Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac) compared with acetaminophen in new consulters with knee osteoarthritis in general practice.Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher , will be randomly allocated to either diclofenac (maximum daily dose of 150 mg) or acetaminophen (maximum daily dose of 3000 mg) for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions.The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.Dutch trial registry NTR1485. Osteoarthritis (OA) is the most frequent chronic joint disease causing pain and disability of especially hip and knee . For mosDespite general consensus that acetaminophen has a better safety profile, there may be insufficient evidence for the efficacy of acetaminophen in mild OA to convince GPs that NSAIDs should be avoided as first choice medication. Indeed, a systematic review of 15 randomized clinical trials  on the comparative effectiveness of NSAIDs versus acetaminophen in patients with hip/knee OA reported that although acetaminophen was more effective than placebo, it provided less pain relief than NSAIDs [A limitation of most RCTs is that they seldom include patients consulting for OA (i.e. new patients) but mostly prevalent cases already receiving treatment for OA. Most studies included a highly selected patient group already using a daily dose of NSAIDs and needing a wash-out period prior to randomization -10. One In view of the lack of trials comparing the efficacy of NSAIDs with acetaminophen in new consulters with OA, we designed an RCT to explore whether there is a clinically relevant difference between diclofenac (an NSAID) and acetaminophen in new patients with knee OA in general practice. A pragmatic open-label design was chosen to approximate GPs' daily practice and because patients are aware of the type of prescribed medication. Secondary aims were to establish: 1) whether there are predefined predictors of treatment responders after 4-6 weeks and at 12-weeks follow-up, and 2) the cost-effectiveness of diclofenac compared to acetaminophen in patients with knee OA in primary care over a 12-week period.Presented below is the protocol of the diclofenac versus acetaminophen trial , which is registered in the Dutch trial registry (NTR1485) .This study is a pragmatic randomized open-label trial with a follow-up period of 12 weeks. In this design, the patients, researchers and GPs are not blinded for the assigned treatment. The study is approved by the Medical Ethics Committee of the Erasmus Medical Center (MC).Figure Patients are eligible for the DIPA trial Table  if they Patients are excluded if they are: 1) contra-indicated for NSAID or acetaminophen use, i.e. gastrointestinal bleedings in history or active, blood dyscrasia, bone marrow depression (myelosuppression), serious heart failure, serious liver or kidney disease (glomerular filtration < 30 ml/min), alcoholism, colitis ulcerosa, Crohn's disease, sulphite hypersensitivity, asthma, urticaria, angioedema, nasal polyps or rhinitis after use of acetylsalicylic acid or other prostaglandin synthetase inhibitors, or use of anti-depressive medication (SSRIs), 2) having an arthroplasty or osteotomy of the knee on the contralateral or unilateral side, 3) already taking NSAIDs or acetaminophen at doses similar to or higher than the study dose, 4) surgery or major trauma of the affected joint within the previous 6 months, 5) myocardial infarction or stroke in the last 6 months, and 6) oral use of a corticosteroid.An academic research network of GPs in the south-west of the Netherlands agreed to participate and to refer patients who consult for a new episode of non-traumatic knee pain to the DIPA trial. The GP takes the patient's history and performs the physical examination as part of the usual daily care. The GP gives study information to the patient, and sends the patient's name and information regarding history taking/physical examination by fax to the research department at Erasmus MC. Within two days after the GP visit, patients are contacted (by the researcher), checked for eligibility (in- and exclusion criteria), and asked for written informed consent. Baseline measurements and randomization then take place.Patients are allocated to the diclofenac or the acetaminophen group using a randomization list  produced by a computer-generated table. The GP is informed about the randomization results and sends a prescription of the allocated medication to the patient's pharmacy.Patients are randomly allocated to either diclofenac (maximum daily intake of 3 × 50 mg) or acetaminophen (maximum daily intake of 3 × 1000 mg). Both medications are prescribed in accordance with the Dutch clinical guidelines for GPs for non-traumatic knee symptoms . The guiThe primary outcomes of this study are: 1) pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS)  and 2) pThe primary and secondary outcome measurements are assessed with questionnaires and diaries. During the study, patients fill out a total of 5 questionnaires . After the informed consent and before randomization, the patient fills out the baseline questionnaire. After the baseline questionnaire, patients receive a follow-up questionnaire every 3 weeks.Five validated instruments are used in all 5 questionnaires.1) The KOOS measures the functional status of patients with knee OA . The KOO2) The measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) identifies different types of pain due to OA. The ICOAP is a reliable and valid to measure constant and intermittent pain .3) The 11-point NRS measures the perceived level of pain intensity  -25. The 4) The EuroQol (EQ-5D) measures quality of life. The EuroQol is a generic questionnaire and consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression . The Eur5) The PRODISQ measures all direct medical, patient, and productivity costs. The PRODISQ consists of 7 modules. In the present study, only modules 1-5 are used because these questions are related to the individual patient, whereas modules 6 and 7 are utilized by management. Modules 1-5 cover: 1) demography and disease, 2) profession, working situation, and income, 3) absence from work, 4) compensation mechanisms, and 5) productivity costs whilst at work (efficiency loss) .Besides these validated questionnaires, the baseline questionnaire addresses patient characteristics , knee-related characteristics , problems at work due to knee problems, and co-morbidities. The four follow-up questionnaires measure medication use, adverse reactions, medical consumption, patients' perceived recovery, and knee-related characteristics.Table During the DIPA trial, patients fill out a diary to score daily pain (using an 11-point NRS), medication use, and compliance. Being a pragmatic trial, patients may change their medication dosage when pain alters. These alterations may be important for interpreting the results of the trial. Therefore, information on compliance to the allocated treatment is also collected.The sample size is calculated to detect clinically relevant differences in pain and function between the two groups (diclofenac versus acetaminophen), measured by the KOOS during the 12-week study period. To detect a clinically relevant difference of 10 points (15%) on the KOOS pain score between the two treatment groups after 12 weeks, 73 patients per group are needed . Based on an expected 5% loss to follow, 154 patients (2 × 77) should be included.All analyses will be performed on an intention-to-treat basis, analyzing all patients in the treatment group to which they were randomly allocated. Analysis per protocol will also be conducted, analyzing only those patients that have measures on the primary outcome measurement at both baseline and 12-weeks follow-up. Descriptive data of baseline characteristics will be presented for both groups to check comparability. Generalized estimating equation (GEE) analysis will be conducted to investigate  the 2, 4, and 6 weeks effectiveness of diclofenac compared to acetaminophen for pain assessed with the diary. Differences between the two groups over the 12-week follow-up will also be assessed with GEE. The outcome variables are pain (measured with the NRS), and pain and function (assessed with the KOOS). Using GEE, the correlation of multiple measurements within one patient is taken into account .To detect predictive variables for treatment responders at 12-weeks follow-up multivariate regression analyses will be used. Treatment response is defined based on the OMERACT-OARSI responder criteria ,31 as a In addition, a cost-utility analysis will be performed that expresses health improvements in QALYs assessed with the EuroQol. If the course of OA (and its related costs) appears to fluctuate (particularly if the difference between treatment arms is not stable over time), an additional modeling study using a Markov model will be performed. Statistical methods will be used to describe uncertainty in costs and effects estimates based on patient data. A 95% confidence interval for the cost-utility ratio will be calculated and an acceptability curve presented. In case of a modeling study, a probabilistic sensitivity analysis will be performed.Recruitment of the 154 patients has started and will end in 2010. We expect to report study results in 2011. The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis.The authors declare that they have no competing interests.SMABZ, BWK, and PAJL conceived the study, developed the trial design, and contributed to writing the article. AMB contributed to the trial design and to writing the article. SPJV is the coordinator, participated in the design of the study, and prepared the article. All authors have read and approved the final version of the article.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/7/prepub


There are no standard criteria for defining or assessing severity of fibromyalgia (FM) as a condition as fibromyalgia is associated with multiple symptom domains. The objective of this study was to evaluate whether patient self-reported severity of FM is associated with severity of pain and sleep interference and the presence of core co-morbidities.We recruited individuals ≥ 18 years of age with a clinician-confirmed diagnosis of FM ≥ 3 months and a current pain rating >2 on a 0-10 numeric rating scale (NRS). Patients completed a questionnaire by mail in which they self-rated their FM severity , their current pain severity and extent of sleep interference , and provided information (yes/no) on the presence of core comorbidities  and medication use for FM. The core symptoms of FM were stratified to assist with patient characterization. Analysis of variance (ANOVA) was used to explore the relationship between self-reported FM severity and continuous variables (pain severity and sleep interference), and Mantel-Haenszel chi-square analysis was used to evaluate the trend in the proportions of patients reporting use of medications and core symptoms of FM by severity of FM. To complement patient-reported FM severity and to understand physicians' perspectives, a survey was performed among 28 physician specialists  to determine what they assessed when evaluating FM severity in clinical practice.The population (N = 129) of FM patients was predominantly female (89.1%), with a mean age of 49.4 ± 11.0 years, and 81.4% reported duration ≥ 2 years. Self-reported FM severity was moderate/severe in 86.0% of patients; mean current pain score was 6.40 ± 2.19 (moderate), and mean sleep interference score was 7.28 ± 2.23 (severe). Greater FM severity was significantly associated with higher levels of current pain and sleep interference (p < 0.0001), the proportion of patients reporting FM medication use (p = 0.0001), and the presence of core comorbidities (p < 0.05). Pain, functional disability, and fatigue severity were ranked as the top three criteria by the highest proportion of physicians when evaluating FM severity.With higher self-reported FM severity, patients have greater pain and sleep interference as well as increased frequency of core comorbidities. Further investigation into understanding FM severity is warranted. Fibromyalgia (FM) is a disorder of unknown etiology that is generally diagnosed according to the American College of Rheumatology (ACR) criteria, which include chronic, widespread pain for at least 3 months, and the presence of 11 out of 18 tender points . AlthougFM has a substantial negative impact on quality of life, resulting in health status that is poorer than other chronic pain conditions such as rheumatoid arthritis and osteoarthritis -7. The bThis multidimensional nature of FM has made it difficult to define and assess the severity of FM as a condition. The indeterminate etiology and lack of specific disease markers exacerbate the problem of assessing FM severity. While several studies investigated the potential use of biologic markers for FM , correlation of these markers with symptoms was equivocal at best -12, rendThe ability to evaluate and measure the severity of FM as a condition is likely to provide several benefits including identification of treatment responders in clinical trials and clinical practice. Characterization of severity levels may also be used as a marker for disease progression. Treatment approaches may be specifically targeted to patients at different levels of severity, with the potential for determining if early treatment may slow or prevent disease progression. There have been few published studies on severity or progression of FM as a disease state, and what little has been reported about the natural history of FM is inconsistent. Although a longitudinal study by Wolfe et al. reported no change in the severity of specific symptoms over time , a revieChronic pain is the symptom of FM that is of primary importance to patients and clinicians and is routinely evaluated as an endpoint in clinical trials and clinical practice. Although pain can be quantitatively evaluated from the patient's perspective, it may not be an adequate surrogate of disease severity, since it may display intrapatient variability in intensity which does not necessarily correlate with the presence or severity of other FM symptoms. A patient-reported instrument frequently used to assess FM is the Fibromyalgia Impact Questionnaire (FIQ) . AlthougIn trying to develop a model of FM severity, Goldenberg et al.  evaluateA study by Giesecke et al.  used cluThe purpose of the current study was to initially characterize FM severity from the perspective of individuals with FM and to determine if patients' perception of FM severity is more than simply their pain. We utilized data from a larger FM patient study to conduct a post-hoc exploratory analysis of symptom severity. Data were collected on several self-reported parameters including patient-rated disease severity and the presence of core comorbid conditions, we report here the preliminary evaluation of whether patient self-reported severity of FM is associated with corresponding severity of pain and sleep interference and the presence of core co-morbidities. This patient perspective is also complemented with the results of a small physician survey designed to understand the physicians' perspective by capturing information on what characteristics the physicians use to assess FM severity in their daily clinical practice.Patients were recruited through newspapers, support groups, and the internet as part of a larger patient reported outcome study conducted in the US to Patients were compensated for participation. For inclusion, patients had to be ≥ 18 years of age with a clinician-confirmed diagnosis of FM ≥ 3 months . Clinicians could be either specialists or general practitioners, and was likely dependent upon the duration of FM since diagnosis. A current pain rating >2 on a 0-10 numeric rating scale (NRS) from the modified Brief Pain Inventory short form (mBPI-sf)  was alsoth 2007).Responses to questions were obtained using a mail-in mail-back questionnaire. Subjects interested in participating were mailed the questionnaires in packets containing written instructions on questionnaire completion and guidance for frequently asked questions. In addition, a researcher from Mapi Values contacted the subjects to review the materials and ask if they had questions on completing the forms. Subjects were also provided a toll free number to call for study-related questions. All study screening materials, informed consent, demographic forms, protocol and other study documents were submitted and approved by the Copernicus Group Institutional Revew Board (IRB), an independent IRB  and provided an evaluation of their current pain severity using the 11-point NRS. Sleep interference was assessed using the sleep interference item from the mBPI-sf, a 0-10 NRS that asks "How, during the past 24 hours, pain due to your fibromyalgia has interfered with your sleep?" Cutoff scores of 0-3, 4-6, and 7-10 were used to characterize mild, moderate, and severe NRS ratings, respectively. These cutpoints were used since they have been previously identified as being optimal for classifying pain in a neuropathic pain condition  . AdditioPatient responses and scores were stratified by self-reported FM severity. Analysis of variance (ANOVA) was used to explore the relationship between self reported FM severity and the continuous variables of pain severity and sleep interference scores, and Mantel-Haenszel chi-square analysis was used to test for trend in the proportions of patients reporting use of medications and core symptoms of FM by severity of FM.as a condition in your patients, what are the top 5 items  that influence your decision-making?" Descriptive analysis was used to evaluate the rankings by proportion of physicians reporting each criterion.To complement the characterization of FM severity as reported by patients, the results of a small, separate physician survey are presented that aimed to explore FM severity from the perspective of the clinician. This survey was performed among 28 physicians considered experts in their respective specialties . The physicians were asked to respond to the question "When you assess the severity of fibromyalgia A total of 129 patients were enrolled in the study, and the demographics . Sleep interference scores were higher (i.e. greater severity) than pain scores at all levels of FM severity.While 111 patients (86.0%) reported their FM severity as being of at least moderate intensity (45.7% moderate and 40.3% severe), 3 patients (2.3%) and 12 patients (9.3%) reported very mild and mild severity, respectively. Due to the low number of patients in the very mild category, this category was collapsed into the mild category representing 15 patients (11.6%). Data were missing for 3 patients (2.3%). The mean NRS scores from the mBPI-sf suggested current pain of moderate severity (6.40 ± 2.19), and pain-related sleep interference that was severe (7.28 ± 2.23). As shown in Figures Similarly, at higher levels of self-reported FM severity, there was a corresponding increase in the proportion of patients who used medications for their FM and who reported core comorbidities including sleep problems, depression and anxiety, and back and neck pain Table . Among pFM severity was also significantly associated with duration of FM since initial diagnosis  may have contributed to this lack of concordance.Although functional disability was ranked second and fatigue was ranked third, these criteria were used overall by 54% and 39% of physicians, respectively. These particular criteria, although identified by physicians, were not assessed in patients as part of the patient survey, and may be considered a limitation of the study, especially since fatigue is a frequent complaint among patients with FM . Indeed,as a condition in your patients, what are the top 5 items  that influence your decision-making?"), physicians were not specifically queried as to how these assessments are made. It should be noted that objective clinical assessment using tender points was cited by only 18% of the physicians, and that nearly all the other criteria were patient-centric. The variety of criteria that these physicians, who routinely treat FM patients, reported using and the lack of concordance on their use, reinforces the need to define what constitutes an adequate measure of FM severity. Being able to define and measure FM severity may have practical benefits in terms of understanding disease progression and evaluating treatment approaches for their potential ability to slow progression. The ability to slow progression is likely to have a broader clinical and economic impact by reducing health resource utilization and associated costs.Since physicians identified and ranked criteria in response to a question , and these levels were mainly associated with FM duration ≤ 1 year, for which the proportion of patients was also correspondingly small (15.9%). Because of these low proportions, the current analysis may have had limited power to evaluate correlations at this end of the severity spectrum.Furthermore, while the assessments were specific for the variables measured, only single items were used for most of the variables, potentially restricting interpretation of our findings. Additionally, for those outcomes evaluated based on an NRS score (i.e. pain and sleep interference), there is no validation of cutoff scores designating severity levels. Therefore, it cannot be definitively stated that a particular self-reported FM severity level correlated with a similar severity of pain or sleep interference. However, extrapolation of pain ranges for the mBPI-sf  that were validated for a neuropathic pain condition, diabetic peripheral neuropathy , suggestThe fact that patients were compensated for participation may have introduced additional bias, since it is not known what effect the use of compensation may have had on the selection of patients. Consequently, the results reported here may not be generalizable to the overall FM population. The small number of patients, although representative of various regions of the US, may also contribute to the lack of generalizability. There were a disproportionate number of female participants, with the implication that gender bias may have skewed the data, since gender differences may be operative in the perception and report of pain as well as in the determinants that contribute to self-rated health status -34. HoweThis study explored the patient and physician perspective of FM severity. With greater patient reported FM severity, there was an increase in other patient reported variables including pain and sleep interference, presence of comorbid conditions and use of medications for FM. This study also suggests that physicians use different domains to rank FM severity. Both these findings need to be validated in further studies. When evaluating severity of FM, physicians should consider the patient perspective.Drs. Alvir, Sadosky, and Zlateva are all employees of Pfizer, Inc. Drs. Evans and Yeh are employees of Mapi Values Inc. and received financial support for this project. Dr Silverman is a consultant to Pfizer and Lilly. Dr. Silverman did not receive financial support for this project.CE and YY designed and initiated the study, and participated in the interpretation of results and manuscript development. SS participated in the interpretation of results and manuscript development. JMJA and YY performed the statistical analyses for the project. AS and GL participated in the analysis and discussion of results, and contributed to manuscript development. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/66/prepub


This review explores the aetiology of temporomandibular disorders and discusses the controversies in variable treatment modalities.Pathologies of the temporomandibular joint (TMJ) and its' associated muscles of mastication are jointly termed temporomandibular disorders (TMDs).TMDs present with a variety of symptoms which include pain in the joint and its surrounding area, jaw clicking, limited jaw opening and headaches. It is mainly reported by middle aged females who tend to recognize the symptoms more readily than males and therefore more commonly seek professional help.Several aetiological factors have been acknowledged including local trauma, bruxism, malocclusion, stress and psychiatric illnesses. The Research Diagnostic Criteria of the Temporomandibular Disorders (RDC/TMD) is advanced to other criteria as it takes into consideration the socio-psychological status of the patient.Several treatment modalities have been recommended including homecare practices, splint therapy, occlusal adjustment, analgesics and the use of psychotropic medication; as well as surgery, supplementary therapy and cognitive behavioural therapy. Although splint therapy and occlusal adjustment have been extensively used, there is no evidence to suggest that they can be curative; a number of evidence-based trials have concluded that these appliances should not be suggested as part of the routine care.Surgery, except in very rare cases, is discouraged since it is the most invasive alternative; recent studies have shown healthier outcome with cognitive behavioural therapy. The temporomandibular system consists of two fundamental components; the temporomandibular joint (TMJ) and the associated neuromuscular system. A temporomandibular disorder (TMD) can result from any defect of one or both. Any problem that prevents this composite system of muscles, bones and joints from 'working in harmony' may result in this disorder. Symptoms may be unilateral or bilateral and involve the face, head or jaw .Two commonly used classification schemes exist. The American Academy of Orofacial Pain (AAOP) classification divides TMD broadly into: (1) muscle-related TMD (myogenous), and 2) joint-related TMD (arthrogenous). The 2 types can be present at the same time, making diagnosis and treatment more testing. The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) also exist. The RDC/TMD criteria comprise a highly well thought-out method  of obtaining a diagnosis along two separate axes. Axis I score provides the clinical diagnosis; while Axis II score provides an evaluation of mandibular function, psychological status, and level of TMD-related psychosocial disability  joint-re.This review discusses the aetiology, diagnosis and the controversies surrounding the most commonly used treatment modalities in temporomandibular disorders due to muscle disorders and dentition-related aspects.Temporomandibular disorders (TMDs) encompass the most common non-infective pain conditions of the orofacial region . StudiesIt has been well documented that females are more aware of the symptoms and as a result outnumber males in many studies . PrevaleDe Kanter et al.  carried A TMD is clinically characterised by pain in the temporomandibular region or in the muscles of mastication, pain radiating behind the eyes, in the face, shoulder, neck and/or the back, headaches, ear ache or tinnitus, jaw clicking, locking or deviation, limited jaw opening, clenching or grinding of the teeth, dizziness and sensitivity of the teeth lacking oral disease ,12. The Several diagnostic stipulations are included under orofacial pain, including chronic headache , neck ache, temporomandibular joint pain dysfunction syndrome, facial arthromyalgia, myofascial face pain, internal derangement of the joint, degenerative joint disease, and there is degree of overlap with atypical odontalgia (phantom tooth pain), oral dysaesthesia , atypical facial pain ,6,11,13,Temporomandibular disorders rarely have a solitary cause and numerous factors have been implicated. This is further compounded by the patient habitually reporting several problems during history taking and clinical examination.Acute trauma such as road traffic accidents is known to cause damage to the TMJ and/or related muscles of mastication. Traumatic injuries from eating, wide jaw opening and dental management have also been reported as possible aetiological factors, but there is diminutive objective evidence to sustain this. At times, trauma to the joint can cause chronic injury which may eventually lead to a TMD .Previous head and neck injury may be a characteristic in patients with TMDs  as well There may be an increased occurrence of generalized joint hypermobility in some TMDs groups . AlthougInitial speculations regarding traditional orthodontic treatment and its probable association with TMDs were groundless. Investigations documented that there was no increase in the prevalence of the TMDs following orthodontic treatment .Patients anguished by TMDs as a result of trauma were compared to TMD patients with a non-traumatic aetiology in a multi central trial . Trauma Bruxism, the most frequent factor found in TMDs, refers to a non-functional grinding and clenching of the teeth. Individuals usually clench their teeth when they are sleeping, but this can occur at some stage in early awakening; constant clenching leads to the wearing of the enamel layer. Symptoms are severe on awakening and over time, the continuous pressure can damage the TMJs .Other parafunctional habits comprise biting foreign objects, pressing the tongue against the teeth and lip biting. These may have a variable and possibly insignificant association with TMDs . The assGlaros et al.  induced Inappropriate pressure can be placed on the joints when teeth are not biting in harmony. Missing teeth may further contribute to this trouble whilst misaligned teeth can also put strain on the jaw muscles. However, the effect of malocclusion was challenged  since thAn anterior openbite is uncommon in symptomatic individuals and, on joint radiography, is not significantly linked with articular disc displacement (i.e. causing a click), with or without reduction of movement. Similarly no notable association has been demonstrated between the degree of dental overjet or overbite and TMDs, and most studies reported no better predominance of crossbite in adults with TMDs when compared with control subjects . HoweverSeveral, but not all, studies of TMD patients have suggested an association between molar loss and pain, clicking and progression to locking. However, there is little correlation between loss of molar support and TMD symptoms in randomly selected individuals . IncidenThere may be a higher frequency and severity of TMDs in patients with restored dentitions compared with those with intact dentitions, but the precise contribution to TMDs aetiology is unclear . SkeletaA systematic review of population-based studies was conducted  to instiA study by Gesch et al.  aimed toStressful life events have been more frequently reported in a group of TMDs patients than in non-affected control group  classification divides TMD broadly into myogenous, sometimes this is called TMD secondary to myofacial pain and dysfunction, and arthrogenous TMD, that is TMD secondary to true articular disease. Myogenous TMD is more common. In its pure form, it lacks apparent destructive changes of the TMJ on radiograph and can be caused by multiple aetiologies such as bruxism and other dentition-related aspects as well as stress and anxiety .Furthermore, there are 3 other pain classifications used for the orofacial region: the International Association for the Study of Pain Classification System, the International Headache Society Classification System and the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) . The RDCSeveral studies have shown that clinicians tend to focus more on the physical component of the examination. The introduction of Research Diagnostic Criteria (RDC) for TMDs transfigured the conventional criteria and lead to an accurate diagnosis of this disorder. This dual-axis system proved to be finer to other instruments, since it can be used to grade and measure both physical and psycho-social components .The RDC for TMDs comprises a complete temporomandibular system examination to be performed by specialists, maxillofacial surgeons, in the field. Additionally, patients are also asked to complete a self-reported 31-item questionnaire . The patPalpation of the lower head of the lateral pterygoid muscle is included in many study protocols and examination schemes of the masticatory system; Turp et al.  searchedFurthermore, palpation of the posterior belly of the digastric muscle in the postmandibular region is incorporated in many study protocols and examination schemes of the masticatory system. Turp et al.  concludeAxis II of the RDC/TMD  is usually acquired through self-reported ratings on Likert-type scales and endorsement of symptoms and limitations. Information like pain-related disability, perceived pain intensity, depression, resulting limitations, and non-specific physical symptoms that suggest somatization tendencies are acquired through this phase. One index of the RDC Axis II, the Graded Chronic Pain Status (GCPS), records both the pain perceived and to which extent it disables the patient; hence TMD patients can be classified as functional  or dysfunctional ; also the GCPS demonstrates how the perception and appraisal of pain affect behaviour ,45.Pain measurement in TMD patients was evaluated through four pain scales: Visual Analogue Scale (VAS), Numerical Scale (NS), Behaviour Rating Scale (BRS) and Verbal Scale (VS). It was concluded that NS was more precise in measuring the reproducibility of pain. However concern was reported because of the subjective aspect of pain measurement, the lack of a "gold standard" for comparison and the expected fluctuation of TMD symptoms. Visual Analogue Scale and Verbal Descriptor Scale were found uncertain in the objective measurement of TMD pain .Diagnostic measures with regard to problems involving the TMJ and related structures remain a controversial subject. Although radiographs, CTs (computed tomography) and MRI (magnetic resonance imaging) were established as being of immense diagnostic value in group II and III of RDC/TMD; they were unsuccessful in patients diagnosed with muscle disorders (Group I) ; MRI wasOther diagnostic procedures including electronic registration (myomonitor), neuromuscular junction testing, somatosensory testing and thermography were recommended by some authorities; but it is accepted universally that diagnosis of Group I (RDC/TMD) patients is primarily based on clinical examination and patient account of pain ,48,49.Turner et al.  examinedThe reliability of clinical TMDs diagnosis using standardized methods and operational definitions contained in the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) was assessed. Data came from reliability assessment trials conducted at 10 international clinical centres, involving 30 clinical examiners assessing 230 subjects. Intraclass correlation coefficients (ICC) were calculated to typify the reliability. The research group concluded that the RDC/TMD demonstrates adequately high reliability for the most common TMDs diagnosis, supporting its use in clinical investigations and decision making .Schmitter et al.  studied Another study evaluated whether non-specialist examiners could reliably use the physical assessment methods described in the RDC/TMD. Screening examinations were performed on patients with self-reported TMD symptoms by two examiners using techniques specified in Axis I of RDC/TMD diagnostic criteria. Both examinations and diagnostic classification were carried out separately and blindly; reliability of the examiners was tested with suitable parametric and non-parametric techniques. Using the examination and diagnosis procedures specified in the RDC/TMD, meticulous non-specialist examiners could assign diagnostic labels to the major subcategories of TMDs with a reasonable level of reliability .A multi-central Italian TMD study  on 210 cRDC/TMD Axis II was evaluated in a randomized clinical trial ; only suYap et al.  comparedTreatment strategies for TMDs are as diverse as the patients that present with it. Each patient is treated in a different way depending on the distinctiveness of the problems. A treatment is aimed towards symptomatic relief and not cures, since most of the conditions that affect the temporomandibular system are irremediable. One should utilize first conservative and reversible treatment; and if this failed, irreversible treatment such as surgery should be offered but only in extreme conditions.Phillips et al.  assessedHomecare practices are number one for most clinicians. However there is a lack of data with reference to their precise clinical benefit in the treatment for TMDs. Commonly used homecare measures may include avoidance of excess chewing, change to a soft consistency diet, limited talking, and avoidance of wide yawning, use of physical therapy such as local application of ice for acute pain or heat for low-grade chronic pain , muscle Physical therapy can also be delivered by a physiotherapist, which might include repetitive active or passive jaw exercises, thermal modalities, manipulation, vapour coolant, spray-and-stretch technique and electro-galvanic stimulation ,62,64.Splint therapy is one of the most debated issues in the management of TMDs . A varieHard acrylic splints may be efficient in reducing muscle and joint pain in up to 87% of studied patients  but are Flat plain splints may speedily lessen nocturnal bruxism  and someOnly about 50% of the clicking, painful joints may be appropriate for repositioning therapy, hence quantifiable benefit is unlikely in all treated cases , and theThe reduction in pain may  be due to the forward positioning of the disc, allowing the retrodiscal tissue space to repair, but, if the retrodistal tissues have not fully repaired when the condyle is returned to the fossa, there will be additional inflammation .Soft splints may diminish TMD-related headaches and clicking , but theA randomised control trial by Dao et al.  evaluateAl-Ani et al.  examinedAnother study was designed to provide an answer to two clinical questions related to patients with masticatory muscle pain: 1) does the use of a full-coverage hard acrylic occlusal appliance (stabilization splint) lead to a significant decrease of symptoms? and 2) is the treatment success achieved with a stabilization splint more pronounced than the success attained with other forms of treatment (including placebo treatment) or no treatment? Thirteen publications, representing nine controlled clinical studies, were identified. Based on the currently best available evidence it appears that most patients with masticatory muscle pain are helped by the incorporation of a stabilization splint. Nevertheless, evidence is equivocal if improvement of pain symptoms after incorporation of the intraoral appliance is caused by a specific effect of the appliance. A stabilization splint does not appear to yield a better clinical effect than a soft splint, a non-occluding palatal splint, physical therapy, or body acupuncture .Occlusal adjustment involves repositioning the mandible in a centric position by prosthodontic or orthodontic means and/or occlusal equilibration. Most studies have only assessed short-term outcome . HoweverForssell et al.  investigA Swedish randomized control trial found that TMD pain in adults could best be improved by traditional treatment with occlusal appliance combined with concise information. The study by Wahlund et al.  also estEarlier, Koh and Robinson ,89 reviePain, and possibly inflammation, may be controlled by non-steroidal anti-inflammatory drugs (NSAIDs) , but theReferral for psychiatric assessment and suitable therapy is an important component of TMD management . A numbeOther suggested agents include 'amitriptyline'  and 'triThere is no evidence for the long-term efficacy of surgical treatment in controlled studies of TMDs, although improved functioning has been reported in an 8-year follow-up post-surgery in 70 patients . A 30-yeThe long-term outcomes of three different surgical treatments for internal derangement of the temporomandibular joint (TMJ), i.e., discoplasty, discectomy without replacement, and discectomy with replacement of the disc with a Proplast-Teflon interpositional implant (PTIPI) were compared by Trumpy and Lyberg. Decrease of symptoms after surgery was reported by 77%, 94%, and 83% of the patients, respectively. Mouth opening increased in 50% to 60% of the patients. The percentage increase ranged from 15% to 26% in the respective groups. Development of osteoarthrosis after surgery was demonstrated in 93% and 100% of the cases in the discectomy and discectomy/disc implant group, respectively, but only in 62% of the discoplasty group . EarlierAcupuncture therapy, dry needling and trigger point injections may provide some reduction in local pain and tenderness, but this benefit last less than six months . MandibuFour independent computerized literature searches were performed . Only raTherapeutic ultrasound may benefit some individuals with TMDs but there appears to be few, if any, controlled studies ,106. SimStudies of transcutaneous electrical nerve stimulation (TENS) have often lacked suitable control groups, have involved small samples, and have used inappropriate methods of assessment . Other mElectromyography (EMG) has been extensively used in conjunction with relaxation and biofeedback therapy. Current data suggests that, whilst EMG biofeedback may provide some control of nocturnal bruxism, the benefit seems to be short-term. Diurnal biofeedback relaxation is ineffective in reducing nocturnal bruxism . The effA randomized controlled trial by Carlson et al.  evaluateShi et al.  assessedSycha et al.  comparedHypnorelaxation has a potentially beneficial effect in the treatment of masticatory myofascial pain disorders (MPD). Winocur et al. evaluated the effectiveness of hypnorelaxation in the treatment of MPD compared with the use of occlusal appliance and/or to minimal treatment. They showed that both active treatment modes  were more effective than minimal treatment regarding alleviating muscular sensitivity to palpation. However, only hypnorelaxation  was significantly more effective than minimal treatment with regard to the patient's subjective report of pain on the Visual Analogue Scale .Cognitive Behavioural Therapy (CBT) aims to enable individuals to better manage their difficulties by applying empirically researched principles of thoughts, feelings and behaviours. These principles translate into practical strategies, which can lead to changes in subjective and objective thoughts, feelings and behavioural states.Interventions in cognitive behavioural therapy include: goal setting, challenging negative automatic thoughts, relaxation and breathing exercises, cognitive visualisation exercises, behavioural coping strategies, stress management and assertion skills.Cognitive behavioural therapy is an effective approach for the management of many conditions including stress, anxiety, depression, mood swings, panic attacks, phobia, post-traumatic stress disorder, eating disorders, insomnia, inadequate coping skills, substance abuse, chronic pain conditions ,113 overCognitive therapy produced continued improvements in pain up to six months after a six-week treatment programme consisting of an intra-oral appliance and stress management with biofeedback, compared to the same programme with non-directive supportive counselling, in a group of TMD patients classified as "dysfunctional" .Dworkin et al.  examinedTMDs and especially muscle disorders are common condition, particularly in young women, and involve pain in the TMJ and/or associated masticatory muscles. The most recommended diagnostic criterion is the RDC/TMD in which assessment of distress and disability, psychological and social factors may be useful in providing an exact diagnosis. Diagnostic techniques of muscle disorders proved to be unaccommodating, so clinicians rely on patients' self-reporting as well as clinical examination.Treatment can range from simple homecare practices, splint therapy, occlusal adjustment, analgesia to psychotrophic medication and rarely surgery. Other treatment modalities like complementary therapy, therapeutic ultrasound and electromyography have been found to be effective but are less commonly used. Cognitive behavioural therapy was found to be very effective in treating TMD; however the reverse outcome was found with the use of splint therapy and occlusal adjustment in TMD.The authors declare that they have no competing interests.WJ, TU, SA, PK, MV, JR, EM contributed to conception and design, designed the review, carried out the literature research, and manuscript preparation. NA, CH contributed to conception and design, carried out the manuscript editing and manuscript review. All authors read and approved the final manuscript.


P = 0.004). PSA ‘response’ occurred in 30 patients (37%) over 4 months after Sr-89. This did not appear to correlate with clinical improvement. This study supports the presumption that improvement in pain following Sr-89 is accompanied by better QoL. The lack of correlation of PSA response and clinical parameters indicates that in the palliative setting, PSA may not provide a useful surrogate for treatment outcome. © 2001 Cancer Research Campaign http://www.bjcancer.com93 patients with hormone refractory metastatic prostate cancer were entered on a prospective study to measure reduction in pain and changes in quality of life (QoL) after the administration of 150 MegaBequerel (MBq) Strontium-89 (Sr-89). QoL was assessed using a validated instrument, the Functional Living Index – Cancer (FLIC) questionnaire. Pain response was measured using the Radiation Therapy Oncology Group scoring system. Overall there was limited QoL improvement over 3 months following Sr-89. However, in the 53 patients (63%) achieving pain responses, QoL did significantly improve within 6 weeks of receiving Sr-89 compared to patients with stable or worsening bone pain, and this was independent of other parameters that might influence QoL outcomes, such as performance status, baseline PSA and extent of skeletal disease (


Background and purpose Methods for identification of patients with illness behavior in orthopedic settings are still being debated. The purpose of this study was to test the association between illness behavior, depressed mood, pain intensity, self-rated disability, and clinical status in patients with chronic musculoskeletal pain (CMP).Methods We examined 174 consecutive sick-listed patients (90 women). Musculoskeletal function was estimated by range of motion, muscle strength, and motor and sensory function. The degree of illness behavior was measured by Waddell signs (WS).Results WS were observed in 47/174 (27%) of the patients, 16% of whom manifested excessive illness behaviour. In general, more patients with WS were depressed  and experienced greater pain . No abnormal physical function could be observed in two-thirds of the patients. Other predictive factors for manifesting WS at the clinical examinations were longer sick leave and previous full sick leave (p < 0.05).Interpretation Excessive illness behavior is related to psychological distress in patients with CMP and long-term disability. Thus, some patients may also require psychological assessment. Looking for WS during consultation is useful for targeting other factors that may be important in the diagnostic process. Illness behaviour has been defined as “the discrepancy between the presence of objective somatic pathology and the patient's response to it” . It has Chronic musculoskeletal pain (CMP) is not just a physical disease, but an illness in which the physical disorder is combined with many somatic and psychosocial factors . The selWe studied the third factor, behavior, and tested the association between illness behavior, depressed mood, pain intensity, self-rated disability, and clinical status in patients who were on long-term sick leave due to CMP.We examined 174 consecutive patients (90 women), mean age 45 (23–63) years, who had been on sick leave for 19 (3–96) months. 94 of the patients were born in Sweden and 80 were immigrants. They were all referred from the Social Insurance Office to the Diagnostic Center at Lundby Hospital, Gothenburg, Sweden for a thorough orthopedic evaluation, including an assessment of the capacity to work. All patients were invited to participate in the study. We received their verbal consent before the orthopedic examination. Only patients who could read and write Swedish were invited to complete the questionnaires: the Disability Rating Index (DRI) , which wPain intensity was estimated by a Likert scale (VRS): none (0), mild (2.5), moderate (5), severe (7.5), and very severe (10). The patients' pain drawings (PPD) showed the location of their pain. There were no statistically significant differences between the ratio of complete data and missing data for the BDI scores, the DRI scores, the pain intensity, the duration of sick leave, or the degree of capacity to work . When these variables were compared by sex and origin of the participants, we found no differences between complete data and missing data .Measurements of physical function included range of motion of the cervical and lumbar spine, all major joints of the upper and lower extremities, and all involved joints as indicated by the PPD. Muscle strength in the lower extremities, shoulder, elbow, and wrist joints was assessed manually. Strength of hand grip was measured with a vigorimeter. Muscle volume was measured by noting the circumferences of the upper and lower extremities. Reflexes, motor function, and sensory function were measured by clinical means. All pain locations (as indicated by PPD) were investigated by palpation as part of the clinical evaluation. Most patients had a wide variety of symptoms and all except 1 had more than 2 pain locations. In making a diagnosis, the results of imaging methods were also taken into account. The diagnostic criterion defined in the ICD-10 was used.The capacity to work. The assessment of the capacity to work in Sweden is a standard procedure, the purposes of which are to determine the cause of sick leave, the degree of disability, and the goals for rehabilitation . Wadell Signs (WS) has been proposed as a tool for the orthopedist to screen psychosocial distress, basically somatization problems in patients with CMP. The following criteria for WS were used in all 174 patients (patients : (1) compatients . Inter-rThe measured variables BDI, DRI, WA, pain intensity, and WS did not have a normal distribution. Thus, we used non-parametric tests: Mann-Whitney test, Kruskall-Wallis median tests, and Spearman correlation coefficients. Categorical data were compared using the chi-squared test. We performed logistic regression analyses  to test the association between WS and BDI, DRI, duration of sick leave, pain intensity at rest, previous capacity to work, and clinical findings, by adjusting for age. The median value was used for ordinal data  as a cutoff point. We built 2 models. The first included depression, duration of sick leave, and previous capacity to work. The second included duration of sick leave, pain at rest, and self-rated disability instead of depression because of the positive correlation between DRI and BDI. Sickness absence was included as a confounder in the association between WS and distress. All p-values reported are 2-sided and significant at the 5% level (< 0.05).The sensitivity, specificity, positive predictor value (PPV), and likelihood ratios (LRs) were calculated using the BDI, the DRI, and the VRS questionnaires as reference standards. The LR tells how much the pretest probability (i.e. the known reference standards) decreases or increases; thus, an LR of 1 or close to it does not change the pretest probability whereas an LR of > 1 increases it .Waddell signs (WS) were observed in 47/174 (27%) of the patients. 1 or 2 WS were observed in 11%, and 3 to 6 WS in 16%. The mean and median values for WS were 3.4 and 3 (range 1–6). The mean number of WS was 4 in patients who were depressed and 2 for other patients (p < 0.001). The mean values of pain intensity, BDI score, and DRI index were higher for patients with WS than for patients without WS .88% of the patients with WS and 71% without WS were unfit for work (i.e. were on full sick leave). A 25–75% capacity to work  was observed in 12% of the patients with WS, as compared to 30% in patients without WS. The logistic regression analyses showed that patients with previous partial capacity to work (50–75%) were less likely to manifest WS during the orthopedic examination than patients with previous inability to work . WS was associated with greater ratings (≥ 7.5) of pain intensity at rest  . The Spe71% of the patients with excessive illness behavior had depressed mood . The probability of manifesting WS during consultation was 4 times higher in patients with a BDI score of >18 than in patients with a BDI score of less than 18 . The disability rating index was also associated with WS. The higher the DRI scores, the greater the probability of manifesting WS during the clinical examination .67% of patients experienced pain in the neck and shoulders, 21% in the lower back, and 12% in other locations. Accompanying back pain was reported in two-thirds of patients who experienced pain in the neck and other locations. There were no differences between the location of pain and WS . All patients reported musculoskeletal pain on palpation. Normal neuromuscular function was observed in 117/174 (67%) of the patients at clinical investigation. The clinical diagnosis for most of the patients was unspecific pain in the neck and back . Minor impairment was documented in 57/174 (33%). According to imaging, few of our patients had spondylosis in the cervical and/or lumbar spine. None of the patients had clinical signs indicating foraminal stenosis.More patients 31/80 (39%) with a non-Swedish background manifested WS than Swedish patients 16/94 (17%) . The mean BDI score for patients with a non-Swedish background was 26 (SD 13), as compared to 17 (SD 11) for Swedish patients (p < 0.001). Moreover, patients with a non-Swedish background rated their pain intensity to be greater than for Swedish patients . There were no associations between WS and sex or age.The ability of the WS test (i.e. specificity) to detect those patients without psychological distress was in the range of 84–88%; however, the sensitivity was poor (< 60%). The proportion of correctly screened patients with psychological distress (PPV) was in the range of 72–88% .The LRs for positive WS varied from 2.6 to 2.7. We found that patients with higher scores on the DRI (> 63) were almost 3 times more likely to manifest WS than those with scores lower than 63. Patients with higher scores regarding intensity of pain (> 7.5) were more likely to manifest WS (LR = 2.7). Moreover, patients who had depressed mood were almost 3 times more likely to manifest WS than others .We found that one quarter of our patients with CMP manifested WS. This is consistent with other studies, which have reported excessive illness behavior in 12–36% of patients with chronic neck pain and low back pain and in up to 50% of subjects undergoing work disability assessment for worker's compensation . The WadIllness behavior does not exclude organic genesis of pain, but indicates distress. 3 or more WS signs may indicate psychosocial issues, pain behavior, or excessive illness behavior . Half ofWe confirm the association between WS and poorer physical performance, which is consistent with previous research . Two-thiIn the present study, the WS test showed high specificity and gave PPV values with acceptable LRs when BDI, DRI, and pain scores were used as reference standards. These subjective scores may reflect psychological distress. We belive that WS may help clinicians to identify psychological distress, which if it is left untreated may impede recovery.The main limitation of our study is the selection of the participants who were referred by the Social Insurance Office. The Office requested a second evaluation of the patient's capacity to work. Thus, among these patients we could expect a greater prevalence of illness behavior, greater disability, and greater pain intensity than in other clinical settings. Moreover, the direction of the association between WS and the variables under study could not be determined due to the cross-sectional design. Furthermore, the observation of WS does not itself constitute a psychological evaluation. The lack of a reliability test is an important limitation of the present study. Previlously, good reliability and validity of the WS had been reported for predicting psychological problems in patients with chronic pain . Even soSick-listing in itself is ineffective as a treatment for long-lasting back pain and is associated with high costs in Sweden . There wIn summary, Illness behavior was found to be closely related to psychological distress in patients with CMP who had been on sick leave for a long time. It was associated with depression, increased experience of pain, and high self-rated disability. Moreover, it was seen more commonly in immigrants. In two-thirds of the patients with CMP, no physical impairment could be detected. These findings support the importance of the association of pain with WS. Thus, in the process of compensating disability due to CMP, one must take into account an approach that also integrates the behavioural risk factors. Consequently, some patients may also require assessment of the behavioural aspects of their pain. Looking for WS during consultation is a useful tool for targeting other factors that may interfere with recovery from CMP.


Background and purpose With an aging population expecting an active life after retirement, patients’ expectations of improvement after surgery are also increasing. We analyzed the relationship between preoperative expectations and postoperative satisfaction and self-reported outcomes with regard to pain and physical function after knee arthroplasty.Patients and methods 102 patients (39 men) with knee osteoarthritis and who were assigned for TKR (mean age 71 (51–86) years) were investigated with KOOS, SF-36, and additional questions concerning physical activity level, expectations, satisfaction, and relevance of the outcome to the patient. These investigations took place preoperatively and postoperatively after 6 months, 1 year, and 5 years of follow-up.Results Response rate at 5 years was 86%. In general, the patients’ preoperative expectations were higher than their postoperative ability. For example, 41% expected to be able to perform activities such as golfing and dancing while only 14% were capable of these activities at 5 years. Having high or low preoperative expectations with regard to walking ability or leisure-time activities had no influence on the KOOS scores postoperatively. 93% of the patients were generally satisfied 5 years postoperatively, while 87% were satisfied with the relief of pain and 80% with their improvement in physical function at that time.Interpretation With an expanding population of mentally alert elderly, we can expect that great demands will be put on joint replacements. This study shows that patients have high preoperative expectations concerning reduction of pain. To a considerable extent, these expectations are fulfilled after one year. Expectations concerning demanding physical activities are not fulfilled to the same degree; however, most patients reported general satisfaction with the outcome indicating that satisfaction is not equivalent to fulfilled expectations. Preoperative counseling should include realistic information on outcomes concerning physical function and pain relief. Osteoarthritis (OA) severely affects overall health and health-related quality of life . The mosIt is well known that the concerns and priorities of patients differ from those of surgeons and that surgeons are more satisfied than patients with the results of TKR and THR  . KnowingQuestions have been raised about the importance of patients’ preoperative expectations concerning the postoperative outcome . With anIt is not always clear, however, what constitutes a realistic expectation. To shed light on this, one must ask the patients about their expectations in relation to their way of living. When we know about their expectations and the results of surgery, it is possible to decide whether the expectations were realistic or not. Identifying patients’ expectations has a number of benefits, including improvement of patient satisfaction .The main aim of this study was to analyze the relationship between preoperative expectations and self-reported improvement of physical function and pain 6 months, 12 months, and 5 years after TKR. The second aim was to investigate the relationship between preoperative patient characteristics and satisfaction after TKR.123 consecutive patients who were on the waiting list for a primary TKR, because of osteoarthritis (OA), at the Department of Orthopedics at Lund University Hospital, Sweden, were sent questionnaires by mail. Patients were recruited from December 1999 through April 2001. 21 patients were excluded: 13 underwent other operative procedures and 8 were not operated during the study period. Thus, preoperative data were available for 102 patients (63 women) with OA of the knee .The study was approved by the Ethics Committee of Lund University (LU 458-99).All questionnaires were mailed to the patients and returned by mail in prepaid envelopes. The questionnaires consisted of one disease-specific questionnaire (the Knee injury and Osteoarthritis Outcome Score (KOOS)), one generic questionnaire (the SF-36), and questions on the relevance of improvement of the following KOOS subscales: expectations, satisfaction, and patient characteristics. The patients received questionnaires preoperatively and after 6 months, 12 months, and 5 years. Longitudinal outcome data from KOOS and SF-36 have been reported elsewhere .KOOS. The KOOS method of scoring is an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) ( (WOMAC) . KOOS wa (WOMAC) , but it  (WOMAC) . KOOS is (WOMAC) .SF-36. The SF-36 is a widely used generic measure of outcome  no household work: TV and reading only; (1) minimal household work, card games, sewing; (2) light yard work, light household work, shopping; (3) heavy yard work, heavy household work; (4) golf, dancing, hiking, water aerobics; (5) recreational sports; (6) competitive sports.Preoperatively, when deciding to have the operation, questions were asked about the relevance of pain relief, reduction in other symptoms, improvement in activities of daily living (ADL) function, improvement in sports and recreational function, and improvement in knee-related quality of life (QOL) (i.e. improvement in the 5 different KOOS domains). Responses were graded on a 5-point Likert scale ranging from extremely important to not important at all.Preoperatively, expectations were assessed in relation to walking ability and leisure activities and in relation to the 5 above-mentioned KOOS domains: pain, other symptoms, ADL function, sports and recreation functions, and knee-related QOL. Patients were also asked to estimate the time to postoperative recovery.Expectations of walking ability were graded on a 6-point Likert scale from need for crutches or other devices to walking unlimited on uneven terrain. Expectations of leisure activity were graded on a 7-point Likert scale from “doing no household work” to “engaging in competitive sports”.Expectations, in relation to the KOOS subscales, were graded on a 5-point Likert scale ranging from “much less” to “much more” for pain and other symptoms; and ranging from “much better” to “much worse” for ADL, sports and recreational activities, and knee-related quality of life.Postoperatively, questions were asked regarding the change experienced in each of the 5 KOOS subscales. The answer options related to the subscales pain and other symptoms ranged from “much less” to “much more”, and for ADL, sports and recreational activities, and knee-related quality of life they ranged from “much better” to “much worse”.Postoperatively, 1 question was asked about satisfaction with the result in general. The responses were graded on a 5-point Likert scale from “totally satisfied” to “very dissatisfied”.5 other questions were asked about satisfaction in relation to the 5 domains of the KOOS . Responses were graded in the same way on a 5-point Likert scale from “totally satisfied” to “very dissatisfied”.To describe the results, continuous outcomes are given as mean (SD) and range. Ordinal outcomes are given as percentages. To study the differences between preoperative expectations and fulfilled expectations, McNemar test was used. To study the possible influence of preoperative expectations on postoperative outcome, the patients were dichotomized in 2 groups: those having high expectations of improvement in walking ability and leisure activities and those having low expectations. For these comparisons, we used the Mann-Whitney U-test. Spearman’s rank correlation was used for correlations of preoperative expectations of pain relief and improvement in ADL function to age, BMI, and number of co-morbidities. The Mann-Whitney test was used for gender associations.To investigate the possible influence of preoperative characteristics on postoperative satisfaction correlations were made between the preoperative characteristics: KOOS subscales pain and ADL, the SF-36 subscales PF, BP, and GH, age, BMI and number of co-morbidities and postoperative satisfaction in relation to the 5 KOOS domains using Spearman’s rank correlation test.To study the difference in physical function (KOOS ADL and SF-36 PF) at the 5-year follow-up between those who reported low back pain, arthritis-related pain, pain in their hips, or pain in their knees, we used the Mann-Whitney U-test. Statistical analysis was done using SPSS version 14.1.At the 5-year follow-up, 9 patients had died and responses were available from 80/93 patients (86%) with a mean age of 76 years . PreoperExpectations of walking ability were better fulfilled than expectations of leisure time activities. Preoperatively, 39% of the patients expected to have unlimited walking ability on even ground. The patients reported the best walking ability 12 months postoperatively, where 28% could walk without limitation on even ground. At 5 years, 21% could walk on even ground without any distance limitations .In general, patients’ expectations about leisure activities were higher than their results at 1 and 5 years after operation. For example, 41% of the patients expected to be able to go dancing and golfing while only 24% reported being able to do so at the 1 year follow-up .Questions concerning ADL function and sport and recreational function were extremely important or very important for 94% and 51% of the patients, respectively. Expectations were higher for ADL function than for sport and recreational function: 96% expected much better or better ADL function while 72% expected much better or better sport and recreational function. There was a greater gap between expectations and reported improvement for sport and recreational function than for ADL at the 12-month follow-up. The best improvement in ADL function was reported at 12 months when 90% reported much better or better ADL function (p = 0.3) while only 25% experienced improvement in sport and recreational function (p < 0.001). At 5 years, 61% experienced improved ADL function (p < 0.001) and 32% experienced improved sport and recreational function (p < 0.001) .Questions concerning pain were extremely or very important for 94% of the patients.Preoperatively, 98% of the patients expected much less or less pain postoperatively. Similarly to physical function, walking ability, and leisure-time activities, the best outcome regarding self-reported pain was seen at the 12-month follow-up when 93% experienced much less or less pain (p = 0.3). After 5 years, 63% experienced much less or less pain than preoperatively (p < 0.001) .Having higher expectations of ability regarding leisure activities was associated with a higher postoperative level of leisure activity and better walking ability. Those who had higher expectations of their ability in leisure activities reported improvement in leisure activities (from level 2 to level 3) (p < 0.001) and improvement in walking ability (from level 3 to level 4) (p = 0.01) at the 5-year follow-up. No single patient achieved a higher level of physical activity than previously anticipated. There were, however, no clinically or statistically significant differences in perceived functional difficulties as measured by KOOS scores for ADL function or for sport and recreational function at 5 years postoperatively when comparing those with high and low expectations of improvement in leisure activities, or when comparing those with higher or lower expectations of walking ability.s = 0.18) and the preoperatively expected change in ADL function and age (rs = 0.20), where older patients had lower expectations. The correlations between the expected change in pain and BMI or number of co-morbidities  and between the expected change in ADL function and BMI or number of co-morbidities , were generally even weaker.There was a weak correlation between the preoperatively expected change in pain and age (rMost patients (93%) were generally satisfied with the result of the operation 5 years postoperatively. The lowest records of specific satisfaction with pain relief, symptom relief, functional improvement, or quality of life were reported for sport and recreational function where only one-third of the patients were totally or quite satisfied at five years .Less preoperative pain was associated with higher postoperative satisfaction for all KOOS subscales. Likewise, better preoperative function and better general health were associated with higher postoperative satisfaction in the KOOS domains pain, symptoms, and ADL. There was a correlation between lower BMI and higher satisfaction with sport and recreation function. No other associations were found between age, BMI, and comorbidities to satisfaction with improvement in the KOOS domains .At the 5-year follow-up, as many as one-third of the patients reported musculoskeletal pain . There wWe found that patients’ high expectations concerning pain relief after TKR were to a great extend fulfilled while their expectations about demanding physical activities were not fulfilled to the same degree.It is known that, despite their age, many knee patients participate in a wide range of recreational activities such as dancing and golfing and are disappointed with the results of joint replacement . These findings are clearly supported by our data where almost all expected improvement in ADL function and as many as three-quarters expected improvement in sport and recreational function.The expectations of patients concerning walking ability and ADL function are fulfilled to a greater extent postoperatively than their expectations concerning more demanding physical activities such as sport and recreation. We found a clear increase in patients’ experience of unfulfilled expectations of physical function between 1 and 5 years, even though there was improvement compared to preoperative function. Our results probably reflect the new generation of patients with OA who expect to continue with an active life for a long time after the operation. Patients may also be influenced by the marketing of new prostheses, the implication being that the patient will achieve a high level of physical activity provided he/she just gets the right implant.The expectations of improvement in physical function were almost as high as the expectations of pain relief . These data are striking, as the primary indication for joint replacement is still pain. The expectations concerning pain were very high, and they were almost fulfilled 1 year after TKR in our study. Thus, expectations concerning pain appear to be realistic—which contrasts with the unrealistic expectations concerning demanding physical activities.Previous studies have also shown a great difference between these two outcome variables, where the degree of pain relief expected has been considerably greater. In the study by The strength of our study is that we assessed the outcomes in a manner that included demanding activities and expectations concerning such activities by using KOOS as outcome measurement. It is also clear that these questions are relevant for the patients. It is notable that even in this elderly population, questions concerning sport and recreational function were relevant for more than half of the patients.Our data make it clear that joint replacement is excellent in terms of treatment of pain but it does not fulfill the patients’ expectations of improved sport and recreational function. Assuming that it is desirable to achieve such an ambition, we must make better efforts concerning postoperative rehabilitation—such as the way in which we treat patients after total hip replacement when we know that postoperative rehabilitation improves the outcome .One can assume that the expectations concerning physical function and pain would be related to age. Our study, as well as the study by Obviously, it is impossible to have any opinion about the patients’ expectations preoperatively without asking for it. There appears to be no relationship between overall severity of preoperative disability  and the patient’s preoperative expectations .The general satisfaction with the procedure was remarkably high 5 years after TKR. However, when the question is broken down further and different domains of satisfaction are separated, another picture presents itself. The patients were least satisfied with their sport and recreational function, which could be a problem in the future with an active elderly population. There was also a tendency of declining satisfaction after 1 year. The decline was more obvious for physical function than for pain. This is an additional reason to assess the outcome with KOOS, where demanding physical activities and leisure activities are taken into consideration.In our study, it appears that general satisfaction mainly concerned pain relief and improved ADL functions, even though patients had high expectations of sport and recreational function. The satisfaction with pain relief was obvious early in the postoperative process while satisfaction with improvement in ADL function was most pronounced after one year.When analyzing the correlation between postoperative satisfaction and preoperatively reported status, we found a significant importance of the self-reported preoperative pain and general health. Individuals with a moderately painful knee before operation and satisfactory general health appear to have been be the most satisfied patients.Fulfilled expectations are not necessary equivalent to satisfaction. The patients in our study were satisfied with the outcome despite unfulfilled expectations. Satisfaction is a complex concept, and it is influenced by many factors but especially by expectations and outcome . GeneralOur study is one of the few studies dealing with patient expectations and satisfaction to have a follow-up period of as long as 5 years. In a previous study, it was stated that to determine the true success of a procedure it is critical to evaluate it over time and that there is a lack of data regarding patients’ expectations for this type of procedure over time . Our stuIn summary, we found that patients’ expectations concerning pain, ADL function, and walking ability were realistic but their expectations concerning sport and recreational function and leisure activities were not. It is important that orthopedic surgeons and physiotherapists inform their patients preoperatively in a way that will give them more realistic expectations of the results of procedures such as total knee replacement.


Neck pain is a highly prevalent condition resulting in major disability. Standard scales for measuring disability in patients with neck pain have a pivotal role in research and clinical settings. The Neck Disability Index (NDI) is a valid and reliable tool, designed to measure disability in activities of daily living due to neck pain. The purpose of our study was the translation and validation of the NDI in a Greek primary care population with neck complaints.The original version of the questionnaire was used. Based on international standards, the translation strategy comprised forward translations, reconciliation, backward translation and pre-testing steps. The validation procedure concerned the exploration of internal consistency , test-retest reliability , construct validity  and responsiveness  of the questionnaire. Data quality was also assessed through completeness of data and floor/ceiling effects.The translation procedure resulted in the Greek modified version of the NDI. The latter was culturally adapted through the pre-testing phase. The validation procedure raised a large amount of missing data due to low applicability, which were assessed with two methods. Floor or ceiling effects were not observed. Cronbach alpha was calculated as 0.85, which was interpreted as good internal consistency. Intraclass correlation coefficient was found to be 0.93 (95% CI 0.84–0.97), which was considered as very good test-retest reliability. Factor analysis yielded one factor with Eigenvalue 4.48 explaining 44.77% of variance. The Spearman correlation coefficient  revealed some relation between the change score in the NDI and Global Rating of Change (GROC). The SEM and MDC were calculated as 0.64 and 1.78 respectively.The Greek version of the NDI measures disability in patients with neck pain in a reliable, valid and responsive manner. It is considered a useful tool for research and clinical settings in Greek Primary Health Care. Neck pain is a highly prevalent condition among the general population. Data from cross-sectional studies show that point estimates range from 10% to 35% . In clinTo our knowledge, five questionnaires measuring disability on a patient's life due to neck pain have been developed and validated . The NecThe purpose of our study was the translation and validation of the NDI in a Greek sample with neck complaints seeking primary care. Our ultimate goal was to develop an instrument in Greek that would facilitate international research in musculoskeletal disorders as well as to serve health practitioners in their everyday clinical practice.The Neck Disability Index is a condition-specific instrument for self-report of disability. It is adapted from the Oswestry Low Back Pain Questionnaire . It consThe procedure was initiated after contacting the developer of the instrument and informing him about the purpose of the study. The translation strategy was selected based on minimal criteria developed by the Scientific Advisory Committee of the Medical Outcomes Trust . FollowiThe last step of the translation procedure was the pre-testing of the translated instrument in a small population of neck pain patients, using a cognitive debriefing process. This process refers to an in-depth interview of patients about their understanding of the questionnaire with the purpose of revealing inappropriate items and translation alternatives. Namely, after completing the questionnaire participants gave their general impression on the clarity of the items, the relevance of the content to their situation, the comprehensiveness of the instructions and their ability to complete it on their own. The same issues were addressed to them for every single item and they were able to make suggestions whenever necessary. Finally, a debriefing summary, including all participant interviews, and a final debriefing decisions grid were sent to the developer for comments. The duration of this phase was 1 month (10 April–10 May). Figure In order to explore the psychometric properties of the Greek version of the NDI, the questionnaire was administered to patients with neck pain, seeking primary care from 3 rural health centers. Patients eligible for the study were consecutively recruited from August to November 2007. Eligibility criteria were: age over 18, a written consent of the patient and absence of symptoms below the elbows related to specific neck disorders. Regarding the last criterion, patients with symptoms below the elbow and one positive finding in the conventional neurological testing and/or a positive Upper Limb Tension Test were excluded from the study.Eligible patients were informed for the purpose of the study and the confidentiality and anonymity of the process. After giving written consent they completed a questionnaire on demographic and clinical characteristics and the Gr-NDI. Patients visited the General Practitioners (GPs) one week later to complete the Gr-NDI with changed item order. According to Deyo , assessiThe GROC rates the self-perception of change. Patients who state deterioration or improvement in a transitional scale, are asked to rate their condition from -7  to -1  and from 7  to 1  respectively .Data quality was assessed through completeness of data and floor/ceiling effects using the 15% criterion by McHorney . Mean scReliability was assessed through internal consistency and test-retest reliability, as follows.Internal consistency evaluates the extent to which items comprising a scale measure the same construct and was calculated using Cronbach's alpha. Values over 0.7 would be considered as acceptable [ceptable .Test-retest reliability (reproducibility) is the ability of an instrument to produce similar results on repeated administration when no real change in health status has occurred within this time frame [me frame . Patientme frame . Test-reme frame . The ICCme frame . The sizme frame . Parametme frame  this levConstruct Validity is the ability of an instrument to reflect a construct and was assessed through Exploratory Factor Analysis using a Varimax rotation [rotation .Responsiveness (sensitivity to change) is the ability of a measuring instrument to detect clinically relevant changes over time [ver time . It was ver time . VariancThe study was approved by the Scientific Committee of the University Hospital of Heraklion (Protocol # 7213/1-8-2007).The developer comments on the translated tool concerned replacement of "pain" with "neck pain". This was applicable for items pain intensity, personal care and lifting. Two other comments about linguistic problems were back translation issues. The translated instrument was pre-tested on four women and one man with neck complaints. Their age ranged from 30 to 76 years and their educational level varied from elementary school to university. The general impression of the participants was that the questionnaire and the instructions were easy to understand and that the items were important to their situation. An older woman with low educational level stated that it was a bit difficult to complete and asked for explanations. The debriefing process also revealed difficulties of a single patient regarding 'lifting' and 'sleeping' items. She stated that her low back pain prevents her from lifting weights and that she does not sleep because of menopausal disturbances. Suggestions were not made since no modification could overcome such problems. Finally, two participants did not drive, resulting in missing data from this item. Since lifting, sleeping and driving are frequently susceptible to neck pain those items were not characterized as inappropriate. See additional file Sixty-eight patients with neck complaints visited the Health Centers. Three patients did not meet the eligibility criteria and were excluded from the study. All eligible subjects agreed to participate in the study and returned to complete the questionnaires for a second time (100% response rate). Older patients asked for feedback from the GPs, which was consistent with the pre-testing findings. Descriptive statistics for missing patterns revealed six cases with at least two missing items, which were removed from all analyses. In addition, the score for cases with one missing item was adjusted by replacing the missing value with the median of the answers on the rest of the questionnaire. Demographic and clinical characteristics of patients and item-level descriptive statistics are presented in Tables Internal consistency of the NDI exceeded the acceptable level resulting in a Cronbach's alpha: 0.85. Based on GROC, 46 patients were considered "stable" and were included in the test-retest analysis. The ICC value calculated from these patients was 0.93 (95% CI 0.84–0.97). The Bland and Altman analysis showed that the means of the difference were -1,49 ± 3,03 Figure .The exploratory factor analysis yielded 1 factor with Eigenvalue: 4.48 explaining 44.77% of variance. Loadings of all items are presented in Table Regarding the analysis of responsiveness the Spearman correlation coefficient, as calculated for stable and improved patients, was 0.3 (P = 0.02). The calculations for sensitivity to change also revealed a SEM: 0.64 and an MDC: 1.78 . Based on the last value, 8.5% of patients had initial scores within 1 MDC distance from the best possible answer (no pain and no disability) revealing no ceiling effect according to the 15% criterion. Respectively, 0% of patients scored within 1 MDC distance from the worst possible answer  revealing no floor effect. Results from reliability and responsiveness analyses are summated in Table The present study was conducted with the purpose of translating and validating the NDI in a Greek population with neck complaints. The translation procedure resulted in some modifications, with the purpose of increasing specificity of the Gr-NDI in detecting disabled patients due to neck pain. Swedish authors also described similar modifications . CulturaThe psychometric properties of the NDI were explored in a sample population with main characteristics: older age, low educational level, chronic neck pain (the majority of patients had previous episodes). The large amount of missing responses for 'driving' (44.6%) was not a translation issue since that finding is consistent with other studies . AdditioRemoving items having low applicability in patients with certain demographical or clinical characteristics , would result in loss of content validity of the questionnaire. However, low applicability raises the issue of dealing with missing data, increasingly discussed in the literature . In ordeHigh internal consistency of the Greek NDI  falls into the range of results from other studies (0.74–0.92). The very good test-retest reliability (ICC: 0.93) is comparable with the results of the Dutch study (ICC: 0.90) since they used similar methods to ours. Our findings are also consistent with the English, French, Swedish and Brazilian studies, although the methods used are varying. Factor analysis revealed one dimension, which is consistent with two other studies ,10. NeveSince the NDI is a condition-specific instrument, it is considered responsive to changes and thus appropriate for evaluative purposes. It is often used as an outcome measure in studies exploring the effectiveness of interventions, in patients with neck pain . CheckinAnother limitation of our study is that global ratings do not represent a standard way of assessing changes in functional status. Therefore definitions of clinically important changes could be inaccurate.We have accumulated enough evidence to show that the Greek version of the Neck Disability Index measures disability in activities of daily leaving in patients with neck pain in a reliable, valid and responsive manner. The questionnaire is considered a useful tool for research and clinical settings in Greek Primary Health Care. It is also appropriate for use in international studies since its psychometric properties are comparable with other versions validated in different countries.NDI: Neck Disability Index; GPs: General Practitioners; GROC: Global Rating of Change; ICC: Intraclass Correlation Coefficient; SEM: Standard Error of Measurement; MDC: Minimal Detectable ChangeThe authors declare that they have no competing interests.All authors read and approved the final manuscript. MNT participated in study design, forward translation, pretesting, carried out data entry, participated in statistical analysis and interpretation of data and wrote the final draft of the manuscript.HTV provided appraisal and made suggestions during all stages of the translation process. He was also consulted during the validation process and revised the final draft of the manuscript. KNK participated in study design, forward translation and pretesting phases and has been involved in the revision of the final draft. MDA and ANP participated in the acquisition of data and the revision of the final draft. CDL conceived the study design, participated in the translation, pretesting and validation phases and revised the initial and the final draft of the manuscript.The pre-publication history for this paper can be accessed here:Greek version of the Neck Disability Index.Click here for file