Objectives: The goal of the present study was to evaluate the results of applying acupuncture or occlusal decompression splints in the treatment of patients diagnosed with the temporomandibular joint pain-dysfunction syndrome.Design of the study: We conducted a randomized clinical trial including 20 patients to whom the mentioned treatments were applied. Results were evaluated through an analogue pain scale, measurements of mouth opening and jaw lateral deviation in millimetres, and assessment of sensitivity to pressure on different points: preauricular, masseter muscle, temporal muscle and trapezius. Parameters were evaluated before and 30 days after the treatment. For standardized pressure, we used a pressure algometer. Results: Patients treated with decompression splints showed reductions in subjective pain and pain upon pressure on temporal, masseter and trapezius muscles, as well as increased mouth opening after the treatment. Patients treated with acupuncture showed pain reduction in the short term and improvements in all of the evaluated para-meters .Conclusion: Acupuncture was an effective complement and/or an acceptable alternative to decompression splints in the treatment of myofascial pain and temporomandibular joint pain-dysfunction syndrome. Key words:Temporomandibular joint, temporomandibular dysfunction, acupuncture, decompression splint, arthralgia, myofascial pain, joint palpation. The term “temporomandibular disorders” was suggested by the American Dental Association as a common label for different clinical conditions involving chronic orofacial pain  . DiffereMyofascial pain, also called myofascial pain-dysfunction syndrome (PDS) is the most frequent subtype of temporomandibular disorder, affecting subjects in every socioeconomic and ethnic level . The aetPain relief is the main goal of such treatments . UsuallyA number of physical techniques have been tried to treat PDS . Some of them have been accepted after exhaustive scientific discussion; others lack evidence enough to support their therapeutic effects .Acupuncture originated in China more than 3000 years ago. Beneficial effects of this technique in the management of PDS have been reported -8. AlthoResults of controlled clinical trials suggest that the effects of acupuncture therapy are similar to those of stabilization splints ,10-13.The goal of this study was to assess the results of applying acupuncture or occlusal decompression splints to treat patients with PDS; as well as to evaluate the efficacy of such treatments.This study included 20 patients, who had visited the Dental Care Services of different Primary Health Centres in the Canary Islands and had been referred to the Department of Stomatology and Oral and Maxillofacial Surgery of the Hospital Insular de Gran Canaria with symptoms compatible with a diagnosis of muscle-related PDS. This study was approved by the Hospital Commission for Research, Teaching and Training.Patients were selected according to the following inclusion criteria:• Three-month or longer history of at least two of the following signs or symptoms: pain upon palpation of the temporomandibular joint (TMJ) or associated muscles of mastication, restriction or deviation of jaw movement, headache plus joint noise. Headache and joint noise were not considered when they occurred separately.• Legal age.• Normal vertical dimension with complete or almost complete dentition.Exclusion criteria were.• Legal involvement such as traffic accidents, sick leave, etc.• Dental malocclusion with variations from normal vertical dimension.• Malignancies or other diseases, especially those involving other joints.• Bone and/or degenerative diseases.• Headache associated with general organic conditions.• Fibromyalgia.• Mental disorders.• Previous treatment with acupuncture and/or decompression splint.• Previous surgery of the TMJ.• Orthodontic treatment at the time of the study.• Wearing a complete removable prosthesis.• Allergy to metal.Patients were randomly allocated to either decompression splint or acupuncture therapy. The studied population consisted of 20 patients  between 18 and 58 years of age (average 39 years); 8 females and 2 males were treated with acupuncture; 9 females and 1 male were treated with decompression splints. All of the enrolled patients signed an informed consent form. All of them underwent.▪ detailed physical examination and preparation of complete clinical record.▪ mouth-dental examination to assess tooth-decay, periodontal disease and general mouth hygiene.▪ specific TMJ examination.▪ orthopantomography.Treatments were applied by two operators: a physician specialized in stomatology, who was in charge of patient examination before and after the treatments, as well as of designing the decompression splints; and an acupuncturist graduated in traditional Chinese medicine, who applied the acupuncture treatment to all patients in the acupuncture group.Patients with the acupuncture therapy were treated with local and distal acupuncture points (acupoints). Local acupoints were: EX-HN5, SJ 21, GB2, SJ17, ST6 .• Visual analogue pain scale, where 0 corresponded to absence of pain and 10 corresponded to the worst imaginable pain.Numerical variables were expressed as mean and standard deviation. Sample normality was evaluated with the non-parametric Kolmogorov-Smirnov test. The pre- and post-treatment mean values were compared by using the Student’s t-test for dependent samples. Hypotheses contrast was considered to be significant for p-values lower than 0.05. We used the SPSS 14.0.1 statistical package.Both groups of patients – treated during five weeks – showed reduction of myofascial pain in the short term.Patients treated with decompression splints showed reductions in subjective pain and pain on pressure points located on the temporal, masseter and trapezius muscles, although differences did not reach statistical significance (p>0.05) Fig. .Patients treated with acupuncture experienced significant improvements in all of the studied parameters . Pain reduction was statistically significant (p<0.05) for all the evaluated points except the one located on the masseter muscle (p=0.068) Fig. .Since we did not conduct long-term patient follow-up these results are restricted to immediate effects of both treatments. Patients who had received a decompression splint were recommended to keep on wearing it on a regular basis.Acupuncture is currently considered an effective therapeutic alternative for most clinical conditions involving chronic pain ,14,15. CThe two most frequent conditions treated with acupuncture are headache and low back pain, although this therapy has also been used to treat sore throat, post-surgical dental pain, oncologic pain, polyneuritis, rheumatoid arthritis, sciatica, bursitis, tendinitis, etc. .Acupuncture is currently considered to be effective to treat dental pain, as well as postoperative and post-chemotherapy nausea and vomiting. Positive results have been reported with migraine, low back pain and temporomandibular disorders. Some authors consider that results are positive, while others consider them difficult to interpret. In general, this therapy is considered a relatively safe procedure . PublishThe prevalence of PDS is equivalent among both men and women. Women however, demand treatment more often; 85% of our subjects were women.Coincidently with other authors ,8 we obsFew studies document long term results of acupuncture or interocclusal splints. List and Helkimo  concludeOcclusal splints are extensively used to treat PDS. Several hypotheses have been proposed to explain their effectiveness -25, all As mentioned, reliable measurement of pain upon palpation of TMJ and associated muscles entails major difficulties, derived from inter- and intra-observer variability, as well as from variations of subjective pain reported by patients at different times . In ordeRaustia et al. -12 studiFinally, we would like to consider a possible placebo effect of acupuncture. Goddar  presenteBecause of time restrictions, patients could not be followed during a longer period and a larger sample of subjects could not be recruited. Longer time and more subjects could have produced better and more conclusive results.The results of this study indicate that acupuncture has analgesic effects in the short-term and is therefore comparably effective to occlusal splints, in the treatment of TMJ-PDS.


Patients with diabetic neuropathy (DPN) and fibromyalgia differ substantially in pathogenetic factors and the spatial distribution of the perceived pain. We questioned whether, despite these obvious differences, similar abnormal sensory complaints and pain qualities exist in both entities. We hypothesized that similar sensory symptoms might be associated with similar mechanisms of pain generation. The aims were (1) to compare epidemiological features and co-morbidities and (2) to identify similarities and differences of sensory symptoms in both entities.DETECT). To identify subgroups of patients with characteristic combinations of symptoms (sensory profiles) a cluster analysis was performed using all patients in both cohorts.The present multi-center study compares epidemiological data and sensory symptoms of a large cohort of 1434 fibromyalgia patients and 1623 patients with painful diabetic neuropathy. Data acquisition included standard demographic questions and self-report questionnaires  were found between both disorders. Patients of both aetiologies chose very similar descriptors to characterize their sensory perceptions. Burning pain, prickling and touch-evoked allodynia were present in the same frequency. Five subgroups with distinct symptom profiles could be detected. Two of the subgroups were characteristic for fibromyalgia whereas one profile occurred predominantly in DPN patients. Two profiles were found frequently in patients of both entities (20-35%).DPN and fibromyalgia patients experience very similar sensory phenomena. The combination of sensory symptoms - the sensory profile - is in most cases distinct and almost unique for each one of the two entities indicating aetiology-specific mechanisms of symptom generation. Beside the unique aetiology-specific sensory profiles an overlap of sensory profiles can be found in 20-35% of patients of both aetiologies. Painful diabetic neuropathy (DPN) is a chronic neuropathic pain syndrome caused by a metabolic damage of primary afferent neurons. Sensory abnormalities predominantly affecting the feet are frequent ,2. The sIn contrast, fibromyalgia syndrome is a chronic painful condition which is characterized by wide spread pain mainly perceived in deep somatic tissues, i.e., in muscles and joints. The definition is based on the American College of Rheumatology (ACR) classification scheme . FibromyDETECT questionnaire.Despite these obvious differences in the disease aetiology and the spatial distribution of the pain there are also striking similarities how the patients express their abnormal sensory perceptions and in particular the quality of their pain. It is well known that DPN patients frequently suffer from heat hyperalgesia, which is thought to be a result of peripheral sensitization of nociceptive afferents, prickling sensations, burning pain and numbness in the affected extremities . In fibrThe present investigation was designed to compare clinical data and sensory symptoms in a large cohort of 1434 fibromyalgia patients and 1623 patients with painful diabetic neuropathy and was performed in collaboration with the German Research Network on Neuropathic Pain (DFNS). For future research and better treatment options for these diseases it is important to know which sensory symptoms and pain qualities are perceived as relevant by the patients themselves. As a result of this idea "Patient-Reported Outcomes" (PROs) are already frequently used in clinical research .The specific aims of this study were(1) to compare epidemiological features and co-morbidities and(2) to identify similarities and differences of sensory symptoms and profiles.The study was performed at 450 outpatient centers throughout Germany, including general practitioners, rheumatologists, orthopaedists, diabetologists, neurologists and pain specialists. Patients included in the study were routinely clinically examined within the course of presenting themselves on a regular basis in the outpatients clinic. Patients presenting with DPN or fibromyalgia as diagnosed by the expert physicians  and at least 18 years old, were given a hand-held computer  and requested to complete electronic questionnaires for the epidemiological and clinical survey. This method of data acquisition was validated in an earlier study [DETECT questionnaire  and fore  was useDescriptive statistical analyses were performed with the SAS package, version 9.2. Data for graphics were transferred to MS Excel 2003. Relations between two dichotomous variables were assessed by 2'2 contingency tables, relations between categorical data in general using k'm contingency tables. The t-test with estimation of variances according to Satterthwaite`s method was used to evaluate differences in continuous variables between two groups of patients. Continuous variables were presented within tables by mean plus/minus standard deviation. Categorical data were tabulated using frequencies and percentages.In order to identify relevant subgroups of patients who are characterized by typical symptom constellation a hierarchical cluster analysis was performed in the entire cohort of both aetiologies. We used the hierarchical WARD-approach with a squared Euclidian distance measure. As there are no objective and compelled rules for determination of an optimal cluster number we used 3 criteria: the development of values of the WARD fusion algorithm with respect to cluster numbers, practical decisions about minimal group numbers and decisions about sense of combining groups as regards content. To prove the evidence of the solution, a k-means cluster, which rearranges cases for better fitting, was performed on basis of these results. The clusters are represented by the patterns of questionnaire scores, thus showing the typical pathological structure of the respecting group. Heuristic interpretations of the clusters were given by experts. As this is a heuristic approach no statistical analysis was performed. In order to eliminate inter-individual differences of the general perception of sensory stimuli  an alternative score was used for the cluster analysis in which the given 0-5 score of each question was subtracted by the mean of all values marked in the 7 questions. In this individual score values above 0 indicate a sensation which is more intensive than the individual mean pain perception, values below 0 indicate a sensation which is less intensive than the individual mean pain perception.A total of 1623 patients with painful diabetic neuropathy and 1434 fibromyalgia patients took part in the survey. The demographic profile of the patients is shown in Table DETECT questionnaire address the quality and intensity of specific pain symptoms. The patients could rate the perceived severity of each of these symptoms from 0-5 . In Table The visual analogue scale (VAS) intensity values for "worst pain", "average pain" and "current pain" were all higher in fibromyalgia than in DPN patients (VAS level differences ranging from 1.3 to 1.6). Seven questions of the painIn addition to characteristic frequencies of each of the sensory symptoms the patients also showed typical combinations of symptoms, i.e. typical sensory profiles. A cluster analysis was performed to identify relevant subgroups of patients who present with a characteristic constellation of sensory symptoms and to detect similarities and differences of these profiles in both entities. Table In accordance with other epidemiological studies the female male ratio in fibromyalgia was found to be 10:1. In patients with DPN the distribution between male and female patients is equivalent. Depressive symptoms and anxiety were significantly more often present in fibromyalgia than in DPN which reflects the results of earlier studies . Sleep dIt is important to estimate which sensory symptoms are clinically relevant as perceived by the patients themselves. Therefore, 'Patient-Reported Outcomes' (PROs) that collect health-related data directly from the patients are increasingly used in clinical research . SensoryPrickling or ant-crawling sensations are well-known features of polyneuropathies. In these disorders the patients perceive their discomfort in both the skin and deeper structures mainly in the feet or hands. The similar high frequency of severe prickling sensations in fibromyalgia patients is intriguing. In contrast to DPN, patients with fibromyalgia locate the prickling mostly into deeper tissues in particular in the muscles. The pathophysiological mechanisms underlying prickling in fibromyalgia might, nonetheless, be similar to that in DPN. Ectopic activity in non-nociceptive afferents from deep somatic tissues potentially induced by relative muscle ischemia might be a potential option. Muscle ischemia was described repeatedly in fibromyalgia -27 and iAnother unexpected finding is the relatively high incidence of touch-evoked allodynia in fibromyalgia (20%). Allodynia is thought to be induced by activation of touch-sensitive cutaneous Ab-fibers that synapse on nociceptive second-order neurons in the CNS. Thus, allodynia might be explained by a convergent afferent input of deep somatic and skin nerves on sensitized second-order neurons .Severe painful attacks were significantly more often described in fibromyalgia than in DPN (40% vs. 29%). The precise meaning of this sensory perception, however, very likely differs in both aetiologies. Patients with DPN experience the classical neuropathic shooting pain which occurs spontaneously for seconds, comparable to the attacks in trigeminal neuralgia. In contrast, if fibromyalgia patients use the descriptor "pain attacks" from our clinical experience they state that even the slightest movement of the affected musculature is capable of inducing a very severe, short lasting pain which ceases immediately after seconds.Thermal sensitivity within the painful area occurs nearly twice as often in fibromyalgia than in DPN (26% vs. 14%). Unfortunately, this question was not designed to differentiate between heat and cold sensitivity. Clinical experience indicates that DPN patients frequently suffer from heat hyperalgesia which is thought to be a characteristic symptom of hyperactive and sensitized cutaneous nociceptors. On the contrary, fibromyalgia patients frequently describe that their pain is enhanced when in contact with cold environmental temperature. This experience is in line with other studies which have found a high prevalence of cold hyperalgesia in fibromyalgia patients ,15. It iNumbness is a descriptor for sensory deafferentiation of the skin. It is the only symptom which is described significantly more often in DPN than in fibromyalgia (30% vs. 19%). It reflects the clinical observation of a length-dependent denervation of hands and feet which occurs in DPN patients. Nevertheless finding numbness also in one fifth of the fibromyalgia patients may be a hint for large fibre dysfunction in a subgroup of this cohort .Pressure induced pain, i.e. deep somatic hyperalgesia, is thought to be characteristic for fibromyalgia, as is reflected in the ACR-criteria. Hyperactive nociceptive processing from sensitized nociceptors innervating deep somatic tissues is likely involved. Assessing tenderness in this study was not standardized . For evaluating tender points in fibromyalgia patients examiners applied either pressure dolorimeter devices or digital palpation. Subjectively 58% of the fibromyalgia patients described the pain intensity to slight pressure as strong or very strong but only 22% of the DPN patients experienced a slight pressure in the affected area as painful. Interestingly, 42% of the fibromyalgia patients did not mark pressure pain as clinically relevant, although all of the included patients fulfilled the ACR-criteria. This finding clearly shows that pressure pain is only one part of the entire clinical picture of fibromyalgia and that for a subset of patients, pressure pain obviously is not the most disabling symptom.We performed a cluster analysis to identify relevant subgroups of patients who demonstrate characteristic sensory profiles Table . This anIt is likely that sensory perceptions and profiles translate into distinct pathophysiological mechanisms. Since many of the sensory profiles are typical either for DPN or fibromyalgia the combination of different pathophysiological mechanisms is likely to be relatively aetiology-specific. However, 20-35% of patients show sensory patterns which can be found in both entities. Thus, in these subgroups there might also be an overlap of pathophysiological mechanisms.Up to the present in the majority of fibromyalgia patients there are no nerve lesions demonstrable. However, it was repeatedly hypothesized that changes in the milieu of muscles and other deep somatic structures (for example induced by ischemia) might lead to a sensitization of peripheral nociceptors that innervate deep somatic structures and as a consequence generate and maintain pain in fibromyalgia patients . It mighAlternatively, sensitization of spinal cord nociceptive neurons might be initiated and maintained by a loss of descending inhibitory control. A dysfunction in pain inhibition has been proposed to be one of the factors which could lead to a disposition to develop fibromyalgia . If thisDETECT questionnaire was not validated in fibromyalgia patients. Originally it was validated to predict the probability of a neuropathic pain component in a cohort of patients suffering from typical neuropathic entities  or nociceptive pain . The fact that also fibromyalgia patients score positive in the painDETECT questionnaire reflects that this patient group suffers from symptoms that can not be categorized as nociceptive pain. Nevertheless fibromyalgia can not be viewed as a neuropathic pain state, which is in accordance with the new definition of neuropathic pain. But it might be that comparable mechanisms like central sensitization processes in both patient groups lead to similarities in symptomatology and therefore in parallels of answering symptom-based questionnaires.The multi-center, cross sectional design of the study represents just a short time frame and allows no conclusion on dynamics or cause and effect of symptoms. The approach of this study was to gather reliable information regarding the incidence of sensory symptoms, which are frequently complained about by fibromyalgia patients and to compare these data with the data of patients suffering from DPN in a large cohort of patients. The painThe answers of self-report questionnaires may be biased by the patients' personal feelings and health state at the time of filling out the questionnaires (exaggeration vs. understatement), by missing responses as well as giving consideration to the researchers and social expectations. This limitation is relevant for all studies which are based on self-report questionnaires. Nevertheless these studies are desperately needed in order to be able to design treatment strategies which target the symptoms reported by patients. Results of self-report questionnaires should be compared with more objective measurements like e.g. standardised sensory testing, functional imaging and laser or heat evoked potentials. Psychological factors like hypervigilance or catastrophizing were not evaluated in this study and may have had an impact on the results. Interpretation of underlying mechanisms in fibromyalgia according to reported sensory symptoms is speculative but is the basis for creating further studies to proof possible concepts.The results of this study indicate that patients can be classified on the basis of their sensory symptoms by the use of patient reported questionnaires. The study shows that DPN and fibromyalgia patients experience very similar sensory phenomena. The combination of sensory symptoms - the sensory profile - is in most cases distinct and almost unique for each one of the two entities indicating aetiology-specific mechanisms of symptom generation. The overlap of sensory profiles which can be found in 20-35% of patients in both aetiologies might be associated with similar mechanisms operating in certain subgroups of DPN and fibromyalgia patients. This questionnaire based approach will be an opportunity to closely monitor our pain patients regarding their sensory symptoms and pain ratings and opens the possibility to focus on treatment strategies for the symptoms the patients suffer from most.In the past three years, RF has received research support, consulting, or speaking fees from Grünenthal, Lilly/Boehringer, Astellas, Pfizer Pharma, UCB/Schwarz Pharma; RB has received research support, consulting, or speaking fees from Grünenthal, Lilly/Boehringer, Mundipharma, Pfizer, UCB/Schwarz, Allergan, Genzyme, Astellas, Sanofi Pasteur, Medtronic, Eisai; TRT has received consulting and speaking fees from Grünenthal, Hexal, Janssen-Cilag, Lilly/Boehringer; Mundipharma, Organon, Pfizer, UCB/Schwarz, Astellas. JK and SR received speaking fees from Pfizer and Grünenthal.The lead investigators  designed the study in collaboration with the DFNS. Data were collected by about 450 investigators  and were analysed statistically by MB. UG was at the time of data acquisition an employee of Pfizer Deutschland GmbH, Germany. UG developed, programmed and supported the technical devices. All authors read and approved the final manuscript.The authors would like to thank all participating patients, colleagues and the staff of the institutions for their contributions to data collection.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/11/55/prepub


Background: Menstrually related migraine (MRM) affects more than                    half of female migraineurs. Because such migraines are often predictable, they                    provide a suitable target for treatment in the mild pain phase. The present                    study was designed to provide prospective data on the efficacy of almotriptan                    for treatment of MRM.Methods: Premenopausal women with MRM were randomized to                    almotriptan (N = 74) or placebo                        (N = 73), taken at onset of the                    first perimenstrual migraine. Patients crossed over to the other treatment for                    the first perimenstrual migraine of their second cycle, followed by a two-month                    open-label almotriptan treatment period.Results: Significantly more patients were pain-free at two hours                    , pain-free from                    2–24 hours with no rescue medication , and pain-free from                    2–24 hours with no rescue medication or adverse events                     with almotriptan versus                    placebo. Nausea (p = .0007) and                    photophobia (p = .0083) at                    two hours were significantly less frequent with almotriptan. Almotriptan                    efficacy was consistent between three attacks, with 56.2% of patients                    pain-free at two hours at least twice. Adverse events were similar with                    almotriptan and placebo.Conclusion: Almotriptan was significantly more effective than                    placebo in women with MRM attacks, with consistent efficacy in longer-term                    follow-up. Menstrually related migraine (MRM) affects >50% of female                migraineurs, with <10% having migraines exclusively in the                perimenstrual period (PMP) ,3. NeuroWomen with MRM may benefit from short-term prevention ,6, but tIn a retrospective analysis of data from women with MRM from a randomized,                comparative study of almotriptan versus zolmitriptan for acute treatment of                migraine, almotriptan was effective and well tolerated , while aThe primary objective was to demonstrate the superiority of almotriptan over                    placebo in the percentage of patients free of pain two hours after drug intake                    during an MRM attack. Secondary objectives were to investigate the efficacy and                    tolerability of almotriptan versus placebo in women with MRM, and the                    consistency of treatment with almotriptan during open-label follow-up.The study (EudraCT: 2005-000244-90) was a two-month, multicenter, randomized,                    double-blind, placebo-controlled crossover trial followed by a two-month active                    treatment open-label follow-up evaluation to assess consistency. The study was                    performed in the neurology, headache or gynecology departments at seven                    hospitals in Italy, in accordance with Good Clinical Practice. The protocol was                    approved by the ethics committees of all participating centers and written                    informed consent was obtained from each patient.Patients enrolled in the study attended the clinic for five study visits,                    including the screening assessment. Each visit other than the screening visit                    took place two to six days after each migraine attack recorded in the study. At                    each visit patients recorded migraine pain intensity, adverse events and                    concomitant medications in a diary. Patients were randomized 1:1 to receive double-blind oral almotriptan malate or                    identical, matching placebo. Patients were assigned a randomization number in                    ascending order by the Statistics Group within Almirall SA., according to the                    relevant standard operating procedure. The randomization list was                    computer-generated, and randomization data were kept strictly confidential,                    accessible only by authorized persons. Data were unblinded only when the trial                    was completed and the data verified and locked. The success of blinding was not                    formally evaluated during the study.Study medication was self-administered at the onset of the first migraine attack                    occurring during the PMP . Participants took one 12.5 mg tablet, preferably in                    the first hour after pain onset or, if possible, when the pain was still of mild                    intensity, and not more than two hours after pain onset. Patients then crossed                    over to the other double-blind treatment  for the first                    migraine in the PMP of their second menstrual cycle. Two boxes  per                    patient were provided, each containing two tablets of study medication or                    placebo in sealed blisters. One tablet was to be used for the treatment of the                    attack, with the other to be used only in case of recurrence. In the open-label                    phase, all patients received almotriptan for the first PMP migraine in their                    third and fourth menstrual cycles. Patients were almotriptan-naive women aged 18–50 years, from any ethnic                    group, who experienced MRM, as defined according to the criteria of the                    International Headache Society . PatientAt baseline, patients were also required to provide a verifiable diary of their                    migraine history covering at least their preceding two menstrual cycles, their                    medical history in general and their latest medication history.Headache pain intensity was rated by patients on a 4-point scale:                    . Migraine-associated symptoms                    , migraine duration and                    use of rescue medication were recorded throughout the study. Rescue medications                    included nonsteroidal anti-inflammatory drugs and paracetamol, and other agents                    that investigators considered to be appropriate for each patient at their                    center. Triptans and ergotamine-containing drugs were not permitted as rescue                    medication. Tolerability was assessed in terms of adverse events, physical                    examinations and vital signs. According to sample size calculations, 130 evaluable patients were required to                    demonstrate superiority of almotriptan over placebo, and thus it was planned to                    screen and randomize 160 patients to account for an estimated 20% of                    withdrawals after randomization. A sample size of 130 patients (pairs of                    observations) achieves 90% power to detect an odds ratio (OR) of 2.00                    using a two-sided McNemar test with a significance level of 0.05 and the                    proportion of patients free of pain at two hours as primary endpoint. The OR is                    equivalent to a difference between two paired proportions of 0.250, which occurs                    when the proportion of patients responding to almotriptan and not to placebo is                    0.500 and the proportion of patients responding to placebo and not to                    almotriptan is 0.250. The proportion of discordant pairs is 0.750.The primary endpoint was the percentage of patients free of pain at two hours                    after drug intake. Secondary endpoints included percentage of patients pain-free                    at time points from 0.25 to 24 hours after drug intake; percentage of patients                    being sustained pain-free ; percentage of patients being SPF with no adverse events                    (SNAE); rate of recurrence (defined as onset of a new attack within 24 hours of                    successful drug treatment of the first migraine attack); percentage of patients                    with rescue medication intake; evolution of migraine-associated symptoms                    . The evaluation of primary endpoint and all the secondary endpoints, with the                    exception of “duration of migraine attack”, was performed by                    means of a generalized linear model implemented with binomial distribution,                    log-link function and generalized estimating equations. The model effects were                    treatment sequence ,                    treatment  and the period (first and second). As this                    was a crossover study, a compound symmetry variance–covariance matrix                    was employed to account for clustered data (repeated measures). p values. The primary efficacy population                    was the modified intent-to-treat (mITT) population, defined as all patients who                    received at least one dose of study medication and for whom data on the primary                    endpoint were available (i.e. double-blind phase completers). A per-protocol                    analysis, from which patients with major protocol violations were excluded, was                    also performed. The safety population included all patients who received at                    least one dose of study medication. A post-hoc analysis was conducted to assess                    the efficacy of almotriptan in comparison with placebo in the subgroups of                    patients with pain of moderate/severe (intensity                    score = 2−3) or mild (intensity                    score = 1) intensity at headache onset.Results were reported as RRs with the associated 95% confidence interval                    (CI) and two-tailed N = 74) or                    placebo–almotriptan (PLA/ALM)                    (N = 73)  and were included in the safety                    analysis. Baseline characteristics were similar in the two treatment arms;                    overall, the mean (± standard deviation [SD]) age of patients was                    34.9 ± 8.0 years, and all patients were Caucasian. The                    double-blind phase was completed by 63/74 (85.1%) and 59/73                    (80.8%) patients in the ALM/PLA and PLA/ALM arms, respectively, and                    these patients formed the mITT population                    (N = 122). The most common reasons for                    withdrawal were loss to follow-up                    (N = 8) and personal request                        (N = 5)  and 176 in the moderate/severe                    subgroup . The study was conducted between May 2005 and October 2008. In total, 194 patients                    were screened, of whom 147 were randomized to almotriptan–placebo                    (ALM/PLA) ((N = 73) . Of the  (N = 5) . The perOf the 122 patients who entered the open-label phase, 105 (86.1%)                    completed the study. The most common reason for withdrawal in the open-label                    phase was loss to follow-up.N = 59/122] vs. 26.2%                        [N = 32/122]; RR, 1.81 ; p = .0008)                        . In                    the post-hoc analysis, almotriptan was associated with a significantly higher                    percentage of patients free of pain at two hours in the mild subgroup                     but not in the                    moderate/severe subgroup  (Almotriptan was associated with a significantly higher percentage of patients                    free of pain at two hours after drug intake compared with placebo (48.4%                        [         . The res= .1100) . Figurep = .0022); the result was also                    statistically significant in the moderate/severe subgroup  but failed to                    achieve significance in the mild subgroup  (p = .0061) (p = .0304) but not in                    the mild subgroup .Overall, 36.1% of patients were classed as SPF while receiving                    almotriptan, compared with 17.2% while receiving placebo                        (= .0766) . Similar= .0061) . Again, N = 48/122) while receiving                    almotriptan and 59.8%                    (N = 73/122) while receiving placebo                    . In the mild and                    moderate/severe subgroups, the percentages were 33.3%                        (N = 12/36) vs. 59.4%                        (N = 19/32)  and                    41.9% (N = 36/86) vs.                    60.0% (N = 54/90) , respectively. The                    duration of migraine attack was significantly shorter in patients receiving                    almotriptan compared with placebo , but was not                    significantly different between the two treatment arms in either the mild or                    moderate/severe subgroups   . Table N = 17/59)                    during almotriptan treatment and 31.3%                    (N = 10/32) during placebo treatment                        (p = .9349).Migraine recurrence within 24 hours of successful treatment occurred in 28.8                    % of patients . Similarly, the incidence of photophobia at two hours                    post-medication  was significantly lower during almotriptan treatment                    compared with placebo. No between-group differences in vomiting, phonophobia or                    osmophobia at two hours after drug intake were reported. The incidence of nausea at two hours after drug intake was significantly lower                    while patients were receiving almotriptan compared with placebo . The percentage ranged from 0.9–1.0%                    at 15 minutes post-intake to 64.8–71.8% at 24 hours. The                    percentages of patients classed as SPF and SNAE were 40.0–41.8%                    and 36.2–39.1%, respectively . Rescue                    medication was used by 17.1–17.3% of patients in the mITT                    population, 12.5–13.9% in the mild subgroup and                    18.9–20.0% in the moderate/severe subgroup. The efficacy of                    almotriptan in terms of percentage of patients pain-free at two hours, SPF, and                    SNAE was highly consistent between the three attacks recorded in the study.                    Overall, 59 of 105 patients (56.2%) responded to treatment in at least                    two of three migraine attacks (i.e. were pain-free at two hours post-intake at                    least twice out of three attacks), while 42 (40.0%) and 39                    (37.1%) patients were SPF and SNAE, respectively, at least twice out of                    three cycles.The recurrence rate in the open-label phase was 29.5–33.9%. The                    incidence of migraine-associated symptoms was generally numerically lower in the                    open-label phase than in the double-blind phase. At two hours after intake, the                    incidences were nausea, 14.4–14.5%; vomiting,                    1.0–2.7%; osmophobia, 1.8–3.8%; photophobia,                    21.2–24.5%; and phonophobia, 18.2–20.2%.N = 122), there was no                    significant difference in the incidence of TEAEs between almotriptan and placebo                    . In the open-label                    phase, TEAEs were reported in 9/132 patients (6.8%). Overall,                    42% of TEAEs were considered by the investigator to be definitely,                    possibly, or probably related to the study drug. All TEAEs were graded as mild                    or moderate, and none led to study discontinuation during either study phase. No                    individual TEAE was reported in >5% of patients, and no serious                    adverse events or deaths were reported during the study. No clinically relevant                    changes in vital signs occurred within or between treatment arms.During the double-blind phase, treatment-emergent adverse events (TEAEs) occurred                    in 8/132 patients (6.1%) in the safety population during almotriptan                    treatment and 8/132 patients (6.1%) during placebo treatment. In the                    mITT population , the percentage of pain-free patients at two hours with                almotriptan was maintained or even increased. Results for secondary                endpoints—including percentage of pain-free patients over time, sustained                freedom from pain with or without adverse events, use of rescue medication and                occurrence of migraine symptoms—confirmed the efficacy of almotriptan in the                overall patient population. Results in the post-hoc analyses of the mild and                moderate/severe subgroups also showed a benefit for almotriptan, although some                results did not achieve statistical significance. It should be noted, however, that                the study was not powered to detect differences between almotriptan and placebo in                the post-hoc analyses.The results of the present study are highly consistent with those from a previous                retrospective analysis of almotriptan in women with MRM, in which 44.9% of                patients receiving almotriptan were pain-free at two hours after medication intake                (48.4% in the present study), with a recurrence rate of 32.8%                (28.8% in the present study)  migraine                excluded. One possible limitation of the study is the analysis of treatment                consistency, for which a more individual intrapatient assessment may have been                preferred. The present results do show, however, that 56% of patients can be                expected to respond to almotriptan for at least two of three migraine attacks.In conclusion, the results of this double-blind, placebo-controlled, crossover study                demonstrated the efficacy of almotriptan in ameliorating the symptoms of migraine                and confirmed its superiority over placebo in women with MRM attacks, which are                usually found to be of longer duration and less responsive to acute treatment than                nonmenstrual attacks . Data fr


Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication.This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo  injection. The randomization will be stratified for setting . Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle.This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started.NTR2966.This trial is registered in the Dutch Trial Registry: number  Recent international guidelines recommend intra-articular (IA) corticosteroid injections for patients with hip osteoarthritis (OA) who have moderate to severe pain and no satisfactory response to oral analgesic/anti-inflammatory agents . Of the Because the hip joint is adjacent to important neurovascular structures and cannot be palpated, IA injection under fluoroscopic or ultrasound guidance is advised. However, these techniques are not always available, especially in a primary care setting. Moreover, apart from being complex, an IA hip injection can be painful for the patient and can lead to septic arthritis. An effective but simpler administration technique would be a welcome addition to the current methods to treat episodes of increased pain in hip OA.A double-blind RCT in patients with subacromial impingement shoulder pain showed almost equal effectiveness of ultrasound-guided subacromial corticosteroid injection compared to gluteal (systemic) injection ; this efA clinically relevant effect of a systemic corticosteroid injection, offers a less complex alternative for treatment of patients with hip OA who are not responsive to oral pain medication. Since IA hip injection is not standard care in the Netherlands, we decided to conduct a trial comparing intramuscular (IM) corticosteroid injection versus IM placebo injection.This RCT will assess the effectiveness of an IM gluteal corticosteroid injection versus an IM gluteal placebo injection for pain in patients with hip OA who have moderate to severe pain and no satisfactory response to oral analgesic/anti-inflammatory agents during 12-weeks follow-up.The study will assess the effectiveness of an IM gluteal corticosteroid injection versus an IM gluteal placebo injection in patients with hip OA with regard to function, mobility and patients' perceived improvement. Adverse reactions will be registered and an explorative subgroup analysis will be performed stratified for setting .This is a double-blinded RCT. The Medical Ethics Committee of the Erasmus University Medical Center approved the trial (MEC2011-115). All patients will provide written informed consent.Patients with hip OA will be recruited in primary care  and via hospital referrals (orthopaedic outpatient clinics in the Rotterdam area). Treating physicians are asked to select patients with hip OA and screen them on the inclusion/exclusion criteria Table . If a paEligible patients will receive written study information from their treating physician. If they show interest, the physician will fax their contact data to the research team. The researcher will contact the patient to answer additional questions. If the patient is interested/willing to participate, an appointment at the research centre will be made to sign an informed consent form and screen on inclusion/exclusion criteria, including assessment of radiologic hip OA. Pelvic anteroposterior (AP) X-rays taken within 6 months prior to enrolment are accepted; otherwise an AP pelvic X-ray will be taken. Two researchers will independently of each other assess grading of hip OA according to Kellgren-Lawrence (K&L) . If the An independent pharmacy assistant will allocate each patient based on computerized randomization lists to either receive placebo  injection or triamcinolone acetate 40 mg injection IM. Randomization is stratified for setting  and uses random blocks of 2 and 4.To assure blinding with respect to the patient, researcher and treating physician, the trial medication will be packed and sealed by the pharmacy of the Erasmus MC, Rotterdam. An independent research assistant (who is not otherwise involved in the study) will prepare and administer, out of sight of the patient, the injection in the upper lateral quadrant of the gluteal musculature. The injection will be administered in the gluteal area ipsilateral of the study hip.Patients who participate in the trial are randomized to either an IM triamcinolone acetate 40 mg injection once or an IM saline injection once.Patients are allowed to continue their usual pain medication or physical therapy, but are requested not to start any new therapies regarding their hip OA during study follow-up.All outcomes are measured at baseline and at 2, 4, 6 and 12 weeks follow-up. The primary outcome is severity of hip pain reported by the patient at 2 weeks. This will be measured with two validated questionnaires: an 11-point numerical rating scale (NRS) in rest and on walking  . The WOMSecondary outcomes include the primary outcomes at 4, 6, and 12 weeks follow-up. Additional secondary outcomes are the disease-specific WOMAC function and stiffness subscales . Both thFor patients' perceived recovery a 7-point Likert scale will be used (score range 1 = 'worse than ever' to 7 = 'major improvement') ,16. QualAnother secondary outcome is the difference in percentage of responders as defined by the OMERACT-OARSI  .At baseline various patient characteristics  are recorded. Table Both hip joints will be examined for presence of groin pain or peri-trochanteric pain at palpation, range of motion and pain at/during movement for flexion/extension, abduction, and for internal/external rotation. Hip rotations will be examined in sitting position with the hips and knees in 90°. Hip flexion/extension and abduction will be examined in supine position. A goniometer will be used to measure degrees of range of motion .To gain insight in knee and lumbar spine co-morbidity both knee joints and lumbar spine will be examined. Pain at palpation of the medial or lateral joint space of the knee, hydrops and range of motion of flexion/extension of the knee will be registered. Pain at palpation of the spinous processes or sacro-iliac joints and lateroflexion and flexion of the lower spine (fingertip-floor distance and classic Schober test) will be examined .At baseline, two blood samples (9 ml) will be collected. One to measure the erythocyte sedimentation rate, which is used for the American College of Rheumatology criteria of hip OA . The othData from the Qvistgaard et al. study (patients with hip OA from primary care and secondary care) were used to calculate our sample size . That stIn that same study  the WOMAWe checked these scores in a Dutch study population with hip OA, i.e. those with a K-L score of the hip ≥ 2 and a VAS pain score ≥ 30, participating in the GOAL study . This shData analysis will be performed based on the 'intention to treat' principle.Descriptive statistics will be used to describe patient's characteristics, items of physical examination, and the severity of radiologic hip OA.Linear mixed models will be used for repeated measures to analyze the continuous outcome measures. Fixed effects will be time, time by therapy and the covariates we adjust for. For patients lost to follow-up, we will include all observed data in the analysis. Adjustment will be made for those baseline variables that change the effect estimate by more than 10%. Similar analyses with Generalized Estimating Equations techniques for repeated measures will be done for dichotomous outcome measures.Subgroup analyses for setting will be analyzed by assessing interaction effects between type of intervention and setting on the primary outcomes; in addition, the estimates will be shown for both settings separately. We realize that these subgroup analyses will remain solely explorative because our sample size is not directed to powerful subgroup analyses.The authors declare that they have no competing interests.SMABZ, JANV, MK, MR, PKB, PJEB and PAJL participated in the design and coordination of the study. DMJD coordinates the trial and is responsible for data acquisition. DMJD and PAJL prepared the article. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/12/280/prepub


We test the hypothesis that the odds of self-reported receipt of lifestyle advice from a health care provider will be lower among outpatient cardiac rehabilitation (OCR) nonattendees and nonreferred patients compared to OCR attendees. Logistic regression was used to analyse cross-sectional data provided by 65% (4971/7678) of patients aged 20 to 84 years discharged from public hospitals with a diagnosis indicating eligibility for OCR between 2002 and 2007. Among respondents, 71% (3518) and 55% (2724) recalled advice regarding physical activity and diet, respectively, while 88% (592/674) of smokers recalled quit advice. OCR attendance was low: 36% (1764) of respondents reported attending OCR, 11% (552) did not attend following referral, and 45% (2217) did not recall being invited. The odds of recalling advice regarding physical activity and diet were significantly lower among OCR nonattendees compared to attendees  and among nonreferred respondents compared to OCR attendees . Patients hospitalised for coronary heart disease should be referred to OCR or a suitable alternative to improve recall of lifestyle advice that will reduce the risk of further coronary events. Coronary heart disease (CHD) is a major cause of death and disability –3. The bHealth education, counseling, and behaviour modification strategies are core components of inpatient and outpatient cardiac rehabilitation (OCR) programs, which are recommended for all patients with CHD –9. UnforDuration of advice has been shown to be predictive of patient recall of advice in relation to physical activity, diet, and smoking, with an additional minute of discussion being associated with a 2.5-fold increase in recall . As Austhttp://www.hnehealth.nsw.gov.au/about_us/clusters_and_acute_hospital_networks/clusters).The Hunter Region, located 130 kilometres north of Sydney in New South Wales, Australia, covers 31,000 square kilometres and has a population of almost 650,000 . The HunThe Hunter New England Heart and Stroke Register (the Register) used computerized hospital discharge records to identify adults aged 20 to 84 years discharged with qualifying cardiovascular events from hospitals in the Hunter and New England regions. Eligible people received a letter from the Register several months after discharge seeking permission to keep their personal details for data linkage and permission to contact them about future research projects. A questionnaire on risk factors and secondary prevention was also enclosed. Data pertaining to Hunter residents discharged from public hospitals in the region between January 2002 and August 2007 with a principal discharge diagnosis  of acute myocardial infarction ; unstable angina pectoris ; congestive heart failure , and ischaemic heart disease  were extracted. Patients without an acute event but undergoing revascularisation (coronary artery bypass graft surgery [CABG] or percutaneous coronary intervention [PCI] including coronary angioplasty and stenting) were included. to …”: (i) “do any physical activity?” (ii) “follow a modified fat diet?” and (iii) “stop smoking?” Only people who reported smoking in the past 6 months were asked if they had received advice to quit. Response options were “yes” and “no” in each case.Participants completed a postal questionnaire approximately 5 months after discharge from hospital . Information regarding advice on lifestyle changes was collected using three questions with the same stem: “Since your admission to hospital have you been advised by a medical person  to attend an outpatient cardiac rehabilitation program?” and “Since your hospital admission have you attended any sessions of an outpatient cardiac rehabilitation program?” The response options were “yes” and “no.” Patients who reported attending any sessions of an OCR program were classified as “attendees,” patients who reported being advised to attend OCR but were not classified as “nonattendees”, and patients who were not advised to attend OCR were classified as “nonreferred”.Information regarding OCR was collected using two questions: “Since your hospital admission have you been advised by a medical person The potential confounding variables considered were limited to those collected by the Register. Those obtained from computerized hospital discharge records were gender , age group (<70/≥70), country of birth , marital status (married or defacto/other), health sector of residence (urban/nonurban), length of stay for the admission preceding survey completion (<4 days/≥4 days), number of events prior to completion of the questionnaire (1/>1), and hospitalization at least once for the following: AMI, UAP, CHF, IHD, and revascularisation (CABG or PCI) (no/yes response to each). 2 (no/yes), a self-reported history of high blood pressure, diabetes, high cholesterol, atrial fibrillation (no/yes response to each), and whether they had seen a general practitioner or specialist since discharge (no/yes response to both).Information about coronary risk factors and secondary prevention, not available through the computerized hospital discharge records, was obtained by questionnaire. This included a family history of CHD  (no/yes), body mass index ≥30 kg/mThe study was approved by the Hunter New England Human Research Ethics Committee  and the University of Newcastle Human Research Ethics Committee . The manager of the Register extracted and coded the data before giving it to the investigators to protect Registrants' privacy. χ2 tests. Multiple logistic regression analyses were used to determine the relationship between participation in OCR and self-reported receipt of advice from a healthcare provider regarding each of the behaviours mentioned above after adjustment for potential confounding variables. Multiple imputation was also performed to examine the impact of missing data. All variables with a P-value less than 0.25 in the χ2 analyses were included in the logistic models to provide the most complete control of confounding possible within the limits of the data set [The data were analysed using Intercooled Stata versions 10.0 and 11.0 . The characteristics of people who did and did not report receiving advice to (i) “do any physical activity?” (ii) “follow a modified fat diet?” and (iii) “stop smoking” were compared using data set . All varAs described elsewhere , 8246 peOverall, 71% (3518/4971) of respondents reported being advised to participate in physical activity, 24% (1177/4971) did not report receiving this advice, and 5.6% (276/4971) of respondents did not answer this question. Among patients who did and did not report having a physical limitation, 68% (1376/2027) and 81% (1912/2359) reported being advised to participate in physical activity, respectively. Overall, 55% (2724/4971) of respondents reported being advised to follow a modified fat diet, 39% (1921/4971) did not report receiving this advice, and 6.6% (326/4971) of respondents did not answer this question. Almost 14% (674/4971) of respondents reported smoking in the last six months. Of these, 88% (592/674) and 7.6% (51/674) did and did not report being advised to quit, respectively, and 4.6% (31/674) did not answer the question.Among respondents, 36% (1764/4971) reported attending OCR, 11% (552/4971) reported being advised to attend but had not, and 45% (2217/4971) reported they had not been advised to attend OCR. OCR participation status was unknown for 8.8% (438/4971) of respondents who did not answer this question. The proportions who reported receiving lifestyle advice, stratified by OCR participation, are shown in P-value less than  .25 in the χ2 analyses and were included in the logistic regression analyses. Missing data ranged from a minimum of 4.0% for Seen GP Since Discharge to a maximum of 13% for Seen Specialist Since Discharge. Among respondents with complete data, 79% (2006/2535) reported being advised to participate in physical activity by a healthcare provider and 21% (529/2535) did not. OCR was significantly associated with self-reported receipt of advice to participate in physical activity after adjustment for potential confounders . Overall, 76% of the cases were classified correctly.All the variables except country of birth, length of stay, and a self-reported history of high blood pressure had a founders . The HosP-value less than  .25 in the χ2 analyses. Missing data ranged from a minimum of 2.5% for Told High Blood Pressure to a maximum of 12% for Seen Specialist Since Discharge. Among respondents with complete data, 63% (1691/2676) reported being advised to follow a modified fat diet by healthcare provider and 37% (985/2676) did not. OCR was significantly associated with self-reported receipt of advice to follow a modified fat diet after adjustment for potential confounders . Overall, 73% of the cases were classified correctly.All the variables except country of birth and length of stay were included in the logistic regression analysis as they had a founders . The HosP-value less than  .25 in the χ2 analyses and were included in the logistic regression analyses. Missing data ranged from a minimum of 2.3% for Told High Blood Pressure to a maximum of 9.3% for Told Atrial Fibrillation. Among respondents with complete data, 92% (446/483) reported being advised to stop smoking by a healthcare provider and 8.1% (37/446) did not. OCR was significantly associated with self-reported receipt of advice to stop smoking after adjustment for potential confounders . Overall, 76% of the cases were classified correctly.Sex, age group, health sector of residence, length of stay for the admission preceding survey completion, at least one admission for AMI, at least one admission for CHF, family history of CHD, body mass index, self-reported history of high blood pressure, self-reported history of atrial fibrillation, and having seen a general practitioner since discharge had a founders . The HosThis retrospective analysis of data collected by the Hunter New England Heart and Stroke Register showed that 55% of patients hospitalised for CHD reported advice from a healthcare provider to follow a modified fat diet, and 71% reported advice to participate in physical activity. Among patients who reported smoking in the past six months, 88% reported being advised to stop smoking. Thus, while most patients received advice about smoking cessation and physical activity, only slightly more than half reported receiving advice about diet.Our findings are consistent with the results of a large European study of recall of lifestyle advice among patients with heart failure . In bothAs hypothesised, the odds of recalling advice from a healthcare provider regarding physical activity and diet were lower among the nonattendees and nonreferred patients compared to OCR attendees. The odds of reporting advice from a healthcare provider to be physically active were 67% lower among nonattendees compared to attendees, and 90% lower among nonreferred patients compared to attendees. Similarly, the odds of reporting advice from a healthcare provider to follow a modified fat diet were 67% lower among nonattendees compared with attendees, and 83% lower among nonreferred patients compared to attendees. The odds of recalling lifestyle advice from a healthcare provider regarding smoking were lower, but not significantly, among nonreferred patients compared to OCR attendees.Only 47% of the respondents recalled being referred to OCR, which is consistent with previous research in the region . Since rStrengths of this study include the large sample and the use of multivariate statistical methodology; however, there are a number of limitations. First, only 65% of eligible patients completed the questionnaire. If the respondents are more health oriented, our study will have overestimated the self-reported receipt of lifestyle advice from a health care provider among patients with CHD. Second, while only patients who reported smoking in the past six months were asked about advice to stop smoking, the appropriateness of nonprovision of advice regarding physical activity and diet could not be established. If, for example, patients who did not recall being advised to “do any physical activity” were physically active already, then not being given this advice would have been appropriate for that person, and our data will have underestimated the proportion of patients recalling advice consistent with current guidelines. Similarly, data on patients advised not to participate in physical activity due to disease severity and were waiting for urgent revascularisation, for example, was not available. Third, the validity and reliability of the Heart and Stroke Register questionnaire is not known. Research verifying patient report of receipt of lifestyle advice from a family physician by direct observation showed that patients recalled less than 50% of discussions about diet, smoking, and exercise . Thus, wAlthough many respondents reported being advised to make lifestyle changes that will reduce the risk of further coronary events, the proportion of patients receiving or recalling advice in relation to diet, and to a lesser extent physical activity, was suboptimal. As hypothesised, the odds of self-reported receipt of advice from a health care provider regarding diet and physical activity were lower among patients who did not attend OCR or were not referred compared with those who attended. OCR nonattendance and nonreferral were not associated with lower smoking cessation advice rates. Although conclusions about causation are not possible, results of this study suggest that patients who do not attend OCR may miss out on or fail to recall advice on lifestyle changes that will reduce the risk of further CHD events. We therefore recommend that patients hospitalised for CHD who have not attended OCR as a consequence of nonreferral be identified by their general practitioner and advised to attend. In addition, we recommend that patients who have not attended OCR despite referral be identified and encouraged to participate in a home-based cardiac rehabilitation program or be referred to appropriate allied health care providers via the preparation of a chronic disease management plan.


Pain is one of the most common reasons for seeking medical care. The purpose of this study was to characterize patients visiting the complementary medicine clinic for a pain complaint.This is a cross-sectional study. The study took place at Clalit Health Services (CHS) complementary clinic in Beer-Sheva, Israel. Patients visiting the complementary clinic, aged 18 years old and older, Hebrew speakers, with a main complaint of pain were included. Patients were recruited consecutively on random days of the month during a period of six months. Main outcome measures were: pain levels, location of pain, and interference with daily activities. Once informed consent was signed patients were interviewed using a structured questionnaire by a qualified nurse. The questionnaire included socio-demographic data, and the Brief Pain Inventory (BPI).Three-hundred and ninety-five patients were seen at the complementary medicine clinic during the study period, 201 (50.8%) of them met the inclusion criteria. Of them, 163 (81.1%) agreed to participate in the study and were interviewed. Pain complaints included: 69 patients (46.6%) with back pain, 65 (43.9%) knee pain, and 28 (32.4%) other limbs pain. Eighty-two patients (50.3%) treated their pain with complementary medicine as a supplement for their conventional treatment, and 55 (33.7%) felt disappointed from the conventional medicine experience. Eighty-three patients (50.9%) claimed that complementary medicine can result in better physical strength, or better mental state 51 (31.3%). Thirty-seven patients (22.7%) were hoping that complementary medicine will prevent invasive procedures.Given the high proportion of patients with unsatisfactory pain relief using complementary and alternative medicine (CAM), general practitioners should gain knowledge about CAM and CAM providers should gain training in pain topics to improve communication and counsel patients. More clinical research to evaluate safety and efficiency of CAM for pain is needed to provide evidence based counseling. Pain is one of the most common reasons for seeking medical care. It is known to affect general health , psycholThe prevalence of chronic pain in the general population ranges from 10% to over 40%, depending on the study and definition . PatientIn a study from United Kingdom among patients who had reported having musculoskeletal pain and who had consulted about their pain in primary care in the previous 12 months, 84% had used at least one CAM treatment for pain in the previous year and 65% were current users of CAM. Most CAM treatments were scored by these patients as being helpful, and users indicated that they intended to use again 87% of the CAM treatments they had already used . In anotIn Israel, 6 to 10 percent of Israelies reported using complementary and alternative medicine ,19 and tIn a study conducted among patients of CHS's complementary medicine clinic in Beer-Sheva, Israel, we found that the most common reason for visiting the complementary clinic were musculoskeletal conditions (47%). Acupuncture and shiatsu massage therapy were the preferred treatments  .As conventional medicine often fails at addressing many patients with a pain experience, and many patients seek other treatment methods. It is important to understand the characteristics of patients attending complementary medicine clinics for a pain complaint.This is a cross-sectional study.The national health insurance system implemented in Israel in 1995, provides health care to the entire population through non-profit health maintenance organizations (sick funds). The present study was conducted within the framework of the complementary medicine clinic of CHS in Southern Israel, treats annually about 3,000 patients who receive about 15,000 treatments. The treatments offered include acupuncture, reflexology, shiatsu, massage therapy, homeopathy, chiropractic, feldenkreiss, bio feedback, naturopathy, herbal medicine, medical hypnosis and Bach flowers. Patients have a preliminary screening meeting with a physician who recommends the appropriate therapy. The treatments are not included in the national basket of health services, thus patients are required to pay out-of-pocket for these treatments.Patients visiting the complementary medicine clinic, aged 18 year old and older, Hebrew speakers, with a main complaint of pain. Patients were recruited consecutively on random days of the month during a period of six months.The screening physician recruited patients for the study. Once informed consent was signed patients were interviewed using a structured questionnaire by a qualified nurse. The personal interview with the patient included socio-demographic data, and the Brief Pain Inventory (BPI) questionnaire that had been translated and validated in our previous work . The BPIData was coded and entered into Epidata 2.1 and was analyzed using SPSS 14.0 software .The study was approved by the institutional review board of Soroka University Medical Center .Out of 395 patients seen at the complementary medicine clinic during the study period, 201 (50.8%) met the inclusion criteria. Of them, 163 (81.1%) agreed to participate in the study and were interviewed.The study population characteristics are described in Table Sixty-nine patients (46.6%) had a back pain, 65 (43.9%) had a knee pain and 28 (32.4%) other limbs pain. One-hundred-and six patients (68.4%) reported a moderate pain level on average (VAS 4-7), and 28% reported a severe pain level (VAS 8-10). The average level of pain during the last pain attack was 5.6 ± 1.9 points of the VAS and the "conventional" treatment helped relief less than half of pain severity (Table Pain impact on daily activities is presented in Table The most common symptoms reported in addition to pain (more than one could be marked) were: sleep disorders (55.2%), tiredness 54.6%) and dizziness (21.5%). Eighty-two patients (50.3%) treated their pain with complementary medicine as a supplement for their conventional treatment, and 55 (33.7%) felt disappointed from the conventional medicine experience. Eighty-three patients (50.9%) claimed that complementary medicine can result in better physical strength, or better mental state 51 (31.3%). Thirty-seven patients (22.7%) were hoping that complementary medicine will prevent invasive procedures. Thirty-eight patients (23.3%) experienced, in the past, acupuncture treatment, 27 (16.6%) had reflexology treatment and 18 (11%) shiatsu treatment , and the average age was 51.9 ± 15.6. Sixty-four patients (39.3%) were self referred. About two thirds reported a moderate pain level on average (VAS 4-7), and a quarter reported on severe pain level (VAS 8-10). The "conventional" treatments helped relief less than half of pain severity.Our patients visiting the complementary medicine clinic indicated that the pain impacted their daily routine, caused work disturbance and influenced considerably their daily life. In many cases, people concurrently used complementary medicine with conventional medicine in hope of finding the "magic bullet" cure, though also realizing they need to find other ways to cope and to improve their quality of life .An earlier study  showed that more women, more educated people and more married people ,20 are rOne of the predictors to attendance to complementary medicine according to the literature is the existence of chronic diseases ,26,27. SThe main reason for attending complementary medicine clinic among patients in our survey was to supplement conventional medicine treatments (50.3% participants). Moreover, in our study, a third of our study population was referred to the complementary medicine clinic by medical teams. It is known, that only a minority of patients report CAM use to their physicians ,28. ThusThe complementary medicine clinic in Beer Sheva offers a large spectrum of treatment modalities. Complementary medicine includes several methods of treatment, all of which aim to promote health and quality of life . The maiIn designing this study, we adopted recommendations to increase the compliance rate for completion of questionnaires . The resOur study's results in the complementary medicine clinic in Beer-Sheva reflect the characteristics of the patients that used the complementary clinic for their pain. Since the population in Beer-Sheva is younger than in the rest of the country we cannot be certain of their generalization to other countries and health care systems. However, the age difference is not clinical significant and the results were similar to previous studies.Patients visiting the complementary medicine clinic indicated that the pain impacted their daily routine, caused work disturbance and influenced considerably their daily life. The most common reasons for patients with a pain complaint visiting the complementary medicine clinic were: as a supplement for conventional treatment, disappointment from conventional medicine and successful previous experience with complementary medicine by a family member or a friend. Given the high proportion of patients with unsatisfactory pain relief using CAM, general practitioners should gain knowledge about CAM and CAM providers should gain training in pain topics to improve communication and counsel patients. More clinical research to evaluate safety and efficiency of CAM for pain is needed to provide evidence based counseling.We hope that our data can promote understanding the meaning of complementary medicine for painful patients.The authors declare that they have no competing interests.RP conceived of the study, and participated in its design and coordination and helped to draft the manuscript. OL conceived of the study, and participated in its design and coordination and helped to draft the manuscript. YP consultation and study design, helped to draft the manuscript. PS coordinating the study, and participated in its design and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6882/11/36/prepub


To examine the effects of integrative medicine (IM) on pain and anxiety in an inpatient orthopedic population.Data were obtained from the electronic health record (EHR) for selected orthopedic inpatient admissions during 2010. Four orthopedic populations were identified by APR-DRG categories: 1) hip replacement, 2) knee replacement, 3) back surgery, and 4) medical back pain. Receipt of IM therapies was the treatment of interest. Primary outcomes were change in patient reported pain and anxiety. Patients rated pain and anxiety levels before and after IM treatments using a self-report intensity scale (0 to 10), with higher scores indicating higher levels of pain and anxiety. Chi-square tests were used to test for significant differences in the percentage of patients who received specific IM therapies. Significant differences in mean pain and anxiety score changes were evaluated using paired t-tests.Overall, there were 2,866 patients with a hip replacement, knee replacement, or back pain/surgery DRG. Of these, 1,013 (35.3%) received at least one IM visit. Of those, 584 (57.7%) had a single therapeutic treatment. Overall, 63.1% of the patients received acupuncture alone or in combination with another therapy, and 24.7% received Korean hand therapy alone or in combination. The most common single treatment was acupuncture (39.7%). All DRG groups experienced significant reductions in pain and anxiety after IM treatment. Knee replacement patients reported the greatest pain reduction, with a decrease of 1.7 points (58.4% reduction), on average, after receiving IM treatment (p<0.001). Back surgery patients reported the greatest post treatment difference in anxiety scores among DRG groups, with a mean decrease of 1.4 points (70.8% reduction) (p<0.001).Orthopedic patients reported lower pain and anxiety scores after receiving integrated therapies. Further research should be done to evaluate the efficacy of specific IM interventions on pain and anxiety within an orthopedic patient population.


Patients with sciatica frequently complain about associated back pain. It is not known whether there are prognostic relevant differences in Magnetic Resonance Imaging (MRI) findings between sciatica patients with and without disabling back pain.The study population contained patients with sciatica who underwent a baseline MRI to assess eligibility for a randomized trial designed to compare the efficacy of early surgery with prolonged conservative care for sciatica. Two neuroradiologists and one neurosurgeon independently evaluated all MR images. The MRI readers were blinded to symptom status. The MRI findings were compared between sciatica patients with and without disabling back pain. The presence of disabling back pain at baseline was correlated with perceived recovery at one year.Of 379 included sciatica patients, 158 (42%) had disabling back pain. Of the patients with both sciatica and disabling back pain 68% did reveal a herniated disc with nerve root compression on MRI, compared to 88% of patients with predominantly sciatica (P<0.001). The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year . Sciatica patients with disabling back pain in absence of nerve root compression on MRI at baseline reported less perceived recovery at one year compared to those with predominantly sciatica and nerve root compression on MRI .Sciatica patients with disabling low back pain reported an unfavorable outcome at one-year follow-up compared to those with predominantly sciatica. If additionally a clear herniated disc with nerve root compression on MRI was absent, the results were even worse. Sciatica is associated with significant short- and sometimes long-term morbidity. This affliction, certainly in the industrialized countries, ranks as one of the most costly and ubiquitous medical problems In classical literature sciatica has been of great interest to Greco-Roman and Eastern scientists and physicians Patients with sciatica frequently complain about associated back pain The objectives of this study were to investigate MRI differences between patients who suffered both from sciatica and disabling back pain as compared to patients who suffered from sciatica only. Furthermore we report on the relevance of disabling low back pain for clinical outcome.The medical ethics committees at the nine participating hospitals  approved the protocol. Written informed consent was obtained from all patients.Patients for this study were patients with intense lumbosacral nerve root pain who underwent a baseline MRI to assess the eligibility for the Sciatica Trial: a multicenter, randomized controlled trial designed to determine whether early surgery results in better outcome compared to a strategy of prolonged conservative treatment with surgery if needed among patients with 6–12 weeks sciatica MRI scans were performed in all nine participating hospitals using standardized protocols tailored to a 1.5 Tesla scanner. Sagittal T1 and axial T1 spin echo images of the lumbar spine were acquired. In addition, T2 weighted sagittal and axial series, and contrast-enhanced (gadolinium-DTPA) T1 fat suppressed images were obtained.Two experienced neuroradiologists (BK and GL) and one neurosurgeon (CV) independently evaluated all MR images. The readers were not provided any clinical information and had not been involved in the selection or care of the included patients.Definitions of imaging characteristics were based on recommendations from the combined task forces of the North American Spine Society, the American Society of Spine Radiology, and the American Society of Neuroradiology for classification of lumbar disc pathology First, the blinded readers had to decide which disc level showed the most severe nerve root compression. For both the presence of disc herniation and nerve root compression a four point scale was used: “definite about the presence”, “probable about the presence”, “possible about the presence” and “definite about the absence”. The first two categories were combined and marked as having the abnormality present. The latter two categories were combined and marked as not having the abnormality present. Clinically relevant characteristics of the disc level and disc herniation were scored. Vertebral Endplate Signal Changes were evaluated from L2–L3 through L5–S1.The patients were assessed by means of the Roland Disability Questionnaire for Sciatica  The majority opinion of the three readers regarding the MRI variables (answer independently given by minimum 2 out of 3 readers) was used in the statistical analysis. Interobserver agreement regarding the MRI findings was determined by use of absolute percentages of agreement and kappa values (weighted in case of ordered data).Disabling back pain was defined as a VAS for back pain of at least 40 as this cutoff value is regularly used when the VAS is categorized into favorable and unfavorable outcome Logistic regression was used to determine the association between perceived recovery at one year and baseline characteristics . The association between the baseline characteristics and perceived recovery at one year was additionally adjusted for treatment received (surgery versus no surgery), age, gender, smoking, Body Mass Index and RDQ score at baseline.Between group differences in continuous outcome measures (RDQ and VAS pain scores) during the first year were analyzed by repeated measurement analysis of variance.We assumed clinical outcome data to be missing at random and used model-based multiple imputation to impute the outcome values, a method in which the distribution of the observed data is used to construct sets of plausible values for the missing observations (10 imputed datasets). Variables included in the imputation model were age, gender, body-mass index, duration of symptoms, smoking, treatment group, all used MRI variables  had a VAS of at least 40 with a mean of 63.3  and 221 (58%) patients had a VAS of back pain of less than 40 with a mean VAS of 12.1 (95% CI 11–14). At baseline, sciatica patients with and without disabling back pain had a statistically significant but clinically small difference in RDQ and VAS-leg pain (17.4 vs. 15.0 and 66.6 vs. 60.7 respectively) . Six of Substantial agreement was found for the MRI assessed presence of disc herniation (kappa range 0.67–0.75) and nerve root compression (kappa range 0.60–0.80) (Table S3 in Of patients with both sciatica and disabling back pain 76% had a disc herniation on MRI compared to 91% of patients without disabling back pain (P<0.001) . Nerve rA comparison of the characteristics of the herniated disc itself between sciatica patients with and without disabling back pain is shown in The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year  . This reThe reported prevalence of perceived recovery at one year was 81% for sciatica patients who had at baseline disabling back pain and nerve root compression, 50% for sciatica patients who had at baseline back pain but no nerve root compression, 91% for sciatica patients who had at baseline no back pain but depicted nerve root compression on MRI, and 73% for sciatica patients who had at baseline no back pain and no nerve root compression (P<0.001) . In the In patients with disabling back pain, those who also had nerve root compression on MRI significantly reported more favorable recovery from their back pain at one year compared to those who had not depicted nerve root compression at baseline .The sensitivity analyses yielded comparable results , the Visual-Analogue Scale for leg pain (1B), and the Visual-Analogue Scale for back pain (1C) in relation to disabling back pain at baseline.Contains list of authors and participants in the Leiden–The Hague Spine Intervention Prognostic Study Group and Tables S1–S7, Figure S1. (DOC)Click here for additional data file.