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1.  Efficacy of a physiotherapy rehabilitation program for individuals undergoing arthroscopic management of femoroacetabular impingement – the FAIR trial: a randomised controlled trial protocol 
Background
Femoroacetabular impingement is a common cause of hip/groin symptoms and impaired functional performance in younger sporting populations and results from morphological abnormalities of the hip in which the proximal femur abuts against the acetabular rim. Many people with symptomatic femoroacetabular impingement undergo arthroscopic hip surgery to correct the bony abnormalities. While many case series over the past decade have reported favourable surgical outcomes, it is not known whether formal rehabilitation is needed as part of the management of patients undergoing this surgical procedure. This randomised controlled trial will investigate the efficacy of a progressive physiotherapist-supervised rehabilitation program (Takla-O’Donnell Protocol) in improving health-related quality of life, physical function and symptoms in individuals undergoing arthroscopic management of femoroacetabular impingement.
Methods/design
100 people aged 16–35 years undergoing hip arthroscopy for symptomatic femoroacetabular impingement will be recruited from surgical practices in Melbourne, Australia and randomly allocated to either a physiotherapy or control group. Both groups will receive written information and one standardised post-operative physiotherapy visit whilst in hospital as per usual care. Those in the physiotherapy group will also receive seven individual 30-minute physiotherapy sessions, including one pre-operative visit (within 2 weeks of surgery) and six post-operative visits at fortnightly intervals (commencing two weeks after surgery). The physiotherapy intervention will incorporate education and advice, manual techniques and prescription of a progressive rehabilitation program including home, aquatic and gym exercises. The control group will not receive additional physiotherapy management. Measurements will be taken at baseline (2 weeks pre-operatively) and at 14 and 24 weeks post-surgery. Primary outcomes are the International Hip Outcome Tool and the sports subscale of the Hip Outcome Score at 14 weeks post-surgery. Secondary outcomes include the Copenhagen Hip and Groin Outcome Score, the activities of daily living subscale of the Hip Outcome Score, the Heidelberg Sports Activity Score, a modified Tegner Activity Scale and participant-perceived overall change.
Discussion
The findings from this randomised controlled trial will provide evidence for the efficacy of a specific physiotherapist-supervised rehabilitation program in improving outcomes following arthroscopic management of symptomatic femoroacetabular impingement.
Trial registration
Australian New Zealand Clinical Trials Registry reference number: ACTRN12613000282785.
doi:10.1186/1471-2474-15-58
PMCID: PMC3941691  PMID: 24571824
Physiotherapy; Physical therapy; Rehabilitation; Hip arthroscopy; Femoroacetabular impingement
2.  Intraoperative Cartilage Degeneration Predicts Outcome 12 Months After Hip Arthroscopy 
Background
When considering arthroscopic surgery for treatment of hip pain, it is important to understand the influence of joint degeneration on the likelihood of success. Previous research has shown poorer outcomes among patients with osteoarthritis but new arthroscopic techniques including femoroacetabular impingement correction and microfracture may lead to better arthroscopic outcomes.
Questions/Purposes
We investigated the effect of intraarthroscopic articular and rim cartilage degeneration on the outcome after hip arthroscopy using contemporary techniques.
Methods
The modified Harris hip score (MHHS) and nonarthritic hip score (NAHS) were completed preoperatively and 12 months postoperatively by 560 patients undergoing hip arthroscopy after March 2007. Change in these scores was compared between patients with and without acetabular or femoral articular cartilage degeneration and between patients with and without rim cartilage degeneration. Correlation and regression analyses were used to predict the change in outcome scores based on the severity of cartilage degeneration.
Results
Hips without degeneration had greater improvement in the outcome scores. The presence of cartilage degeneration showed negative correlations with change in outcomes. The best model to explain change in MHHS included preoperative score, articular cartilage degeneration grade, and rim lesion grade (adjusted R2 = 0.24).
Conclusions
Our data support previous findings regarding the negative influence of cartilage degeneration on improvement after hip arthroscopy. Nevertheless, many patients with cartilage degeneration still improved and the severity of degeneration accounts for little of the resulting variance in change. Future studies must determine the clinical importance of the improvements gained by patients with cartilage degeneration and identify other predictors of outcome.
Level of Evidence
Level III, prognostic study. See Instructions for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-012-2594-y
PMCID: PMC3549183  PMID: 22992870
3.  Self-reported knee joint instability is related to passive mechanical stiffness in medial knee osteoarthritis 
Background
Self-reported knee joint instability compromises function in individuals with medial knee osteoarthritis and may be related to impaired joint mechanics. The purpose of this study was to evaluate the relationship between self-reported instability and the passive varus-valgus mechanical behaviour of the medial osteoarthritis knee.
Methods
Passive varus-valgus angular laxity and stiffness were assessed using a modified isokinetic dynamometer in 73 participants with medial tibiofemoral osteoarthritis. All participants self-reported the absence or presence of knee instability symptoms and the degree to which instability affected daily activity on a 6-point likert scale.
Results
Forward linear regression modelling identified a significant inverse relationship between passive mid-range knee stiffness and symptoms of knee instability (r = 0.27; P < 0.05): reduced stiffness was indicative of more severe instability symptoms. Angular laxity and end-range stiffness were not related to instability symptoms (P > 0.05).
Conclusions
Conceivably, a stiffer passive system may contribute toward greater joint stability during functional activities. Importantly however, net joint stiffness is influenced by both active and passive stiffness, and thus the active neuromuscular system may compensate for reduced passive stiffness in order to maintain joint stability. Future work is merited to examine the role of active stiffness in symptomatic joint stability.
doi:10.1186/1471-2474-14-326
PMCID: PMC3840574  PMID: 24252592
Knee osteoarthritis; Passive stiffness; Instability; Varus-valgus laxity
4.  Addition of telephone coaching to a physiotherapist-delivered physical activity program in people with knee osteoarthritis: A randomised controlled trial protocol 
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
doi:10.1186/1471-2474-13-246
PMCID: PMC3552972  PMID: 23231928
5.  A physiotherapist-delivered integrated exercise and pain coping skills training intervention for individuals with knee osteoarthritis: a randomised controlled trial protocol 
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
doi:10.1186/1471-2474-13-129
PMCID: PMC3524463  PMID: 22828288
6.  Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol 
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
doi:10.1186/1471-2474-12-276
PMCID: PMC3247187  PMID: 22141334
7.  Decline in Health-Related Quality of Life reported by more than half of those waiting for joint replacement surgery: a prospective cohort study 
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.
doi:10.1186/1471-2474-12-108
PMCID: PMC3121657  PMID: 21605398
9.  Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial 
Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis.
Design Randomised controlled trial.
Setting Community in Melbourne, Australia.
Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis.
Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months.
Main outcome measures Primary symptomatic outcome was change in overall knee pain (past week) measured on an 11 point numerical rating scale. Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans. Secondary clinical outcomes included changes in measures of pain, function, stiffness, and health related quality of life. Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions.
Results Between group differences did not differ significantly for the primary outcomes of change in overall pain (−0.3 points, 95% confidence intervals −1.0 to 0.3) and change in medial tibial cartilage volume (−0.4 mm3, 95% confidence interval −15.4 to 14.6), and confidence intervals did not include minimal clinically important differences. None of the changes in secondary outcomes showed differences between groups.
Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles.
Trial registration Australian New Zealand Clinical Trials Registry ACTR12605000503628 and ClinicalTrials.gov NCT00415259.
doi:10.1136/bmj.d2912
PMCID: PMC3100910  PMID: 21593096
10.  Unloading shoes for osteoarthritis of the knee: protocol for the SHARK randomised controlled trial 
Background
Knee osteoarthritis (OA) is a common and disabling condition. Abnormalities in knee loading play an important role in disease pathogenesis, yet there are few non-surgical treatments for knee OA capable of reducing knee load. This two-arm randomised controlled trial is investigating the efficacy of specially-designed unloading shoes for the treatment of symptoms in people with knee OA.
Methods/Design
164 people with symptomatic medial tibiofemoral joint OA will be recruited from the community and randomly allocated to receive either unloading shoes or control shoes. Unloading shoes have a specially-designed triple-density midsole where the medial side is softer than normal and the lateral side harder as well as a lateral wedge between the sole and sock-liner. Control shoes are standard athletic shoes and do not contain these features. Participants will be blinded to shoe allocation and will be instructed to wear the shoes as much as possible every day for 6 months, for a minimum of 4 hours per day. The primary outcomes are knee pain (numerical rating scale) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index) measured at baseline and 6 months. Secondary outcomes include additional measures of knee pain, knee stiffness, participant global ratings of change in symptoms, quality-of-life and physical activity.
Conclusions
The findings from this study will help determine whether specially-designed unloading shoes are efficacious in the management of knee OA.
Trial registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12613000851763.
doi:10.1186/1471-2474-15-48
PMCID: PMC3942305  PMID: 24555418
11.  Validity and inter-rater reliability of medio-lateral knee motion observed during a single-limb mini squat 
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.
doi:10.1186/1471-2474-11-265
PMCID: PMC2998461  PMID: 21080945
12.  Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol 
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
doi:10.1186/1471-2474-11-238
PMCID: PMC2966457  PMID: 20946621
13.  Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial 
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
doi:10.1186/1471-2474-11-36
PMCID: PMC2830179  PMID: 20163739
14.  Laterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear? 
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.
doi:10.1186/1471-2474-10-146
PMCID: PMC2791095  PMID: 19939281
15.  Paraspinal muscle control in people with osteoporotic vertebral fracture 
European Spine Journal  2007;16(8):1137-1144.
The high risk of sustaining subsequent vertebral fractures after an initial fracture cannot be explained solely by low bone mass. Extra-osseous factors, such as neuromuscular characteristics may help to explain this clinical dilemma. Elderly women with (n = 11) and without (n = 14) osteoporotic vertebral fractures performed rapid shoulder flexion to perturb the trunk while standing on a flat and short base. Neuromuscular postural responses of the paraspinal muscles at T6 and T12, and deep lumbar multifidus at L4 were recorded using intramuscular electromyography (EMG). Both groups demonstrated bursts of EMG that were initiated either before or shortly after the onset of shoulder flexion (P < 0.05). Paraspinal and multifidus onset occurred earlier in the non-fracture group (50–0 ms before deltoid onset) compared to the fracture group (25 ms before and 25 ms after deltoid onset) in the flat base condition. In the short base condition, EMG amplitude increased significantly above baseline earlier in the non-fracture group (75–25 ms before deltoid onset) compared to the fracture group (25–0 ms before deltoid onset) at T6 and T12; yet multifidus EMG increased above baseline earlier in the fracture group (50–25 ms before deltoid) compared to the non-fracture group (25–0 ms before deltoid). Time to reach maximum amplitude was shorter in the fracture group. Hypothetically, the longer time to initiate a postural response and shorter time to reach maximum amplitude in the fracture group may indicate a neuromuscular contribution towards subsequent fracture aetiology. This response could also be an adaptive characteristic of the central nervous system to minimise vertebral loading time.
doi:10.1007/s00586-006-0276-8
PMCID: PMC2200788  PMID: 17203276
Osteoporosis; Vertebral fracture; Paraspinal muscle; Electromyography; Neuromuscular control
16.  The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial 
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
doi:10.1186/1471-2474-8-121
PMCID: PMC2235855  PMID: 18067658
17.  Effectiveness of targeted falls prevention programme in subacute hospital setting: randomised controlled trial 
BMJ : British Medical Journal  2004;328(7441):676.
Objective To assess the effectiveness of a targeted, multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital.
Design Randomised controlled trial of a targeted multiple intervention programme implemented in addition to usual care compared with usual care alone.
Setting Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients.
Participants 626 men and women aged 38 to 99 years (average 80 years) were recruited from consecutive admissions to subacute hospital wards.
Intervention Falls risk alert card with information brochure, exercise programme, education programme, and hip protectors.
Main outcome measures Incidence rate of falls, injuries related to falls, and proportion of participants who experienced one or more falls during their stay in hospital.
Results Participants in the intervention group (n = 310) experienced 30% fewer falls than participants in the control group (n = 316). This difference was significant (Peto log rank test P = 0.045) and was most obvious after 45 days of observation. In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls (relative risk 0.78, 95% confidence interval 0.56 to 1.06) and 28% fewer falls resulted in injury (log rank test P = 0.20).
Conclusions A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting.
PMCID: PMC381222  PMID: 15031238
18.  A review of anatomical and mechanical factors affecting vertebral body integrity 
Background: The aetiology of osteoporotic vertebral fracture is multifactorial and may be conceptualised using a systems framework. Previous studies have established several correlates of vertebral fracture including reduced vertebral cross-sectional area, weakness in back extensor muscles, reduced bone mineral density, increasing age, worsening kyphosis and recent vertebral fracture. Alterations in these physical characteristics may influence biomechanical loads and neuromuscular control of the trunk and contribute to changes in subregional bone mineral density of the vertebral bodies.
Methods: This review discusses factors that have received less attention in the literature, which may contribute to the development of vertebral fracture. A literature review was conducted using electronic databases including Medline, Cinahl and ISI Web of Science to examine the potential contribution of trabecular architecture, subregional bone mineral density, vertebral geometry, muscle force, muscle strength, neuromuscular control and intervertebral disc integrity to the aetiology of osteoporotic vertebral fracture.
Interpretation: A better understanding of factors such as biomechanical loading and neuromuscular control of the trunk may help to explain the high incidence of subsequent vertebral fracture after sustaining an initial vertebral fracture. Consideration of these issues may be important in the development of prevention and management strategies.
PMCID: PMC1074712  PMID: 15912196
osteoporosis; vertebral fracture; bone density; spinal biomechanics; neuromuscular control
19.  Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomised controlled trial 
BMJ : British Medical Journal  2003;327(7407):135.
Objectives To test the hypotheses that therapeutic taping of the knee improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment.
Design Randomised single blind controlled trial with three intervention arms (therapeutic tape, control tape, and no tape) of three weeks' duration and three week follow up.
Setting Outcome assessment was performed in a university based laboratory. Taping interventions were applied by eight physiotherapists in metropolitan private practice.
Participants 87 patients with symptoms of knee osteoarthritis as defined by the American College of Rheumatology.
Main outcome measures Primary outcome measure was pain as measured by visual analogue scale and participant perceived rating of change. Secondary measures of pain and disability included the Western Ontario and MacMaster Universities osteoarthritis index, knee pain scale, and the SF-36.
Results The therapeutic tape group reported a greater reduction in pain on all primary outcomes than either of the other two groups. A significant association was evident between intervention and change in pain at three weeks (P=0.000), with 73% (21/29) of the therapeutic tape group reporting improvement compared with 49% (14/29) of the control tape group and 10% (3/29) of the no tape group. Significantly greater improvement in pain and disability was observed on most secondary outcomes in the therapeutic tape group compared with the no tape group. Benefits of therapeutic tape were maintained three weeks after stopping treatment.
Conclusions Therapeutic knee taping is an efficacious treatment for the management of pain and disability in patients with knee osteoarthritis.
PMCID: PMC165705  PMID: 12869456
20.  Effect of altered reproductive function and lowered testosterone levels on bone density in male endurance athletes 
The effect of intense physical activity on female reproductive hormones is well recognised1–3 and there is evidence that menstrual disturbances associated with hypo-oestrogenism adversely affect bone density especially at the lumbar spine.4 5 Physical activity can also have a range of effects on male reproductive function depending upon the intensity and duration of the activity and the fitness of the individual.6 In particular, endurance training may be associated with reductions in circulating testosterone levels. Since testosterone has important anabolic roles, alterations in reproductive hormone profiles may have detrimental skeletal consequences similar to those seen in females with menstrual disturbances. The aim of this brief review is to present the limited literature on the relation between bone density and testosterone levels in male endurance athletes.
PMCID: PMC1332330  PMID: 8889111
male endurance athletes; testosterone; bone density; reproductive function
21.  Strength Training for Arthritis Trial (START): design and rationale 
Background
Muscle loss and fat gain contribute to the disability, pain, and morbidity associated with knee osteoarthritis (OA), and thigh muscle weakness is an independent and modifiable risk factor for it. However, while all published treatment guidelines recommend muscle strengthening exercise to combat loss of muscle mass and strength in knee OA patients, previous strength training studies either used intensities or loads below recommended levels for healthy adults or were generally short, lasting only 6 to 24 weeks. The efficacy of high-intensity strength training in improving OA symptoms, slowing progression, and affecting the underlying mechanisms has not been examined due to the unsubstantiated belief that it might exacerbate symptoms. We hypothesize that in addition to short-term clinical benefits, combining greater duration with high-intensity strength training will alter thigh composition sufficiently to attain long-term reductions in knee-joint forces, lower pain levels, decrease inflammatory cytokines, and slow OA progression.
Methods/Design
This is an assessor-blind, randomized controlled trial. The study population consists of 372 older (age ≥ 55 yrs) ambulatory, community-dwelling persons with: (1) mild-to-moderate medial tibiofemoral OA (Kellgren-Lawrence (KL) = 2 or 3); (2) knee neutral or varus aligned knee ( -2° valgus ≤ angle ≤ 10° varus); (3) 20 kg.m-2 ≥ BMI ≤ 45 kg.m-2; and (3) no participation in a formal strength-training program for more than 30 minutes per week within the past 6 months. Participants are randomized to one of 3 groups: high-intensity strength training (75-90% 1Repetition Maximum (1RM)); low-intensity strength training (30-40%1RM); or healthy living education. The primary clinical aim is to compare the interventions’ effects on knee pain, and the primary mechanistic aim is to compare their effects on knee-joint compressive forces during walking, a mechanism that affects the OA disease pathway. Secondary aims will compare the interventions’ effects on additional clinical measures of disease severity (e.g., function, mobility); disease progression measured by x-ray; thigh muscle and fat volume, measured by computed tomography (CT); components of thigh muscle function, including hip abductor strength and quadriceps strength, and power; additional measures of knee-joint loading; inflammatory and OA biomarkers; and health-related quality of life.
Discussion
Test-retest reliability for the thigh CT scan was: total thigh volume, intra-class correlation coefficients (ICC) = 0.99; total fat volume, ICC = 0.99, and total muscle volume, ICC = 0.99. ICC for both isokinetic concentric knee flexion and extension strength was 0.93, and for hip-abductor concentric strength was 0.99. The reliability of our 1RM testing was: leg press, ICC = 0.95; leg curl, ICC = 0.99; and leg extension, ICC = 0.98. Results of this trial will provide critically needed guidance for clinicians in a variety of health professions who prescribe and oversee treatment and prevention of OA-related complications. Given the prevalence and impact of OA and the widespread availability of this intervention, assessing the efficacy of optimal strength training has the potential for immediate and vital clinical impact.
Trial registration
ClinicalTrials.gov, NCT01489462
doi:10.1186/1471-2474-14-208
PMCID: PMC3722013  PMID: 23855596
22.  The effects of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: ‘SCOPEX’ a randomised control trial protocol 
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
doi:10.1186/1471-2474-13-233
PMCID: PMC3529104  PMID: 23181415
23.  Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design 
Background
Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain.
Methods/Design
Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months.
Discussion
The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people.
Trial registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12609001001280
doi:10.1186/1472-6882-12-161
PMCID: PMC3493360  PMID: 22992309

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