type. Participants will attend the Epworth Hospital for a magnetic resonance imaging scan of the knee which will take about 1 hour. Participants will be randomly allocated into one of two groups (i) wedged shoe insoles (ii) control shoe insoles (with no wedging). Participants will wear the insoles in both shoes full time for 12 months. They will be provided with several pairs for replacement and for different shoes. Participants will be asked to complete a log-book during this time to record their insole wear compliance, any negative effects of the insoles, medication use, visits to health professionals and any additional home support. Some of the questionnaires will be completed at home after wearing the insoles for 6 months. At 12 months, participants will return to the Centre for repeat testing and to the Epworth for another knee scan.
Trial website
Trial related presentations / publications
BMJ. 2011; 342: d2912.
Published online 2011 May 18. doi: 10.1136/bmj.d2912
Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial
Kim L Bennell, Kelly-Ann Bowles, Craig Payne, Flavia Cicuttini, Elizabeth Williamson, Andrew Forbes, Fahad Hanna, Miranda Davies-Tuck, Anthony Harris, and Rana S Hinman,
Public notes

Contacts
Principal investigator
Name 35182 0
Prof Kim Bennell
Address 35182 0
University of Melbourne
Country 35182 0
Australia
Phone 35182 0
+61 3 83444135
Fax 35182 0
Email 35182 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 9859 0
Mrs Mrs Kelly-Ann Bowles
Address 9859 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 9859 0
Australia
Phone 9859 0
+61 3 83020019
Fax 9859 0
+61 3 83443771
Email 9859 0
kbowles@unimelb.edu.au
Contact person for scientific queries
Name 787 0
Prof Professor Kim Bennell
Address 787 0
School of Physiotherapy
University of Melbourne
Parkville VIC 3010
Country 787 0
Australia
Phone 787 0
+61 3 83444135
Fax 787 0
+61 3 83443771
Email 787 0
k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary