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ItemEffects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trialBennell, K ; Bowles, K-A ; Payne, C ; Cicuttini, FM ; Osborne, R ; Harris, A ; Hinman, R (BMC, 2007-09-24)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.
ItemThe effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trialBennell, KL ; Hunt, MA ; Wrigley, TV ; Hunter, DJ ; Hinman, RS (BMC, 2007-12-07)BACKGROUND: Lower limb strengthening exercises are an important component of the treatment for knee osteoarthritis (OA). Strengthening the hip abductor and adductor muscles may influence joint loading and/or OA-related symptoms, but no study has evaluated these hypotheses directly. The aim of this randomised, single-blind controlled trial is to determine whether hip abductor and adductor muscle strengthening can reduce knee load and improve pain and physical function in people with medial compartment knee OA. METHODS/DESIGN: 88 participants with painful, radiographically confirmed medial compartment knee OA and varus alignment will be recruited from the community and randomly allocated to a hip strengthening or control group using concealed allocation stratified by disease severity. The hip strengthening group will perform 6 exercises to strengthen the hip abductor and adductor muscles at home 5 times per week for 12 weeks. They will consult with a physiotherapist on 7 occasions to be taught the exercises and progress exercise resistance. The control group will be requested to continue with their usual care. Blinded follow up assessment will be conducted at 12 weeks after randomisation. The primary outcome measure is the change in the peak external knee adduction moment measured during walking. Questionnaires will assess changes in pain and physical function as well as overall perceived rating of change. An intention-to-treat analysis will be performed using linear regression modelling and adjusting for baseline outcome values and other demographic characteristics. DISCUSSION: Results from this trial will contribute to the evidence regarding the effect of hip strengthening on knee loads and symptoms in people with medial compartment knee OA. If shown to reduce the knee adduction moment, hip strengthening has the potential to slow disease progression. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTR12607000001493.
ItemLaterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear?Hinman, RS ; Bowles, KA ; Bennell, KL (BMC, 2009-11-25)OBJECTIVE: This study aimed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis (OA) declined after one month of wear, and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month. METHODS: Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i) no insoles and; ii) insoles wedged laterally 5 degrees in random order. Testing occurred at baseline and after one month of use of the insoles. Participants recorded daily use of insoles in a log-book. Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse, compared across conditions and time with repeated measures general linear models. Correlations were obtained between total insole use and change in gait parameters with used insoles at one month, and change scores were compared between high and low users of insoles using general linear models. RESULTS: There was a significant main effect for condition, whereby insoles significantly reduced the adduction moment (all p < 0.001). However there was no significant main effect for time, nor was an interaction effect evident. No significant associations were observed between total insole use and change in gait parameters with used insoles at one month, nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time. CONCLUSION: Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use, suggesting that significant wedge degradation does not occur over the short-term.
ItemEfficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trialBennell, KL ; Hinman, RS ; Metcalf, BR ; Buchbinder, R ; McConnell, J ; McColl, G ; Green, S ; Crossley, KM (BMJ PUBLISHING GROUP, 2005-06-01)OBJECTIVE: To determine whether a multimodal physiotherapy programme including taping, exercises, and massage is effective for knee osteoarthritis, and if benefits can be maintained with self management. METHODS: Randomised, double blind, placebo controlled trial; 140 community volunteers with knee osteoarthritis participated and 119 completed the trial. Physiotherapy and placebo interventions were applied by 10 physiotherapists in private practices for 12 weeks. Physiotherapy included exercise, massage, taping, and mobilisation, followed by 12 weeks of self management. Placebo was sham ultrasound and light application of a non-therapeutic gel, followed by no treatment. Primary outcomes were pain measured by visual analogue scale and patient global change. Secondary measures included WOMAC, knee pain scale, SF-36, assessment of quality of life index, quadriceps strength, and balance test. RESULTS: Using an intention to treat analysis, physiotherapy and placebo groups showed similar pain reductions at 12 weeks: -2.2 cm (95% CI, -2.6 to -1.7) and -2.0 cm (-2.5 to -1.5), respectively. At 24 weeks, pain remained reduced from baseline in both groups: -2.1 (-2.6 to -1.6) and -1.6 (-2.2 to -1.0), respectively. Global improvement was reported by 70% of physiotherapy participants (51/73) at 12 weeks and by 59% (43/73) at 24 weeks. Similarly, global improvement was reported by 72% of placebo participants (48/67) at 12 weeks and by 49% (33/67) at 24 weeks (all p>0.05). CONCLUSIONS: The physiotherapy programme tested in this trial was no more effective than regular contact with a therapist at reducing pain and disability.