Background

Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many people with knee OA also experience co-morbidities that further add to the OA burden. Uptake of and adherence to physical activity recommendations is suboptimal in this patient population, leading to poorer OA outcomes and greater impact of associated co-morbidities. This pragmatic randomised controlled trial will investigate the clinical- and cost-effectiveness of adding telephone coaching to a physiotherapist-delivered physical activity intervention for people with knee OA.

Methods/Design

168 people with clinically diagnosed knee OA will be recruited from the community in metropolitan and regional areas and randomly allocated to physiotherapy only, or physiotherapy plus nurse-delivered telephone coaching. Physiotherapy involves five treatment sessions over 6 months, incorporating a home exercise program of 4–6 exercises (targeting knee extensor and hip abductor strength) and advice to increase daily physical activity. Telephone coaching comprises 6–12 telephone calls over 6 months by health practitioners trained in applying the Health Change Australia (HCA) Model of Health Change to provide behaviour change support. The telephone coaching intervention aims to maximise adherence to the physiotherapy program, as well as facilitate increased levels of participation in general physical activity. The primary outcomes are pain measured by an 11-point numeric rating scale and self-reported physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index subscale after 6 months. Secondary outcomes include physical activity levels, quality-of-life, and potential moderators and mediators of outcomes including self-efficacy, pain coping and depression. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 and 18 months.

Discussion

The findings will help determine whether the addition of telephone coaching sessions can improve sustainability of outcomes from a physiotherapist-delivered physical activity intervention in people with knee OA.

Trial Registration

Australian New Zealand Clinical Trials Registry reference: ACTRN12612000308897

Background

Meniscectomy is a risk factor for knee osteoarthritis, with increased medial joint loading a likely contributor to the development and progression of knee osteoarthritis in this group. Therefore, post-surgical rehabilitation or interventions that reduce medial knee joint loading have the potential to reduce the risk of developing or progressing osteoarthritis. The primary purpose of this randomised, assessor-blind controlled trial is to determine the effects of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during functional tasks in people who have recently undergone a partial medial meniscectomy.

Methods/design

62 people aged 30–50 years who have undergone an arthroscopic partial medial meniscectomy within the previous 3 to 12 months will be recruited and randomly assigned to a neuromuscular exercise or control group using concealed allocation. The neuromuscular exercise group will attend 8 supervised exercise sessions with a physiotherapist and will perform 6 exercises at home, at least 3 times per week for 12 weeks. The control group will not receive the neuromuscular training program. Blinded assessment will be performed at baseline and immediately following the 12-week intervention. The primary outcomes are change in the peak external knee adduction moment measured by 3-dimensional analysis during normal paced walking and one-leg rise. Secondary outcomes include the change in peak external knee adduction moment during fast pace walking and one-leg hop and change in the knee adduction moment impulse during walking, one-leg rise and one-leg hop, knee and hip muscle strength, electromyographic muscle activation patterns, objective measures of physical function, as well as self-reported measures of physical function and symptoms and additional biomechanical parameters.

Discussion

The findings from this trial will provide evidence regarding the effect of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during various tasks in people with a partial medial meniscectomy. If shown to reduce the knee adduction moment, neuromuscular exercise has the potential to prevent the onset of osteoarthritis or slow its progression in those with early disease.

Trial Registration

Australian New Zealand Clinical Trials Registry reference: ACTRN12612000542897

Background

Knee osteoarthritis (OA) is a prevalent chronic musculoskeletal condition with no cure. Pain is the primary symptom and results from a complex interaction between structural changes, physical impairments and psychological factors. Much evidence supports the use of strengthening exercises to improve pain and physical function in this patient population. There is also a growing body of research examining the effects of psychologist-delivered pain coping skills training (PCST) particularly in other chronic pain conditions. Though typically provided separately, there are symptom, resource and personnel advantages of exercise and PCST being delivered together by a single healthcare professional. Physiotherapists are a logical choice to be trained to deliver a PCST intervention as they already have expertise in administering exercise for knee OA and are cognisant of the need for a biopsychosocial approach to management. No studies to date have examined the effects of an integrated exercise and PCST program delivered solely by physiotherapists in this population. The primary aim of this multisite randomised controlled trial is to investigate whether an integrated 12-week PCST and exercise treatment program delivered by physiotherapists is more efficacious than either program alone in treating pain and physical function in individuals with knee OA.

Methods/design

This will be an assessor-blinded, 3-arm randomised controlled trial of a 12-week intervention involving 10 physiotherapy visits together with home practice. Participants with symptomatic and radiographic knee OA will be recruited from the community in two cities in Australia and randomized into one of three groups: exercise alone, PCST alone, or integrated PCST and exercise. Randomisation will be stratified by city (Melbourne or Brisbane) and gender. Primary outcomes are overall average pain in the past week measured by a Visual Analogue Scale and physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes include global rating of change, muscle strength, functional performance, physical activity levels, health related quality of life and psychological factors. Measurements will be taken at baseline and immediately following the intervention (12 weeks) as well as at 32 weeks and 52 weeks to examine maintenance of any intervention effects. Specific assessment of adherence to the treatment program will also be made at weeks 22 and 42. Relative cost-effectiveness will be determined from health service usage and outcome data.

Discussion

The findings from this randomised controlled trial will provide evidence for the efficacy of an integrated PCST and exercise program delivered by physiotherapists in the management of painful and functionally limiting knee OA compared to either program alone.

Trial registration

Australian New Zealand Clinical Trials Registry reference number: ACTRN12610000533099

Background

Osteoarthritis of the knee involving predominantly the medial tibiofemoral compartment is common in older people, giving rise to pain and loss of function. Many people experience progressive worsening of the disease over time, particularly those with varus malalignment and increased medial knee joint load. Therefore, interventions that can reduce excessive medial knee loading may be beneficial in reducing the risk of structural progression. Traditional quadriceps strengthening can improve pain and function in people with knee osteoarthritis but does not appear to reduce medial knee load. A neuromuscular exercise program, emphasising optimal alignment of the trunk and lower limb joints relative to one another, as well as quality of movement performance, while dynamically and functionally strengthening the lower limb muscles, may be able to reduce medial knee load. Such a program may also be superior to traditional quadriceps strengthening with respect to improved pain and physical function because of the functional and dynamic nature. This randomised controlled trial will investigate the effect of a neuromuscular exercise program on medial knee joint loading, pain and function in individuals with medial knee joint osteoarthritis. We hypothesise that the neuromuscular program will reduce medial knee load as well as pain and functional limitations to a greater extent than a traditional quadriceps strengthening program.

Methods/Design

100 people with medial knee pain, radiographic medial compartment osteoarthritis and varus malalignment will be recruited and randomly allocated to one of two 12-week exercise programs: quadriceps strengthening or neuromuscular exercise. Each program will involve 14 supervised exercise sessions with a physiotherapist plus four unsupervised sessions per week at home. The primary outcomes are medial knee load during walking (the peak external knee adduction moment from 3D gait analysis), pain, and self-reported physical function measured at baseline and immediately following the program. Secondary outcomes include the external knee adduction moment angular impulse, electromyographic muscle activation patterns, knee and hip muscle strength, balance, functional ability, and quality-of-life.

Discussion

The findings will help determine whether neuromuscular exercise is superior to traditional quadriceps strengthening regarding effects on knee load, pain and physical function in people with medial knee osteoarthritis and varus malalignment.

Trial Registration

Australian New Zealand Clinical Trials Registry reference: ACTRN12610000660088

Background

In many healthcare systems, people with severe joint disease wait months to years for joint replacement surgery. There are little empirical data on the health consequences of this delay and it is unclear whether people with substantial morbidity at entry to the waiting list continue to deteriorate further while awaiting surgery. This study investigated changes in Health-Related Quality of Life (HRQoL), health status and psychological distress among people waiting for total hip (THR) and knee replacement (TKR) surgery at a major metropolitan Australian public hospital.

Methods

134 patients completed questionnaires including the Assessment of Quality of Life (AQoL) instrument, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Kessler Psychological Distress Scale after entering an orthopaedic waiting list (baseline) and before surgery (preadmission). To quantify potential decline in wellbeing, we calculated the proportion of people experiencing clinically important deterioration using published guidelines and compared HRQoL and psychological distress outcomes with population norms.

Results

Most participants (69%) waited ≥6 months for surgery (median 286 days, IQR 169-375 days). Despite poor physical and psychological wellbeing at baseline, there was an overall deterioration in HRQoL during the waiting period (mean AQoL change -0.04, 95%CI -0.08 to -0.01), with 53% of participants experiencing decline in HRQoL (≥0.04 AQoL units). HRQoL prior to surgery remained substantially lower than Australian population norms (mean sample AQoL 0.37, 95%CI 0.33 to 0.42 vs mean population AQoL 0.83, 95%CI 0.82 to 0.84). Twenty-five per cent of participants showed decline in health status (≥9.6 WOMAC units) over the waiting period and prevalence of high psychological distress remained high at preadmission (RR 3.5, 95%CI 2.8 to 4.5). Most participants considered their pain (84%), fatigue (76%), quality of life (73%) and confidence in managing their health (55%) had worsened while waiting for surgery.

Conclusions

Despite substantial initial morbidity, over half of the participants awaiting joint replacement experienced deterioration in HRQoL during the waiting period. These data provide much-needed evidence to guide health professionals and policymakers in the design of care pathways and resource allocation for people who require joint replacement surgery.

Background

Muscle function may influence the risk of knee injury and outcomes following injury. Clinical tests, such as a single-limb mini squat, resemble conditions of daily life and are easy to administer. Fewer squats per 30 seconds indicate poorer function. However, the quality of movement, such as the medio-lateral knee motion may also be important. The aim was to validate an observational clinical test of assessing the medio-lateral knee motion, using a three-dimensional (3-D) motion analysis system. In addition, the inter-rater reliability was evaluated.

Methods

Twenty-five (17 women) non-injured participants (mean age 25.6 years, range 18-37) were included. Visual analysis of the medio-lateral knee motion, scored as knee-over-foot or knee-medial-to-foot by two raters, and 3-D kinematic data were collected simultaneously during a single-limb mini squat. Frontal plane 2-D peak tibial, thigh, and knee varus-valgus angles, and 3-D peak hip internal-external rotation, and knee varus-valgus angles were calculated.

Results

Ten subjects were scored as having a knee-medial-to-foot position and 15 subjects a knee-over-foot position assessed by visual inspection. In 2-D, the peak tibial angle (mean 89.0 (SE 0.7) vs mean 86.3 (SE 0.4) degrees, p = 0.001) and peak thigh angle (mean 77.4 (SE 1.0) vs mean 81.2 (SE 0.5) degrees, p = 0.001) with respect to the horizontal, indicated that the knee was more medially placed than the ankle and thigh, respectively. Thus, the knee was in more valgus (mean 11.6 (SE 1.5) vs 5.0 (SE 0.8) degrees, p < 0.001) in subjects with the knee-medial-to-foot than in those with a knee-over-foot position. In 3-D, the hip was more internally rotated in those with a knee-medial-to-foot than in those with a knee-over-foot position (mean 10.6 (SE 2.1) vs 4.8 (SE 1.8) degrees, p = 0.049), but there was no difference in knee valgus (mean 6.1 (SE 1.8) vs mean 5.0 (SE 1.2) degrees, p = 0.589). The kappa value and percent agreement, respectively, was >0.90 and 96 between raters.

Conclusions

Medio-lateral motion of the knee can reliably be assessed during a single-leg mini-squat. The test is valid in 2-D, while the actual movement, in 3-D, is mainly exhibited as increased internal hip rotation. The single-limb mini squat is feasible and easy to administer in the clinical setting and in research to address lower extremity movement quality.

Background

Hip osteoarthritis (OA) is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function.

Methods

The trial will be conducted at the University of Melbourne Centre for Health, Exercise and Sports Medicine. 128 participants with hip pain greater or equal to 40/100 on visual analogue scale (VAS) and evidence of OA on x-ray will be recruited. Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region. The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice. The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel. The participants and the study assessor will be blinded to the treatment allocation. Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) immediately after the 12 week intervention. Participants will also be followed up at 36 weeks post baseline.

Conclusions

The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice. The findings from this randomised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA.

Trial Registration

Australian New Zealand Clinical Trials Registry reference: ACTRN12610000439044

Background

This randomised, single-blind controlled pilot trial aimed to determine the effectiveness of a physiotherapy program, including exercise and manual therapy, in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture.

Methods

20 participants were randomly allocated to an intervention (n = 11) or control (n = 9) group. The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary. The control group received no treatment. Blinded assessment was conducted at baseline and 11 weeks. Questionnaires assessed self-reported changes in back pain, physical function, and health-related quality of life. Objective measures of thoracic kyphosis, back and shoulder muscle endurance (Timed Loaded Standing Test), and function (Timed Up and Go test) were also taken.

Results

Compared with the control group, the intervention group showed significant reductions in pain during movement (mean difference (95% CI) -1.8 (-3.5 to -0.1)) and at rest (-2.0 (-3.8 to -0.2)) and significantly greater improvements in Qualeffo physical function (-4.8 (-9.2 to -0.5)) and the Timed Loaded Standing test (46.7 (16.1 to 77.3) secs). For the perceived change in back pain over the 10 weeks, 9/11 (82%) participants in the intervention group rated their pain as 'much better' compared with only 1/9 (11%) participants in the control group.

Conclusion

Despite the modest sample size, these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures, but need to be confirmed in a larger sample.

Trail registration

NCT00638768

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° 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.

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