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1.  Incidence and prevalence of upper-extremity musculoskeletal disorders. A systematic appraisal of the literature 
Background
A systematic appraisal of the worldwide incidence and prevalence rates of UEDs available in scientific literature was executed to gauge the range of these estimates in various countries and to determine whether the rates are increasing in time.
Methods
Studies that recruited at least 500 people, collected data by using questionnaires, interviews and/or physical examinations, and reported incidence or prevalence rates of the whole upper-extremity including neck, were included.
Results
No studies were found with regard to the incidence of UEDs and 13 studies that reported prevalence rates of UEDs were included. The point prevalence ranged from 1.6–53%; the 12-months prevalence ranged from 2.3–41%. One study reported on the lifetime prevalence (29%). We did not find evidence of a clear increasing or decreasing pattern over time. The case definitions for UEDs used in the studies, differed enormously. Therefore, it was not possible to pool the data.
Conclusion
There are substantial differences in reported prevalence rates on UEDs. Main reason for this is the absence of a universally accepted way of labelling or defining UEDs. If we want to make progress in this field, the first requirement is to agree on unambiguous terminology and classification of EUDs.
doi:10.1186/1471-2474-7-7
PMCID: PMC1434740  PMID: 16448572
2.  Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial) 
Background
Patients with traumatic knee complaints regularly consult their general practitioner (GP). MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs. Therefore, this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care, in patients with persistent traumatic knee complaints.
Design and methods
This is a multi-centre, open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study. Eligible patients (aged 18–45 years) have knee complaints due to trauma (or sudden onset) occurring in the preceding 6 months and consulting their GP. Participants are randomised to: 1) an MRI group, i.e. GP referral to MRI, or 2) a usual care group, i.e. no MRI. Primary outcomes are knee-related daily function, medical costs (healthcare use and productivity loss), and quality of life. Secondary outcomes are disability due to knee complaints, severity of knee pain, and patients’ perceived recovery and satisfaction. Outcomes are measured at baseline and at 1.5, 3, 6, 9 and 12 months follow-up. Also collected are data on patient demographics, GPs’ initial working diagnosis, GPs’ preferred management at baseline, and MRI findings.
Discussion
In the Netherlands, the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown. Although GPs increasingly refer patients to MRI, the Dutch clinical guideline ‘Traumatic knee complaints’ for GPs does not recommend referral to MRI, mainly because the cost-effectiveness is still unknown.
Trial registration
Dutch Trial Registration: NTR3689.
doi:10.1186/1471-2474-15-63
PMCID: PMC3973891  PMID: 24588860
Traumatic knee complaint; General practice; Magnetic resonance imaging; Randomised controlled non-inferiority trial; Cost-utility; Cost-effectiveness
3.  Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial 
Background
Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.
The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication.
Methods/Design
This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline) injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics). Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle.
Discussion
This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started.
Trial Registration
This trial is registered in the Dutch Trial Registry: number NTR2966.
doi:10.1186/1471-2474-12-280
PMCID: PMC3268743  PMID: 22151921
4.  Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial 
Background
Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA.
Methods/Design
Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed.
Discussion
The results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.
doi:10.1186/1471-2474-12-232
PMCID: PMC3198764  PMID: 21992502
5.  Trochanteric osteotomy versus posterolateral approach: function the first year post surgery. A pilot study 
Background
Although no prospective studies have compared functional results of trochanteric osteotomy and a non-trochanteric approach, most surgeons feel that trochanteric osteotomy is outdated in simple hip arthroplasty. Reasons not to perform an osteotomy include the fear of longer rehabilitation and worse (final) functional outcome.
Method
This prospective study examines differences in rehabilitation between posterolateral and trochanteric approach one year post-surgery using questionnaires (WOMAC, SF-36, HHS) and functional tests (walking, climbing stairs, rising from sitting, and strength tests). Of the 109 patients 24 had a trochanteric osteotomy: the selected approach was based on the surgeon's preference. The trochanteric osteotomy group included more patients with developmental dysplasia of the hip. Before the start of the study no power analysis was performed.
Results
Data from the questionnaires showed no significant differences between the two groups at 3, 6 and 12-months follow-up. At 3-months follow-up patients in the trochanteric osteotomy group scored lower on the functional tests. This difference had disappeared at 6 and 12-months follow-up, except for abduction force which remained lower in the trochanteric osteotomy group in patients with a non union of the TO.
Conclusion
For simple hip arthroplasty an approach without osteotomy seems a logical choice. Although the power of this study is low, in experienced hands trochanteric osteotomy seems to give good functional results at 6-12 months post surgery if trochanteric union is obtained. Therefore, one should not hesitate to perform an osteotomy in difficult cases.
doi:10.1186/1471-2474-12-138
PMCID: PMC3141609  PMID: 21703030
6.  Adverse effects of extra-articular corticosteroid injections: a systematic review 
Background
To estimate the occurrence and type of adverse effects after application of an extra-articular (soft tissue) corticosteroid injection.
Methods
A systematic review of the literature was made based on a PubMed and Embase search covering the period 1956 to January 2010. Case reports were included, as were prospective and retrospective studies that reported adverse events of corticosteroid injection. All clinical trials which used extra-articular corticosteroid injections were examined. We divided the reported adverse events into major (defined as those needing intervention or not disappearing) and minor ones (transient, not requiring intervention).
Results
The search yielded 87 relevant studies:44 case reports, 37 prospective studies and 6 retrospective studies. The major adverse events included osteomyelitis and protothecosis; one fatal necrotizing fasciitis; cellulitis and ecchymosis; tendon ruptures; atrophy of the plantar fat was described after injecting a neuroma; and local skin effects appeared as atrophy, hypopigmentation or as skin defect. The minor adverse events effects ranged from skin rash to flushing and disturbed menstrual pattern. Increased pain or steroid flare after injection was reported in 19 studies. After extra-articular injection, the incidence of major adverse events ranged from 0-5.8% and that of minor adverse events from 0-81%. It was not feasible to pool the risk for adverse effects due to heterogeneity of study populations and difference in interventions and variance in reporting.
Conclusion
In this literature review it was difficult to accurately quantify the incidence of adverse effects after extra-articular corticosteroid injection. The reported adverse events were relatively mild, although one fatal reaction was reported.
doi:10.1186/1471-2474-11-206
PMCID: PMC2945953  PMID: 20836867
7.  Stimulation of osteogenic differentiation in human osteoprogenitor cells by pulsed electromagnetic fields: an in vitro study 
Background
Although pulsed electromagnetic field (PEMF) stimulation may be clinically beneficial during fracture healing and for a wide range of bone disorders, there is still debate on its working mechanism. Mesenchymal stem cells are likely mediators facilitating the observed clinical effects of PEMF. Here, we performed in vitro experiments to investigate the effect of PEMF stimulation on human bone marrow-derived stromal cell (BMSC) metabolism and, specifically, whether PEMF can stimulate their osteogenic differentiation.
Methods
BMSCs derived from four different donors were cultured in osteogenic medium, with the PEMF treated group being continuously exposed to a 15 Hz, 1 Gauss EM field, consisting of 5-millisecond bursts with 5-microsecond pulses. On culture day 1, 5, 9, and 14, cells were collected for biochemical analysis (DNA amount, alkaline phosphatase activity, calcium deposition), expression of various osteoblast-relevant genes and activation of extracellular signal-regulated kinase (ERK) signaling. Differences between treated and control groups were analyzed using the Wilcoxon signed rank test, and considered significant when p < 0.05.
Results
Biochemical analysis revealed significant, differentiation stage-dependent, PEMF-induced differences: PEMF increased mineralization at day 9 and 14, without altering alkaline phosphatase activity. Cell proliferation, as measured by DNA amounts, was not affected by PEMF until day 14. Here, DNA content stagnated in PEMF treated group, resulting in less DNA compared to control.
Quantitative RT-PCR revealed that during early culture, up to day 9, PEMF treatment increased mRNA levels of bone morphogenetic protein 2, transforming growth factor-beta 1, osteoprotegerin, matrix metalloproteinase-1 and -3, osteocalcin, and bone sialoprotein. In contrast, receptor activator of NF-κB ligand expression was primarily stimulated on day 14. ERK1/2 phosphorylation was not affected by PEMF stimulation.
Conclusions
PEMF exposure of differentiating human BMSCs enhanced mineralization and seemed to induce differentiation at the expense of proliferation. The osteogenic stimulus of PEMF was confirmed by the up-regulation of several osteogenic marker genes in the PEMF treated group, which preceded the deposition of mineral itself. These findings indicate that PEMF can directly stimulate osteoprogenitor cells towards osteogenic differentiation. This supports the theory that PEMF treatment may recruit these cells to facilitate an osteogenic response in vivo.
doi:10.1186/1471-2474-11-188
PMCID: PMC2936347  PMID: 20731873
8.  Functional capacity and actual daily activity do not contribute to patient satisfaction after total knee arthroplasty 
Background
After total knee arthroplasty (TKA) only 75-89% of patients are satisfied. Because patient satisfaction is a prime goal of all orthopaedic procedures, optimization of patient satisfaction is of major importance. Factors related to patient satisfaction after TKA have been explored, but no studies have included two potentially relevant factors, i.e. the functional capacity of daily activities and actual daily activity. This present prospective study examines whether functional capacity and actual daily activity (in addition to an extensive set of potential factors) contribute to patient satisfaction six months after TKA.
Methods
A total of 44 patients were extensively examined preoperatively and six months post surgery. Functional capacity was measured with three capacity tests, focusing on walking, stair climbing, and chair rising. Actual daily activity was measured in the patient's home situation by means of a 48-hour measurement with an Activity Monitor. To establish which factors were related to patient satisfaction six months post surgery, logistic regression analyses were used to calculate odds ratios.
Results
Preoperative and postoperative functional capacity and actual daily activity had no relation with patient satisfaction. Preoperatively, only self-reported mental functioning was positively related to patient satisfaction. Postoperatively, based on multivariate analysis, only fulfilled expectations regarding pain and experienced pain six months post surgery were related to patient satisfaction.
Conclusions
Functional capacity and actual daily activity do not contribute to patient satisfaction after TKA. Patients with a better preoperative self-reported mental functioning, and patients who experienced less pain and had fulfilled expectations regarding pain postoperatively, were more often satisfied.
doi:10.1186/1471-2474-11-121
PMCID: PMC2896921  PMID: 20553584
9.  Total knee arthroplasty after high tibial osteotomy. A systematic review 
Background
Previous osteotomy may compromise subsequent knee replacement, but no guidelines considering knee arthroplasty after prior osteotomy have been developed. We describe a systematic review of non-randomized studies to analyze the effect of high tibial osteotomy on total knee arthroplasty.
Methods
A computerized search for relevant studies published up to September 2007 was performed in Medline and Embase using a search strategy that is highly sensitive to find nonrandomized studies. Included were observational studies in which patients had total knee arthroplasty performed after prior high tibial osteotomy. Studies that fulfilled these criteria, were assessed for methodologic quality by two independent reviewers using the critical appraisal of observational studies developed by Deeks and the MINORS instrument. The study characteristics and data on the intervention, follow-up, and outcome measures, were extracted using a pre-tested standardized form. Primary outcomes were: knee range of motion, knee clinical score, and revision surgery. The grade of evidence was determined using the guidelines of the GRADE working group.
Results
Of the 458 articles identified using our search strategy, 17 met the inclusion criteria. Fifteen studies were cohort study with a concurrent control group, one was a historical cohort study and one a case-control study. Nine studies scored 50% or more on both methodological quality assessments. Pooling of the results was not possible due to the heterogeneity of the studies, and our analysis could not raise the overall low quality of evidence. No significant differences between primary total knee arthroplasty and total knee arthroplasty after osteotomy were found for knee range of motion in four out of six studies, knee clinical scores in eight out of nine studies, and revision surgery in eight out of eight studies after a median follow-up of 5 years.
Conclusion
Our analysis suggests that osteotomy does not compromise subsequent knee replacement. However, the low quality of evidence precludes solid clinical conclusions.
doi:10.1186/1471-2474-10-88
PMCID: PMC2720911  PMID: 19619275
10.  Kinesiophobia in patients with non-traumatic arm, neck and shoulder complaints: a prospective cohort study in general practice 
Background
Complaints of arm, neck and shoulder are common in Western societies. Of those consulting a general practitioner (GP) with non-traumatic arm, neck or shoulder complaints, about 50% do not recover within 6 months.
Kinesiophobia (also known as fear of movement/(re)injury) may also play a role in these complaints, as it may lead to avoidance behaviour resulting in hypervigilance to bodily sensations, followed by disability, disuse and depression. However, in relation to arm, neck and shoulder complaints little is known about kinesiophobia and its associated variables.
Therefore this study aimed to: describe the degree of kinesiophobia in patients with non-traumatic complaints of arm, neck and shoulder in general practice; to determine whether mean scores of kinesiophobia change over time in non-recovered patients; and to evaluate variables associated with kinesiophobia at baseline.
Methods
In this prospective cohort study set in general practice, consulters with a first or new episode of non-traumatic arm, neck or shoulder complaints (aged 18–64 years) entered the cohort. Baseline data were collected on kinesiophobia using the Tampa Scale for Kinesiophobia, the 13-item adjusted version: TSK-AV, and on patient-, complaint-, and psychosocial variables using self-administered questionnaires. The mean TSK-AV score was calculated. In non-recovered patients the follow-up TSK-AV scores at 6 and 12 months were analyzed with the general linear mixed model. Variables associated with kinesiophobia at baseline were evaluated using multivariate linear regression analyses.
Results
The mean TSK-AV score at baseline was 24.8 [SD: 6.2]. Among non-recovered patients the mean TSK-AV score at baseline was 26.1 [SD: 6.6], which remained unchanged over 12- months follow-up period. The strongest associations with kinesiophobia were catastrophizing, disability, and comorbidity of musculoskeletal complaints. Additionally, having a shoulder complaint, low social support, high somatization and high distress contributed to the kinesiophobia score.
Conclusion
The mean TSK-AV score in our population seems comparable to those in other populations in primary care.
In patients who did not recover during the 12- month follow-up, the degree of kinesiophobia remained unchanged during this time period.
The variables associated with kinesiophobia at baseline appear to be in line with the fear-avoidance model.
doi:10.1186/1471-2474-8-117
PMCID: PMC2219996  PMID: 18045457
11.  Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice 
Background
Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy.
This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated.
Methods/Design
This study is a pragmatic, open label randomised trial.
A total of 150 patients (age 18–80 years) visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect of injection therapy minus effect of usual care).
Discussion
This study design is appropriate to estimate effectiveness and cost-effectiveness of the injection therapy. We choose to use a pragmatic study design and are thus not able to study specific effects of the injection with corticosteroids. A distinction between placebo effect of the injection and specific effects of the corticosteroids is therefore not possible.
Trial Registration
The trial is listed in the Dutch Trial Registry with the number ISRCTN16994576
doi:10.1186/1471-2474-8-95
PMCID: PMC2045096  PMID: 17880718
12.  The effect of high tibial osteotomy on the results of total knee arthroplasty: a matched case control study 
Background
We performed a matched case control study to assess the effect of prior high tibia valgus producing osteotomy on results and complications of total knee arthroplasty (TKA).
Methods
From 1996 until 2003 356 patients underwent all cemented primary total knee replacement in our institution. Twelve patients with a history of 14 HTO were identified and matched to a control group of 12 patients with 14 primary TKA without previous HTO. The match was made for gender, age, date of surgery, body mass index, aetiology and type of prosthesis. Clinical and radiographic outcome were evaluated after a median duration of follow-up of 3.7 years (minimum, 2.3 years). The SPSS program was used for statistical analyses.
Results
The index group had more perioperative blood loss and exposure difficulties with one tibial tuberosity osteotomy and three patients with lateral retinacular releases. No such procedures were needed in the control group. Mid-term HSS, KSS and WOMAC scores were less favourable for the index group, but these differences were not significant. The tibial slope of patients with prior HTO was significantly decreased after this procedure. The tibial posterior inclination angle was corrected during knee replacement but posterior inclination was significantly less compared to the control group. No deep infection or knee component loosening were seen in the group with prior HTO.
Conclusion
We conclude that TKA after HTO seems to be technically more demanding than a primary knee arthroplasty, but clinical outcome was almost identical to a matched group that had no HTO previously.
doi:10.1186/1471-2474-8-74
PMCID: PMC1955448  PMID: 17683549
13.  Intrinsic differentiation potential of adolescent human tendon tissue: an in-vitro cell differentiation study 
Background
Tendinosis lesions show an increase of glycosaminoglycan amount, calcifications, and lipid accumulation. Therefore, altered cellular differentiation might play a role in the etiology of tendinosis. This study investigates whether adolescent human tendon tissue contains a population of cells with intrinsic differentiation potential.
Methods
Cells derived from adolescent non-degenerative hamstring tendons were characterized by immunohistochemistry and FACS-analysis. Cells were cultured for 21 days in osteogenic, adipogenic, and chondrogenic medium and phenotypical evaluation was carried out by immunohistochemical and qPCR analysis. The results were compared with the results of similar experiments on adult bone marrow-derived stromal cells (BMSCs).
Results
Tendon-derived cells stained D7-FIB (fibroblast-marker) positive, but α-SMA (marker for smooth muscle cells and pericytes) negative. Tendon-derived cells were 99% negative for CD34 (endothelial cell marker), and 73% positive for CD105 (mesenchymal progenitor-cell marker). In adipogenic medium, intracellular lipid vacuoles were visible and tendon-derived fibroblasts showed upregulation of adipogenic markers FABP4 (fatty-acid binding protein 4) and PPARG (peroxisome proliferative activated receptor γ). In chondrogenic medium, some cells stained positive for collagen 2 and tendon-derived fibroblasts showed upregulation of collagen 2 and collagen 10. In osteogenic medium Von Kossa staining showed calcium deposition although osteogenic markers remained unaltered. Tendon-derived cells and BMCSs behaved largely comparable, although some distinct differences were present between the two cell populations.
Conclusion
This study suggests that our population of explanted human tendon cells has an intrinsic differentiation potential. These results support the hypothesis that there might be a role for altered tendon-cell differentiation in the pathophysiology of tendinosis.
doi:10.1186/1471-2474-8-16
PMCID: PMC1808058  PMID: 17319938
14.  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
15.  The effect of glucosamine sulphate on osteoarthritis: design of a long-term randomised clinical trial [ISRCTN54513166] 
Background
Pharmacological treatment for osteoarthritis (OA) can be divided into two groups: symptom-modifying drugs and disease-modifying drugs. Symptom-modifying drugs are currently the prescription of choice for patients with OA, as disease-modifying drugs are not yet available in usual care. However, there has recently been a lot of debate about glucosamine sulphate (GS), a biological agent that is thought to have both symptom-modifying and disease-modifying properties. This assumption has yet to be proved.
The objective of this article is to present the design of a blind randomised clinical trial that examines the long-term symptom-modifying and disease-modifying effectiveness of GS in patients with hip OA. This trial is ongoing and will finish in March 2006.
Methods/design
Patients with hip OA meeting the ACR-criteria are randomly allocated to either 1500 mg of oral GS or placebo for the duration of two years. The primary outcome measures, which are joint space narrowing (JSN), and change in the pain and function score of the Western Ontario McMaster Universities Osteoarthritis index (WOMAC), are determined at baseline and after two years of follow-up during the final assessment. Intermediate measures at three-month intervals throughout the trial are used to study secondary outcome measures. Secondary outcome measures are changes in WOMAC stiffness score, quality of life, medical consumption, side effects and differences in biomarker CTX-II.
doi:10.1186/1471-2474-6-20
PMCID: PMC1090586  PMID: 15850497

Results 1-15 (15)