A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson's disease: a study protocol for a randomised controlled trial.

BACKGROUND: Parkinson's disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals' needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. METHODS/DESIGN: PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. PRIMARY OUTCOME: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. DISCUSSION: The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382. Registered on 18 April 2016.

Epidemiology of sporting and recreational injuries in a paediatric orthopaedic outpatients department.

Knowledge of the number and type of injuries attending the paediatric orthopaedic outpatients is crucial in the future planning of any new paediatric hospital. We prospectively collected data on all new patients attending two paediatric orthopaedic out-patients departments, over a four month period. There were a total of 1,791 completed questionnaires. Sporting and recreational injuries represented 270% and 28% of the total attending, respectively. The new use of heelies represented 11% of the recreational injuries. The upper limb injuries represented 74% of the total, with the lower limb accounting for 25%. Treatment was nonoperative or operative. The number of patients, and the types of injuries presenting demonstrates the workload involved in diagnosing and treating these injuries. A total of 827 casts were applied. With almost half of those attending the clinic requiring a cast, the workload on the plaster technicians is substantial, and has implications for future service planning.

Heely injuries: a new epidemic warranting a government health warning!

INTRODUCTION: Heelys, the new craze gripping the nation, were first introduced to Ireland in 2005 having been available in the United States since 2000. Designed as "the only shoe with a removable wheel in the sole" and initially marketed among rollerbladers and skateboarders they have been adopted by children as contemporary footwear. MATERIAL AND METHODS: From April to June 2006, all patients presenting to trauma orthopaedic services at our institutions with injuries sustained while wearing Heelys were included in this study. RESULTS: Thirty-nine patients are included in this study. The mean age was 9.1 years (range 7-13, median 9 years). Of the 39 patients referred to the orthopaedic service, 8 required admissions to hospital. One patient admitted following a head injury, required craniotomy and evacuation of an extradural haematoma. CONCLUSION: The significance of the injuries encountered demonstrates the potentially devastating results from the use of Heelys. The public perception of safety is incorrect and manufacturers rightly recommend strongly the use of safety gear.

Adolescent idiopathic scoliosis: metric analysis of the deformity.

In order to explore the concept that scoliosis is fundamentally a loss of left-right symmetry. surface topography was used to measure asymmetry in three dimensions at three levels on the back surface. Statistical analysis of prospectively collected topographic, radiographic and clinical data, in girls with adolescent idiopathic scoliosis, was carried out and comparisons were made with theoretically perfect symmetry (test value of zero). All scoliosis showed statistically significant differences in coronal dimensions, index points on the convex side of the scoliosis being further from the mid-line than those on the concave side. Primary thoracic scoliosis differed from thoracolumbar and lumbar in that they showed directional asymmetry at all levels and in all directions, the side of the scoliosis convexity being broader, taller and thicker. This asymmetry is not due to posture, spinal balance or trunk rotation, as left and right sides are being compared independently of their orientation in space. The asymmetry is of size in three dimensions and size is determined by growth. Growth is a three dimensional process, but does not necessarily occur equally in all three. Differential growth is both directional and regional, particularly during the pubertal growth spurt, when proportions change substantially, and is controlled by many genes, as well as by hormones and signalling molecules. The implication is that scoliotic deformity is the result of asymmetric growth, not confined to the vertebrae, but affecting the entire trunk. This is a developmental, rather than pathological, phenomenon. It makes questions of aetiology redundant and natural history logical.

Handedness and spinal deformity.

Biological lateralisation is clearly manifest in scoliosis, yet its relevance is unclear. Goldberg et al. (Spine. 15(2):61-64. 1990) found an association between curve pattern and hand-preference in a screened population, but no increase in sinistrality. Milenkovic et al, (European Journal of Epidemiology, 19:969-972,2004) concluded left-handedness was a risk factor in a screened group. The database was reassessed to determine whether clinically significant scoliosis was associated with sinistrality or differed from the population norm of 10%. Patients attending the scoliosis clinic were asked their preferred writing hand. 1,636 patients were identified with complete data. Overall, left handedness occurred in 11.5%, greater than the general population (p=0.04) Left hand preference was found to be increased in boys with infantile idiopathic scoliosis and in girls with infantile, juvenile, congenital and syndromic scoliosis, but was reduced in girls with adolescent idiopathic scoliosis. Scoliosis lateralisation was random in infantile and congenital scoliosis, while left curve patterns were decreased in girls with juvenile idiopathic scoliosis and increased in boys with syndromic scoliosis. Curve pattern and handedness correlated in asymmetry in boys and girls and in girls with radiologically confirmed adolescent idiopathic scoliosis, but not in any other type. This study cannot confirm findings of left-handedness as a risk factor for spinal deformity. Its incidence is reduced in girls with adolescent idiopathic scoliosis, and the increased sinistrality in infantile scoliosis is not a new finding (Rauterberg & Tonnis Ger. Z.Orthop. 109(14):676-689. 1971). Lateralisation is undoubtedly a factor in scoliosis, but does not have a simple causal relationship, probably deriving from the underlying scoliotic process, rather than contributing to it.

Surface topography and vectors: a new measure for the three dimensional quantification of scoliotic deformity.

The monitoring of spinal deformity uses many techniques: clinical history and physical examination for patient status, radiography for precise spinal delineation and Cobb angle, topography to quantify cosmesis and to approximate the Cobb angle. Experience with a system based on Raster photography has shown that adequate correlation with the Cobb angle is achieved, but that the relationship between spinal curvature and cosmetic effect is not simple. A measure was developed to quantify the asymmetry of the back, making it available to statistical analysis, without expressing it in terms of the Cobb angle or referring to trunk balance or rotation. The calculation expresses symmetry about the median saggittal plane (first thoracic vertebra to natal cleft), reflecting the right half onto the left and measuring the three-dimensional displacement between corresponding fixed points on the trunk. Tolerance limits were calculated and correlation with Cobb angles using routine scans was analysed. There were statistically significant correlations between the Cobb angle and all vectors except the middle antero-posterior. All vectors correlated with each other, except again for the middle Z or anteroposterior which correlated only with the middle and lowermost sets. Applied to natural history and to surgical outcome, this new parameter provides a different quantification of back shape which can be used both for patient assessment and monitoring, for the evaluation of the cosmetic (as opposed to the radiological) effect of treatment, and for aetiology and natural history studies.

Minor head injuries in children.

Traumatic head injury continues to be a major problem facing the pediatric specialists despite efforts to reduce its incidence. Aims of our study were assessment of the incidence of hospital admissions of children with minor head injuries, their treatment and outcome. In this prospective study we included 101 patient with head injury. We assessed the hospital admission criteria of children with minor head injuries, their length of stay, symptoms and neurological status, in-hospital imaging and consultations to other medical specialities, together with the outcome of patients on their discharge from the hospital. Of 101 patient 54 (53.46%) were male and 47 (46.53%) female. Average age was 3 years with age range from 5/52 to 12 years. Majority of patients (46.53%) were less than 1 year old. Fall was the most common mechanism of injury (92.07% of all patients). Injuries were witnessed in 51 case (50.49%), unwitnessed in 19 cases (18.81%) and unknown in 31 cases (30.69%). 95 patients did not have associated extracranial injuries, while 5 patients had associated lacerations and one had associated extracranial fracture. Length of stay was from 1 day in 80.19% of all cases to more than 2 days in 6.93%. GCS was recorded on admission and discharge and majority of patients were discharged with GCS of 15. 93% of admissions had no neurological deficit. 79% had 1 or more symptoms including vomiting, sleepiness, LOC and headaches. Over half of patients (55%) had no imaging done. 45 patients (45%) had skull x-ray. CT was performed in 7 (15%) patients and 7 fractures were found on x-ray and CT. 3 patients were admitted to ICU. All injuries were closed and all received conservative treatment. In less than 1 year old group of patients 95% of them were also seen by medical team and social worker. The outcome was good for all patients. We conclude that majority of patients with minor head injury could be supervised and observed at home by a competent care giver. Admitted patients need radiological evaluation, preferably a CT scan.

Kyphectomy in children with myelomeningocele: a long-term outcome study.

Twenty-four children with myelomeningocele and a kyphotic deformity treated by surgical correction between 1980 and 1994 were reviewed. Different techniques of instrumentation and spinal fusion were used. The mean age at surgery was 9.5 years. The mean kyphotic angle was 121 degrees preoperatively, 50 degrees postoperatively, and 57 degrees at final follow-up. The postoperative complication rate was high. Delayed wound healing and late skin breakdown with exposure of instrumentation were common problems. Further surgery to remove protruding hardware was necessary in 18 patients. Long posterior instrumentation with fixation to the pelvis had significantly better stability on follow-up than other methods. Despite the prolonged postoperative morbidity in the majority of the study group, the long-term clinical and radiologic outcome at a mean follow-up of 10 years was excellent.

Human nucleus pulposis can respond to a pro-inflammatory stimulus.

STUDY DESIGN: Disc tissue obtained from patients undergoing surgery for scoliosis, lumbar radiculopathy, and discogenic pain was cultured under basal and lipopolysaccharide-stimulated conditions and the medium analyzed for production of a range of pro-inflammatory mediators. OBJECTIVES: This study was conducted to confirm that the human intervertebral disc is capable of responding to a pro-inflammatory stimulus and to identify the principal mediators involved in any response. SUMMARY OF BACKGROUND DATA: Degenerate human disc tissue has been shown to spontaneously secrete a number of pro-inflammatory mediators. The importance of these molecules in the pathophysiology of symptomatic disc degeneration is increasingly recognized. Human nucleus pulposus has been shown to synthesize increased amounts of interleukin (IL)-6, prostaglandin E2 (PGE2), and nitric oxide in response to stimulation with IL-1beta. Murine nucleus pulposus synthesizes increased amounts of IL-1beta, IL-6, IL-10, and granulocyte-macrophage colony-stimulating factor in response to lipopolysaccharide stimulation. Lipopolysaccharide is a potent inducer of tumor necrosis factor-alpha (TNF-alpha), which is thought to play an important role in the pathophysiology of sciatica. To date, human nucleus pulposus has not been shown to secrete TNF-alpha in response to a pro-inflammatory stimulus. METHODS: Human disc tissue obtained from patients undergoing surgery for scoliosis, lumbar radiculopathy, and discogenic pain was cultured under basal and lipopolysaccharide-stimulated conditions and the medium subsequently analyzed for a range of pro-inflammatory mediators. RESULTS: None of the specimens produced any TNF-alpha, IL-1beta, granulocyte-macrophage colony-stimulating factor, or leukotriene B4. Measurable quantities of IL-6, IL-8, PGE2, MCP-1, basic fibroblast growth factor, and trans forming growth factor-beta1 were produced by a number of specimens. Lipopolysaccharide significantly increased IL-6, IL-8, and PGE2 production in both control and degenerate disc tissue. Degenerate disc specimens responded more vigorously to lipopolysaccharide stimulation than scoliotic specimens. CONCLUSIONS: We conclude that both scoliotic and degenerate human nucleus pulposus can respond to an exogenous pro-inflammatory stimulus by secreting increased amounts of IL-6, IL-8, and PGE2 but not TNF-alpha and that degenerate disc tissue is more sensitive to a pro-inflammatory stimulus than its scoliotic counterpart.

Respiratory function and cosmesis at maturity in infantile-onset scoliosis.

STUDY DESIGN: Retrospective review of patient records, clinical and radiographic, and patient recall for full pulmonary function studies and surface topography. OBJECTIVES: Assessment of outcome of treatment policy after age 15 during the previous 30 years to establish the efficacy of management protocols in a group that is too small and too varied for more formal assessment. BACKGROUND DATA: Spinal deformity presenting during infancy or early childhood poses a clinical problem caused by small numbers, long growth period, variable presentation and treatment methods, and, finally, the length of time that must pass before meaningful outcome results can be assessed. The aims of treatment are to preserve respiratory function and cosmetic appearance. MATERIALS AND METHODS: The records of patients with infantile onset, nonsyndromic, and noncongenital scoliosis were reviewed. Thirty two were at least age 15 years at the time of review and 21 of these agreed to attend for full pulmonary function testing (spirometry, lung volumes, gas diffusion) and surface topography, whereas two more had recent spirometry results available in their record. Treatment had been serial casting with Risser jacket, bracing, or surgery. RESULTS: Those whose scoliosis resolved or was stabilized by nonoperative means (N = 6) at an acceptable Cobb angle had normal cosmesis and pulmonary function (mean FEV1 = 98.7%, mean FVC = 96.6%). Those who were managed by casting or bracing and underwent surgery after age 10 (N = 6, mean age at surgery 12.9 y) had variable cosmesis and acceptable pulmonary function (mean FEV1 = 79%, mean FVC = 68.3%). Those whose deformity necessitated early surgery (N = 11, mean age at surgery 4.1 y) had recurrence of deformity and diminished respiratory function (mean FEV1= 41%, range 14%-72%, mean FVC = 40.8%, range 12%-67%). CONCLUSIONS: Although these are small numbers and treatment methods have changed since the beginning of the series, the results indicate that this condition is not simple to treat and for some children still has the risk for serious deformity and respiratory compromise. There is, as yet, no evidence that early surgical intervention in this group of patients with infantile scoliosis has altered their prognosis in any meaningful way.

Usefulness of functional outcome questionnaires in primary screening of spinal disease.

Back pain screening clinics are established to clinically screen patients with back pain for organic lumbar pathology. The aim of this study is to assess the relationship between clinical signs of organic pathology and the level of disability as measured by functional outcome scores. Sixty-nine patients who were found to have clinical signs of organic pathology and 69 age- and sex-matched patients from 512 patients who were found to have no signs of organic pathology in the same time period in the back pain screening clinic were selected. The Oswestry Disability, Short Form-36, and visual analogue (pain) scores between the two groups were statistically analyzed. We found a significant increase in the level of disability in the group with organic pathology; however, the variation in the scores makes them unspecific for use in screening of acute spinal pathology. We also found a strong relationship between psychologic disability and length of symptoms.

Screening of lower back pain, low back pain clinic. The clinical experience.

Acute low back pain is a common complaint with high prevalence in society. Orthopaedic and specialist spinal services may be overwhelmed by large numbers of patients with low back pain who do not require investigation or surgical intervention. This phenomenon has led to the establishment of back pain screening clinics as a system of triage for those with acute low back pain. In March 2001, a back pain screening clinic was established in the Adelaide and Meath Hospitals incorporating the National Children's hospital. Six hundred and sixty-five patients were seen in the first year of this clinic. Of these, only ninety-six required referral to the orthopaedic spinal clinic. Just twenty-nine of these patients required surgical intervention. The introduction of this service resulted in a reduction in the waiting periods for the specialised spine clinic. We conclude that back pain screening clinics result in a clinical and economical improvement in the care of those suffering from acute low back pain. This is achieved by the systematic and efficient assessment, treatment and referral of patients afflicted with acute low back pain.

Intervertebral discs which cause low back pain secrete high levels of proinflammatory mediators.

Herniated intervertebral disc tissue has been shown to produce a number of proinflammatory mediators and cytokines, but there have been no similar studies using discs from patients with discogenic low back pain. We have compared the levels of production of interleukin-6 (IL-6), interleukin-8 (IL-8) and prostaglandin E2 (PGE2) in disc tissue from patients undergoing discectomy for sciatica (63) with that from patients undergoing fusion for discogenic low back pain (20) using an enzyme-linked immunoabsorbent assay. There was a statistically significant difference between levels of production of IL-6 and IL-8 in the sciatica and low back pain groups (p < 0.006 and p < 0.003, respectively). The high levels of proinflammatory mediator found in disc tissue from patients undergoing fusion suggest that production of proinflammatory mediators within the nucleus pulposus may be a major factor in the genesis of a painful lumbar disc.

The relationship between minor asymmetry and early idiopathic scoliosis.

School scoliosis screening programmes have consistently produced large numbers of referrals with minimal trunk asymmetry which then must be assessed, evaluated and perhaps investigated and monitored over a period of time before it is felt safe to discharge them as 'non-progressive.' Beyond measures to reduce their number, they have received less attention than the more interesting cases requiring treatment or surgery, which they outnumber to a significant extent. Examination of the figures from a historical database shows that the patients have no greater probability of developing significant scoliosis than their 'normal' peers . So they should not be classed as scoliosis but they are still relevant to the broader picture of aetiology.

Surface topography and the several components of scoliotic deformity.

Using previously established values for the smallest detectable difference in topographic parameters, the effectiveness of the Quantec system for monitoring progress in scoliosis was investigated. It was found that, while a significant change in Cobb angle was always accompanied by a meaningful change in at least one topographic parameter, the pattern of shape change was highly individual. It is concluded that deformity in scoliosis is not determined exclusively by the spinal curve.

Adolescent idiopathic scoliosis: is the search for aetiology constrained by the orthosis?

While the aetiology of adolescent idiopathic scoliosis is unknown, it is widely believed that the deformity can be controlled by mechanical forces applied by a corset and acting, via skin and soft tissues, to exert pressure on vertebral growth-plates (Hueter-Volkmann Law). The reported efficacy of bracing in reducing the incidence of small degrees of progression reinforces this concept. The supposed mode of action conditioned the model of pathomechanism and precludes other hypotheses. Since the critical Cobb angle changes are usually less than the probable measurement error, another criterion (treatment outcome) is also relevant. At our centre, bracing for adolescent idiopathic scoliosis has not been practised for 9 years. Out of the 153 untreated, unselected patients presenting to the general scoliosis clinic in that time and who were at least 15 years old at the last review, 43 (27.6%) of them have undergone surgery. This does not differ statistically from 22.45% (229 of 1,020) braced patients reported by Lonstein and Winter in 1994. If bracing does not significantly improve prognosis, its efficacy cannot be accepted and the hypothesis of aetiology which it underpins has no greater standing than any other.

Adolescent idiopathic scoliosis: natural history and prognosis.

Retrospective review of the scoliosis database showed adolescent idiopathic scoliosis to be the most common but least significant variety of spinal deformity. Data from 112 girls diagnosed on repeat screening showed the importance of menarche as a date in the natural history. In the whole database, there were 514 aged at least 15 years at last review, 45 boys and 469 girls. Braces were prescribed for a total of 38, mostly during the early part of the period and gradually abandoned without an increase in surgical rate. Progression depended on the age and maturity of the patient as well as the initial Cobb angle. Surgery was recommended for 27% overall. A sub-group with more complete data diagnosed after bracing had been discontinued confirmed the findings.

The natural history of early onset scoliosis.

A retrospective analysis of the natural history and treatment outcome of scoliosis, both idiopathic and syndromic, presenting before age 10 years was undertaken. The pattern was generally one of relentless progression, with little discernible benefit from orthotic treatment and surgical correction as the outcome for the majority. This result makes imperative a properly constructed study on the evolution and long-term outcome of this less common but more significant type of spinal deformity.

Growth patterns in patients with unoperated congenital vertebral anomaly.

Retrospective analysis of height and weight data recorded during routine clinic visits of children with congenital vertebral anomaly were related to decimal age and compared with national centiles. Individuals were dropped from the study at surgery. Growth followed a normal trajectory until puberty, although girls tended to be smaller than average. At puberty, they lagged behind their peers and at maturity were shorter than average. This does not appear to be a hormonal problem, and suggests a fundamental failure of growth.