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

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.

Changes in quality of life and coping among people with multiple sclerosis over a 2 year period

There is a need to investigate the impact of different coping strategies on quality of life (QOL) of people with multiple sclerosis (MS), in order to better inform intervention programs for this population. This study evaluated the relationship between QOL and coping over a 2 year period among people with MS. Participants were 382 people with MS (144 male, 238 females) and 291 people without a neurological or other chronic illness from the general population (101 males, 190 females). People with MS experienced lower QOL than the control group in the domains of global QOL, independence, social and spiritual QOL scales, as well as the problem solving and social/emotional support coping scales. Interestingly, people with MS experienced higher psychological QOL than the general population, and higher detachment and focusing on the positive coping. Over time, people with MS demonstrated increases in their global QOL as well as in their social/emotional support coping. Women demonstrated higher levels than men of global QOL and Social/emotional support coping. The results of these findings have implications for information and intervention programs for people with MS.