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1.  A survey of footwear advice, beliefs and wear habits in people with knee osteoarthritis 
Background
Expert opinion recommends cushioned and supportive footwear for people with knee osteoarthritis (OA). However, little is known about the footwear advice people receive from healthcare professionals, or the beliefs and footwear habits of people with knee OA. This study aimed to determine i) what types of shoes people are advised to wear for their knee OA and by whom; ii) establish which types of shoes people with knee OA believe are best for managing their knee OA symptoms and (iii) which shoes they wear most often.
Methods
204 people with symptomatic knee OA completed an online survey. The survey comprised 14 questions asking what footwear advice people had received for their knee OA and who they received it from, individual beliefs about optimal footwear styles for their knee OA symptoms and the types of footwear usually worn.
Results
Only one third (n = 69, 34%) of participants reported receiving footwear advice for their knee OA, and this was most frequently received from a podiatrist (n = 47, 68%). The most common advice was to wear sturdy/supportive shoes (n = 96, 47%) or shoes with arch supports (n = 84, 41%). These were also amongst the shoe styles that participants believed were best for their knee OA (n = 157 (77%) and n = 138 (68%) respectively). The type of shoes most frequently worn were athletic (n = 131, 64%) and sturdy/supportive shoes (n = 116, 57%).
Conclusions
Most people with knee OA who completed our survey had not received advice about footwear for their knee OA symptoms. Our participants typically believed that sturdy/supportive shoes were best for their knee OA and this shoe style was most frequently worn, which is reflective of expert opinion. Future research is needed to confirm whether sturdy/supportive shoes are indeed optimal for managing symptoms of knee OA.
Electronic supplementary material
The online version of this article (doi:10.1186/s13047-014-0043-8) contains supplementary material, which is available to authorized users.
doi:10.1186/s13047-014-0043-8
PMCID: PMC4210582  PMID: 25352917
Knee; Arthritis; OA; Footwear; Shoes; Survey
2.  Internet-mediated physiotherapy and pain coping skills training for people with persistent knee pain (IMPACT – knee pain): a randomised controlled trial protocol 
Background
Persistent knee pain in people over 50 years of age is often attributable to knee osteoarthritis (OA), a common joint condition that causes physical and psychological dysfunction. Exercise and pain coping skills training (PCST) can help reduce the impact of persistent knee pain, however, access to health professionals who deliver these services can be challenging. With increasing access to the Internet, remotely delivered Internet-based treatment approaches may provide alternatives for healthcare delivery. This pragmatic randomised controlled trial will investigate whether an Internet-delivered intervention that combines PCST and physiotherapist-guided exercise (PCST + Ex) is more effective than online educational material (educational control) in people with persistent knee pain.
Methods/Design
We will recruit 148 people over 50 years of age with self-reported persistent knee pain consistent with knee OA from the Australian community. Following completion of baseline questionnaires, participants will be randomly allocated to access a 3-month intervention of either (i) online educational material, or (ii) the same online material plus an 8-module (once per week) Internet-based PCST program and seven Internet-delivered physiotherapy sessions with a home exercise programs to be performed 3 times per week. Outcomes will be measured at baseline, 3 months and 9 months with the primary time point at 3 months. Primary outcomes are average knee pain on walking (11-point numeric rating scale) and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index subscale). Secondary outcomes include additional measures of knee pain, health-related quality-of-life, perceived global change in symptoms, and potential moderators and mediators of outcomes including self-efficacy for pain management and function, pain coping attempts and pain catastrophising. Other measures of adherence, adverse events, harms, use of health services/co-interventions, and process measures including appropriateness and satisfaction of the intervention, will be collected at 3, 6 and 9 months.
Discussion
The findings will help determine the effectiveness and acceptability of Internet access to a combination of interventions that are known to be beneficial to people with persistent knee pain. This study has the potential to guide clinical practice towards innovative modes of healthcare provision.
Trial registration
Australian New Zealand Clinical Trials Registry reference: ACTRN12614000243617.
doi:10.1186/1471-2474-15-279
PMCID: PMC4137067  PMID: 25125068
Knee osteoarthritis; Knee pain; Physiotherapy; Pain coping skills; Internet; Health care delivery; Randomised control trial
3.  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
4.  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
5.  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
6.  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
7.  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
8.  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
9.  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
10.  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
12.  Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders 
Background
Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups.
Methods/Design
A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes.
Discussion
This trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257.
doi:10.1186/1471-2474-12-104
PMCID: PMC3121656  PMID: 21599941
13.  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
14.  Predictors of symptomatic response to glucosamine in knee osteoarthritis: an exploratory study 
Objective
To evaluate whether patient characteristics and/or radiographic disease patterns predict symptomatic response to treatment with glucosamine in osteoarthritis (OA) of the knee.
Design
Exploratory prospective correlational study.
Setting
Institutional.
Patients
39 participants with chronic knee pain from the local community.
Interventions
Glucosamine sulphate (1.5 g/day) for 12 weeks.
Main outcome measures
Pain and physical function were assessed with visual analogue scales (VASs) and participant‐perceived global change scores (GCSs). Regression modelling evaluated the relationship between treatment outcome and age, body mass index (BMI), pain and function self‐efficacy and presence/absence of osteophytes in the medial and lateral tibiofemoral joint (TFJ) and patellofemoral joint (PFJ) compartments.
Results
13 (33%) participants were men. The mean (SD) age and BMI were 53.6 (13.1) years and 27.9 (4.6) kg/m2, respectively. 13 (33%), 19 (49%) and 24 (62%) participants had medial TFJ, lateral TFJ and PFJ osteophytes, respectively. Glucosamine significantly improved pain (mean change on VAS =  −1.4, 95% CI −0.6 to −2.2; p = 0.002) and activity restriction (−1.9, 95% CI −1.0 to −2.8; p<0.001). At 12 weeks, 30 (77%) and 27 (69%) participants reported improvement in pain and physical function, respectively. Regression modelling showed that no evaluated variables predicted change in pain on VAS. Decreased function self‐efficacy, presence of PFJ osteophytes and absence of medial TFJ osteophytes predicted functional improvement on VAS. BMI, pain self‐efficacy and function self‐efficacy predicted improvement in pain by GCS.
Conclusions
Although glucosamine significantly improved symptoms, most of the variance in outcome at 12 weeks was unexplained by the predictors evaluated. However, glucosamine may be more effective at improving symptoms in patients with knee OA who have a lower BMI, PFJ osteophytes and lower functional self‐efficacy.
doi:10.1136/bjsm.2006.033381
PMCID: PMC2465359  PMID: 17261554
15.  Ice‐water immersion and delayed‐onset muscle soreness: a randomised controlled trial 
Objective
To determine if ice‐water immersion after eccentric quadriceps exercise minimises the symptoms of delayed‐onset muscle soreness (DOMS).
Design
A prospective randomised double‐blind controlled trial was undertaken. 40 untrained volunteers performed an eccentric loading protocol with their non‐dominant leg.
Interventions
Participants were randomised to three 1‐min immersions in either ice water (5±1°C) or tepid water (24°C).
Main outcome measures
Pain and tenderness (visual analogue scale), swelling (thigh circumference), function (one‐legged hop for distance), maximal isometric strength and serum creatine kinase (CK) recorded at baseline, 24, 48 and 72 h after exercise. Changes in outcome measures over time were compared to determine the effect of group allocation using independent t tests or Mann–Whitney U tests.
Results
No significant differences were observed between groups with regard to changes in most pain parameters, tenderness, isometric strength, swelling, hop‐for‐distance or serum CK over time. There was a significant difference in pain on sit‐to‐stand at 24 h, with the intervention group demonstrating a greater increase in pain than the control group (median change 8.0 vs 2.0 mm, respectively, p = 0.009).
Conclusions
The protocol of ice‐water immersion used in this study was ineffectual in minimising markers of DOMS in untrained individuals. This study challenges the wide use of this intervention as a recovery strategy by athletes.
doi:10.1136/bjsm.2006.033985
PMCID: PMC2465319  PMID: 17261562
16.  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
17.  Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial 
Background
The patellofemoral joint (PFJ) is one compartment of the knee that is frequently affected by osteoarthritis (OA) and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA.
Methods
90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA) will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week) compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks). Physiotherapy treatment will consist of (i) quadriceps muscle retraining; (ii) quadriceps and hip muscle strengthening; (iii) patellar taping; (iv) manual PFJ and soft tissue mobilisation; and (v) OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction.
Conclusion
This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the potential to reduce the personal and societal burden of this increasing public health problem.
Trial Registration
Australia New Zealand Clinical Trials Registry ACTRN12608000288325
doi:10.1186/1471-2474-9-122
PMCID: PMC2556332  PMID: 18793446
18.  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
19.  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.
doi:10.1186/1471-2474-8-96
PMCID: PMC2147062  PMID: 17892539
20.  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

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