Clinical guidelines generally portray acute low back pain as a benign and self-limiting condition. However, evidence about the clinical course of acute low back pain is contradictory and the risk of subsequently developing chronic low back pain remains uncertain. There are few high quality prognosis studies and none that have measured pain, disability and return to work over a 12 month period. This study aims to provide the first estimates of the one year prognosis of acute low back pain (pain of less than 2 weeks duration) in patients consulting primary care practitioners. A secondary aim is to identify factors that are associated with the prognosis of low back pain.The study is a prospective inception cohort study. Consecutive patients consulting general medical practitioners, physiotherapists and chiropractors in the Sydney metropolitan region will complete a baseline questionnaire regarding their back pain. Subsequently these patients will be followed up by telephone 6 weeks, 3 months and 12 months after the initial consultation. Patients will be considered to have recovered from the episode of back pain if they have no pain and no limitation of activity, and have returned to pre-injury work status. Life tables will be generated to determine the one year prognosis of acute low back pain. Prognostic factors will be assessed using Cox regression.This study will provide the first estimates of the one year prognosis of acute low back pain in a representative sample of primary care patients. It is widely agreed that acute low back pain is common, can be seriously disabling, and imposes an enormous social and economic burden on the community . To imprWhile most of the low back pain guidelines review the evidence prior to making recommendations for therapy, few have adopted an evidence-based approach to making recommendations on prognosis. The guidelines often do not refer to original research but instead have relied upon narrative review papers or previous guidelines. For example the commonly cited statistic on prognosis in the 2000 UK Guideline  "90% recAlthough most current guidelines suggest a favourable prognosis, recent systematic reviews suggest that while patients with an acute episode of low back pain may improve rapidly, the risk of developing chronic low back pain (i.e. pain persisting longer than 3 months) is uncertain ,6. StudiThe notion that acute low back pain has a favourable prognosis, a view common to all guidelines, should be reconsidered because of the inconsistency in the outcomes reported and the lack of long-term follow-up data. Acute low back pain may not be a benign, self-limiting condition. Our paper reports the design of a study which will determine the medium-term (1 year) prognosis for people with acute low back pain presenting to community primary care providers . The outcomes of interest will be time to recovery, which is defined by measures of pain, disability and work status. A secondary aim is to develop a prognostic model of acute low back pain.The study will be an inception cohort study. It is part of a larger cohort study which will also assess the accuracy of the diagnostic triage for detecting serious spinal pathology in patients presenting with acute low back pain. Only the prognosis component of the study is described here.The target population is patients with acute low back pain who consult practitioners from three major primary care professions, namely chiropractors, physiotherapists and general medical practitioners. Consecutive patients will be invited to complete a baseline assessment and have a series of three follow-up assessments performed via telephone calls over a 12-month period.A cohort of 1,000 subjects with acute low back pain will be recruited from the Sydney metropolitan region. Data from the 2001 Australian Census will be used to characterize the socioeconomic levels of postcode (zipcode) areas within the Sydney Metropolitan region. A number of postcode areas will be recruited to the study in order to achieve a range of socio-economic levels.All practitioners within the study area will be invited to participate in the study. Practitioner names and clinic addresses will be extracted from telephone directories, professional registry listings and through professional associations of the three practitioner groups. Every practitioner identified within the study area will be sent a letter of invitation and a reply paid postcard, enabling them to indicate whether they intend to participate in the study, or whether they require further information. Three weeks after the letters are mailed out, all practitioners who have not replied via postcard will be contacted by telephone and invited to participate in the study. Practitioners will be excluded if they are not current primary care providers, e.g. specialists or retired practitioners, are not practising within the study area, or the practitioner details are not sufficient to contact them regarding the study. A record will be kept of practitioners who choose not to participate and where given, the reasons for their decisions.Participating practitioners will be trained in either small groups or individual sessions. Training involves an explanation of the purpose and methods of the study and instruction on how to perform a standardized diagnostic triage. The practitioners will be asked to identify all eligible patients presenting at their clinics, assist patients to complete the baseline questionnaire, record the results of 25 clinical assessment "red flags", and record their diagnoses based on the AHCPR clinical practice guidelines . PractitParticipating practitioners will be asked to screen all patients with the primary complaint of low back pain who present to their clinics. To be eligible for inclusion, patients must consult one of the practitioners for management of an episode of acute low back pain. We have used the definition for an episode of acute low back pain proposed by de Vet and colleagues . This isA record will be kept of patients who choose not to participate and their reasons for doing so, as well as patients with back pain who are ineligible to participate, and the reasons for exclusion. Recruitment will continue at all sites from the date of training until the target sample of 1,000 participants is achieved. With this sample size, the 95% confidence interval for an observed proportion of 5% extends from 3.8% to 6.5%, and the 95% confidence interval for an observed proportion of 50% extends from 46.9% to 53.1%. Practitioners will be contacted every two weeks to ensure that they are adhering to the study protocol. Also, practitioners will be reminded to recruit all eligible patients so that the cohort consists as far as possible of a consecutive sample.Baseline data will be used to comprehensively describe the inception cohort and test putative predictors of prognosis. The specific classes of predictors being measured are socio-demographic characteristics, general health, previous history, and psychological characteristics .As there is no universally accepted single measure of recovery from low back pain, we will sample three dimensions of recovery: pain intensity, disability due to pain, and work status. The first two questions are adaptations of items 7 and 8 of the SF-36 : "How muCompleted assessment booklets will be collected every two weeks from study practitioners by a research assistant. When the booklets have been retrieved, the data concerning the participant contact details, assessment date and baseline data will be entered into a database. Any missing or conflicting data from the assessment booklet will be checked immediately, with every attempt made to contact the participant as soon after collection of the booklet as possible. Follow-up assessments will be conducted 6 weeks, 3 months and 12 months after the initial assessment.At each follow-up time point, participants will be asked whether they have become pain-free, have no disability due to back pain, and returned to their pre-injury work status. Only when participants report achieving one of these points and remained there for a whole month, are they considered "recovered" in this dimension at the beginning of that month . ParticiFor participants, there will be a A$10 (incl. GST) compensation for time and inconvenience for each of the telephone follow-ups with an additional A$10 (incl. GST) payment if all telephone follow-ups are completed, to be paid following the 12 month follow-up. Practitioners will also be compensated A$50 (incl. GST) for each eligible patient enrolled, and A$10 (incl. GST) for each patient who is screened but ineligible.Several mechanisms will be used to ensure study data are of high quality. First, participating practitioners will be trained in the trial protocol and the Agency for Health Care Policy and Research (AHCPR) clinical assessment  in a staData will be collected on when people return to pre-injury work status and/or had no disability and/or had no pain, to enable construction of life tables. The life tables will be used to describe the prognosis of patients with non-specific low back pain presenting to primary care practitioners. Median survival times (days to recovery) will be determined for each of the three recovery measures.Cox regression will be used to evaluate putative prognostic factors. The independent variables for the regression will be chosen from among those collected at baseline . A correlation matrix will be inspected to determine relationships between candidate variables and outcome. Variables with strong correlations (p < 0.10) will be identified and entered into the regression model.Linear regression will be used to predict continuous outcomes such as days off work. If necessary, dependent variables will be transformed so that they satisfy assumptions of normality of residuals and heteroscedasticity. If there is evidence of non-linear effects, quadratic or higher order terms will be added to the regression model.Patients with acute low back pain of less than 2 weeks duration will be recruited from the three primary care professions who most frequently manage low back pain in Australia. This will provide a representative cohort of patients to allow better provision of prognostic information to primary care providers. The choice of outcome measures reflects a standardised definition for an episode of low back pain  proposedThis study has been designed to include key methodological features that have been recognised as minimising bias in prognostic studies. These features include sampling of a representative inception cohort with a high rate of follow-up . The proThe author(s) declare that they have no competing interests.All authors participated in the design of the study. NH drafted the manuscript with input from the other authors. All authors read, revised and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Health service policy in the United Kingdom emphasises the importance of self-care by patients with chronic conditions. Written information for patients about their condition is seen as an important aid to help patients look after themselves. From a discourse analysis perspective written texts such as patient information leaflets do not simply describe the reality of a medical condition and its management but by drawing on some sorts of knowledge and evidence rather than others help construct the reality of that condition. This study explored patient information leaflets on osteoarthritis (OA) to see how OA was constructed and to consider the implications for self-care.Systematic and repeated readings of six patient information leaflets on osteoarthritis to look for similarities and differences across leaflets, contradictions within leaflets and the resources called on to make claims about the nature of OA and its management.Biomedical discourse of OA as a joint disease dominated. Only one leaflet included an illness discourse albeit limited, and was also the only one to feature patient experiences of living with OA. The leaflets had different views on the causes of OA including the role of lifestyle and ageing. Most emphasised patient responsibility for preventing the progression of OA. Advice about changing behaviour such as diet and exercise was not grounded in lived experience. There were inconsistent messages about using painkillers, exercise and the need to involve professionals when making changes to lifestyle.The nature of the discourse impacted on how OA and the respective roles of patients and professionals were depicted. Limited discourse on illness meant that the complexity of living with OA and its consequences was underestimated. Written information needs to shift from joint biology to helping patients live with osteoarthritis. Written information should incorporate patient experience and value it alongside biomedical knowledge. In current NHS policy, the provision of comprehensive information for patients is viewed as a necessary resource for effective self management of health -3. LeaflThis can be seen in a study by Coulter and colleagues which evaluated written patient information . They foA woman who had been suffering from chronic back pain for some time felt the leaflet judged her negatively and implied (with statements like 'back pain need not cripple you unless you let it') that her inability to do certain things was her own fault.' (Page 71 [(Page 71 )The woman interpreted the information to mean that she had control over whether or not chronic back pain resulted in disability. The particular phrase to which she took exception drew on a biomedical rather than a social model of disability . In a soDixon-Woods (2001) identified two distinct discourses in patient information materials . One In the Expert Patients Programme patients with long term conditions are seen as being knowledgeable about their condition. Skelton contrasts two models of patient education . One is Osteoarthritis is the most prevalent form of arthritis and the most common reason for loss of mobility in those aged 65 and over ,16. Peoparc) and the medical profession  The BMA booklet included arthritic conditions other than osteoarthritis. So in the BMA booklet analysis was restricted to the chapter on osteoarthritis and the generic chapters for arthritis and rheumatism on treatments and living with the conditions. , charitable and voluntary organisations  stated that some people with evidence of thinning of the cartilage are asymptomatic.However four leaflets arc, Patient UK and AC) made a related point about the poor correspondence between the degree of pathology seen on an X-ray and the severity of symptoms. Thus the biological changes to the joint defined the disease but not the experience of symptoms – the illness. (See definition at end of methods section.) There was no discussion about the two different ways of seeing OA – as a disease or an illness. When the leaflets talked about OA it was not always clear whether they were referring to the disease or the illness, or where they were clear a biomedical disease discourse was privileged.A different set of leaflets 'Actual' arthritis is taken to mean what is happening to joint pathology not the symptoms that the patient experiences. The AC leaflet also implied that people with evidence of pathology could have symptoms which were imperceptible.Pain can vary in severity and can be so mild that many people don't even notice it. (AC)Postulating the existence of symptoms, which a patient may not experience, maintained the integrity of the disease discourse i.e. the existence of a relationship between pathology and symptoms. From an illness perspective the assertion makes less sense; if a pain is so mild to be imperceptible is it a pain?arc did address psychological aspects of coping with OA and advised on the need to have a positive outlookTwo leaflets did not move beyond biomedical aspects of OA as a disease (BUPA and NHS Direct). The BMA booklet had a chapter called 'Living with arthritis and rheumatism'. The focus of this though was to educate patients about exercise, joint protection and pain control, not to consider the broader issues of daily life with arthritis. Make every effort to make life fuller and more interesting than before. Your morale will drop after too much rest and inactivity, whereas hobbies and interests take your mind off your problems. (arc)arc described as typical. The case histories were biomedical rather than biographical and suggested that with a positive outlook, common sense and adherence to medical advice the impact of OA on daily life could be minimised. In contrast throughout the AC leaflet there were brief quotes from people actually living with OA.The advice was not set in the context of people's lives and what making life fuller and more interesting might mean. A pen picture accompanying the advice shows an older woman sitting at a table with books, pen and paper. The leaflet had three case histories which were fictional, though the experiences of how the three people managed their OA My knee and spine are more painful when the weather turns bad.If I go out socialising, I accept I might feel a bit off colour the next day. (Quotes from people with OA in AC leaflet)The quotes illuminated the difficulties and trade offs that patients faced in real life. This was the only leaflet to use lay knowledge as a resource. However, the quote above about the effect of the weather on symptoms came soon after a heading entitled 'Myths'. The juxtaposition of myths and patient quote had the effect of suggesting that the patient's perception was a myth. Patients lived experience of arthritis was not well integrated into the text and the result was that lay knowledge was distanced from professional knowledge rather than complementing it.The AC leaflet was also the only one to have a section concerned with caring for oneself as opposed to caring for one's joints, in which the individual nature of both illness and people's emotional response to illness was discussed.From time to time, your arthritis will get on top of you. Anger, frustration, uncertainty, depression and fear are all very understandable and very common. (AC)arc leaflet.Compare this recognition of the individuality of those with arthritis with generic advice in the Although osteoarthritis is often painful and upsetting, it usually does not cause crippling arthritis or severe deformity of joints. For most patients it will be more of a nuisance than a major problem. (arc)arc the patient was viewed as one of a population of people with osteoarthritis; an average patient whose health could be categorised according to the degree of pathology in their joints. The distinction between problem and nuisance was a biomedical interpretation.In arc and AC wrote about causal relationships between risk factors and OA.A range of factors, which included age, genetics, gender, ethnic origin, joint injury, and over use of joints, were variously mentioned as being associated with the likelihood of developing OA. While acknowledging that the causes of OA were not known, NHS Direct, For many people this (obesity) is an important factor in causing osteoarthritis especially at the knee. (arc)Lifestyle advice featured in all six leaflets. Body weight and exercise dominated. All agreed that losing 'excess' weight and regular exercise could help prevent worsening and/or relieve OA by reducing stress on the joints and strengthening the muscles around them. The importance of exercise was particularly emphasised in the BMA and AC leaflets. The BMA adapted political rhetoric to make the point.Exercise, exercise and exercise are probably the three most important factors in keeping the joints healthy! (BMA)arc wrote of physiotherapists advising on correct exercises. Thus exercise was only helpful for OA if it was the 'right sort'. Advice on how much exercise to take resulted in more contradictory messages. While it can be seen from the quote above that the BMA was very keen to promote exercise, they also advised the patient to respect pain and not to push to continue with activities that made pain worse. AC and arc stressed the need to achieve an optimal balance between exercise and rest, though arc said that extra pain caused by exercise would be unlikely to damage a joint. Thus the reader was simultaneously advised to look after their joints by exercise and not to be afraid of moving them, but then to avoid straining them by overdoing things and to respect pain. The state of medical knowledge in relation to exercise and OA appeared uncertain, but there was no reference to this.All apart from BUPA were concerned with promoting exercise to help improve not only joint health but also general health. However, the BMA and the AC leaflet introduced the idea of a right kind and a wrong kind of exercise for OA and arc and Patient UK encouragingly told the reader that even losing a few pounds would help. NHS Direct wrote of the need to 'shed excess weight' which made losing weight sound as straightforward as taking off an overcoat. AC advised 'sticking to your ideal weight' even though a patient quote in their leaflet showed that knowing about ideal weight was one thing and achieving it quite another.Most information was about lifestyle goals rather than advice on the process of their achievement. Nevertheless, the way that the goals were described indicated the authors' perception of the ease or difficulty of the process of attainment. I know it's best not to be overweight with OA, but it's difficult. (Quote from patient with OA in AC leaflet.)The BMA booklet had a chart for readers to calculate their body mass index but the booklet said little about how to reach an ideal BMI.In most of the information on lifestyle individualism was evident, where lifestyle was taken to mean those behaviours which have been identified as risk factors for disease and with an underlying assumption that individuals are able to choose a 'healthy' lifestyle by modifying their behaviour. The BMA saw modern lifestyles as a major reason why the prevalence of musculoskeletal problems had increased.The result of body abuse – lack of exercise, overweight, poor posture and overuse syndromes are the scourges of modern life in affluent societies. Abolishing these scourges would reduce not only locomotor problems but also diabetes, high blood pressure and heart disease. (BMA)Thus in some leaflets patients were held partially responsible for having developed OA. Ageing was handled in a rather different way from lifestyle and it is to this that we now turn.While all leaflets agreed that the occurrence of pathological changes of OA increased with age, except for Patient UK and BUPA they resisted the idea that OA was part of the natural ageing process. AC expressed this strongly.They  no longer see osteoarthritis as being an inevitable part of ageing or a wear and tear disease, but more a challenge to fight. (AC)AC opposed the use of the term wear and tear since it suggested that OA was an inevitable consequence of growing older. However, a statement made a little later from the one above said:It is not known exactly why older people tend to develop it, but it is probably due to bodily changes which come with old age, such as the muscles becoming weaker, putting on weight and the body becoming less able to heal itself. (AC)disease OA is natural and inevitable in later life was too simplistic but soon after, that it was the idea that disability caused by OA is inevitable in later life, which was out of date. Severing the link between OA and normal ageing enabled OA to be viewed as a disease which should be a subject of biomedical research and which was a legitimate concern of doctors, but also one for which patients should take responsibility.In this explanation OA sounded as if it was the result of normal ageing processes and perhaps even wear and tear. The BMA booklet also found it hard to consistently disentangle what is and is not normal in old age. To begin with it said the idea that the Responsibility for preventing the onset and progression of OA was placed to some degree with patients.So to a certain extent the person with osteoarthritis is in control of his or her own outcome. (arc)Most people can lead a full active life with osteoarthritis by properly managing the condition and making small, common sense alterations to life. (AC)While emphasising the importance of self-help there were differences between the leaflets in the extent to which patients should act autonomously. On nine occasions AC advised the patient to see their doctor before taking up exercise, changing their diet or trying alternative medicine. BUPA and NHS Direct did this once.Exercises must be prescribed by your doctor and done under medical or paramedical supervision. Physiotherapists are trained in this work. (NHS Direct)arc takes a more indirect approach pointing out that therapists can offer help and guidance if it is needed but left it to the readers' discretion. Likewise the BMA did not advise seeing the doctor before trying out exercises or changing diet but did consider that seeing a physiotherapist could be useful. While AC was keen that patients see their GP before embarking on specific self-help measures it was the only leaflet to use the word self-management and to promote self-management courses.arc thought that patients would only need occasional advice from doctors and therapists.All leaflets anticipated that patients while helping themselves would have some contact with primary health care professionals in particular their GP. The amount of contact envisaged varied. The AC leaflet said it was important to visit the GP and that the patient and GP must work together to manage the patient's arthritis. While arc least enthusiastic. arc and Patient UK had different advice about the role of painkillers.BUPA placed least emphasis on self-help. Their leaflet was more concerned with the potential of medical intervention. More than a quarter of the leaflet was taken up with medicines and surgery. Surgery was presented as a fairly routine treatment whereas in the other leaflets it was shown as an option of last resort and reserved for the most severe cases. The orientation of the leaflets towards the use of drugs varied. BUPA was most and (Painkillers) do not affect the arthritis itself but take the edge off pain and stiffness. They are best used occasionally for bad spells, or when extra exercise is likely. (arc)It is best to take (paracetamol) regularly to keep pain away, rather than 'now and again' when pain flares up. (Patient UK)arc's advice directly contradicted that in Patient UK. Neither gave the evidence for why analgesics should or should not be used regularly or indicated whether this is an area of choice for patients.arc and BMA spoke reassuringly about the potential of biomedicine.Most leaflets mainly conveyed the idea that for the majority of patients with OA, i.e. those with a less severe pathology who do not warrant surgery, biomedical treatments were limited to consulting health professionals for lifestyle advice and the use of painkillers. Nevertheless Modern medicine has a lot to offer (BMA)arc and BUPA wrote with a degree of scepticism about complementary treatments.Unlike their discourse on orthodox treatments, BMA, There are many complementary and alternative approaches to treating osteoarthritis, although the evidence that they work is usually only anecdotal. (BUPA)A few (complementary medicines) like acupuncture, have a proven short-term pain-relieving effect. But many do no more than produce a 'placebo' effect  (arc)Patient UK and NHS Direct did not include information on complementary therapies. The AC leaflet had conflicting ideas. On the one hand it made the point that complementary therapies could have a positive effect on symptoms and outlook on life but not the underlying condition. On the other hand it said that the Alexander technique can alleviate conditions caused by poor posture and that osteopathy can allow the body to heal itself. AC expressed some concern about the relationship between orthodox and complementary medicine.Complementary therapies can generally be used alongside orthodox treatment, although doctors may vary in their attitudes to them. (AC)The differences in the handling of orthodox and complementary therapies could be quite subtle yet succeed in raising suspicion about the latter. The BMA had boxes with guidelines for using simple analgesics, non-steroidal inflammatory drugs, long term steroids and complementary medicines. While the question of undesirable interactions between conventional and complementary treatments was flagged, such interaction between over the counter and prescribed medicines was not. The complementary medicine taker was also singled out for being told to relate the cost of treatment to effectiveness and recommended to keep a diary to monitor symptoms to assess if the complementary therapy had any effect.arc and NHS Direct they were incorporated into the biomedical discourse on treatment. AC and BUPA placed them in a separate section from medicines and the BMA put them within the treatment chapter but in their own section. Where food supplements were described alongside mainstream treatments they appeared to attract greater scientific certainty.All leaflets mentioned the food supplements glucosamine and chondroitin. In Patient UK, arc, BMA, and NHS Direct placed greater responsibility for preventing OA from starting and progressing with the patient. Patient UK's leaflet largely reported the facts of OA as understood from the results of medical research. Patient UK said that OA could be considered a normal part of ageing but that it was not always progressive. It did not make patient behaviour central to progression and presented a range of suggestions to help with symptoms, many of which did not require access to a doctor. arc portrayed OA as a not serious medical condition which scientific research would cure in time. Arthritis Care's leaflet was the only one to include an illness discourse albeit limited and not fully integrated. It was the only one to refer to self-management but at the same time repeatedly encouraged patients to get medical approval before embarking on any course of action that could be loosely considered a treatment.Although the biomedical model dominated, there were variations as to how OA was seen and understood. In the BUPA leaflet OA was a natural part of the ageing process which biomedicine could successfully treat by means of drugs or surgery. In contrast information from AC, The differences between the leaflets could be confusing if a patient were to try and follow the advice in all of them. However it was what they had in common – the dominance of the disease discourse – that arguably would potentially have more impact on developing people's abilities to self care . In the Advice about how to self-care paid great attention to the biological effects of OA but much less to the social ones. OA is more likely to be found amongst the elderly. How those with OA understand the significance of symptoms is influenced by how they interpret normal ageing . SandersBury (1988) suggests a reorientation of the focus for care from repairing damage caused by disease to education and understanding for living with chronic illness . Researcarc about the success of biomedicine, as well as the close ongoing relationship envisaged by AC between doctor and patient. AC's advice to check with the doctor did not recognise the reality that many patients are reluctant to consult unless they consider they have a legitimate reason to do so [Advice in the six leaflets about changing behaviour such as diet and exercise was not grounded in lived experience. Advice was sometimes simplistic – 'shed weight', or assumed compliance with medical direction, and laid responsibility for change solely with the individual. There was no acknowledgement of psychosocial barriers to making lifestyle changes or indeed getting treatment  and littto do so . CheckinA consequence of the leaflets' focus on disease meant that the nature and meaning of the illness, together with patient experience of chronic symptoms and disability was by and large not addressed or used as a resource. The gap between lay and professional understanding of illness can be a common source of patient dissatisfaction in the consultation . A profeA disease discourse dominated the leaflets. This impacted on how the causality and treatment of OA and the respective roles of patients and professionals were seen and understood. The limited discourse on illness meant that the complexity of living with OA and its consequences was underestimated. If written information is to help support self care then the focus needs to shift from joint biology to helping patients live with osteoarthritis. Written information should provide an illness discourse by incorporating and valuing patients' experience of OA.The author(s) declare that they have no competing interests.JG conceived and carried out the study, and drafted the manuscript. BNO contributed to the analysis and interpretation of data, and critically revised the manuscript. Both authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Tibial osteotomy is a treatment for younger and/or physically active patients suffering from uni-compartmental knee osteoarthritis. The open wedge osteotomy by the hemicallotasis technique includes the use of external fixation. The use of external fixation has several advantages, as early mobilization and the opportunity for optimal correction. However, the hemicallotasis technique has also been described as a cumbersome procedure for the patient. The aim of this study was to prospectively evaluate patient-relevant outcomes during the first 2 post-operative years. Especially the treatment period, during which external fixation was used, was closely monitored.In an uncontrolled study, fifty-eight consecutive patients, 30 men and 28 women (mean age 54 years) were operated on by the hemicallotasis technique were evaluated with the patient-relevant outcome measure Knee injury and Osteoarthritis Outcome Score (KOOS) preoperatively, during the treatment with external fixation, one week after removal of the external fixation, at 6 months, and at one and two years postoperatively.At the 2-year postoperative follow-up, all subscales of the KOOS were improved (p < 0.001), mostly in pain  and knee-related quality of life , compared to the preoperative status. Significant improvements in pain and other symptoms, function of daily life and quality of life were seen already during the treatment period (mean 98 ± 18 days) with the external fixation. More demanding functions such as kneeling, squatting, jumping and running, were improved first after extraction of the external fixation device and the pins.Tibial osteotomy by the hemicallotasis technique yields large improvement in self-rated pain, function and quality of life, which persists over two years. Surprisingly, large improvements occurred already during the immediate post-operative period when the external fixation was still used. Tibial osteotomy is a treatment for younger and/or physically active patients suffering from uni-compartmental knee osteoarthritis (OA) . TraditiThe purpose was, in a prospective study, to evaluate pain, function and quality of life during two years in patients operated on for knee OA with tibial osteotomy by the hemicallotasis technique. Especially the treatment period, during which external fixation was used, was closely monitored.58 consecutive patients (30 men and 28 women), mean age 54 years (36–69) were operated on for knee OA by HCO at the Department of Orthopaedics, Lund University Hospital, Sweden were included in a uncontrolled study. Patient characteristics are given in Table When a patient was recommended HCO, written and verbal information was given by a specially trained nurse in our outpatient clinic for patients treated with external fixation.® Bussolengo, Italy) in the diaphyseal bone. A 5 – 7-cm longitudinal skin incision for the osteotomy was placed ventral to the tibial tuberosity. After a transverse incision of the periosteum, an osteotomy was performed. The periosteum was sutured and the wound was closed. After draping the pin sites and the incision, the fixator (Orthofix® T-garche) was mounted. For valgus deformity, the surgical procedure was the same except that a fibulotomy was performed 10 – 15 cm below the head of the fibula [Four conical pins were inserted, 2 hydroxyapatite (HA)-coated pins in the metaphyseal bone and 2 standard pins  of the knee, the instrument was locked. Eight weeks postoperatively the instrument was dynamised, unlocking the fixation partly to allow micro movement of the osteotomy at weight bearing, in order to stimulate bone healing. About 12 weeks postoperatively, the first healing control by radiography and ultrasound examination was done. If the osteotomy healing was satisfying the patient made a weight bearing test; i.e., walking (with or without crutches) for an extended period of time varying from some hours to some days without the instrument but still with the pins in situ. If no symptoms arouse, the pins were removed at the out patient clinic. If the patient developed symptoms, the fixation was applied again for another 2–4 weeks.Exercise and physical therapy were recommended to the patients when receiving the preoperative information. Immediately after surgery the patients were informed by a physiotherapist. Full weight-bearing and free mobilization was allowed postoperatively. Physiotherapy was prescribed individually and related to the needs for each patient. The patient and physiotherapist decided jointly the length of the rehabilitation period needed.. A difference of 10 points was considered a clinically significant difference [KOOS (Knee injury and Osteoarthritis Outcome Score) ,9 was usfference .Physical activity level was categorized as competitive sports, recreational sports or no sport at all. Regular walks were classified as recreational sports. At baseline, information was obtained regarding physical activity level earlier in life and during the year prior to surgery. According to Buckwalter and Lane , the actComplications such as a loose pin, delayed healing, pseudoarthrosis, septic arthritis, interrupted treatment, deep venous thrombosis and nervous injury were recorded. A loose pin was defined as a pin, which could be removed by hand without use of a wrench. Pin site infection was classified according to the Checketts- Otterburns classification . Grades The patients were defined as non-smokers if they, at the preoperative visit, reported that they never had smoked or stopped smoking since more than 6 month. The radiographic hip-knee-ankle (HKA)-angle was determined after the correction was performed and at the 2-year follow-up. A HKA-angle of <180 degrees was indicated varus alignment of the knee.The KOOS questionnaire was distributed to the 58 patients by mail and returned in a pre-stamped envelope.The patients were asked to answer the Swedish version of KOOS LK 1.0, preoperatively, one week after removal of the external fixator and the pins, 6 months, one year and two years postoperatively. 50 of the patients were also asked to answer the KOOS during the treatment with external fixator at 4, 7 and 10 weeks postoperatively. The evaluation time points during the treatment with external fixator reflected the different phases of the treatment: a) correction, b) after correction, when the instrument was locked and c) the final stage of the treatment.The study was approved by the Ethics Committee at the Medical Faculty, Lund University.The underlying data obtained from questionnaires such as the KOOS are ordinal, which implies the use of non-parametric statistics. However, means and standard deviations are often given instead of medians and inter-quartile ranges for this type of questionnaire data. Postoperative change over time were assessed by Friedman's test, and changes between two postoperative measurements were assessed by Wilcoxon's rang test for each of the five KOOS subscales. The level of significance was set to p 0.05. The influence of 7 potential predictor variables  on improvements at the 2 year follow-up compared to baseline in pain and knee-related QOL was analyzed by means of linear regression analysis. First, the influence of each potential predictor was assessed in simple regression analysis. Those predictors that implied p < 0.20 were considered further in a multivariate regression analysis.52/58 patients (90 %) were evaluated at the 2-year follow-up  patients were working. 10 of the patients  had decreased their time spent working compared to preoperatively . Parallel improvement was seen in function and quality of life as determined by the KOOS (p < 0.001) Table . Since 6The major improvements in pain and ADL function were obtained during the treatment with the external fixator, thereafter further but smaller improvements were seen until the 2-year follow-up as exemplified in Figure At 7 weeks a significant improvement compared to preoperatively was seen with regard to symptoms (p = 0.002), activities of daily living p = 0.003) and knee-related quality of life (p < 0.0001)  at the 6-month follow-up. At the one-year follow-up, improvement was seen in sport and recreation function (p = 0.0001) which assessed more demanding functions such as kneeling, squatting, jumping and running. At the 2-year follow-up improvement were seen in the subscales pain (p = 0.01), symptom (p = 0.02) and ADL (p = 0.02) Table .Worse preoperative pain and complications were predictors of poor improvement in the KOOS subscale pain Table . Age, BMThis study shows large improvements in self-rated pain, function and quality of life at 2 years for patients operated on for knee OA by tibial osteotomy using the hemicallotasis technique. Surprisingly, substantial improvements were seen already during the immediate postoperative period when the external fixation was still used.To our knowledge, this follow-up study is the first evaluating the patients' perspective of the HCO including the treatment period. Clinical scores have been used by Magyar et al in a randomized study comparing close wedge osteotomy and HCO, and by Gerdhem et al when evaluating the HCO ,6. Both Magyar et al  found noMost of the improvements in all subscales of the KOOS, except for sport/recreational function, were obtained during the treatment period, when using the external fixation. The KOOS questionnaire was sensitive enough to detect significant changes over just a few weeks. Four weeks postoperatively, pain related to the correction was common, but the pain gradually diminished. Seven weeks postoperatively, the correction was completed and the external fixator was locked. When visiting the outpatient clinic, the patients told that they felt improvements almost day by day, as confirmed by the improvements in all KOOS subscales except for sports/recreation function. During the later part of the treatment, patients gained more knee stability and gradually decreased the use of crutches, but were still prevented from certain activities due to the external fixator. This clinical improvement was detected by the KOOS, especially the subscale ADL. One week after finishing the treatment with external fixator knee-related QOL was further improved, probably due to the extraction of the fixator and the pins. The similar decrease of number of patients with moderate to extreme pain during walking and at rest reported during the treatment in external fixation, indicate that the treatment by the HCO effected activity-induced pain as well as pain at rest.Most probably the early pain reduction seen is due to the gradually corrected alignment of the leg. Alternative explanations to the early improvements seen include decrease of intraosseous pressure ,16.The gender distribution in our study was almost even reflecting that knee injuries, and thus post-traumatic OA due to knee injuries, are more common in men , whereasPatients having tibial osteotomy in the current study and patients having knee arthroplasty in a previous study report similar preoperative pain and function . This isLong-term results have been shown to depend on the achieved correction of the healed osteotomy -24. 57/5As a predictor for poor improvements in pain over time, worse preoperative pain accounted for 21% of the variance. This is a factor that should be taken into consideration when selecting patients for high tibial osteotomy. This may indicate that operating earlier would give a better result as also discussed for total joint replacement .Ten patients had complications and not unexpectedly, these complications were predictors of poor improvement in pain over time.Our study showed that tibial osteotomy by the hemicallotasis technique yields large improvement in self-rated pain, function, and quality of life, which persists over two years. Surprisingly, most improvements were seen already during the immediate post-operative period when the external fixation was still used. This new knowledge should be incorporated in the information to the patients to help them make treatment choices regarding knee OA and in the pre-operative information of the hemicallotasis technique.The author(s) declare that they have no competing interests.AWD, STL and ER designed the study. AWD collected the data, analyzed the data and drafted the manuscript. STL and ER revised the manuscript. All three authors read and approved of the final manuscript.The pre-publication history for this paper can be accessed here:


A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks.Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out.This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. Whiplash injuries are a major health and economic problem around the world. In the UK, their annual cost to the economy is about £2,553 million (1990 prices), representing about 18% of the total costs of all road traffic collisions and 0.4% of the Gross Domestic Product. Over 90% of departments suggest using analgesics and gradually increasing movement of the neck. Some departments use soft collars as well, suggesting that they should be removed and the neck exercised on a regular basis.MINT is a multi-centre randomised controlled trial to estimate the clinical effectiveness of a stepped care approach to whiplash injuries on clinical outcomes over 12 months, the effectiveness in pre-specified sub-groups of patients , and the costs and cost-effectiveness of each strategy.The trial will use two separate randomisations: the first stage is a cluster randomised trial in which NHS Trusts are randomised to use the Whiplash Book or give their usual advice, for all patients presenting with whiplash injuries. The second stage is individual randomisation to physiotherapy or the control intervention of a single advice session reinforcing the advice given in ED, for patients still experiencing whiplash symptoms at three weeks. The two parts of the trial have a common system of follow-up at four, eight and 12 months.The trial is being run in 12 NHS Acute Trusts in the UK: Heart of England NHS Foundation Trust , North Bristol NHS Trust , Oxford Radcliffe Hospitals NHS Trust , University Hospitals Coventry and Warwickshire NHS Trust , Gloucestershire Hospitals NHS Trust , South Warwickshire General Hospitals NHS Trust , Worcestershire Acute Hospitals NHS Trust , University Hospitals Birmingham NHS Trust , Kettering General Hospital NHS Trust , Buckinghamshire Hospitals NHS Trust , and Gwent Healthcare NHS Trust . Some Trusts comprise several hospitals and have more than one Emergency Department.MINT was approved by the Trent Multicentre Research Ethics Committee and by the Local Research Ethics Committee and the Research and Development Committee of each participating centre.All people who attend ED with a whiplash injury of less than six weeks duration will be included in the trial, except those with any of the following exclusion criteria:1. Age less than 18 years.2. Fractures or dislocations of the spine or other bones.3. Head injuries with more than a transient loss of consciousness or with a Glasgow Coma Score of 12 or less at any stage of their assessment in hospital.4. Admission to in-patient services.5. Severe psychiatric illness.Because the first part of the trial is cluster randomised, individual consent for participation is not sought. This is an accepted procedure for cluster randomised trials where individuals do not have a choice of whether to receive the trial intervention. All eliClinicians in ED are responsible for identifying eligible participants. Details of whiplash patients are recorded on the trial proforma, a short form developed specifically for MINT that replaces the normal methods of clinical data collection in participating centres. It is intended to avoid duplication of recording of information for clinical and research purposes, and hence allows collection of a routine core clinical data set, including injury severity, pain intensity and WAD grade diagnosis. It contains tick boxes to ensure that clinicians have provided potential participants with the trial information sheet and have discussed the study with them, and also records if the patient would prefer not to receive the study questionnaires. The proforma is self-copying; one copy is filed in the medical notes as a treatment record and the second copy is passed to the research team to notify them that a patient has been asked to participate. Completed proformas are collected in a secure place in the ED and forwarded to the MINT research team twice a week.Patients are informed about the possibility that they may be eligible for stage 2 of the study but detailed information about this is not given at this stage, as the majority of patients who participate in stage 1 will not have persistent symptoms at 3 weeks and hence will not be eligible for stage 2. Patients are also asked for their contact details , to assist with sending out and following up questionnaires.The unit of randomisation is the NHS Trust. Participating Trusts were randomised before the start of recruitment by the project statisticians, to usual advice or the Whiplash Book. Trusts were pair matched on size (number of ED attendances per year), star rating, and ethnic composition of the surrounding area. We randomised by Trust rather than by ED to avoid contamination when staff of one Trust worked in more than one ED. Randomisation used a table of random numbers, starting at a random place to ensure that the allocations were not known before randomisation. The allocation depended on whether the next digit was even or odd. One of each pair was randomised to the Whiplash Book, and the other member was allocated to usual advice.Training of ED staff in the trial procedures is given before the start of recruitment, and there is frequent contact between the centres and the trial team to identify and resolve any problems. Eligible patients are given a letter of introduction about the study, signed by their local ED consultant, and the study is discussed with them. If they are willing to participate, they are told that they will receive a questionnaire in a few days time. They are asked to return this and to contact the MINT study team if they continue to have problems after two weeks. The introduction letter does not mention randomisation of hospitals to The Whiplash Book or usual advice, but simply states that the hospital is taking part in a study of advice given to patients with whiplash injuries. ED clinicians provide a copy of either the ED's usual advice leaflet or the Whiplash Book, and verbal guidance on management of whiplash injuries. We have obtained copies of the usual advice leaflets from all of the EDs participating in MINT, so that the content of the advice in the control arm can be documented.All whiplash patients that are eligible for MINT and have not asked to be excluded are sent a copy of the MINT baseline questionnaire within a week of their ED attendance. This includes demographic information and baseline administration of some of the outcome measures. If the questionnaire is not returned within a week, participants are sent a reminder by SMS text message, email or post.Participants in Stage 1 are asked to contact the study office if they continue to have symptoms two weeks after their attendance at ED. An appointment is then made for the patient with a research physiotherapist based at their local hospital. At this appointment, their eligibility for Stage 2 of the trial is assessed. If eligible, trial participation is discussed and the patient is asked to sign a study consent form prior to randomisation. Information about Stage 2 of MINT is sent to patients several days before their research clinic appointment, ensuring that they have sufficient time to consider participation.Participants in Stage 1 of MINT are eligible for the second part of the trial if they:• Report symptoms in the 24 hours before attendance at the physiotherapy research clinic approximately three weeks after attendance at ED• Are WAD grade I-III at this time• Do not have any contra-indications to physiotherapy treatment. These include central cord compression or upper motor neuron lesion, complete nerve root compression or lower motor neuron lesion, suspected vascular injury or haemorrhagic event.Randomisation to physiotherapy or reinforcement of advice is via a central telephone randomisation service, based at the Cancer Research Clinical Trials Unit, University of Birmingham. Randomisation is stratified by centre, to avoid imbalance between centres giving different advice in ED, and members of the same household are assigned to the same intervention, to reduce the chance of contamination. This will be taken into account in the trial analysis. If eligible patients decline participation, their reasons for doing so are recorded.All interventions are delivered by physiotherapists who are independent of the recruitment and randomisation procedures, and have attended a 1.5 day training session by the trial team. The same therapists deliver both the physiotherapy and control interventions, and each treatment session is recorded in a treatment log. A sample of sessions of both interventions is observed for quality control purposes. All treatments should be completed within four months of the patient's first attendance at ED.(a) PhysiotherapyParticipants who are randomised to the physiotherapy package have up to six sessions of therapy, over an eight week period. The components of the intervention are described in a training and reference manual. The choice of physiotherapy treatments has been made using two principles; first, there is evidence that the treatments are effective for chronic neck dysfunction and are likely to be effective for whiplash injuries, based on expert opinion or limited trial evidence, and second, the treatments target established and potentially modifiable risk factors for developing late whiplash syndrome, including reduced cervical range of motion, high pain intensity, and adverse psychological reactions to the injury.Three treatments are included in the physiotherapy package:(1) Mobilisation (gentle manipulation) of the cervical and upper thoracic spine according to Maitland.(2) Exercises for the cervical spine, thoracic spine and shoulder to improve range of movement and muscle control.(3) A cognitive behavioural approach to treatment delivery, which has been effective in physiotherapy for other painful conditions.Manipulation (Maitland Grade IV) of the cervical spine is excluded from this treatment package. Both whiplash injury and cervical manipulation have the potential to cause damage to the vertebral artery that may result in a cerebrovascular event. In common with some, but not all, authorities we consider that recent trauma is a contraindication to cervical manipulation.(b) Reinforcement of adviceParticipants randomised to reinforcement of advice receive a single 40-minute session of advice from a physiotherapist. At this session, the physiotherapist re-states the advice that the patient was given at the time of their ED attendance , discusses any queries that the patient may have, and may check the exercises that the patient was given in ED. The physiotherapist can only give advice regarding progression of exercises or activities specified in the Whiplash Book or usual advice. They cannot prescribe new exercises or use any "hands on" treatment. No review appointments are offered to these patients. They are advised to see their GP if they have ongoing problems.Participants may seek other forms of treatment during the follow up period from their GP or other health professionals. If the trial interventions are effective, this should be evident in a reduction in additional treatments. Such treatments, including changes in the amount or types of analgesia used, use of physical treatments , alternative therapies, or referral to secondary care services will be recorded as a treatment outcome.Follow-up data collection is by postal questionnaire. The outcome measures are detailed in Table Participants are asked at 12 month follow-up whether they have pursued and settled a compensation claim related to their whiplash injury. It is not asked at 4 or 8 month follow-up to avoid stimulation of claims among the trial population.A research assistant who has not been involved in the recruitment or randomisation processes is responsible for mailing follow up questionnaires, and for entering responses onto the study database. Blinding of the study team will be maintained until final analysis of the data has been completed.The analysis will be by intention to treat. All patients will be analysed in the groups to which they were randomised, regardless of the treatment that they actually received. The two main comparisons will be Whiplash Book versus usual advice, and physiotherapy package versus reinforcement of ED advice. The comparison of ED advice interventions will use appropriate methods to take account of the cluster randomisation. EstimatFour pre-specified subgroup analyses will be undertaken:1. severe physical symptoms at trial entry (WAD Grade III versus WAD Grade I or II)2. adverse psychological reactions at trial entry (yes/no)3. pre-existing neck pain versus no pre-existing neck pain4. compensation; claim being pursued versus not being pursuedStatistical tests of interaction will be used to perform subgroup analyses.Economic analysis will use cost-minimisation, or cost-effectiveness and cost-utility analysis, depending on the clinical results. For cost-utility analysis, the EQ-5D will be used to generate utility scores, which will provide an estimate of the incremental cost of any benefit gained in terms of improved health status. Decision modelling will be used to investigate the costs and benefits of the different patient management routes, and uncertainty will be quantified by multi-way sensitivity analyses.For the primary outcome of NDI, there is consensus that a minimal clinically importance difference lies in the range of 3–5 percentage points, with a standard deviation of about 8%. The comThe author(s) declare that they have no competing interests.SEL designed the study, secured funding and contributed to writing the paper.SG contributed to protocol revisions and drafted the paper.MRU contributed to design of the study and securing funding and revised the paper.MWC contributed to design of the study and securing funding and revised the paper.DA was responsible for statistical aspects of study development, contributed to securing funding and revised the paper.AS was responsible for economic aspects of study development, contributed to securing funding and revised the paper.MAW was responsible for the clinical trial co-ordination and design of the intervention.EMW was responsible for assisting with the clinical trial co-ordination and design of the intervention.EJW was responsible for the trial co-ordination, recruitment, data cleaning and management.SM was responsible for statistical analyses of the study and development and maintenance of the study databases.AG was responsible for economic analyses of the study.All authors read and approved the manuscript.The pre-publication history for this paper can be accessed here:


The Bladder cooling reflex (BCR) i.e. uninhibited detrusor contractions evoked by intravesical instillation of cold saline, is a segmental reflex believed to be triggered by menthol sensitive cold receptors in the bladder wall, with the afferent signals transmitted by C fibres. The BCR is a neonatal reflex that becomes suppressed by descending signals from higher centres at approximately the time when the child gains full voluntary control of voiding. It re-emerges in adults with neurogenic detrusor overactivity as a consequence of loss of central descending inhibition, resulting from conditions such as spinal cord injury or multiple sclerosis. We have recently shown an increase of nerve fibres expressing the cool and menthol receptor TRPM8 in both overactive (IDO) and painful bladder syndrome (PBS), but its functional significance is unknown. We have therefore studied the bladder cooling reflex and associated sensory symptoms in patients with PBS and overactivity disorders.The BCR, elicited by ice water test (IWT) was performed in patients with painful bladder syndrome , idiopathic detrusor overactivity , neurogenic detrusor overactivity  and stress urinary incontinence . The IWT was performed by intravesical instillation of cold saline (0 – 4°C). A positive IWT was defined as presence of uninhibited detrusor contraction evoked by cold saline, associated with urgency or with fluid expulsion. Patients were asked to report and rate any pain and cold sensation during the test.A positive IWT was observed in IDO  and NDO  patients, but was negative in all control and PBS patients. Thirteen (76.5%) PBS patients reported pain during the IWT, with significantly higher pain scores during ice water instillation compared to the baseline (P = 0.0002), or equivalent amount of bladder filling (100 mls) with saline at room temperature (P = 0.015). None of the control or overactive (NDO/IDO) patients reported any pain during the IWT.The BCR in DO may reflect loss of central inhibition, which appears necessary to elicit this reflex; the pain elicited in PBS suggests afferent sensitisation, hence sensory symptoms are evoked but not reflex detrusor contractions. The ice water test may be a useful and simple marker for clinical trials in PBS, particularly for novel selective TRPM8 antagonists. The bladder cooling reflex (BCR) is a segmental reflex believed to be triggered by menthol sensitive cold receptors in the bladder wall, mediated by a spinal reflex pathway -3. It isThe BCR evoked by cooling the bladder wall by intravesical instillation of cold saline (Ice Water test), is activated at bladder volumes or pressures below threshold for the ordinary voiding reflex, suggesting that it originates from specific cold receptors rather than mechanoreceptors . This hyPrevious studies have demonstrated the BCR to be most consistently present in neurogenic detrusor overactivity (NDO) . It has The urinary bladder C fibres are considered to be normally inactive, and termed "silent" C-fibres . Their sThe significance of the increase of nerve fibres expressing the cool and menthol receptor TRPM8 in both overactive bladders and PBS is uncertain, with respect to the BCR and sensory dysfunction – in the absence of a superimposed bladder infection NDO is usually a painless condition, while pain predominates in PBS. We were not aware of any previous studies of the BCR in PBS. We therefore studied the BCR in patients with overactive and painful bladder syndromes, and compared the results with controls. We also recorded the symptoms associated with intravesical ice water instillation in these patients.The BCR, elicited by the ice water test (IWT) was performed in 64 women (age range 28–65 years). The patients had painful bladder syndrome , who met the NIDDK research criteria for interstitial cystitis , or idioIn the PBS group, Pain score was also recorded on a Visual Analogue Scale (VAS) for worst, least and average pain during the last 24 hours before the study  on a scaThe study was approved by the local research ethical committee . Informed written consent was obtained from all patients before study. Normal urinalysis was established prior to the urodynamic study. All the patients underwent routine urodynamics with intravesical instillation of normal saline at room temperature up to capacity at the rate of 50 ml/min.The IWT was performed at the end of routine urodynamics after emptying the bladder, by intravesical instillation of cold saline (0° to 4°C) up to a maximum of 100 ml at a rate of 50 ml/min. The ice water was retained in the bladder for 1 min. A positive IWT was defined as presence of uninhibited detrusor contraction evoked by cold saline, associated with urgency or with fluid expulsion . A P value of less than 0.05 was considered to be statistically significant. The Stata version 8 program was used for statistical analyses.2O. None of the control or PBS patients demonstrated a positive IWT  of the patients reported cold sensation in the suprapubic region . Although, this incidence was higher in the PBS group  compared to the controls , the difference in the risk was 0.17 and missed statistical significance (P = 0.08). No significant association was observed of this cold sensation with a positive IWT or pain.Pain associated with bladder filling to capacity during urodynamics was reported by 16 of the 17 PBS patients (94.1%). This pain was described as sharp, generally in the suprapubic region. Six of the patients also reported pain in the perineum, and pain was referred to the back/sacral area in one patient. The Pain score at maximum cystometric capacity (MCC) was significantly higher compared to the baseline scores , Mean ± SEM, 4.94 ± 0.53, VAS (Baseline), 0.64 ± 0.21, P = 0.0005)  patients reported pain during the IWT. The pain was similar in character (sharp) and distribution to the pain seen at maximum cystometric capacity. Pain Scores were significantly higher during IWT compared to baseline scores , Mean ± SEM, 4.71 ± 0.69, VAS (Baseline), 0.64 ± 0.21, P = 0.0002)  patients reported pain during IWT or during routine urodynamics.This is the first study to evaluate the outcome of ice water test in patients with painful bladder syndrome, in comparison with overactive bladder disorders and controls. None of our controls or PBS patients had a positive IWT, indicating the inhibitory signals from higher centres being preserved, result in a negative IWT Fig , 4b. AllOpinion varies with respect to thermal perception from the bladder mucosa. Some investigators  have conThe most interesting finding of this study was the report of pain during intravesical instillation of ice water by PBS patients but not by other groups. The BCR is thought to be triggered by TRPM8 receptors in the bladder, with afferent signals relayed by unmyelinated fibres . In a prSignificantly higher pain scores were seen in the PBS patients during the ice water test and at capacity during urodynamics, compared to baseline scores prior to urodynamics. One of the limitations of the study was that the order of urodynamic investigation  was not randomized. However, the hyperalgesia to bladder filling in PBS has been demonstrated in previous studies . AlteredClinical trials in PBS/IC have thus far used visual analogue scales for pain rating, and have lacked well defined tools for evaluation of pathophysiologic mechanisms that produce pain. The ice water-induced bladder pain may prove to be a useful marker for recruitment and assessment of efficacy in PBS clinical trials, particularly for antagonists of TRPM8. This may also apply to other targets expressed by polymodal small nerve fibres, even TRPV1. The test is simple, rapid and minimally-invasive.The pain elicited by ice water instillation in patients with Painful Bladder Syndrome suggests peripheral and/or central sensitisation, evoking pain symptoms without reflex detrusor contractions. The ice water test may be a useful marker for clinical trials in PBS, and to differentiate this condition from overactive bladder disorders.BCR : Bladder cooling reflexBOO : Bladder outlet obstructionIDO : Idiopathic detrusor overactivityIWT : Ice water testNDO : Neurogenic detrusor overactivityPBS : Painful bladder syndromeThe author(s) declare that they have no competing interests.GM was involved in clinical assessment of patients, performed the ice water test, analysis of data and writing the manuscript. JW performed the urodynamics and IWT, analysis of data and helped writing the manuscript. IPC, CB and SKA helped conceive the study, with interpretation of the data, and writing the manuscript. PA conceived the study and participated in its design and coordination, interpretation and completion of the manuscript. All authors read and approved the manuscript.The pre-publication history for this paper can be accessed here:


The PedsQL™ Present Functioning Visual Analogue Scales (PedsQL™ VAS) were designed as an ecological momentary assessment (EMA) instrument to rapidly measure present or at-the-moment functioning in children and adolescents. The PedsQL™ VAS assess child self-report and parent-proxy report of anxiety, sadness, anger, worry, fatigue, and pain utilizing six developmentally appropriate visual analogue scales based on the well-established Varni/Thompson Pediatric Pain Questionnaire (PPQ) Pain Intensity VAS format.The six-item PedsQL™ VAS was administered to 70 pediatric patients ages 5–17 and their parents upon admittance to the hospital environment (Time 1: T1) and again two hours later (Time 2: T2). It was hypothesized that the PedsQL™ VAS Emotional Distress Summary Score  and the fatigue VAS would demonstrate moderate to large effect size correlations with the PPQ Pain Intensity VAS, and that patient" parent concordance would increase over time.Test-retest reliability was demonstrated from T1 to T2 in the large effect size range. Internal consistency reliability was demonstrated for the PedsQL™ VAS Total Symptom Score  and Emotional Distress Summary Score . As hypothesized, the Emotional Distress Summary Score and Fatigue VAS were significantly correlated with the PPQ Pain VAS in the medium to large effect size range, and patient and parent concordance increased from T1 to T2.The results demonstrate preliminary test-retest and internal consistency reliability and construct validity of the PedsQL™ Present Functioning VAS instrument for both pediatric patient self-report and parent proxy-report. Further field testing is required to extend these initial findings to other ecologically relevant pediatric environments. Patient-reported outcomes (PROs) are self-report instruments that directly measure the patient's perceptions of the impact of disease and treatment as clinical trial endpoints, and include multi-item health-related quality of life (HRQOL) instruments, as well as single-item measures , daily diaries, treatment adherence, and healthcare satisfaction ,2. PediaThe PedsQL™ Measurement Model was designed as a modular approach to measuring pediatric PROs, developed to integrate the relative merits of generic and disease-specific approaches . AlthougThe PedsQL™ includes child self-report for ages 5–18 and parent proxy-report for ages 2–18 ,11. The Developments in ecological momentary assessment (EMA) suggest the benefits of measuring symptoms at-the-moment in ecologically relevant environments . The meaAs a continuous measurement scale, the VAS potentially avoids the clustering of symptom reports that may occur with single-item categorical response methods . In bothr = 0.99) [A 10 cm (100 mm) line length has been found to have the smallest measurement error in comparison to line lengths of 5 and 20 cm . In adul = 0.99) . From a  = 0.99) ,19. Pric = 0.99) . Thus, i = 0.99) .The VAS has been shown to be a reliable and valid PRO measure of pediatric patients' pain intensity in children as young as 5 years of age ,31,32. UThe experience of hospitalization entails many of the "precipitants"  of pain and other symptoms posited by the Biobehavioral Model of Pediatric Pain ,35, and One of the major positive changes in the typical pediatric hospitalization experience has been in the routine implementation of a policy of open visitation rights for parents, including overnight stays, which has resulted in parental social support and coping guidance throughout the hospitalization experience, resulting in a significant attenuation of many of the emotional distress symptoms previously documented in the older pediatric hospitalization literature . HoweverBased on the extant pediatric hospitalization stress and coping literature , we thusAs part of a larger architecture doctoral dissertation study on the effects of the hospital environment on pediatric patients, all children that were admitted to the hospital in the 5–17 age group and their parents during the recruitment period were asked to participate. Seventy-five families were approached, and 70 families agreed to participate (93% participation rate). The reasons for declining participation included that the child was too emotionally upset or in pain (secondary to sickle cell anemia crisis) to participate.Seventy children and their parents completed the PedsQL™ Present Functioning Visual Analogue Scales. The children were ages 5–17 , No ethnicity data were collected. The children were hospitalized for treatment of acute  and chronic  conditions as reported by the inpatient nursing staff. However, the larger architecture doctoral dissertation study of which these data are derived from did not have access to individual patient medical records, and thus it was not possible to link patient characteristics regarding medical condition to the VAS data. Pediatric patients and their parents were approached for permission to be part of the study once they had been admitted into their hospital room.Pediatric patients and their parents completed the PedsQL™ VAS upon admittance, after they had consented to be part of the study, and then two hours later, before any medical procedures were performed. Data were collected concurrently at two sites: Scott & White Memorial Hospital in Temple, Texas, and Christus St. Elizabeth's Hospital in Beaumont, Texas. The length of recruitment was 3 weeks for the Scott & White Memorial Hospital and 6 weeks for the Christus St. Elizabeth's Hospital. Institutional Review Board approval was obtained from both of these institutions prior to data collection.The PedsQL™ VAS instrument contains six items that measure anxiety, sadness, anger, worry, fatigue, and pain at the present moment, and where derived from the PedsQL™ Emotional Functioning Scale items  and PedsThe Varni/Thompson Pediatric Pain Questionnaire (PPQ) Pain Intensity VAS measurement properties were initially tested in pediatric rheumatology patients as young as 5 years old and their parents, demonstrating greater perceived pain intensity associated with greater rheumatic disease activity . SubsequTest-retest reliability was evaluated by computing both Pearson Product Moment Correlation coefficients and Intraclass Correlations (ICC) for each item and scale from Time 1 to Time 2. Pearson Product Moment Correlation coefficient effect sizes are designated as small (.10–.29), medium (.30–.49), and large (≥.50) . IntraclConstruct validity for the PedsQL™ VAS was investigated through an analysis of the intercorrelations among the emotional distress and fatigue items with the benchmark PPQ Pain Intensity VAS criterion. Computing the intercorrelations among scales provides initial information on the construct validity of an instrument . Paired The concordance between patient self-report and parent proxy-report was determined through computing both Pearson Product Moment Correlation coefficients and Intraclass Correlations (ICC) at both Time 1 and Time 2. Given no significant differences between sites in terms of VAS scores after a Bonferroni correction for the number of tests conducted, data were pooled across sites. Statistical analyses were conducted with SPSS.Means and standard deviations for pediatric patient self-report and parent proxy-report across the different age groups are presented in Table Test-retest reliability from Time 1 to Time 2 demonstrated mainly moderate to larger effect sizes for patient self-report and parent proxy-report  research with adult patients demonstrates the utility of at-the-moment assessment in disentangling the interrelationships between such diverse constructs as pain, mood, fatigue, coping, and social support through a daily process analysis, the application of these methods and technologies to the pediatric population will requirement measurement instruments that are developmentally appropriate. The PedsQL™ Present Functioning Visual Analogue Scales represent one approach to meeting that need.This study demonstrates preliminary reliability and validity of the PedsQL™ Present Functioning Visual Analogue Scales for both child self-report and parent-proxy report. The PedsQL™ VAS was designed as a pediatric measurement instrument for the ecological momentary assessment of anxiety, sadness, anger, worry, fatigue, and pain in pediatric patients ages 5–18.PedsQL™ Pediatric Quality of Life Inventory™PRO Patient-Reported OutcomesHRQOL Health-Related Quality of LifeVAS Visual Analogue ScaleThe author(s) declare that they have no competing interests.JWV and SAS designed the instrument. SAS and JWV drafted the manuscript. SAS performed the statistical analyses. SJE conceptualized the rationale and design of the original dissertation study from which the data were collected. JWV and TMB consulted on the statistical analyses. TMB participated in manuscript preparation. All authors read and approved the final manuscript.


Temporomandibular disorders (TMDs) are by far the most predominant condition affecting the temporomandibular joint (TMJ), however many patients have mild self-limiting symptoms and should not be referred for specialist care.The aim of this pilot study was to develop a simple, cost-effective management programme for TMDs using CD-ROM. 41 patients (age 18–70) participated in this study, patients were divided into three groups: the 1st group were involved in an attention placebo CD-ROM , the 2nd group received information on CD-ROM designed to increase their control and self efficacy, while the 3rd group received the same programme of the 2nd group added to it an introduction to self-relaxing techniques followed by audio tape of progressive muscle relaxation exercises. Each of the groups was asked to complete a number of questionnaires on the day of initial consultation and six weeks afterwards.The two experimental groups (2nd & 3rd) were equally effective in reducing pain, disability and distress, and both were more effective than the attention placebo group (1st), however the experimental groups appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood.This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here. Temporomandibular disorders comprise the most common non-infective pain condition of the orofacial region . It is bTMDs is clinically characterized by pain in the temporomandibular region or in the muscles of mastication, pain radiating , headaches, earaches or tinnitus, jaw clicking, locking or deviation, limited jaw opening, clenching or grinding of the teeth, dizziness and sensitivity of the teeth without the presence of an oral disease ,3.TMDs signs were also identified in asymptomatic individuals -6; a croDe Kanter et al.  carried The aetiology of TMDs is both of structural and psychological concepts. Structural concepts are classified as conditions related to the temporomandibular joint (TMJ) itself , conditions related to the muscles of mastication  or occlusal factors (i.e. bruxism); recent studies had shown that occlusal factors were not found to be directly involved with TMDs; nevertheless they could contribute with other factors or aggravate an existing condition -11.Psychological theories includes stressful life events ,13, postClinicians may obfuscate the problem by concentrating on examination of the physical component  and disregard the psycho-social and behavioral factors. The introduction of Research Diagnostic Criteria (RDC), by Dworkin and LeResche  at the UThe aim of this pilot study was to develop a simple, cost-effective and evidence-based management programme for TMDs, using CD-ROM. A comparison group received adjunctive relaxation training, known to be effective in the management of this disorder.41 TMDs patients, awaiting for consultation appointment, took part in this pilot study; patients were then divided into three groups from which some received psycho-educational programmes and the other received placebo programmes; these programmes were designed at the Eastman Dental Institute, University College London. The multi-central trial protocol was approved by the joint UCL/UCLH committees of the ethics for human research.Inclusion criteria included English speakers with age of 18–70 years old and should satisfy the research diagnostic criteria (RDC/TMD) . PatientAn information sheet explaining the aim of our study in simple non-scientific terms was given to each of the patients. Each patient was asked to sign a consent form. All patients were invited to complete a number of questionnaires at the time of the initial appointment Table .Information collected from every patient included: age, gender, pain duration (months), frequency of pain (days with pain during preceding month) and jaw opening. Additional information included information on joint sounds, myalgia, arthralgia, the number of healthcare visits over the past 6 months regarding their temporomandibular joint (TMJ) problems and information about their analgesic or prophylactic medications.12 of those patients were subjected to an attention placebo CD-ROM comprising anatomical information on the TMJ and the muscles of mastication group 1), 15 patients received information on CD-ROM designed to empower them (increasing their control and self-efficacy) (group 2); the rest of the patients received group 2 treatment with an additional introduction to self-relaxation techniques, followed by an audiotape of progressive muscle relaxation exercises to be dispatched from a central source (independent of the researcher) (group 3).Patients were also asked to complete a number of questionnaires  six weeks following the educational programme; which would enable us to conduct correlation analysis. Patients were also asked to complete feedback questionnaires {Pain Stages of Change Questionnaire (PSOCQ)}.The voiceover for the CD was edited and manipulated using CoolEdit 95 . Original photographs were captured with digital cameras (Nikon CoolPix 950 and Kodak CD 215). Other photographs were sourced from the Photo-Objects Collection .Images were manipulated and edited in Paintshop Pro version 5  and Adobe Photoshop version 5.5 . The elements were brought together using Macromedia Flash version 4 . The Flash movie settings were 100% image quality and 22 MHz mono sound. Given the technology used, the programme can, with additional editing, be reconfigured to stream across the Internet rather than run from a CD. The resulting CD requires a PC running Windows 95, 98 or 2000 with pointing device, sound card, 64 MB RAM and an 8-speed CD player.The Chi-squared statistic was used to test for differences in clinical examinations as well as questionnaires and checklists between the three groups at the first specialist consultation and at the follow up consultation after 6 weeks. The same test was used also to look for differences between the groups.41 patients participated in this study, 1st group comprised 12 patients, 2nd group 15 patients, and the rest of patients represented group 3; mean age was 37 years old; female overrepresentation reached a mean of 89%.Patients in group 1 represented those with the highest duration of pain that reached an average of 95 months; as well as the frequency of pain (days per month); the same group had an increase in deviation on opening and assisted opening when compared to the other groups Table .Joint sound and arthralgia were found to predominate in the first group; while myalgia was more common in the second group. Patients in this study required health care services four times in six months. 40% of patients in group 2 required analgesic medications; while 17% of group 1 required prophylactic medication Table .Patients in group 1 showed higher scores of OHIP, VAS, VRI, BDI and IPQ (consequence and performance) when compared to group 2, which showed high scores in STAI and IPQ (performance and cure); while group 3 scores were high in the IPQ  Table . Group 1Correlation analysis was conducted for the entire group Table . SignifiDisability also correlated with pain , consequence , diverting attention  and catastrophising (0.432). Pain over the past month  correlated with pain , frequency (0.436), disability (0.459), consequence (0.551) and catastrophising (0.675).Monthly frequency of pain also correlated with belief in the performance  and negative with cyclical nature  of the pain. Health care visits correlated negatively with a belief in care .Feedback questionnaires were considered for the entire group together so that blinding of the investigator to group was not compromised. Feedback about the programme was generally positive , with patients appreciating the decision of cause and treatment options, and the self-management advice, whilst some expressed understandable disappointment at the lack of definitive cure.Patients were asked to rate the programme on Likert-type scales of 1 to 5 for "bad" to "excellent", resulting in means (± SD) of about 4.1 ± 0.9 for overall usefulness; 4.1 ± 0.9 for usefulness of information; and 3.8 ± 1.0 for usefulness of advice. Similar scales were used to rate the programme in relation to a written leaflet (4.2 ± 0.8) and to a personal consultation (3.3 ± 1.1). 78% of the patients considered the length of the programme to be appropriate, and 85% felt they were likely to practice any self-help suggestions from the programme.The literature on the topic of education programmes for chronic pain is sparse, despite their importance in the care of patients with, for example, fibromyalgia . ArthritA pilot study conducted by Tutty et al.  on telepOther studies have established benefits from telephone and mail-delivered self-assessment programmes -27, for Although education programmes are advocated for TMDs, they have not been adequately evaluated. Relaxation training, however, has shown to be equally effective as conventional occlusal splint therapy  and beneTMDs patient improvement after conservative dental treatment was modestly associated with changes in beliefs and coping with and without a brief cognitive-behavior intervention , suggestIn this study, it was hypothesized that the two experimental groups (2nd & 3rd) would be equally effective in reducing, pain disability and distress, and both are more effective than the attention placebo group. Primary outcome improvements were expected to be associated with the modest ameliorations in pain related cognitions, including self-efficacy.The experimental groups (2nd & 3rd) appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood. However, it should be noted that the groups, although randomly selected, did in fact differ at the outset, and these trends must be discounted.The ultimate goal is an interventions specifically aimed at ameliorating cognitions and behavior in TMDs, in order to reduce the associated pain, disability and distress.This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here.The author(s) declare that they have no competing interests.WJ: carried out the literature research, manuscript preparation, and manuscript reviewGM: designed the study, carried out the literature research, clinical study and statistical analysisCF: designed the study, carried out the literature research, clinical study, statistical analysis and manuscript preparationME: carried out the literature research, manuscript preparation, and manuscript reviewMK: carried out the literature research, manuscript preparation, and manuscript reviewCH: carried out the literature research, manuscript preparation, and manuscript reviewTU: carried out the literature research, manuscript preparation, and manuscript reviewSN: designed the study, carried out the literature research, clinical study, statistical analysis and manuscript preparation