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1.  Physical activity is associated with a low prevalence of musculoskeletal disorders in the Royal Norwegian Navy: a cross sectional study 
Background
Despite considerable knowledge about musculoskeletal disorders (MSD) and physical, psychosocial and individual risk factors there is limited knowledge about physical activity as a factor in preventing MSD. In addition, studies of physical activity are often limited to either leisure activity or physical activity at work. Studies among military personnel on the association between physical activity at work and at leisure and MSD are lacking. This study was conducted to find the prevalence of MSD among personnel in the Royal Norwegian Navy and to assess the association between physical activity at work and at leisure and MSD.
Methods
A questionnaire about musculoskeletal disorders, physical activity and background data (employment status, age, gender, body mass index, smoking, education and physical stressors) was completed by 2265 workers (58%) 18 to 70 years old in the Royal Norwegian Navy. Multiple logistic regression with 95% confidence intervals was used to assess the relationship between physical activity and musculoskeletal disorders.
Results
A total of 32% of the workers reported musculoskeletal disorders often or very often in one or more parts of the body in the past year. The most common musculoskeletal disorders were in the lower back (15% often or very often), shoulders (12% often or very often) and neck (11% often or very often). After adjustment for confounders, physical activity was inversely associated with musculoskeletal disorders for all body sites except elbows, knees and feet.
Conclusion
The one-year prevalence of musculoskeletal disorders among workers in the Royal Norwegian Navy was rather low. A physically active lifestyle both at work and at leisure was associated with fewer musculoskeletal disorders among personnel in the Royal Norwegian Navy. Prospective studies are necessary to confirm the cause and effect in this association.
doi:10.1186/1471-2474-8-56
PMCID: PMC1929072  PMID: 17601352
2.  Reliability and validity study of Persian modified version of MUSIC (musculoskeletal intervention center) – Norrtalje questionnaire 
Background
Musculoskeletal disorders (MSDs) are a major health problem in the world. Self-reported questionnaires are a known method for estimating the prevalence of MSDs among the population. One of the studies concerning MSDs and their relation to work-related physical and psychosocial factors, as well as non-work-related factors, is the MUSIC-Norrtalje study in Sweden. In this study, the research group developed a questionnaire, which has been validated during its development process and is now considered a well-known instrument. The aim of this study is to validate the Persian version of this questionnaire.
Methods
The first step was to establish two expert panel groups in Iran and Sweden. The Focus Group Discussion (FGD) method was used to detect questionnaire face and content validity. To detect questionnaire reliability, we used the test-retest method.
Results
Except for two items, all other questions that respondents had problems with in the focus group (20 of 297), had unclear translations; the ambiguity was related to the stem of the questions and the predicted answers were clear for the participants. The concepts of 'household/spare time' and 'physical activity in the workplace' were not understood by the participants of FGD; this has been solved by adding further descriptions to these phrases in the translation. In the test-retest study, the reliability coefficient was relatively high in most items (only 5 items out of 297 had an ICC or kappa below 0.7).
Conclusion
The findings from the present study provide evidence that the Persian version of the MUSIC questionnaire is a reliable and valid instrument.
doi:10.1186/1471-2474-8-88
PMCID: PMC2078587  PMID: 17764557
3.  Treatment of myofascial trigger points in common shoulder disorders by physical therapy: A randomized controlled trial [ISRCTN75722066] 
Background
Shoulder disorders are a common health problem in western societies. Several treatment protocols have been developed for the clinical management of persons with shoulder pain. However available evidence does not support any protocol as being superior over others. Systematic reviews provide some evidence that certain physical therapy interventions (i.e. supervised exercises and mobilisation) are effective in particular shoulder disorders (i.e. rotator cuff disorders, mixed shoulder disorders and adhesive capsulitis), but there is an ongoing need for high quality trials of physical therapy interventions. Usually, physical therapy consists of active exercises intended to strengthen the shoulder muscles as stabilizers of the glenohumeral joint or perform mobilisations to improve restricted mobility of the glenohumeral or adjacent joints (shoulder girdle). It is generally accepted that a-traumatic shoulder problems are the result of impingement of the subacromial structures, such as the bursa or rotator cuff tendons. Myofascial trigger points (MTrPs) in shoulder muscles may also lead to a complex of symptoms that are often seen in patients diagnosed with subacromial impingement or rotator cuff tendinopathy. Little is known about the treatment of MTrPs in patients with shoulder disorders.
The primary aim of this study is to investigate whether physical therapy modalities to inactivate MTrPs can reduce symptoms and improve shoulder function in daily activities in a population of chronic a-traumatic shoulder patients when compared to a wait-and-see strategy. In addition we investigate the recurrence rate during a one-year-follow-up period.
Methods/Design
This paper presents the design for a randomized controlled trial to be conducted between September 2007 – September 2008, evaluating the effectiveness of a physical therapy treatment for non-traumatic shoulder complaints. One hundred subjects are included in this study. All subjects have unilateral shoulder pain for at least six months and are referred to a physical therapy practice specialized in musculoskeletal disorders of the neck-, shoulder-, and arm.
After the initial assessment patients are randomly assigned to either an intervention group or a control-group (wait and see). The primary outcome measure is the overall score of the Dutch language version of the DASH (Disabilities of Arm, Shoulder and Hand) questionnaire.
Discussion
Since there is only little evidence for the efficacy of physical therapy interventions in certain shoulder disorders, there is a need for further research. We found only a few studies examining the efficacy of MTrP therapy for shoulder disorders. Therefore we will perform a randomised clinical trial of the effect of physical therapy interventions aimed to inactivate MTrPs, on pain and impairment in shoulder function in a population of chronic a-traumatic shoulder patients. We opted for an intervention strategy that best reflects daily practice. Manual high velocity thrust techniques and dry-needling are excluded. Because in most physical therapy interventions, blinding of the patient and the therapist is not possible, we will perform a randomised, controlled and observer-blinded study.
Trial Registration
This randomized clinical trial is registered at current controlled trials ISRCTN75722066.
doi:10.1186/1471-2474-8-107
PMCID: PMC2246010  PMID: 17983467
4.  Obesity and pronated foot type may increase the risk of chronic plantar heel pain: a matched case-control study 
Background
Chronic plantar heel pain (CPHP) is one of the most common musculoskeletal disorders of the foot, yet its aetiology is poorly understood. The purpose of this study was to examine the association between CPHP and a number of commonly hypothesised causative factors.
Methods
Eighty participants with CPHP (33 males, 47 females, mean age 52.3 years, S.D. 11.7) were matched by age (± 2 years) and sex to 80 control participants (33 males, 47 females, mean age 51.9 years, S.D. 11.8). The two groups were then compared on body mass index (BMI), foot posture as measured by the Foot Posture Index (FPI), ankle dorsiflexion range of motion (ROM) as measured by the Dorsiflexion Lunge Test, occupational lower limb stress using the Occupational Rating Scale and calf endurance using the Standing Heel Rise Test.
Results
Univariate analysis demonstrated that the CPHP group had significantly greater BMI (29.8 ± 5.4 kg/m2 vs. 27.5 ± 4.9 kg/m2; P < 0.01), a more pronated foot posture (FPI score 2.4 ± 3.3 vs. 1.1 ± 2.3; P < 0.01) and greater ankle dorsiflexion ROM (45.1 ± 7.1° vs. 40.5 ± 6.6°; P < 0.01) than the control group. No difference was identified between the groups for calf endurance or time spent sitting, standing, walking on uneven ground, squatting, climbing or lifting. Multivariate logistic regression revealed that those with CPHP were more likely to be obese (BMI ≥ 30 kg/m2) (OR 2.9, 95% CI 1.4 – 6.1, P < 0.01) and to have a pronated foot posture (FPI ≥ 4) (OR 3.7, 95% CI 1.6 – 8.7, P < 0.01).
Conclusion
Obesity and pronated foot posture are associated with CPHP and may be risk factors for the development of the condition. Decreased ankle dorsiflexion, calf endurance and occupational lower limb stress may not play a role in CPHP.
doi:10.1186/1471-2474-8-41
PMCID: PMC1884155  PMID: 17506905
5.  Effectiveness of calf muscle stretching for the short-term treatment of plantar heel pain: a randomised trial 
Background
Plantar heel pain is one of the most common musculoskeletal disorders of the foot and ankle. Treatment of the condition is usually conservative, however the effectiveness of many treatments frequently used in clinical practice, including stretching, has not been established. We performed a participant-blinded randomised trial to assess the effectiveness of calf muscle stretching, a commonly used short-term treatment for plantar heel pain.
Methods
Ninety-two participants with plantar heel pain were recruited from the general public between April and June 2005. Participants were randomly allocated to an intervention group that were prescribed calf muscle stretches and sham ultrasound (n = 46) or a control group who received sham ultrasound alone (n = 46). The intervention period was two weeks. No participants were lost to follow-up. Primary outcome measures were 'first-step' pain (measured on a 100 mm Visual Analogue Scale) and the Foot Health Status Questionnaire domains of foot pain, foot function and general foot health.
Results
Both treatment groups improved over the two week period of follow-up but there were no statistically significant differences in improvement between groups for any of the measured outcomes. For example, the mean improvement for 'first-step' pain (0–100 mm) was -19.8 mm in the stretching group and -13.2 mm in the control group (adjusted mean difference between groups -7.9 mm; 95% CI -18.3 to 2.6). For foot function (0–100 scale), the stretching group improved 16.2 points and the control group improved 8.3 points (adjusted mean difference between groups 7.3; 95% CI -0.1 to 14.8). Ten participants in the stretching group experienced an adverse event, however most events were mild to moderate and short-lived.
Conclusion
When used for the short-term treatment of plantar heel pain, a two-week stretching program provides no statistically significant benefit in 'first-step' pain, foot pain, foot function or general foot health compared to not stretching.
doi:10.1186/1471-2474-8-36
PMCID: PMC1867816  PMID: 17442119
6.  Autonomic and muscular responses and recovery to one-hour laboratory mental stress in healthy subjects 
Background
Stress is a risk factor for musculoskeletal pain. We wanted to explore stress related physiology in healthy subjects in order to gain insight into mechanisms of pain development which may relate to the pathophysiology of musculoskeletal pain disorders.
Methods
Continuous blood pressure, heart rate, finger skin blood flow, respiration, surface electromyography together with perception of pain, fatigue and tension were recorded on 35 healthy women and 9 healthy men before, during a 60 minute period with task-related low-grade mental stress, and in the following 30 minute rest period.
Results
Subjects responded physiologically to the stressful task with an increase in trapezius and frontalis muscle activity, increased blood pressure, respiration frequency and heart rate together with reduced finger skin blood flow. The blood pressure response and the finger skin blood flow response did not recover to baseline values during the 30-minute rest period, whereas respiration frequency, heart rate, and surface electromyography of the trapezius and frontalis muscles recovered to baseline within 10 minutes after the stressful task. Sixty-eight percent responded subjectively with pain development and 64% reported at least 30% increase in pain. Reduced recovery of the blood pressure was weakly correlated to fatigue development during stress, but was not correlated to pain or tension.
Conclusion
Based on a lack of recovery of the blood pressure and the acral finger skin blood flow response to mental stress we conclude that these responses are more protracted than other physiological stress responses.
doi:10.1186/1471-2474-8-81
PMCID: PMC2045095  PMID: 17697337
7.  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
8.  The Prevalence of low back pain in Africa: a systematic review 
Background
Low back pain (LBP) is the most prevalent musculoskeletal condition and one the most common causes of disability in the developed nations. Anecdotally, there is a general assumption that LBP prevalence in Africa is comparatively lower than in developed countries. The aim of this review was to systematically appraise the published prevalence studies conducted on the African continent to establish the prevalence of LBP in Africa.
Methods
A comprehensive search was conducted in April 2006. The following databases PEDro, Psychinfo, Science Direct, SportsDiscus, PubMed, CINAHL, Biblioline Pro-African Wide NiPAD and SA ePublications were individually searched using specifically developed search strategies for epidemiological research conducted on LBP amongst the African population. Two reviewers independently evaluated the methodological quality of the studies reviewed.
Results
A total of 27 eligible epidemiological studies were included in this review. The majority of the studies (63%) were conducted in South Africa (37%) and Nigeria (26%). The most common population group involved workers (48%), while scholars comprised 15% of the population. 67% of the studies were found to be methodologically sound, and the LBP prevalence of these were analyzed. The mean LBP point prevalence among the adolescents was 12% and among adults was 32%. The average one year prevalence of LBP among adolescents was 33% and among adults was 50%. The average lifetime prevalence of LBP among the adolescents was 36% and among adults was 62%.
Conclusion
The findings support the global burden of disease of LBP, in addition to suggesting that LBP prevalence among Africans is rising and is of concern. Further research into the most effective strategies to prevent and manage LBP in Africa is warranted.
doi:10.1186/1471-2474-8-105
PMCID: PMC2198912  PMID: 17976240
9.  Characteristics of children with hip displacement in cerebral palsy 
Background
Hip dislocation in children with cerebral palsy (CP) is a common and severe problem. The dislocation can be avoided, by screening and preventive treatment of children with hips at risk. The aim of this study was to analyse the characteristics of children with CP who develop hip displacement, in order to optimise a hip surveillance programme.
Methods
In a total population of children with CP a standardised clinical and radiological follow-up of the hips was carried out as a part of a hip prevention programme. The present study is based on 212 children followed until 9–16 years of age.
Results
Of the 212 children, 38 (18%) developed displacement with Migration Percentage (MP) >40% and further 19 (9%) MP between 33 and 39%. Mean age at first registration of hip displacement was 4 years, but some hips showed MP > 40% already at two years of age. The passive range of hip motion at the time of first registration of hip displacement did not differ significantly from the findings in hips without displacement.
The risk of hip displacement varied according to CP-subtype, from 0% in children with pure ataxia to 79% in children with spastic tetraplegia. The risk of displacement (MP > 40%) was directly related to the level of gross motor function, classified according to the gross motor function classification system, GMFCS, from 0% in children in GMFCS level I to 64% in GMFCS level V.
Conclusion
Hip displacement in CP often occurs already at 2–3 years of age. Range of motion is a poor indicator of hips at risk. Thus early identification and early radiographic examination of children at risk is of great importance. The risk of hip displacement varies according to both CP-subtype and GMFCS. It is sometimes not possible to determine subtype before 4 years of age, and at present several definitions and classification systems are used. GMFCS is valid and reliable from 2 years of age, and it is internationally accepted.
We recommend a hip surveillance programme for children with CP with radiographic examinations based on the child's age and GMFCS level.
doi:10.1186/1471-2474-8-101
PMCID: PMC2194677  PMID: 17963501
10.  Knee complaints and consequences on work status; a 10-year follow-up survey among floor layers and graphic designers 
Background
The purpose of the study was to examine if knee complaints among floor layers predict exclusion from the trade.
Methods
In 1994/95 self-reported data were obtained from a cohort of floor layers and graphic designers with and without knee straining work activities, respectively. At follow-up in 2005 the questionnaire survey was repeated. The study population consisted of 81 floor layers and 173 graphic designers who were presently working in their trades at baseline (1995). All participants were men aged 36–70 years in 2005.
We computed the risk of losing gainful employment in the trade according to occurrence of knee complaints at baseline, using Cox proportional hazard regression adjusted for a number of potential confounding variables. Moreover, the crude and adjusted odds risk ratio for knee complaints according to status of employment in the trade were computed, using graphic designers as reference.
Results
A positive but non-significant association between knee complaints lasting more than 30 days the past 12 months and exclusion from the trade was found among floor layers (Hazard Ratio = 1.4, 95% CI = 0.6–3.5).
The frequency of self-reported knee complaints was lower among floor layers presently at work in the trade in year 2005 (26.3%) compared with baseline in 1995 (41.1%), while the opposite tendency was seen among graphic designers (20.7% vs. 10.7%).
Conclusion
The study suggests that knee complaints are a risk factor for premature exclusion from a knee demanding trade. However, low power of the study precludes strong conclusions. The study also indicates a healthy worker effect among floor layers and a survivor effect among graphic designers.
doi:10.1186/1471-2474-8-93
PMCID: PMC2203991  PMID: 17877790
11.  The pectoralis minor length test: a study of the intra-rater reliability and diagnostic accuracy in subjects with and without shoulder symptoms 
Background
Postural abnormality and muscle imbalance are thought to contribute to pain and a loss of normal function in the upper body. A shortened pectoralis minor muscle is commonly identified as part of this imbalance. Clinical tests have been recommended to test for shortening of this muscle. The aim of this study was to evaluate the intra-rater reliability and diagnostic accuracy of the pectoralis minor length test.
Methods
Measurements were made in 45 subjects with and 45 subjects without shoulder symptoms. Measurements were made with the subjects lying in supine. In this position the linear distance from the treatment table to the posterior aspect of the acromion was measured on two occasions (separated by a minimum of 30 minutes and additional data collection on other subjects to reduce bias) by one rater. The reliability of the measurements was analyzed using intraclass correlation coefficients (ICC), 95% confidence intervals (CI) and standard error of measurement (SEM). The diagnostic accuracy of the test was investigated by determining the sensitivity, specificity, positive and negative likelihood ratios of the test against a 'gold standard' reference. The assessor remained 'blinded' to data input and the measurements were staggered to reduce examiner bias.
Results
The pectoralis minor length test was found to have excellent intra-rater reliability for dominant and non-dominant side of the subjects without symptoms, and for the painfree and painful side of the subjects with symptoms. The values calculated for the sensitivity, specificity, positive and negative likelihood ratios suggest this test performed in the manner investigated in this study and recommended in the literature, lacks diagnostic accuracy.
Conclusion
The findings of this study suggest that although the pectoralis minor length test demonstrates acceptable clinical reliability, its lack of specificity suggests that clinicians using this test to inform the clinical reasoning process with regard treatment planning must do so with caution.
Trial registration
National Research Register: N0060148286
doi:10.1186/1471-2474-8-64
PMCID: PMC1934353  PMID: 17620136
12.  A mixed methods study to investigate needs assessment for knee pain and disability: population and individual perspectives 
Background
The new Musculoskeletal Services Framework outlines the importance of health care needs assessment. Our aim was to provide a model for this for knee pain and disability, describing felt need (individual assessment of a need for health care) and expressed need (demand for health care). This intelligence is required by health care planners in order to implement the new Framework.
Methods
A multi-method approach was used. A population survey (n = 5784) was administered to adults aged 50+ registered with 3 general practices. The questionnaire contained a Knee Pain Screening Tool to identify the prevalence of knee pain and health care use in the population, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Survey responders who scored "severe" or "extreme" on at least one item on the pain or physical function scale on the WOMAC were categorised into "severe" groups. Qualitative interviews were undertaken with 22 survey responders to explore in detail the experience of living with knee pain and disability. A sample of interviewees (n = 10) completed an open format patient diary to explore the experience of knee pain in everyday life.
Results
The 12-month period prevalence of knee pain was 49.5%, of which half was severe. Severe difficulties were reported with domestic duties, bending, bathing, climbing stairs and getting in or out of a car. Some self-care is occurring. The majority (53%) of responders with severe pain or disability had not consulted their GP in the last 12 months. The qualitative study revealed reasons for this including a perception that knee pain is part of normal ageing, little effective prevention and treatment is available and the use of medications causes side effects and dependency.
Conclusion
This study adds to previous work by highlighting a gap between felt and expressed need and the reasons for this mismatch. There is evidence of self-management, but also missed opportunities for effective interventions (e.g. lifestyle advice). A targeted and integrated approach between clinicians and health care planners for primary and secondary prevention is required if aspects of the new Musculoskeletal Services Framework are to be successfully implemented.
doi:10.1186/1471-2474-8-59
PMCID: PMC1925074  PMID: 17610732
13.  Lumbar position sense and the risk of low back injuries in college athletes: a prospective cohort study 
Background
Impaired proprioception in the lumbar spine has often been reported in people with low back pain. However, no prospective studies exist to assert the cause and effect of this association. We hypothesized that athletes with a history of low back injury (LBI) would demonstrate poorer lumbar position sense (PS) than athletes without a history of LBI, and that this deficit would be a risk factor for future LBI.
Methods
This was a prospective cohort study with 2–3 year follow-up. Lumbar spine PS in the transverse plane was evaluated in 292 athletes using three tests: 1) passive and 2) active trunk repositioning, and 3) motion perception threshold. Mean absolute (accuracy) and variable (precision) errors were computed.
Results
There were no significant differences in the repositioning errors or motion perception threshold between athletes with and without a history of LBI or between those who did and did not get injured during the follow-up. Active trunk repositioning resulted in smaller errors than passive repositioning (1.6°± 0.8°) versus 2.1°± 1.0°) and 1.7°± 0.8°) versus 2.3°± 1.1°) for the absolute and relative errors, respectively).
Conclusion
Poor trunk PS in transverse plane is not associated with LBI in athletes, nor does it appear that poor trunk PS predisposes athletes to LBI.
doi:10.1186/1471-2474-8-129
PMCID: PMC2259335  PMID: 18166132
14.  Expression of genes for bone morphogenetic proteins BMP-2, BMP-4 and BMP-6 in various parts of the human skeleton 
Background
Differences in duration of bone healing in various parts of the human skeleton are common experience for orthopaedic surgeons. The reason for these differences is not obvious and not clear.
Methods
In this paper we decided to measure by the use of real-time RT-PCR technique the level of expression of genes for some isoforms of bone morphogenetic proteins (BMPs), whose role is proven in bone formation, bone induction and bone turnover. Seven bone samples recovered from various parts of skeletons from six cadavers of young healthy men who died in traffic accidents were collected. Activity of genes for BMP-2, -4 and -6 was measured by the use of fluorescent SYBR Green I.
Results
It was found that expression of m-RNA for BMP-2 and BMP-4 is higher in trabecular bone in epiphyses of long bones, cranial flat bones and corpus mandibulae then in the compact bone of diaphyses of long bones. In all samples examined the expression of m-RNA for BMP-4 was higher than for BMP-2.
Conclusion
It was shown that m-RNA for BMP-6 is not expressed in the collected samples at all. It is postulated that differences in the level of activation of genes for BMPs is one of the important factors which determine the differences in duration of bone healing of various parts of the human skeleton.
doi:10.1186/1471-2474-8-128
PMCID: PMC2244626  PMID: 18162128
15.  INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty 
Background
The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure.
Methods/Designs
Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture.
We will randomly assign participants to receive either vertebroplasty or the control intervention.
Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month.
Discussion
Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty.
Trial Registration
Current Controlled Trials ISRCTN81871888
doi:10.1186/1471-2474-8-126
PMCID: PMC2257946  PMID: 18096050
16.  Outcome and quality of life after surgically treated ankle fractures in patients 65 years or older 
Background
Despite high incidence of ankle fractures in the elderly, studies evaluating outcome and impact of quality of life in this age group specifically are sparse. The aim of this study was to evaluate outcome and quality of life 6 and 12 months after injury in patients 65 years or older who had been operated on due to an ankle fracture.
Methods
Sixty patients 65 years or older were invited to participate in the study. 6 and 12 months after the injury a questionnaire including inquiry to participate, the Olerud-Molander Ankle Score (OMAS), Short-Form 36 (SF-36), Linear Analogue Scale (LAS), Self-rated Ankle Function and some supplementary questions was sent home to the patients. The supplementary questions concerned subjective experience of ankle instability, sporting and physical activity level before injury and recaptured activity level at follow-ups, need of walking aid before injury, state of living before injury and at follow-ups and co-morbidities. After the 12-month follow-up the patients were also called for a radiological examination.
Results
Fifty patients (83%) answered the questionnaire at 6-month and 46 (77%) at the 12-month follow-up. Although, 45 (90%) fractures were low-energy trauma 44 (88%) were bi- or trimalleolar and post-operative reduction results were complete in 23 (46%) ankles. The median OMAS improved from 60 (Interquartile range (IQR) 36) at 6-month to 70 (IQR 35) at 12-month (p = 0.002), but at 12-month still sixty percent or more of the patients reported pain, swelling, problems when stair-climbing and reduced activities of daily life. Twenty (40%) rated their ankle function as 'good' or 'very good' at 6-month and 30 (60%) at 12-month. Forty-one (82%) were physically active before injury but still one year after only 18/41 had returned to their pre-injury physical activity level. According to SF-36 four dimensions differed from the age- and gender matched normative data of the Swedish population, 'physical function', 'role physical' and 'role emotional' were below norms at 6-month for women (p = 0.010, p = 0.024 and 0.031) and 'general health' was above norms at 12-month for men (p = 0.044).
Conclusion
One year after surgically treated ankle fractures a majority of patients continue to have symptoms and reported functional limitations. However, SF-36 scores indicate that only females had functional status below the age- and gender matched normative data of the Swedish population.
doi:10.1186/1471-2474-8-127
PMCID: PMC2259334  PMID: 18096062
17.  Oxidative stress as a risk factor for osteoporosis in elderly Mexicans as characterized by antioxidant enzymes 
Background
Oxidative stress (OxS) has recently been linked with osteoporosis; however, we do not know the influence of OxS as an independent risk factor for this disease.
Methods
We conducted a case-control study in 94 subjects ≥60 years of age, 50 healthy and 44 with osteoporosis. We measured total antioxidant status, plasma lipid peroxides, antioxidant activity of superoxide dismutase and glutathione peroxidase (GPx), and calculated the SOD/GPx ratio. Bone mineral density was obtained at the peripheral DXA in calcaneus using a portable Norland Apollo Densitometer®. Osteoporosis was considered when subjects had a BMD of 2.5 standard deviations or more below the mean value for young adults.
Results
GPx antioxidant activity was significantly lower in the group of subjects with osteoporosis in comparison with the group of healthy subjects (p < 0.01); in addition, the SOD/GPx ratio was significantly higher in the group of individuals with osteoporosis (p < 0.05). In logistic regression analysis, we found OxS to be an independent risk factor for osteoporosis (odds ratio [OR] = 2.79; 95% confidence interval [95% CI] = 1.08–7.23; p = 0.034).
Conclusion
Our findings suggest that OxS is an independent risk factor for osteoporosis linked to increase of SOD/GPx ratio.
doi:10.1186/1471-2474-8-124
PMCID: PMC2225394  PMID: 18088440
18.  The PRICE study (Protection Rest Ice Compression Elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946] 
Background
Cryotherapy (the application of ice for therapeutic purposes) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain.
Methods/Design
The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression) or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise). After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS). Additional outcomes will include pain (10 cm Visual Analogue Scale), swelling (modified figure-of-eight method) and activity levels (activPAL™ physical activity monitor, PAL Technologies, Glasgow, UK). Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA) will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will be analysed using repeated measures analysis of co-variance (ANCOVA).
Discussion
This paper describes the rationale and design of a randomised controlled trial which will examine the effectiveness of two different cryotherapy protocols in the early management of acute ankle sprain.
Trial Registration
ISRCTN13903946
doi:10.1186/1471-2474-8-125
PMCID: PMC2228299  PMID: 18093299
19.  The Roman Bridge: a "double pulley – suture bridges" technique for rotator cuff repair 
Background
With advances in arthroscopic surgery, many techniques have been developed to increase the tendon-bone contact area, reconstituting a more anatomic configuration of the rotator cuff footprint and providing a better environment for tendon healing.
Methods
We present an arthroscopic rotator cuff repair technique which uses suture bridges to optimize rotator cuff tendon-footprint contact area and mean pressure.
Results
Two medial row 5.5-mm Bio-Corkscrew suture anchors (Arthrex, Naples, FL), which are double-loaded with No. 2 FiberWire sutures (Arthrex, Naples, FL), are placed in the medial aspect of the footprint. Two suture limbs from a single suture are both passed through a single point in the rotator cuff. This is performed for both anchors. The medial row sutures are tied using the double pulley technique. A suture limb is retrieved from each of the medial anchors through the lateral portal, and manually tied as a six-throw surgeon's knot over a metal rod. The two free suture limbs are pulled to transport the knot over the top of the tendon bridge. Then the two free suture limbs that were used to pull the knot down are tied. The end of the sutures are cut. The same double pulley technique is repeated for the other two suture limbs from the two medial anchors, but the two free suture limbs are used to produce suture bridges over the tendon, by means of a Pushlock (Arthrex, Naples, FL), placed 1 cm distal to the lateral edge of the footprint.
Conclusion
This technique maximizes the advantages of two techniques. On the one hand, the double pulley technique provides an extremely secure fixation in the medial aspect of the footprint. On the other hand, the suture bridges allow to improve pressurized contact area and mean footprint pressure. In this way, the bony footprint in not compromised by the distal-lateral fixation, and it is thus possible to share the load between fixation points. This maximizes the strength of the repair and provides a barrier preventing penetration of synovial fluid into the healing area of tendon and bone.
doi:10.1186/1471-2474-8-123
PMCID: PMC2235854  PMID: 18088422
20.  Removal of nucleus pulposus from the intervertebral disc – the use of chymopapain enhances mechanical removal with rongeurs: a laboratory study 
Background
A laboratory study was conducted, on cadaveric sheep spines to develop an effective procedure for removing as much nucleus as possible from an intervertebral disc with minimal disruption to the annulus. The results of many studies involving removal of nucleus, including chemonucleolysis, using chymopapain, have been published but we are not aware of any previous quantitative studies on procedures for removing as much nucleus as possible from the disc.
Methods
All procedures were performed via a 3 mm trocar. Four procedures were compared: (I) unilateral approach using rongeurs alone, (II) bilateral approach using rongeurs alone, (III) unilateral approach using rongeurs followed by chymopapain and (IV) bilateral approach using rongeurs followed by chymopapain.
Results
The percentages of nucleus removed were: (I) 34%, (II) 41%, (III) 52% and (IV) 75%; there were significant differences between the four sets of results according to ANOVA.
Conclusion
Significantly more nucleus is removed using a bilateral than a unilateral approach; significantly more nucleus is removed if chymopapain is used in addition to rongeurs. A brush is useful in removing strands of nucleus loosened by chymopapain.
doi:10.1186/1471-2474-8-122
PMCID: PMC2231359  PMID: 18078511
21.  The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial 
Background
Lower limb strengthening exercises are an important component of the treatment for knee osteoarthritis (OA). Strengthening the hip abductor and adductor muscles may influence joint loading and/or OA-related symptoms, but no study has evaluated these hypotheses directly. The aim of this randomised, single-blind controlled trial is to determine whether hip abductor and adductor muscle strengthening can reduce knee load and improve pain and physical function in people with medial compartment knee OA.
Methods/Design
88 participants with painful, radiographically confirmed medial compartment knee OA and varus alignment will be recruited from the community and randomly allocated to a hip strengthening or control group using concealed allocation stratified by disease severity. The hip strengthening group will perform 6 exercises to strengthen the hip abductor and adductor muscles at home 5 times per week for 12 weeks. They will consult with a physiotherapist on 7 occasions to be taught the exercises and progress exercise resistance. The control group will be requested to continue with their usual care. Blinded follow up assessment will be conducted at 12 weeks after randomisation. The primary outcome measure is the change in the peak external knee adduction moment measured during walking. Questionnaires will assess changes in pain and physical function as well as overall perceived rating of change. An intention-to-treat analysis will be performed using linear regression modelling and adjusting for baseline outcome values and other demographic characteristics.
Discussion
Results from this trial will contribute to the evidence regarding the effect of hip strengthening on knee loads and symptoms in people with medial compartment knee OA. If shown to reduce the knee adduction moment, hip strengthening has the potential to slow disease progression.
Trial Registration
Australia New Zealand Clinical Trials Registry ACTR12607000001493
doi:10.1186/1471-2474-8-121
PMCID: PMC2235855  PMID: 18067658
22.  Chondrocyte outgrowth into a gelatin scaffold in a single impact load model of damage/repair – effect of BMP-2 
Background
Articular cartilage has little capacity for repair in vivo, however, a small number of studies have shown that, in vitro, a damage/repair response can be induced. Recent work by our group has shown that cartilage can respond to single impact load and culture by producing repair cells on the articular surface. The purpose of this study was to identify whether chondrocyte outgrowth into a 3D scaffold could be observed following single impact load and culture. The effect of bone morphogenic-2 (BMP-2) on this process was investigated.
Methods
Cartilage explants were single impact loaded, placed within a scaffold and cultured for up to 20 days +/- BMP-2. Cell numbers in the scaffold, on and extruding from the articular surface were quantified and the immunohistochemistry used to identify the cellular phenotype.
Results
Following single impact load and culture, chondrocytes were observed in a 3D gelatin scaffold under all culture conditions. Chondrocytes were also observed on the articular surface of the cartilage and extruding out of the parent cartilage and on to the cartilage surface. BMP-2 was demonstrated to quantitatively inhibit these events.
Conclusion
These studies demonstrate that articular chondrocytes can be stimulated to migrate out of parent cartilage following single impact load and culture. The addition of BMP-2 to the culture medium quantitatively reduced the repair response. It may be that the inhibitory effect of BMP-2 in this experimental model provides a clue to the apparent inability of articular cartilage to heal itself following damage in vivo.
doi:10.1186/1471-2474-8-120
PMCID: PMC2244625  PMID: 18053249
23.  Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study 
Background
There is evidence of functional growth hormone (GH) deficiency, expressed by means of low insulin-like growth factor 1 (IGF-1) serum levels, in a subset of fibromyalgia patients. The efficacy of GH versus placebo has been previously suggested in this population. We investigated the efficacy and safety of low dose GH as an adjunct to standard therapy in the treatment of severe, prolonged and well-treated fibromyalgia patients with low IGF-1 levels.
Methods
Twenty-four patients were enrolled in a randomized, open-label, best available care-controlled study. Patients were randomly assigned to receive either 0.0125 mg/kg/d of GH subcutaneously (titrated depending on IGF-1) added to standard therapy or standard therapy alone during one year. The number of tender points, the Fibromyalgia Impact Questionnaire (FIQ) and the EuroQol 5D (EQ-5D), including a Quality of Life visual analogic scale (EQ-VAS) were assessed at different time-points.
Results
At the end of the study, the GH group showed a 60% reduction in the mean number of tender points (pairs) compared to the control group (p < 0.05; 3.25 ± 0.8 vs. 8.25 ± 0.9). Similar improvements were observed in FIQ score (p < 0.05) and EQ-VAS scale (p < 0.001). There was a prompt response to GH administration, with most patients showing improvement within the first months in most of the outcomes. The concomitant administration of GH and standard therapy was well tolerated, and no patients discontinued the study due to adverse events.
Conclusion
The present findings indicate the advantage of adding a daily GH dose to the standard therapy in a subset of severe fibromyalgia patients with low IGF-1 serum levels.
Trial Registration
NCT00497562 (ClinicalTrials.gov).
doi:10.1186/1471-2474-8-119
PMCID: PMC2212629  PMID: 18053120
24.  The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study 
Background
Traction is commonly used for the treatment of low back pain (LBP), predominately with nerve root involvement; however its benefits remain to be established. The aim of this study was to test the feasibility of a pragmatic randomized controlled trial to compare the difference between two treatment protocols (manual therapy, exercise and advice, with or without traction) in the management of acute/sub acute LBP with 'nerve root' involvement.
Methods
30 LBP patients with nerve root pain were recruited and randomly assigned to one of two treatment groups. Primary outcome measures were the: McGill pain questionnaire, Roland Morris disability questionnaire, and the SF36 Questionnaire; recorded at baseline, discharge, 3 and 6 months post-discharge.
Results
27 patients completed treatment with a loss of another four patients at follow up. Intention to treat analysis demonstrated an improvement in all outcomes at follow up points but there appeared to be little difference between the groups.
Conclusion
This study has shown that a trial recruiting patients with 'nerve root' problems is feasible. Further research based upon a fully powered trial is required to ascertain if the addition of traction has any benefit in the management of these patients.
Trial Registration
Registration number: ISRCTN78417198
doi:10.1186/1471-2474-8-118
PMCID: PMC2217540  PMID: 18047650
25.  Mechanical properties during healing of Achilles tendon ruptures to predict final outcome: A pilot Roentgen stereophotogrammetric analysis in 10 patients 
Background
There are presently few methods described for in vivo monitoring of the mechanics of healing human tendon ruptures, and no methods for prediction of clinical outcome. We tested if Roentgen stereophotogrammetric analysis (RSA) can be used to follow the restoration of mechanical properties during healing of ruptured Achilles tendons, and if early measurements can predict clinical results.
Methods
Achilles tendon repair was studied with RSA in 10 patients with a total rupture. Tantalum beads were implanted in conjunction with surgical repair. The patients were evaluated at 6, 12 and 18 weeks, and after 1 year. RSA was performed with two different mechanical loadings, and the strain induced by increasing load was measured. The transverse area was determined by ultrasound. CT scan at 12 weeks confirmed that the tantalum beads were located within the tendons. Functional testing was done after 1 year. A heel raise index was chosen as primary clinical outcome variable.
Results
The strain was median 0.90, 0.32 and 0.14 percent per 100 N tendon force at 6 weeks, 18 weeks and one year respectively. The error of measurement was 0.04 percent units at 18 weeks. There was a large variation between patients, which appears to reflect biological variation. From 6 to 18 weeks, there was a negative correlation between increase in transverse area and increase in material properties, suggesting that healing is regulated at the organ level, to maximize stiffness. Modulus of elasticity during this time correlated with a heel raise index at one year (Rho = 0.76; p = 0.02).
Conclusion
We conclude that the RSA method might have potential for comparing different treatments of Achilles tendon ruptures.
doi:10.1186/1471-2474-8-116
PMCID: PMC2244624  PMID: 18039357

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