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1.  The PEX study – Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749] 
Background
Patellofemoral complaints are frequently seen in younger and active patients. Clinical strategy is usually based on decreasing provoking activities as sports and demanding knee activities during work and leisure and reassuring the patient on the presumed good outcome.
Exercise therapy is also often prescribed although evidence on effectiveness is lacking.
The objective of this article is to present the design of a randomized clinical trial that examines the outcome of exercise therapy supervised by a physical therapist versus a clinically accepted "wait and see" approach (information and advice about the complaints only).
The research will address to both effectiveness and cost effectiveness of supervised exercise therapy in patients with patellofemoral pain syndrome (PFPS).
Methods/design
136 patients (adolescents and young adults) with patellofemoral pain syndrome are recruited in general practices and sport medicine centers. They will be randomly allocated receiving either 3 months of exercise therapy (or usual care.
The primary outcome measures are pain, knee function and perception of recovery after 3 months and 12 months of follow up and will be measured by self reporting.
Measurements will take place at baseline, 6 weeks, and 3 monthly until 1 year after inclusion in the study.
Secondary outcome measurements include an economic evaluation.
A cost-utility analysis will be performed that expresses health improvements in Quality Adjusted Life Years (QALYs) and incorporates direct medical costs and productivity costs
Discussion
This study has been designed after reviewing the literature on exercise therapy for patellofemoral pain syndrome. It was concluded that to merit the effect of exercise therapy a trial based on correct methodological concept needed to be executed.
The PEX study is a randomized clinical trial where exercise therapy is compared to usual care. This trial started in April 2005 and will finish in June 2007. The first results will be available around December 2007.
doi:10.1186/1471-2474-7-31
PMCID: PMC1431535  PMID: 16545120
2.  Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial 
Objective To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.
Design Prospective, single blind, randomised clinical trial.
Setting Single centre trial within a community setting in Brisbane, Australia.
Participants 179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks’ duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.
Interventions Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.
Main outcome measures Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.
Results Foot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.
Conclusion While foot orthoses are superior to flat inserts according to participants’ overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.
Trial registration Australian Clinical Trials Registry ACTRN012605000463673 and ClinicalTrials.gov NCT00118521.
doi:10.1136/bmj.a1735
PMCID: PMC2572211  PMID: 18952682
3.  Effectiveness of Elastic Resistance in Rehabilitation of Patients With Patellofemoral Pain Syndrome 
Sports Health  2011;3(2):190-194.
Context:
Patellofemoral pain syndrome (PFPS) is associated with muscle imbalance at the knee and hip. Therapeutic exercise is effective at reducing pain associated with PFPS.
Objective:
To identify and analyze clinical trials of elastic resistance in patients with PFPS to determine its efficacy.
Data Sources:
PubMed, CINAHL, and PEDro databases were searched for terms relevant to PFPS rehabilitation in patients aged 12 to 40 years.
Study Selection:
Only peer-reviewed clinical trials lasting at least 4 weeks and specifying the use of elastic resistance in their protocols were included.
Data Extraction:
Eight eligible studies were analyzed for design, sample, intervention, outcomes, and clinical application.
Results:
The studies included in this review lacked high-quality design, often using exercise as a “quasi-control” condition. Most studies did not provide specific exercise prescription or progression. Although participants in each study reported significant improvements in pain, deficiencies in scientific design limit the conclusion.
Conclusion:
Elastic resistance exercise may reduce pain and improve function and strength in patients with PFPS.
doi:10.1177/1941738111398595
PMCID: PMC3445141  PMID: 23016008
patellofemoral pain; elastic resistance; therapeutic exercise
4.  Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial 
Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome.
Design Open label randomised controlled trial.
Setting General practice and sport physician practice.
Participants Patients with a new episode of patellofemoral pain syndrome recruited by their general practitioner or sport physician.
Interventions The intervention group received a standardised exercise programme for 6 weeks tailored to individual performance and supervised by a physical therapist, and were instructed to practise the tailored exercises at home for 3 months. The control group were assigned usual care, which comprised a “wait and see” approach of rest during periods of pain and refraining from pain provoking activities. Both the intervention group and the control group received written information about patellofemoral pain syndrome and general instructions for home exercises.
Main outcome measures The primary outcomes were self reported recovery (7 point Likert scale), pain at rest and pain on activity (0-10 point numerical rating scale), and function (0-100 point Kujala patellofemoral score) at 3 months and 12 months follow-up.
Results A total of 131 participants were included in the study: 65 in the intervention group and 66 in the control group. After 3 months, the intervention group showed better outcomes than the control group with regard to pain at rest (adjusted difference −1.07, 95% confidence interval −1.92 to −0.22; effect size 0.47), pain on activity (−1.00, −1.91 to −0.08; 0.45), and function (4.92, 0.14 to 9.72; 0.34). At 12 months, the intervention group continued to show better outcomes than the control group with regard to pain (adjusted difference in pain at rest −1.29, −2.16 to −0.42; effect size 0.56; pain on activity −1.19, −2.22 to −0.16; effect size 0.54), but not function (4.52, −0.73 to 9.76). A higher proportion of patients in the exercise group than in the control group reported recovery (41.9% v 35.0% at 3 months and 62.1% v 50.8% at 12 months), although the differences in self reported recovery between the two groups were not statistically significant. Predefined subgroup analyses revealed that patients recruited by sport physicians (n=30) did not benefit from the intervention, whereas those recruited by general practitioners (n=101) showed significant and clinically relevant differences in pain and function in favour of the intervention group.
Conclusion Supervised exercise therapy resulted in less pain and better function at short term and long term follow-up compared with usual care in patients with patellofemoral pain syndrome in general practice. Exercise therapy did not produce a significant difference in the rate of self reported recovery.
Trial registration ISRCTN83938749.
doi:10.1136/bmj.b4074
PMCID: PMC2764849  PMID: 19843565
5.  Predictors of short and long term outcome in patellofemoral pain syndrome: a prospective longitudinal study 
Background
Patellofemoral pain syndrome (PFP) is a common musculoskeletal condition that has a tendency to become chronic and problematic in a proportion of affected individuals. The objective of this study was to identify prognostic factors that may have clinical utility in predicting poor outcome on measures of pain and function in individuals with PFP.
Methods
A prospective follow-up study was conducted of 179 participants in a randomised clinical trial. Nine baseline factors (age, gender, body mass index, arch height, duration of knee pain, worst pain visual analogue scale, Kujala Patellofemoral Score (KPS), functional index questionnaire (FIQ), step down repetitions) were investigated for their prognostic ability on outcome assessed at six, 12 and 52 weeks (worst pain, KPS and FIQ). Factors with significant univariate associations were entered into multivariate linear regression models to identify a group of factors independently associated with poor outcome.
Results
Long symptom duration was the most consistent predictor of poor outcome over 52 weeks rated on the KPS and the FIQ (β-0.07, 95% confidence interval -0.1 to -0.03, p < 0.000; and -0.02, -0.03 to -0.01, p < 0.000, respectively). Worse KPS at baseline was predictive of outcome at six, 12 and 52 weeks. Gender, body mass index and arch height were generally not associated with outcome (univariate analysis), while age, worst pain, FIQ and step downs were excluded during multivariate analyses.
Conclusions
Patients presenting with PFP of long duration who score worse on the KPS have a poorer prognosis, irrespective of age, gender and morphometry. These results suggest that strategies aimed at preventing chronicity of more severe PFP may optimise prognosis.
doi:10.1186/1471-2474-11-11
PMCID: PMC2823664  PMID: 20082723
6.  Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: A randomised clinical trial 
Background
Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.
Methods/design
A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18–40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.
Discussion
The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions.
Trial registration
Australian Clinical Trials Registry ACTRN012605000463673
ClinicalTrials.gov NCT00118521
doi:10.1186/1471-2474-9-27
PMCID: PMC2279129  PMID: 18304317
7.  Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial 
BMC Medicine  2007;5:38.
Background
Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS). As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS.
Methods
A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28), treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28), treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs) to assess activity-related symptoms. We also estimated the direct healthcare costs.
Results
Both groups showed marked improvement during the follow-up. The mean improvement in the Kujala score was 12.9 (95% confidence interval (CI) 8.2–17.6) in the arthroscopy group and 11.4 (95% CI 6.9–15.8) in the control group. However, there was no difference between the groups in mean improvement in the Kujala score (group difference 1.1 (95% CI -7.4 - 5.2)) or in any of the VAS scores. Total direct healthcare costs in the arthroscopy group were estimated to exceed on average those of the control group by €901 per patient (p < 0.001).
Conclusion
In this controlled trial involving patients with chronic PFPS, the outcome when arthroscopy was used in addition to a home exercise program was no better than when the home exercise program was used alone.
Trial registration
Current Controlled Trials ISRCTN 41800323
doi:10.1186/1741-7015-5-38
PMCID: PMC2249589  PMID: 18078506
8.  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
9.  Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial 
Objective To compare the effectiveness of subacromial corticosteroid injection combined with timely exercise and manual therapy (injection plus exercise) or exercise and manual therapy alone (exercise only) in patients with subacromial impingement syndrome.
Design Pragmatic randomised clinical trial.
Setting Primary care based musculoskeletal service.
Patients Adults aged 40 or over with subacromial impingement syndrome with moderate or severe shoulder pain.
Interventions Injection plus exercise or exercise only.
Main outcome measures Primary outcome was the difference in improvement in the total shoulder pain and disability index at 12 weeks.
Results 232 participants were randomised (115 to injection plus exercise, 117 to exercise only). The mean age was 56 (range 40-78), 127 were women, and all had had a median of 16 weeks of shoulder pain (interquartile range 12-28). At week 12 there was no significant difference between the groups in change in total pain and disability index (mean difference between change in groups 3.26 (95% confidence interval −0.81 to 7.34), P=0.116). Improvement was significantly greater in the injection plus exercise group at week 1 (6.56, 4.30 to 8.82) and week 6 (7.37, 4.34 to 10.39) for the total pain and disability index (P<0.001), with no differences at week 24 (−2.26, −6.77 to 2.25, P=0.324).
Conclusions In the treatment of patients with subacromial impingement syndrome, injection plus exercise and exercise only are similarly effective at 12 weeks.
Trial registration ISRCT 25817033; EudraCT No 2005-003628-20.
doi:10.1136/bmj.c3037
PMCID: PMC2893301  PMID: 20584793
10.  Do Females with Patellofemoral Pain have Abnormal Hip and Knee Kinematics during Gait? 
Physiotherapy theory and practice  2010;26(3):150-159.
Purpose
To test the hypothesis that females with patellofemoral pain (PFP) have increased hip adduction, hip medial rotation, and knee valgus (medial collapse) during the stance phase of gait.
Methods
Twenty subjects with PFP and 20 pain-free subjects participated. Subjects underwent 3-dimensional motion analysis during free speed and fast speed walking. Hip frontal and transverse plane angles and knee frontal plane angles were calculated at 2 time points (peak knee extensor moment (PkMOM), and maximum knee extension/hyperextension angle (MxExt)) and averaged over 3 trials. Within each walking task, Student’s t-tests compared group differences in all variables. A post-hoc analysis was performed comparing a subgroup of 4 PFP subjects (those whose pain level was above 30/100) to pain-free subjects.
Results
Initially, there were no group differences during free speed walking. During fast speed walking, subjects with PFP had less hip adduction at PkMOM and greater hip adduction at MxExt. The subgroup of PFP subjects had greater hip adduction at PkMOM and greater knee valgus at MxExt during free speed walking and greater hip adduction and knee valgus at MxExt during fast speed walking.
Conclusions
During low-level tasks, frontal plane components of medial collapse were present at the hip and knee in a subgroup of PFP subjects with higher pain levels. Symptom behavior may be important in identifying individuals with medial collapse movement impairments.
doi:10.3109/09593980903423111
PMCID: PMC3226335  PMID: 20331371
biomechanics; medial collapse; 3-d motion analysis; lower extremity overuse injuries
11.  Patellofemoral arthroplasty: a multi-centre study with minimum 2-year follow-up 
International Orthopaedics  2008;33(6):1597-1601.
Recently, patellofemoral arthroplasty has attracted increased interest as a salvage treatment for isolated patellofemoral arthritis. However, there are very few reports of the experience with modern generation patellofemoral arthroplasties. This investigation describes a collective experience of four centres reporting on the outcome in patients of the use of one patellofemoral arthroplasty device. There were 70 patients (79 knees) who had failed an extensive non-operative treatment regimen and/or various conventional alternative surgical treatments. At a mean follow-up of three years (range: 2–6 years), there were 66 knees that had Knee Society Scores greater than 80 points (84%). Seventy-one knees (90%) functioned without pain in daily activity and stair climbing. Symptomatic isolated patellofemoral arthritis was successfully treated with a patellofemoral arthroplasty in the short term. We are encouraged by these excellent early results and await longer follow-up.
doi:10.1007/s00264-008-0692-y
PMCID: PMC2899172  PMID: 19057900
12.  Effectiveness of community physiotherapy and enhanced pharmacy review for knee pain in people aged over 55 presenting to primary care: pragmatic randomised trial 
BMJ : British Medical Journal  2006;333(7576):995.
Objectives To evaluate the effectiveness of two primary care strategies for delivering evidence based care to people aged 55 or over with knee pain: enhanced pharmacy review and community physiotherapy.
Design Pragmatic multicentre randomised clinical trial.
Setting 15 general practices in North Staffordshire.
Participants 325 adults aged 55 years or over (mean 68 years) consulting with knee pain; 297 (91%) reached six month follow-up.
Interventions Enhanced pharmacy review (pharmacological management in accordance with an algorithm); community physiotherapy (advice about activity and pacing and an individualised exercise programme); control (advice leaflet reinforced by telephone call).
Main outcome measure Change in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) at 3, 6, and 12 months.
Results Mean baseline WOMAC pain score was 9.1 (SD 3.7), and mean baseline function score was 29.9 (SD 12.8). At three months, the mean reductions in pain scores were 0.41 (SD 2.8) for control, 1.59 (3.2) for pharmacy, and 1.56 (3.4) for physiotherapy; reductions in function scores were 0.80 (8.5), 2.61 (9.8), and 4.79 (10.8). Compared with control, mean differences in change scores for physiotherapy were 1.15 (95% confidence interval 0.2 to 2.1) for pain and 3.99 (1.2 to 6.8) for function; those for pharmacy were 1.18 (0.3 to 2.1) for pain and 1.80 (−0.8 to 4.5) for function. These differences were not sustained to six or 12 months. Significantly fewer participants in the physiotherapy group reported consulting their general practitioner for knee pain in the follow-up period, and use of non-steroidal anti-inflammatory drugs was lower in the physiotherapy and pharmacy groups than in the control group.
Conclusions Evidence based care for older adults with knee pain, delivered by primary care physiotherapists and pharmacists, resulted in short term improvements in health outcomes, reduced use of non-steroidal anti-inflammatory drugs, and high patient satisfaction. Physiotherapy seemed to produce a shift in consultation behaviour away from the traditional general practitioner led model of care.
Trial registration UK National Research Register N0286046917; Current Controlled Trials ISRCTN55376150.
doi:10.1136/bmj.38977.590752.0B
PMCID: PMC1635605  PMID: 17056608
13.  An educational approach based on a non-injury model compared with individual symptom-based physical training in chronic LBP. A pragmatic, randomised trial with a one-year follow-up 
Background
In the treatment of chronic back pain, cognitive methods are attracting increased attention due to evidence of effectiveness similar to that of traditional therapies. The purpose of this study was to compare the effectiveness of performing a cognitive intervention based on a non-injury model with that of a symptom-based physical training method on the outcomes of low back pain (LBP), activity limitation, LBP attitudes (fear-avoidance beliefs and back beliefs), physical activity levels, sick leave, and quality of life, in chronic LBP patients.
Methods
The study was a pragmatic, single-blind, randomised, parallel-group trial. Patients with chronic/recurrent LBP were randomised to one of the following treatments: 1. Educational programme : the emphasis was on creating confidence that the back is strong, that loads normally do not cause any damage despite occasional temporary pain, that reducing the focus on the pain might facilitate more natural and less painful movements, and that it is beneficial to stay physically active. 2. Individual symptom-based physical training programme : directional-preference exercises for those centralising their pain with repetitive movements; 'stabilising exercises' for those deemed 'unstable' based on specific tests; or intensive dynamic exercises for the remaining patients. Follow-up questionnaires (examiner-blinded) were completed at 2, 6 and 12 months. The main statistical test was an ANCOVA adjusted for baseline values.
Results
A total of 207 patients participated with the median age of 39 years (IQR 33-47); 52% were female, 105 were randomised to the educational programme and 102 to the physical training programme. The two groups were comparable at baseline. For the primary outcome measures, there was a non-significant trend towards activity limitation being reduced mostly in the educational programme group, although of doubtful clinical relevance. Regarding secondary outcomes, improvement in fear-avoidance beliefs was also better in the educational programme group. All other variables were about equally influenced by the two treatments. The median number of treatment sessions was 3 for the educational programme group and 6 for the physical training programme group.
Conclusions
An educational approach to treatment for chronic LBP resulted in at least as good outcomes as a symptom-based physical training method, despite fewer treatment sessions.
Trial registration
Clinicaltrials.gov: # NCT00410319
doi:10.1186/1471-2474-11-212
PMCID: PMC2954985  PMID: 20849601
14.  Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial 
BMJ : British Medical Journal  2002;325(7367):752.
Objectives
To determine whether a home based exercise programme can improve outcomes in patients with knee pain.
Design
Pragmatic, factorial randomised controlled trial of two years' duration.
Setting
Two general practices in Nottingham.
Participants
786 men and women aged ⩾45 years with self reported knee pain.
Interventions
Participants were randomised to four groups to receive exercise therapy, monthly telephone contact, exercise therapy plus telephone contact, or no intervention. Patients in the no intervention and combined exercise and telephone groups were randomised to receive or not receive a placebo health food tablet.
Main outcome measures
Primary outcome was self reported score for knee pain on the Western Ontario and McMaster universities (WOMAC) osteoarthritis index at two years. Secondary outcomes included knee specific physical function and stiffness (scored on WOMAC index), general physical function (scored on SF-36 questionnaire), psychological outlook (scored on hospital anxiety and depression scale), and isometric muscle strength.
Results
600 (76.3%) participants completed the study. At 24 months, highly significant reductions in knee pain were apparent for the pooled exercise groups compared with the non-exercise groups (mean difference –0.82, 95% confidence interval –1.3 to –0.3). Similar improvements were observed at 6, 12, and 18 months. Regular telephone contact alone did not reduce pain. The reduction in pain was greater the closer patients adhered to the exercise plan.
Conclusions
A simple home based exercise programme can significantly reduce knee pain. The lack of improvement in patients who received only telephone contact suggests that improvements are not just due to psychosocial effects because of contact with the therapist.
What is already known on this topicPhysiotherapy is often prescribed for the treatment of knee painPrevious trials have usually been short and used intensive supervision and sophisticated equipmentThe impact of psychological factors in reducing pain is unclearWhat this study addsHome based programmes involving exercise for up to 30 minutes a day significantly reduce self reported knee painSocial support alone does not improve health outcomesReductions in pain are greater for patients the closer they adhere to exercise programmes
PMCID: PMC128377  PMID: 12364304
15.  Communication style and exercise compliance in physiotherapy (CONNECT). A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods 
Background
Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations.
Methods/Design
This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded.
We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects.
Discussion
This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients’ adherence to rehabilitation recommendations.
Trial Registration
Current Controlled Trials ISRCTN63723433
doi:10.1186/1471-2474-13-104
PMCID: PMC3475041  PMID: 22703639
Communication; Motivation; Patient; Low back pain; Disability; Well-being; Adherence; Compliance; Physical therapy; Physiotherapy
16.  COMPARISON OF HIP AND KNEE STRENGTH AND NEUROMUSCULAR ACTIVITY IN SUBJECTS WITH AND WITHOUT PATELLOFEMORAL PAIN SYNDROME 
Purpose/Background:
Historically, patellofemoral pain syndrome (PFPS) has been viewed exclusively as a knee problem. Recent findings have suggested an association between hip muscle weakness and PFPS. Altered neuromuscular activity about the hip also may contribute to PFPS; however, more limited data exist regarding this aspect. Most prior investigations also have not concurrently examined hip and knee strength and neuromuscular activity in this patient population. Additional knowledge regarding the interaction between hip and knee muscle function may enhance the current understanding of PFPS. The purpose of this study was to compare hip and knee strength and electromyographic (EMG) activity in subjects with and without PFPS.
Methods:
Eighteen females with PFPS and 18 matched controls participated in this study. First, surface EMG electrodes were donned on the gluteus medius, vastus medialis, and vastus lateralis. Strength measures then were taken for the hip abductors, hip external rotators, and knee extensors. Subjects completed a standardized stair-stepping task to quantify muscle activation amplitudes during the loading response, single leg stance, and preswing intervals of stair descent as well as to determine muscle onset timing differences between the gluteus medius and vastii muscles and between the vastus medialis and vastus lateralis at the beginning of stair descent.
Results:
Females with PFPS demonstrated less strength of the hip muscles. They also generated greater EMG activity of the gluteus medius and vastus medialis during the loading response and single leg stance intervals of stair descent. No differences existed with respect to onset activation of the vastus medialis and vastus lateralis. All subjects had a similar delay in gluteus medius onset activation relative to the vastii muscles.
Conclusion:
Rehabilitation should focus on quadriceps and hip strengthening. Although clinicians have incorporated gluteus medius exercise in rehabilitation programs, additional attention to the external rotators may be useful.
Level of Evidence: 4
PMCID: PMC3230156  PMID: 22163090
gluteus medius; knee; patella; surface electromyography
17.  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
18.  Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial 
BMJ : British Medical Journal  2007;335(7617):436.
Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.
Design Multicentre, randomised controlled trial.
Setting 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom.
Participants 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis.
Interventions Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119).
Main outcome measures The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months.
Results Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval −1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (−0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture.
Conclusion The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects.
Trial registration Current Controlled Trials ISRCTN88597683.
doi:10.1136/bmj.39280.509803.BE
PMCID: PMC1962890  PMID: 17699546
19.  Why don't patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee 
STUDY OBJECTIVES—To understand reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee.
DESIGN—A qualitative study, nested within a randomised controlled trial, examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis. In the intervention arm, participants undertook a series of simple exercises and repositioning of the kneecap using tape. In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions, guided by a topic schedule, to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy. Interviews were audiotaped, fully transcribed and analysed thematically according to the method of constant comparison. A model explaining factors influencing compliance was developed.
SETTING—Patients were interviewed at home. The study was nested within a pragmatic randomised controlled trial.
PARTICIPANTS—Twenty participants in the intervention arm of the randomised trial were interviewed three months after they had completed the physiotherapy programme. Eight were interviewed again one year later.
MAIN RESULTS—Initial compliance was high because of loyalty to the physiotherapist. Reasoning underpinning continued compliance was more complex, involving willingness and ability to accommodate exercises within everyday life, the perceived severity of symptoms, attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis. A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms.
CONCLUSIONS—Non-compliance with physiotherapy, as with drug therapies, is common. From the patient's perspective, decisions about whether or not to comply are rational but often cannot be predicted by therapists or researchers. Ultimately, this study suggests that health professionals need to understand reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention.


Keywords: compliance; physiotherapy; qualitative research
doi:10.1136/jech.55.2.132
PMCID: PMC1731838  PMID: 11154253
20.  A systematic review of randomized controlled trials on exercise parameters in the treatment of patellofemoral pain: what works? 
Purpose
There is research evidence which supports the effectiveness of exercise in reducing pain and increasing function in patients with patellofemoral pain syndrome. However, what is unclear are the parameters underpinning this intervention. This has led to uncertainty when operationalizing exercises for patients with patellofemoral pain syndrome in clinical practice. The aim of this review was to evaluate the parameters of exercise programs reported in primary research, to provide clinicians with evidence-based recommendations for exercise prescription for patellofemoral pain.
Methods
A systematic review of randomized controlled trials was undertaken. Only trials that identified exercise to be effective in treating patellofemoral pain were included. Appropriate databases and reference lists were searched using established keywords. Data relating to common exercise parameters such as the type of exercise, length, and frequency of intervention, intensity, repetitions, sets, and specific technique were extracted, along with details of co-interventions that may have been used.
Results
A total of ten randomized controlled trials were included in this review and from these trials 14 interventions arms were evaluated. All 14 interventions focused on active exercises, all but two of which also included a passive stretching component. The current body of evidence demonstrates positive results with exercise interventions such as knee extension, squats, stationary cycling, static quadriceps, active straight leg raise, leg press, and step-up and down exercises for patients with patellofemoral pain syndrome. A progressive regime of daily exercises of two to four sets of ten or more repetitions over an intervention period of 6 weeks or more, combined with exercises to address flexibility of the lower limb musculature was commonly used.
Conclusion
Currently, the primary research on this topic supports the use of closed kinetic chain, strengthening exercises for musculature of the lower limb, combined with flexibility options. The current evidence base supports a prescription of daily exercises of two–four sets of ten or more repetitions over a period of 6 weeks or more.
doi:10.2147/JMDH.S24595
PMCID: PMC3215347  PMID: 22135495
patellofemoral pain syndrome; PFPS; repetitions; lower limb; musculature
21.  Effect of Therapeutic Modalities on Patients With Patellofemoral Pain Syndrome 
Sports Health  2011;3(2):182-189.
Context:
Patellofemoral pain syndrome (PFPS) is a common orthopaedic condition for which operative and nonoperative treatments have been used. Therapeutic modalities have been recommended for the treatment of patients with PFPS—including cold, ultrasound, phonophoresis, iontophoresis, neuromuscular electrical stimulation, electrical stimulation for pain control, electromyographic biofeedback, and laser.
Objective:
To determine the effectiveness of therapeutic modalities for the treatment of patients with PFPS.
Data Sources:
In May and August 2010, Medline was searched using the following databases: PubMed, CINAHL, Web of Science Citation Index, Science Direct, ProQuest Nursing & Allied Health, and Your Journals@OVID.
Study Selection:
Selected studies were randomized controlled trials that used a therapeutic modality to treat patients with PFPS. The review included articles with all outcome measures relevant for the PFPS patient: knee extension and flexion strength (isokinetic and isometric), patellofemoral pain assessment during activities of daily life, functional tests (eg, squats), Kujala patellofemoral score, and electromyographic recording from knee flexors and extensors and quadriceps femoris cross-sectional areas.
Data Extraction:
Authors conducted independent quality appraisals of studies using the PEDro Scale and a system designed for analysis of studies on interventions for patellofemoral pain.
Results:
Twelve studies met criteria: 1 on the effects of cold and ultrasound together, ice alone, iontophoresis, and phonophoresis; 3, neuromuscular electrical stimulation; 4, electromyographic biofeedback; 3, electrical stimulation for control of pain; and 1, laser.
Discussion:
Most studies were of low to moderate quality. Some reported that therapeutic modalities, when combined with other treatments, may be of some benefit for pain management or other symptoms. There was no consistent evidence of any beneficial effect when a therapeutic modality was used alone. Studies did not consistently provide added benefit to conventional physical therapy in the treatment of PFPS.
Conclusions:
None of the therapeutic modalities reviewed has sound scientific justification for the treatment of PFPS when used alone.
doi:10.1177/1941738111398583
PMCID: PMC3445135  PMID: 23016007
systematic review; patellofemoral pain syndrome; therapeutic modalities
22.  'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial 
Background
Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect.
Methods/Design
This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined.
Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost.
Qualitative methods will be used to explore factors associated with the success or failure of the service, the acceptability of PhysioDirect to patients and staff, and ways in which the service could be improved.
Discussion
It is still relatively unusual to evaluate new forms of service delivery using randomised controlled trials. By combining rigorous trial methods with economic analysis of cost-effectiveness and qualitative research this study will provide robust evidence to inform decisions about the widespread introduction of PhysioDirect services.
Trial registration
Current Controlled Trials ISRCTN55666618
doi:10.1186/1472-6963-9-136
PMCID: PMC2729308  PMID: 19650913
23.  Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial 
European Spine Journal  2008;17(9):1193-1200.
Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.
doi:10.1007/s00586-008-0718-6
PMCID: PMC2527421  PMID: 18663487
Low back pain; Physiotherapy; Randomized controlled trial; Graded activity; Group training
24.  Is Body Composition Associated With An Increased Risk of Developing Anterior Knee Pain in Adolescent Female Athletes? 
Objective
To determine the relationship between relative body composition and body mass to height, anterior knee pain, or patellofemoral pain (PFP) in adolescent female athletes.
Background
Patellofemoral pain is common in female athletes and has an undefined etiology. The purpose of this study was to examine whether there was an association among higher body mass index (BMI), BMI z-scores, and relative body fat percentage in the development of PFP in an adolescent female athlete population. We hypothesized that female athletes who developed PFP over the course of a competitive basketball season had higher relative body mass or body fat percentage compared with those who did not develop PFP.
Methods
Fifteen middle school basketball teams that consisted of 248 basketball players (mean age, 12.76 ± 1.13 years; height, 158.43 ± 7.78 cm; body mass, 52.35 ± 12.31 kg; BMI, 20.73 ± 3.88 kg/m2) agreed to participate in this study over the course of 2 basketball seasons, resulting in 262 athlete-seasons. Testing included the completion of the Anterior Knee Pain Scale (AKPS), International Knee Documentation Committee (IKDC) form, standardized history, physician-administered physical examination, maturational estimates, and anthropometrics.
Results
Of the 262 athlete-seasons monitored, 39 athletes developed PFP over the course of the study. The incidence rate of new PFP was 1.57 per 1000 athlete-exposures. The cumulative incidence of PFP was 14.9%. There was no difference in BMI between those who developed PFP (mean body mass, 20.2 kg/m2; 95% CI, 18.9–21.4) and those who did not develop PFP (mean body mass, 20.8 kg/m2; 95% CI, 20.3–21.3; P > 0.05). Body mass index z-scores were not different between those who developed PFP (mean, 0.3; 95% CI, 0.7–0.6) and those who did not develop PFP (mean, 0.4; 95% CI, 0.3–0.6; P > 0.05). A similar trend was noted in relative body fat percentage, with mean scores of similar ranges in those who developed PFP (mean body fat percentage, 22.2%; 95% CI, 19.4–24.9) to the referent group who did not (mean body fat percentage, 22.9%; 95% CI, 21.8–24.1; P > 0.05).
Conclusions
Our results do not indicate a relationship between relative body composition or relative body mass to height to the propensity to develop PFP in middle school–aged female basketball players. Although previous data indicate a relationship between higher relative body mass and overall knee injury, these data did not support this association with PFP specifically. These data suggest the underlying etiology of PFP may be neuromuscular in nature. Further research is needed to understand the predictors, etiology, and ultimate prevention of this condition.
doi:10.3810/psm.2012.02.1947
PMCID: PMC3398745  PMID: 22508247
patellofemoral pain; anterior knee pain; biomechanics; body mass index; BMI z-score; anthropometrics; body fat; patellofemoral pain
25.  Patellofemoral pain syndrome (PFPS): a systematic review of anatomy and potential risk factors 
Background
Patellofemoral Pain Syndrome (PFPS), a common cause of anterior knee pain, is successfully treated in over 2/3 of patients through rehabilitation protocols designed to reduce pain and return function to the individual. Applying preventive medicine strategies, the majority of cases of PFPS may be avoided if a pre-diagnosis can be made by clinician or certified athletic trainer testing the current researched potential risk factors during a Preparticipation Screening Evaluation (PPSE). We provide a detailed and comprehensive review of the soft tissue, arterial system, and innervation to the patellofemoral joint in order to supply the clinician with the knowledge required to assess the anatomy and make recommendations to patients identified as potentially at risk. The purpose of this article is to review knee anatomy and the literature regarding potential risk factors associated with patellofemoral pain syndrome and prehabilitation strategies. A comprehensive review of knee anatomy will present the relationships of arterial collateralization, innervations, and soft tissue alignment to the possible multifactoral mechanism involved in PFPS, while attempting to advocate future use of different treatments aimed at non-soft tissue causes of PFPS.
Methods
A systematic database search of English language PubMed, SportDiscus, Ovid MEDLINE, Web of Science, LexisNexis, and EBM reviews, plus hand searching the reference lists of these retrieved articles was performed to determine possible risk factors for patellofemoral pain syndrome.
Results
Positive potential risk factors identified included: weakness in functional testing; gastrocnemius, hamstring, quadriceps or iliotibial band tightness; generalized ligamentous laxity; deficient hamstring or quadriceps strength; hip musculature weakness; an excessive quadriceps (Q) angle; patellar compression or tilting; and an abnormal VMO/VL reflex timing. An evidence-based medicine model was utilized to report evaluation criteria to determine the at-risk individuals, then a defined prehabilitation program was proposed that begins with a dynamic warm-up followed by stretches, power and multi-joint exercises, and culminates with isolation exercises. The prehabilitation program is performed at lower intensity level ranges and can be conducted 3 days per week in conjunction with general strength training. Based on an objective one repetition maximum (1RM) test which determines the amount an individual can lift in good form through a full range of motion, prehabilitation exercises are performed at 50–60% intensity.
Conclusion
To reduce the likelihood of developing PFPS, any individual, especially those with positive potential risk factors, can perform the proposed prehabilitation program.
doi:10.1186/1476-5918-7-9
PMCID: PMC2443365  PMID: 18582383

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