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1.  Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials 
Background
Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.
Methods
Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature.
Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.
Results
Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 – -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.
Conclusion
OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.
doi:10.1186/1471-2474-6-43
PMCID: PMC1208896  PMID: 16080794
2.  Reproducibility of cervical range of motion in patients with neck pain 
Background
Reproducibility measurements of the range of motion are an important prerequisite for the interpretation of study results. The aim of the study is to assess the intra-rater and inter-rater reproducibility of the measurement of active Range of Motion (ROM) in patients with neck pain using the Cybex Electronic Digital Inclinometer-320 (EDI-320).
Methods
In an outpatient clinic in a primary care setting 32 patients with at least 2 weeks of pain and/or stiffness in the neck were randomly assessed, in a test- retest design with blinded raters using a standardized measurement protocol. Cervical flexion-extension, lateral flexion and rotation were assessed.
Results
Reliability expressed by the Intraclass Correlation Coefficient (ICC) was 0.93 (lateral flexion) or higher for intra-rater reliability and 0.89 (lateral flexion) or higher for inter-rater reliability. The 95% limits of agreement for intra-rater agreement, expressing the range of the differences between two ratings were -2.5 ± 11.1° for flexion-extension, -0.1 ± 10.4° for lateral flexion and -5.9 ± 13.5° for rotation. For inter-rater agreement the limits of agreement were 3.3 ± 17.0° for flexion-extension, 0.5 ± 17.0° for lateral flexion and -1.3 ± 24.6° for rotation.
Conclusion
In general, the intra-rater reproducibility and the inter-rater reproducibility were good. We recommend to compare the reproducibility and clinical applicability of the EDI-320 inclinometer with other cervical ROM measures in symptomatic patients.
doi:10.1186/1471-2474-6-59
PMCID: PMC1343553  PMID: 16351719
3.  TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052] 
Background
Many older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes.
Methods
TOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year). Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study.
Discussion
This study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.
doi:10.1186/1471-2474-6-55
PMCID: PMC1314890  PMID: 16274477
4.  The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606] 
Background
While one in ten Australians suffer from chronic low back pain this condition remains extremely difficult to treat. Many contemporary treatments are of unknown value. One potentially useful therapy is the use of motor control exercise. This therapy has a biologically plausible effect, is readily available in primary care and it is of modest cost. However, to date, the efficacy of motor control exercise has not been established.
Methods
This paper describes the protocol for a clinical trial comparing the effects of motor control exercise versus placebo in the treatment of chronic non-specific low back pain. One hundred and fifty-four participants will be randomly allocated to receive an 8-week program of motor control exercise or placebo (detuned short wave and detuned ultrasound). Measures of outcomes will be obtained at follow-up appointments at 2, 6 and 12 months after randomisation. The primary outcomes are: pain, global perceived effect and patient-generated measure of disability at 2 months and recurrence at 12 months.
Discussion
This trial will be the first placebo-controlled trial of motor control exercise. The results will inform best practice for treating chronic low back pain and prevent its occurrence.
doi:10.1186/1471-2474-6-54
PMCID: PMC1291370  PMID: 16271149
5.  Low back pain in military recruits in relation to social background and previous low back pain. A cross-sectional and prospective observational survey 
Background
Traditionally, studies on the etiology of low back pain have been carried out in adult populations. However, since low back pain often appears early in life, more research on young populations is needed. This study focuses on the importance of social background factors and previous low back pain in the development of low back pain in military recruits.
Methods
During a three-month period, Danish military recruits with different social backgrounds live and work under the same conditions. Thus, there is an opportunity to investigate the influence of social background on the development of low back pain, when persons are removed from their usual environment and submitted to a number of new stressors. In addition, the importance of the recruits' previous low back pain history in relation to low back pain during military service was studied. This was done by means of questionnaires to 1,711 recruits before and after this three-month period.
Results
Sedentary occupation was negatively associated with long-lasting low back pain (>30 days during the past year) at baseline with an odds ratios of 0.55 (95% CI: 0.33–0.90). This effect vanished during service. Having parents with higher education increased the risk of low back pain during service (OR: 1.9;1.2–3.0, for the highest educated group), but not of the consequences (leg pain and exemption from duty), whereas high IQ decreased the risk of these consequences (odds ratios as low as 0.2;0.1–0.8 for exemption from duty in the group with highest IQ). Long-lasting low back pain prior to service increased the risk of long-lasting low back pain (OR: 4.8;2.1–10.8), leg pain (OR: 3.3;1.3–8.3) and exemption from duty during service (OR: 5.9;2.4–14.8).
Conclusion
Sedentary occupation is negatively associated with low back pain at baseline. This protective effect disappears, when the person becomes physically active. For predicting trouble related to the low back during service, the duration of low back pain prior to service and IQ-level are the most important factors.
doi:10.1186/1471-2474-6-25
PMCID: PMC1180830  PMID: 15918894
6.  Cross-cultural adaptation of the VISA-A questionnaire, an index of clinical severity for patients with Achilles tendinopathy, with reliability, validity and structure evaluations 
Background
Achilles tendinopathy is considered to be one of the most common overuse injuries in elite and recreational athletes and the recommended treatment varies. One factor that has been stressed in the literature is the lack of standardized outcome measures that can be used in all countries. One such standardized outcome measure is the Victorian Institute of Sports Assessment – Achilles (VISA-A) questionnaire, which is designed to evaluate the clinical severity for patients with Achilles tendinopathy. The purpose of this study was to cross-culturally adapt the VISA-A questionnaire to Swedish, and to perform reliability, validity and structure evaluations.
Methods
Cross-cultural adaptation was performed in several steps including translations, synthesis of translations, back translations, expert committee review and pre-testing. The final Swedish version, the VISA-A Swedish version (VISA-A-S) was tested for reliability on healthy individuals (n = 15), and patients (n = 22). Tests for internal consistency, validity and structure were performed on 51 patients.
Results
The VISA-A-S had good reliability for patients (r = 0.89, ICC = 0.89) and healthy individuals (r = 0.89–0.99, ICC = 0.88–0.99). The internal consistency was 0.77 (Cronbach's alpha). The mean [95% confidence interval] VISA-A-S score in the 51 patients (50 [44–56]) was significantly lower than in the healthy individuals (96 [94–99]). The VISA-A-S score correlated significantly (Spearman's r = -0.68) with another tendon grading system. Criterion validity was considered good when comparing the scores of the Swedish version with the English version in both healthy individuals and patients. The factor analysis gave the factors pain/symptoms and physical activity
Conclusion
The VISA-A-S questionnaire is a reliable and valid instrument and comparable to the original version. It measures two factors: pain/symptoms and physical activity, and can be used in both research and the clinical setting.
doi:10.1186/1471-2474-6-12
PMCID: PMC555595  PMID: 15748297
7.  Comparison of foot orthoses made by podiatrists, pedorthists and orthotists regarding plantar pressure reduction in The Netherlands 
Background
There is a need for evidence of clinical effectiveness of foot orthosis therapy. This study evaluated the effect of foot orthoses made by ten podiatrists, ten pedorthists and eleven orthotists on plantar pressure and walking convenience for three patients with metatarsalgia. Aims were to assess differences and variability between and within the disciplines. The relationship between the importance of pressure reduction and the effect on peak pressure was also evaluated.
Methods
Each therapist examined all three patients and was asked to rate the 'importance of pressure reduction' through a visual analogue scale. The orthoses were evaluated twice in two sessions while the patient walked on a treadmill. Plantar pressures were recorded with an in-sole measuring system. Patients scored walking convenience per orthosis. The effects of the orthoses on peak pressure reduction were calculated for the whole plantar surface of the forefoot and six regions: big toe and metatarsal one to five.
Results
Within each discipline there was an extensive variation in construction of the orthoses and achieved peak pressure reductions. Pedorthists and orthotists achieved greater maximal peak pressure reductions calculated over the whole forefoot than podiatrists: 960, 1020 and 750 kPa, respectively (p < .001). This was also true for the effect in the regions with the highest baseline peak pressures and walking convenience rated by patients A and B. There was a weak relationship between the 'importance of pressure reduction' and the achieved pressure reduction for orthotists, but no relationship for podiatrists and pedorthotists.
Conclusion
The large variation for various aspects of foot orthoses therapy raises questions about a consistent use of concepts for pressures management within the professional groups.
doi:10.1186/1471-2474-6-61
PMCID: PMC1326204  PMID: 16368005
8.  The effect of cartilage and bone density of mushroom-shaped, photooxidized, osteochondral transplants: an experimental study on graft performance in sheep using transplants originating from different species 
Background
Differences in overall performance of osteochondral photooxidized grafts were studied in accordance of their species origin and a new, more rigorous cleansing procedure using alcohol during preparation.
Methods
Photooxidized mushroom-shaped grafts of bovine, ovine, human and equine origin were implanted in the femoral condyles of 32 sheep (condyles: n = 64). No viable chondrocytes were present at the time of implantation. Grafts were evaluated at 6 months using plastic embedded sections of non-decalcified bone and cartilage specimens. Graft incorporation, the formation of cyst-like lesions at the base of the cartilage junction as well as cartilage morphology was studied qualitatively, semi-quantitatively using a score system and quantitatively by performing histomorphometrical measurements of percentage of bone and fibrous tissue of the original defects. For statistical analysis a factorial analysis of variance (ANOVA- test) was applied.
Results
Differences of graft performance were found according to species origin and cleansing process during graft preparation. According to the score system cartilage surface integrity was best for equine grafts, as well as dislocation or mechanical stability. The equine grafts showed the highest percentage for bone and lowest for fibrous tissue, resp. cystic lesions. The new, more rigorous cleansing process decreased cartilage persistence and overall graft performance.
Conclusion
Performance of grafts from equine origin was better compared to bovine, ovine and human grafts. The exact reason for this difference was not proven in the current study, but could be related to differences in density of cartilage and subchondral bone between species.
doi:10.1186/1471-2474-6-60
PMCID: PMC1343563  PMID: 16356173
9.  Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489] 
Background
The aim of this study was to evaluate the long-term efficacy and tolerability of etoricoxib, a COX-2 selective inhibitor, in osteoarthritis (OA) patients.
Methods
A double-blind, randomized, multicenter study was conducted in 617 patients with OA of the knee. The base study was 14 weeks in duration and consisted of 2 parts; in Part I (6 weeks), patients were allocated to once daily oral etoricoxib 5, 10, 30, 60, 90 mg or placebo. In Part II (8 weeks); the placebo, etoricoxib 5 and 10 mg groups were reallocated to etoricoxib 30, 60, or 90 mg qd or diclofenac 50 mg t.i.d. Treatment was continued for consecutive 12 and 26 week extensions. Primary efficacy endpoints were the WOMAC VA 3.0 pain subscale and investigator global assessment of disease status. Safety and tolerability were assessed by collecting adverse events throughout the study.
Results
Compared with placebo, the etoricoxib groups displayed significant (p < 0.05), dose-dependent efficacy for all primary endpoints in Part I; efficacy was maintained throughout the 52 weeks of the study. During the 46-week active-comparator controlled period, the etoricoxib groups demonstrated clinical efficacy that was similar to that of diclofenac 150 mg and was generally well tolerated, with a lower incidence of gastrointestinal (GI) nuisance symptoms compared with diclofenac (13.1, 14.7, and 13.5% for etoricoxib 30, 60, and 90 mg, respectively compared with 22.5% for diclofenac).
Conclusion
In this extension study, etoricoxib, at doses ranging from 30 to 90 mg, demonstrated a maintenance of significant clinical efficacy in patients with OA through 52 weeks of treatment. Etoricoxib displayed clinical efficacy similar to diclofenac 150 mg and was generally well tolerated.
doi:10.1186/1471-2474-6-58
PMCID: PMC1327669  PMID: 16321158
10.  Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617] 
Background
Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain.
Methods/design
This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain.
doi:10.1186/1471-2474-6-57
PMCID: PMC1298305  PMID: 16280089
11.  Lumbar segmental instability: a criterion-related validity study of manual therapy assessment 
Background
Musculoskeletal physiotherapists routinely assess lumbar segmental motion during the clinical examination of a patient with low back pain. The validity of manual assessment of segmental motion has not, however, been adequately investigated.
Methods
In this prospective, multi-centre, pragmatic, diagnostic validity study, 138 consecutive patients with recurrent or chronic low back pain (R/CLBP) were recruited. Physiotherapists with post-graduate training in manual therapy performed passive accessory intervertebral motion tests (PAIVMs) and passive physiological intervertebral motion tests (PPIVMs). Consenting patients were referred for flexion-extension radiographs. Sagittal angular rotation and sagittal translation of each lumbar spinal motion segment was measured from these radiographs, and compared to a reference range derived from a study of 30 asymptomatic volunteers. Motion beyond two standard deviations from the reference mean was considered diagnostic of rotational lumbar segmental instability (LSI) and translational LSI. Accuracy and validity of the clinical assessments were expressed using sensitivity, specificity, and likelihood ratio statistics with 95% confidence intervals (CI).
Results
Only translation LSI was found to be significantly associated with R/CLBP (p < 0.05). PAIVMs were specific for the diagnosis of translation LSI (specificity 89%, CI 83–93%), but showed poor sensitivity (29%, CI 14–50%). A positive test results in a likelihood ratio (LR+) of 2.52 (95% CI 1.15–5.53). Flexion PPIVMs were highly specific for the diagnosis of translation LSI (specificity 99.5%; CI 97–100%), but showed very poor sensitivity (5%; CI 1–22%). Likelihood ratio statistics for flexion PPIVMs were not statistically significant. Extension PPIVMs performed better than flexion PPIVMs, with slightly higher sensitivity (16%; CI 6–38%) resulting in a likelihood ratio for a positive test of 7.1 (95% CI 1.7 to 29.2) for translation LSI.
Conclusion
This study provides the first evidence reporting the concurrent validity of manual tests for the detection of abnormal sagittal planar motion. PAIVMs and PPIVMs are highly specific, but not sensitive, for the detection of translation LSI. Likelihood ratios resulting from positive test results were only moderate. This research indicates that manual clinical examination procedures have moderate validity for detecting segmental motion abnormality.
doi:10.1186/1471-2474-6-56
PMCID: PMC1310529  PMID: 16274487
12.  The use and diagnostic yield of radiology in subjects with longstanding musculoskeletal pain – an eight year follow up 
Background
Longstanding musculoskeletal pain is common in the general population and associated with frequent use of health care. Plain radiography is a common diagnostic approach in these patients despite knowledge that the use in the investigation of musculoskeletal pain is associated with low diagnostic yield, substantial costs and high radiation exposure. The aim of this study was to assess the use of diagnostic imaging and the proportion of pathological findings with regard to duration and distribution of pain in a cohort from the general population.
Methods
An eight-year longitudinal study based on questionnaires at three occasions and medical records on radiological examinations done in medical care. Thirty subjects were selected from an established population based cohort of 2425 subjects that in 1995 answered a postal survey on pain experience. At baseline there were ten subjects from each of three pain groups; No chronic pain, Chronic regional pain, and Chronic widespread pain (CWP). Those who presented with CWP at two or all three occasions were considered to have a longstanding or re-occurring CWP. In total the thirty subjects underwent 102 radiological examinations during the eight year follow up.
Results
There was a non-significant (p = 0.10) finding indicating that subjects with chronic pain at baseline (regional or widespread) were examined three times more often than those with no chronic pain. When the indication for the examination was pain, there was a low proportion of positive findings in subjects with longstanding CWP, compared to all others (5.3% vs 28.9%; p = 0.045). On the other hand, in examinations on other indications than pain the proportion of positive findings was high in the CWP group (62.5% vs 14.8%; p = 0.001).
Conclusion
Radiological examinations had a low diagnostic yield in evaluation of pain in subjects with longstanding/reoccurring CWP. These subjects had on the other hand more often positive findings when examined on other indications than pain. This may indicate that subjects with longstanding/reoccurring CWP are more prone to other diseases. It is a challenge for caregivers, often primary care physicians, to use radiological examinations to the best for their patients.
doi:10.1186/1471-2474-6-53
PMCID: PMC1298304  PMID: 16269075
13.  Back pain reporting in young girls appears to be puberty-related 
Background
There is a large increase in back pain reporting in the early teens. In no previous study has the prevalence of low back pain been investigated in relation to the onset of puberty. The objective of this study was to establish whether the onset of puberty is associated with back pain reporting in young girls.
Methods
A subsample of 254 girls aged 8–10 years and 165 girls aged 14–16 years from a cross-sectional survey of 481 children aged 8–10 years and 325 adolescents aged 14–16 years of both sexes.
Main outcome measures were back pain defined as low back pain, mid back pain, and/or neck pain in the past month.
Other variables of interest were Puberty (five different stages), age, body mass index, and smoking. Independent information on onset of puberty was obtained through a physical examination and on back pain through an individual structured interview. The association was studied between onset of puberty and the outcome variable (the one month period prevalence of back pain), controlling for overweight, and smoking. Odds ratios with 95% confidence intervals were used to describe bivariate associations, logistic regression with robust standard errors was used for multivariate analyses.
Results
There is a highly significant trend for increased back pain reporting with increasing level of puberty until maturity is reached. The biggest leap appears between the second level (beginning of puberty) and the third level (mid puberty) and the findings remain after controlling for the covariates. These results emanate from the low back, whereas pain in the mid back and neck do not seem to be linked with pubertal stage.
Conclusion
In girls, the reporting of low back pain increases in frequency during puberty until maturity, regardless of age. Why some girls are susceptible to back pain in the early stage of puberty is unknown.
doi:10.1186/1471-2474-6-52
PMCID: PMC1291369  PMID: 16262898
14.  A sonography assisted technique for the removal of a femoral interlocking nail – a technical note 
Background
Open methods for removal of femoral interlocking nails involve an incision (up to 10 cm) over the trochanter to find the tip of the nail. The distal locking screws are some times difficult to palpate and an incision (up to about 5 cm) is often needed for exposure. Intra-operative fluoroscopy is often used as an adjunct technique to minimize the surgical wound. However, patients and surgeons are exposed to a radiation hazard. Sonography can provide a real-time and efficient alternative to fluoroscopy.
Methods
Sonography of soft tissue has been established to identify a foreign body. A metallic implant has a hyperechoic image; therefore, we can identify the correct position of the screws preoperatively and intraoperatively.
Results
We have developed a technique using sonography and minimal incisions for the removal of a femoral interlocking nail. The proximal wound is 2.5 cm in length and the wound is 0.5 cm in length for each distal locking screw.
Conclusion
The sonography can be used to minimize the length of incision and prevent radiation exposure in the removal of intramedullary femoral nails.
doi:10.1186/1471-2474-6-51
PMCID: PMC1274328  PMID: 16229748
15.  The McKenzie method for the management of acute non-specific low back pain: design of a randomised controlled trial [ACTRN012605000032651] 
Background
Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.
Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP.
Methods/design
This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3.
Discussion
This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.
doi:10.1186/1471-2474-6-50
PMCID: PMC1274327  PMID: 16221311
16.  Comparison of plasma endothelin levels between osteoporotic, osteopenic and normal subjects 
Background
It has been demonstrated that endothelins (ET) have significant roles in bone remodeling, metabolism and physiopathology of several bone diseases. We aimed to investigate if there was any difference between the plasma ET levels of osteoporotic patients and normals.
Methods
86 patients (70 women and 16 men) with a mean age of 62.6 (ranges: 51–90) years were included in this study. Patients were divided into groups of osteoporosis, osteopenia and normal regarding reported T scores of DEXA evaluation according to the suggestions of World Health Organization. According to these criteria 19, 43 and 24 were normal, osteopenic and osteoporotic respectively. Then total plasma level of ET was measured in all patients with monoclonal antibody based sandwich immunoassay (EIA) method. One-way analysis of variance test was used to compare endothelin values between normals, osteopenics and osteoporotics.
Results
Endothelin total plasma level in patients was a mean of 98.36 ± 63.96, 100.92 ± 47.2 and 99.56 ± 56.6 pg/ml in osteoporotic, osteopenic and normal groups respectively. The difference between groups was not significant (p > 0.05).
Conclusion
No significant differences in plasma ET levels among three groups of study participants could be detected in this study.
doi:10.1186/1471-2474-6-49
PMCID: PMC1242236  PMID: 16174297
17.  Evaluation of easily measured risk factors in the prediction of osteoporotic fractures 
Background
Fracture represents the single most important clinical event in patients with osteoporosis, yet remains under-predicted. As few premonitory symptoms for fracture exist, it is of critical importance that physicians effectively and efficiently identify individuals at increased fracture risk.
Methods
Of 3426 postmenopausal women in CANDOO, 40, 158, 99, and 64 women developed a new hip, vertebral, wrist or rib fracture, respectively. Seven easily measured risk factors predictive of fracture in research trials were examined in clinical practice including: age (<65, 65–69, 70–74, 75–79, 80+ years), rising from a chair with arms (yes, no), weight (< 57, ≥ 57kg), maternal history of hip facture (yes, no), prior fracture after age 50 (yes, no), hip T-score (>-1, -1 to >-2.5, ≤-2.5), and current smoking status (yes, no). Multivariable logistic regression analysis was conducted.
Results
The inability to rise from a chair without the use of arms (3.58; 95% CI: 1.17, 10.93) was the most significant risk factor for new hip fracture. Notable risk factors for predicting new vertebral fractures were: low body weight (1.57; 95% CI: 1.04, 2.37), current smoking (1.95; 95% CI: 1.20, 3.18) and age between 75–79 years (1.96; 95% CI: 1.10, 3.51). New wrist fractures were significantly identified by low body weight (1.71, 95% CI: 1.01, 2.90) and prior fracture after 50 years (1.96; 95% CI: 1.19, 3.22). Predictors of new rib fractures include a maternal history of a hip facture (2.89; 95% CI: 1.04, 8.08) and a prior fracture after 50 years (2.16; 95% CI: 1.20, 3.87).
Conclusion
This study has shown that there exists a variety of predictors of future fracture, besides BMD, that can be easily assessed by a physician. The significance of each variable depends on the site of incident fracture. Of greatest interest is that an inability to rise from a chair is perhaps the most readily identifiable significant risk factor for hip fracture and can be easily incorporated into routine clinical practice.
doi:10.1186/1471-2474-6-47
PMCID: PMC1208898  PMID: 16143046
18.  Classifying health-related quality of life outcomes of total hip arthroplasty 
Background
Primary total hip arthroplasty (THA) is an effective treatment for hip osteoarthritis, assessed by whatever distribution-based measures of responsiveness. Yet, the group level evaluation has provided very little evidence contributes to our understanding of the large variation of treatment outcome. The objective is to develop criteria that classify individual treatment health related quality of life (HRQOL) outcome after primary THA, adjusted by preoperative scores.
Methods
We prospectively measured 147 patients' disease specific HRQOL on the date of consultation and 12 months post operation by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Regression models were used to determine the "expected" outcome for a certain individual baseline score. The ceiling effect of WOMAC measurement is addressed by implementing a left-censoring method.
Results
The classification criteria are chosen to be the lower boundary of the 95% confidence interval (CI) of the estimated median from the regression. The robustness of the classification criteria was demonstrated using the Monte-Carlo simulation.
Conclusion
The classification criteria are robust and can be applied in general orthopaedic research when the sample size is reasonable large (over 500).
doi:10.1186/1471-2474-6-48
PMCID: PMC1242235  PMID: 16144550
19.  Quadriceps force generation in patients with osteoarthritis of the knee and asymptomatic participants during patellar tendon reflex reactions: an exploratory cross-sectional study 
Background
It has been postulated that muscle contraction is slower in patients with osteoarthritis of the knee than asymptomatic individuals, a factor that could theoretically impair joint protection mechanisms. This study investigated whether patients with osteoarthritis of the knee took longer than asymptomatic participants to generate force during reflex quadriceps muscle contraction. This was an exploratory study to inform sample size for future studies.
Methods
An exploratory observational cross sectional study was carried out. Two subject groups were tested, asymptomatic participants (n = 17), mean (SD) 56.7 (8.6) years, and patients with osteoarthritis of the knee, diagnosed by an orthopaedic surgeon, (n = 16), age 65.9 (7.8) years. Patellar tendon reflex responses were elicited from participants and measured with a load cell. Force latency, contraction time, and force of the reflex response were determined from digitally stored data. The Mann-Whitney U test was used for the between group comparisons in these variables. Bland and Altman within-subject standard deviation values were calculated to evaluate the measurement error or precision of force latency and contraction time.
Results
No significant differences were found between the groups for force latency (p = 0.47), contraction time (p = 0.91), or force (p = 0.72). The two standard deviation measurement error values for force latency were 27.9 ms for asymptomatic participants and 16.4 ms for OA knee patients. For contraction time, these values were 29.3 ms for asymptomatic participants and 28.1 ms for OA knee patients. Post hoc calculations revealed that the study was adequately powered (80%) to detect a difference between the groups of 30 ms in force latency. However it was inadequately powered (59%) to detect this same difference in contraction time, and 28 participants would be required in each group to reach 80% power.
Conclusion
Patients with osteoarthritis of the knee do not appear to have compromised temporal parameters or magnitude of force generation during patellar tendon reflex reactions when compared to a group of asymptomatic participants. However, these results suggest that larger studies are carried out to investigate this area further.
doi:10.1186/1471-2474-6-46
PMCID: PMC1232853  PMID: 16137326
20.  Knee disorders in primary care: design and patient selection of the HONEUR knee cohort 
Background
Knee complaints are a frequent reason for consultation in general practice. These patients constitute a specific population compared to secondary care patients. However, information to base treatment decisions on is generally derived from specialistic settings. Our cohort study is aimed at collecting knowledge about prognosis and prognostic factors of knee complaints presented in a primary care setting. This paper describes the methods used for data collection, and discusses potential selectiveness of patient recruitment.
Methods
This is a descriptive prospective cohort study with one-year follow-up. 40 Dutch GPs recruited consecutive patients with incident knee complaints aged 12 years and above from October 2001 to October 2003. Patients were assessed with questionnaires and standardised physical examinations. Additional measurements of subgroups included MRI for recent knee traumas and device assessed function measurements for non-traumatic patients.
After the inclusion period we retrospectively searched the computerized medical files of participating GPs to obtain a sample to determine possible selective recruitment. We assessed differences in proportions of gender, traumatic onset of injury and age groups between participants and non-participants using Odds Ratios (OR) and 95% confidence intervals.
Results
We recruited 1068 patients. In a sample of 310 patients visiting the GP, we detected some selective recruitment, indicating an underrepresentation of patients aged 12 to 35 years (OR 1.70; 1.15–2.77), especially among men (OR 2.16; 1.12–4.18). The underrepresentation of patients with traumatic onset of injury was not statistically significant.
Conclusion
This cohort is unique in its size, setting, and its range of both age and type of knee complaints. We believe the detected selective recruitment is unlikely to introduce significant bias, as the cohort will be divided into subgroups according to age group or traumatic onset of injury for future analyses. However, the underrepresentation of men in the age group of 12 to 35 years of age warrants caution. Based on the available data, we believe our cohort is an acceptable representation of patients with new knee complaints consulting the GP, and we expect no problems with extrapolation of the results to the general Dutch population.
doi:10.1186/1471-2474-6-45
PMCID: PMC1208897  PMID: 16117830
21.  Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886] 
Background
Topical NSAIDs have been proven to relieve the symptoms of osteoarthritis (OA) in short-term studies (2 weeks). To justify its chronic use, efficacy of a topical NSAID over a longer term of study should be demonstrated. The efficacy and safety of a topical diclofenac solution over a 6-week treatment course in symptomatic primary OA of the knee was investigated.
Methods
216 men and women, age 40–85 years, with radiologically confirmed primary OA of the knee and a flare of pain at baseline following discontinuation of prior therapy were enrolled into this double-blind study. Participants applied either a topical diclofenac solution (Pennsaid®) or vehicle control solution (carrier with no diclofenac); 40 drops 4 times daily directly to the painful knee(s), without massage, for 6 weeks. Pre-planned primary efficacy outcome measures included the core continuous variables pain relief and improved physical function measured by the Western Ontario and McMaster Universities (WOMAC) LK3.1 OA Index, and improved patient global assessment (PGA). Secondary efficacy measure was reduced stiffness. Safety assessments included adverse events and vital signs.
Results
The topical diclofenac group had a significantly greater mean change in score (final minus baseline) compared to the vehicle control group for pain (-5.2 vs. -3.3, p = 0.003), physical function (-13.4 vs. -6.9, p = 0.001), PGA (-1.3 vs. -0.7, p = 0.0001) and stiffness (-1.8 vs. -0.9, p = 0.002). The mean difference between treatment arms (95% confidence interval [CI]) was 1.9 (0.7 to 3.2), 6.5 (2.5 to 10.5), 0.6 (0.2 to 0.9), and 0.9 (0.3 to 1.4), respectively. Safety analyses showed that topical diclofenac caused skin irritation, mostly minor local skin dryness, in 42/107 (39%), leading to discontinuation of treatment in 5/107 (5%) participants.
Conclusion
This topical diclofenac solution demonstrated relief at 6 weeks of the symptoms of primary osteoarthritis of the knee.
doi:10.1186/1471-2474-6-44
PMCID: PMC1201146  PMID: 16086839
22.  Severely disabling chronic pain in young adults: prevalence from a population-based postal survey in North Staffordshire 
Background
Severely disabling chronic pain in the adult population is strongly associated with a range of negative health consequences for individuals and high health care costs, yet its prevalence in young adults is less clear.
Methods
All adults aged 18–25 years old registered with three general practices in North Staffordshire were invited to complete a postal questionnaire containing questions on pain within the last 6 months, pain location and duration. Severity of chronic pain was assessed by the Chronic Pain Grade. Severely disabling chronic pain was defined as pain within the last six months that had lasted for three months or more and was highly disabling-severely limiting (Grade IV).
Results
858 responses from 2,389 were received (adjusted response = 37.0%). The prevalence of any pain within the previous six months was 66.9% (95%CI: 63.7%, 70.1%). Chronic pain was reported by 14.3% (95%CI: 12.0%, 16.8%) of respondents with severely disabling chronic pain affecting 3.0% (95%CI: 2.0%, 4.4%) of this population. Late responders were very similar to early responders in their prevalence of pain. Cross-checking the practice register against the electoral roll suggested register inaccuracies contributed to non-response.
Conclusion
Pain is a common phenomenon encountered by young adults, affecting 66.9% of this study population. Previously observed age-related trends in severely disabling chronic pain in older adults extend to younger adults. Although a small minority of younger adults are affected, they are likely to represent a group with particularly high health care needs. High levels of non-response in the present study means that these estimates should be interpreted cautiously although there was no evidence of non-response bias.
doi:10.1186/1471-2474-6-42
PMCID: PMC1187895  PMID: 16042761
23.  Testing the effectiveness of an innovative information package on practitioner reported behaviour and beliefs: The UK Chiropractors, Osteopaths and Musculoskeletal Physiotherapists Low back pain ManagemENT (COMPLeMENT) trial [ISRCTN77245761] 
Background
Low back pain (LBP) is a common and costly problem. Initiatives designed to assist practitioner and patient decisions about appropriate healthcare for LBP include printed evidence-based clinical guidelines. The three professional groups of chiropractic, osteopathy and musculoskeletal physiotherapy in the UK share common ground with their approaches to managing LBP and are amongst those targeted by LBP guidelines. Even so, many seem unaware that such guidelines exist. Furthermore, the behaviour of at least some of these practitioners differs from that recommended in these guidelines.
Few randomised controlled trials evaluating printed information as an intervention to change practitioner behaviour have utilised a no-intervention control. All these trials have used a cluster design and most have methodological flaws. None specifically focus upon practitioner behaviour towards LBP patients. Studies that have investigated other strategies to change practitioner behaviour with LBP patients have produced conflicting results. Although numerous LBP guidelines have been developed worldwide, there is a paucity of data on whether their dissemination actually changes practitioner behaviour. Primarily because of its low unit cost, sending printed information to large numbers of practitioners is an attractive dissemination and implementation strategy. The effect size of such a strategy, at an individual practitioner level, is likely to be small. However, if large numbers of practitioners are targeted, this strategy might achieve meaningful changes at a population level.
Methods
The primary aim of this prospective, pragmatic randomised controlled trial is to test the short-term effectiveness (six-months following intervention) of a directly-posted information package on the reported clinical behaviour (primary outcome), attitudes and beliefs of UK chiropractors, osteopaths and musculoskeletal physiotherapists. We sought to randomly allocate a combined sample of 1,800 consenting practitioners to receive either the information package (intervention arm) or no information above that gained during normal practice (control arm). We collected questionnaire data at baseline and six-months post-intervention. The analysis of the primary outcome will assess between-arm differences of proportions of responses to questions on recommendations about activity, work and bed-rest, that fall within categories previously defined by an expert consensus exercise as either 'guideline-consistent' and 'guideline-inconsistent'.
doi:10.1186/1471-2474-6-41
PMCID: PMC1208895  PMID: 16033646
24.  The clubfoot assessment protocol (CAP); description and reliability of a structured multi-level instrument for follow-up 
Background
In most clubfoot studies, the outcome instruments used are designed to evaluate classification or long-term cross-sectional results. Variables deal mainly with factors on body function/structure level. Wide scorings intervals and total sum scores increase the risk that important changes and information are not detected. Studies of the reliability, validity and responsiveness of these instruments are sparse. The lack of an instrument for longitudinal follow-up led the investigators to develop the Clubfoot Assessment Protocol (CAP).
The aim of this article is to introduce and describe the CAP and evaluate the items inter- and intra reliability in relation to patient age.
Methods
The CAP was created from 22 items divided between body function/structure (three subgroups) and activity (one subgroup) levels according to the International Classification of Function, Disability and Health (ICF). The focus is on item and subgroup development.
Two experienced examiners assessed 69 clubfeet in 48 children who had a median age of 2.1 years (range, 0 to 6.7 years). Both treated and untreated feet with different grades of severity were included. Three age groups were constructed for studying the influence of age on reliability. The intra- rater study included 32 feet in 20 children who had a median age of 2.5 years (range, 4 months to 6.8 years).
The Unweighted Kappa statistics, percentage observer agreement, and amount of categories defined how reliability was to be interpreted.
Results
The inter-rater reliability was assessed as moderate to good for all but one item. Eighteen items had kappa values > 0.40. Three items varied from 0.35 to 0.38. The mean percentage observed agreement was 82% (range, 62 to 95%). Different age groups showed sufficient agreement. Intra- rater; all items had kappa values > 0.40 [range, 0.54 to 1.00] and a mean percentage agreement of 89.5%. Categories varied from 3 to 5.
Conclusion
The CAP contains more detailed information than previous protocols. It is a multi-dimensional observer administered standardized measurement instrument with the focus on item and subgroup level. It can be used with sufficient reliability, independent of age, during the first seven years of childhood by examiners with good clinical experience.
A few items showed low reliability, partly dependent on the child's age and /or varying professional backgrounds between the examiners. These items should be interpreted with caution, until further studies have confirmed the validity and sensitivity of the instrument.
doi:10.1186/1471-2474-6-40
PMCID: PMC1190184  PMID: 16022741
25.  Does Alendronate reduce the risk of fracture in men? A meta-analysis incorporating prior knowledge of anti-fracture efficacy in women 
Background
Alendronate has been found to reduce the risk of fractures in postmenopausal women as demonstrated in multiple randomized controlled trials enrolling thousands of women. Yet there is a paucity of such randomized controlled trials in osteoporotic men. Our objective was to systematically review the anti-fracture efficacy of alendronate in men with low bone mass or with a history of prevalent fracture(s) and incorporate prior knowledge of alendronate efficacy in women in the analysis.
Methods
We examined randomized controlled trials in men comparing the anti-fracture efficacy of alendronate to placebo or calcium or vitamin D, or any combination of these. Studies of men with secondary causes of osteoporosis other than hypogonadism were excluded. We searched the following electronic databases (without language restrictions) for potentially relevant citations: Medline, Medline in Process (1966-May 24/2004), and Embase (1996–2004). We also contacted the manufacturer of the drug in search of other relevant trials. Two reviewers independently identified two trials (including 375 men), which met all inclusion criteria. Data were abstracted by one reviewer and checked by another. Results of the male trials were pooled using Bayesian random effects models, incorporating prior information of anti-fracture efficacy from meta-analyses of women.
Results
The odds ratios of incident fractures in men (with 95% credibility intervals) with alendronate (10 mg daily) were: vertebral fractures, 0.44 (0.23, 0.83) and non-vertebral fractures, 0.60 (0.29, 1.44).
Conclusion
In conclusion, alendronate decreases the risk of vertebral fractures in men at risk. There is currently insufficient evidence of a statistically significant reduction of non-vertebral fractures, but the paucity of trials in men limit the statistical power to detect such an effect.
doi:10.1186/1471-2474-6-39
PMCID: PMC1182376  PMID: 16008835

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