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Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial.

Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R - BMC Musculoskelet Disord (2007)

Bottom Line: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use.To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis.To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics.

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for Health, Exercise & Sports Medicine, School of Physiotherapy, University of Melbourne, Australia. k.bennell@unimelb.edu.au

ABSTRACT

Background: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA.

Methods/design: Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics.

Discussion: Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA.

Trial registration: ACTR12605000503628; NCT00415259.

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Related in: MedlinePlus

Trial protocol.
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Figure 1: Trial protocol.

Mentions: This will be a double-blind randomised controlled trial (Figure 1). Potential participants will undergo telephone screening followed by clinical examination by a physiotherapist or medical practitioner and a podiatrist to ensure they fulfil selection criteria. A screening x-ray will be performed to assess knee joint alignment and disease severity. Eligible participants will then be stratified by disease severity (Kellgren and Lawrence grade 2 and 3 [31] and randomly allocated in permuted blocks of 6 to 12 to lateral wedge or control flat insoles groups. The randomisation sequence will be generated a priori using the random number function in Excel by an independent investigator not directly involved in assessment of participants. Allocation will be sealed in opaque and consecutively numbered envelopes held in a central location. These will be opened in sequence by a person not involved in the study after recruitment and baseline testing of participants.


Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial.

Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R - BMC Musculoskelet Disord (2007)

Trial protocol.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2147062&req=5

Figure 1: Trial protocol.
Mentions: This will be a double-blind randomised controlled trial (Figure 1). Potential participants will undergo telephone screening followed by clinical examination by a physiotherapist or medical practitioner and a podiatrist to ensure they fulfil selection criteria. A screening x-ray will be performed to assess knee joint alignment and disease severity. Eligible participants will then be stratified by disease severity (Kellgren and Lawrence grade 2 and 3 [31] and randomly allocated in permuted blocks of 6 to 12 to lateral wedge or control flat insoles groups. The randomisation sequence will be generated a priori using the random number function in Excel by an independent investigator not directly involved in assessment of participants. Allocation will be sealed in opaque and consecutively numbered envelopes held in a central location. These will be opened in sequence by a person not involved in the study after recruitment and baseline testing of participants.

Bottom Line: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use.To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis.To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics.

View Article: PubMed Central - HTML - PubMed

Affiliation: Centre for Health, Exercise & Sports Medicine, School of Physiotherapy, University of Melbourne, Australia. k.bennell@unimelb.edu.au

ABSTRACT

Background: Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA.

Methods/design: Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics.

Discussion: Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA.

Trial registration: ACTR12605000503628; NCT00415259.

Show MeSH
Related in: MedlinePlus