Hypersensitivity of the central nervous system is widely present in pain patients and recognized as one of the determinants of chronic pain and disability. Electronic pressure algometry is often used to explore aspects of central hypersensitivity. We hypothesized that a simple pain provocation test with a clothes peg provides information on pain sensitivity that compares meaningfully to that obtained by a well-established electronic pressure algometer. "Clinically meaningful" was defined as a medium (r = 0.3-0.5) or high (r > 0.5) correlation coefficient according to Cohen's conventions.We tested 157 in-patients with different pain types. A calibrated clothes peg was applied for 10 seconds and patients rated the pain intensity on a 0 to 10 numerical rating scale. Pressure pain detection threshold (PPdt) and pressure pain tolerance threshold (PPtt) were measured with a standard electronic algometer. Both methods were performed on both middle fingers and ear lobes. In a subgroup of 47 patients repeatability (test-retest reliability) was calculated.Clothes peg values correlated with PPdt values for finger testing with r = -0.54 and for earlobe testing with r = -0.55 . Clothes peg values also correlated with PPtt values for finger testing with r = -0.55 (p < 0.001). Test-retest reliability (repeatability) showed equally stable results for clothes peg algometry and the electronic algometer .Information on pain sensitivity provided by a calibrated clothes peg and an established algometer correlate at a clinically meaningful level. Many clinical centres routinely measure pressure pain sensitivity while assessing pain patients. Pressure pain detection threshold (PPdt) is defined as the point in which a steadily increasing non-painful pressure stimulus turns into a painful pressure sensation. Pressure pain tolerance threshold (PPtt) is defined as the highest level of pain, which a subject is prepared to tolerate  acting as a standardized pain stimulus.Clinically meaningfully was defined as a medium (r = 0.3-0.5) or high (r > 0.5) correlation coefficient according to Cohen's conventions [Our hypothesis was that this simple and easy-to-administer pain provocation test would provide information on pain sensitivity which correlates clinically meaningfully with the results provided by a well-established electronic pressure algometer. ventions .The study protocol was approved by the local ethics committee.At the Bern University Hospital 170 consecutive in-patients suffering from pain were asked to participate, 157 of them consented to participate in the algometric study.orthopaedic pain group) and the medical-psychosomatic department . Eligibility criterion was an acute or chronic pain condition as the primary clinical problem. Patients with pain disorders of neuropathic origin  were not included because of expected inhomogeneous peripheral pain sensitivity condition. We also excluded patients with craniocerebral trauma and those with an inflamed or traumatised algometric measuring site .Our aim was to explore the two test methods in a wide range of pain types. Therefore, we recruited patients in different clinical departments, i.e. the orthopaedic department  of the two methods, clothes peg test and pressure algometry were repeated in a consecutive subgroup of chronic patients of the medical-psychosomatic department with pain duration of more than 6 months. Patients needed to stay in the hospital for at least 7 days to qualify for repeatability analysis. The retest assessments were performed exactly the same way as the previous test session, i.e. at the same time of the day, under identical conditions, and by the same tester.To assess the psychological status of the patients, they were asked to fill in a self-rating test each time they underwent pain testing. We applied the validated German Version of the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), which is designed to rate symptoms and levels of depression in non-psychiatric populations . Total HFor our pain provocation test we used polypropylene clothes pegs . For algometric procedures we selected clothes pegs with a clamping force of exactly 10 Newton at an extension of 5 mm  was selected for training purposes (see below).A separate sample of clothes pegs with 2 . The instrument was calibrated following the standard protocol as recommended by the manufacturer: A 1-kg weight provided by the manufacturer was applied to the 1.0 cm2 diameter applicator head attached to the end of the nozzle. The acceptable calibration values ranged from 99 to 101 kPa.For testing PPdt and PPtt, we used an established electronic pressure algometer with a probe of 1.0 cmtrial run. To avoid any local pain sensitization, the trial run tests were performed on the index finger, the subsequent actual testing was performed on the middle fingers. Additionally, the trial run was deliberately carried out with several "demo clothes pegs" of different clamping forces . This preliminary challenge with clothes pegs of obviously varying forces was done with the intention to let the patients assume that test pegs can objectively cause different degrees of pain ("blinding"). The use of clothes pegs of varying forces was important especially with regard to the retest-setting. It follows that the patients could not automatically presume that every test peg causes the same pain intensity.Before algometry was started, the tester explained the procedure to the patients. The experiment was performed in a quiet setting without any interruptions and shielded from other patients. Each of the two tests was once performed for training purposes as a test series were carried out with a 10 Newton-calibrated clothes peg. For each measurement the test pin was applied on the middle fingers and ear lobes for 10 seconds. The patient afterwards indicated the pain intensity on a numerical pain rating scale (NRS) on which 0 stands for „no pain" and 10 for „the most intense pain imaginable". Since pain increases during the 10 seconds stimulation, patients were explicitly asked about the intensity of pain they perceived at the end of the test (i.e. at 10 seconds).All actual The tests were performed on both sides of the body to average out possible side-specific differences in perception . Accordipressure pain detection threshold (PPdt) was performed 3 times on each site and the average was used for data analyses. The electronic algometer was set to deliver a steadily increasing pressure (50 kPa for one second). The patients pressed the button as soon as the pressure sensation turned into pain. At this time, the algometer freezes the pressure, its value can be read from the display. A 1 min break between each test procedure was planned in order to avoid local pain sensitization.Each of the four anatomical sites was tested once with the clothes peg. Electronic algometry for testing the pressure pain tolerance threshold (PPtt) was carried out by applying the electronic algometer to the middle finger of the dominant hand. For this purpose, the applied pressure was increased in steps of 50 kPa. The patient pressed the button as soon as his or her maximally tolerable pain level was attained. Considering that this test is particularly unpleasant, we performed it only once.At the end of the clothes peg and PPdt test series a one-time determination of the test-retest reliabilityThe whole test series was repeated in a subgroup of long-time patients for the determination of mean values with standard deviation (SD) and because some variables showed a skewed distribution, also as median plus interquartile range (IQR). The level of significance was set at p < 0.05 (two-tailed). As the data were not normally distributed, correlation with Spearman's rho was calculated to measure the correlation between the electronic and clothes peg algometric method. According to Cohen's conventions, r = 0.3-0.5 corresponds to a correlation size of a medium effect and r > 0.5 corresponds to a large effect [For the analyses we used SPSS 17 for Windows. Variables were expressed as percentages, Repeatability coefficients and plotted test-retest differences against test-retest means using the Bland Altman technique were computed for those patients who qualified for repeatability analysis (cf. chapter "Patients and design") .In addition, we plotted test-retest differences against test-retest time in order to investigate whether repeatability was time-dependent.The PPdt and clothes peg tests could be performed in all of the 157 patients. Six patients refused to test PPtt because of fear of severe pain.Main characteristics of the patients are shown in Table orthopaedic patients (n = 34) suffered from acute traumatic pain: 12 patients had a trauma of upper extremities or shoulders, 17 had bone fractures or joint lesions of the lower extremities, 9 had a trauma in the thoracic, spinal or pelvic region. Seven patients had a polytrauma with ≥ 3 lesions. The other half of the orthopaedic patients (n = 36) suffered from pain of osteoarthritic degenerative origin: 11 had hip arthritis, 11 had knee arthritis, 7 had degenerative shoulder problems, and 10 had degenerative low back pain. The vast majority of the patients of the medical-psychosomatic department suffered from chronic pain syndromes which were incompletely explained by persistent peripheral tissue damage: 5 patients suffered from chronic tension headache, 11 had chronic cervical pain syndromes, 3 suffered from chronic temporomandibular or atypical facial pain syndromes, 27 had chronic low or upper back pain, 8 had chronic abdominal or pelvic pain, 6 suffered from functional hemisided pain syndromes, and 16 had chronic atypical postsurgical pain syndromes. Twenty-three of the medical-psychosomatic patients suffered from pain without any structural findings or any history of peripherally induced pain: 15 of them were diagnosed with fibromyalgia, 8 with trunk accentuated somatoform pain syndrome.We found a wide range of different pain types: Approximately half of the Forty-one (47%) of the medical-psychosomatic pain patients showed clinically elevated depression scores (HADS-D ≥ 9 points), whereas only 6 patients (9%) had elevated depression-scores in the orthopaedic group.Pain sensitivity data are described in Table medium effect (r = 0.3-0.5), all other correspond to a large effect (> 0.5).The comparison between clothes peg values and PPdt (respectively PPtt) revealed an inverse correlation across all patients, i.e. the higher the pain in the clothes peg test, the lower the pressure pain threshold, and vice versa. Table Forty-seven patients from the medical-psychosomatic department qualified for repeatability analysis. Test-retest time varied between 7 and 41 days . For both algometric methods, repeatability coefficients were smaller than one SD of test-retest means, indicating a more than four-fold lower within-individual variance over time than between individuals Table .pressure pain detection threshold (PPdt) and the pressure pain tolerance threshold (PPtt). This meaningful level of correlation could equally be seen in both anatomical sites tested  as well as in orthopaedic and non-orthopaedic patients. Moreover, the validity check for repeatability yielded comparably stable and highly reproducible values. All of these correlations and qualitative similarities suggest that the two methods may be to some extent interchangeable.The information on pain sensitivity provided by a calibrated clothes peg versus the measurements with an established electronic algometer (Somedic Type II) correlate at a clinically meaningful level, virtually all revealing large effect sizes according to Cohen's conventions. The clothes peg values show this correlation both in respect to the PPdt, at which, in response to gradually increased pressure applied, non-painful perception of pressure changes into painful perception of pressure. At the onset of pain, the test stops at once. In contrast, the pressure applied with a clothes peg is invariable. Patients tend to perceive the steady amount of pressure on their finger as being beneath or slightly above the pressure pain threshold. The pressure exerted by a clothes peg on an ear lobe, however, is perceived as being consistently and clearly above the pain threshold. Therefore, the clothes peg test on the ear indirectly assesses the patient's ability to endure pain. Electronic testing using a pressure algometer checks for a patient's ability to endure pain if PPtt is determined. Therefore, clothes peg exposure tests integrate aspects of pain sensitivity, which are otherwise accounted for separately by assessing PPdt and PPtt, and they correlate with both parameters to the same extent.Interestingly, the correlation between the two compared algometric methods was achieved even though the detailed measurement approach is not exactly identical for the two methods. Specifically, the electronic pressure algometer checks for the differ in pain sensitivity. Even if average values of the clothes peg test obtained on ear lobe and finger are highly correlated, individual patient testing often reveals variations in reaction to patterns depending on whether the clothes peg is applied on a finger (pressure sensitivity in proximity of the pain threshold) or on an ear lobe (endurance of pressure pain close to the tolerance limit). It is further worthwhile to carry out the clothes peg test symmetrically on both sides of the body. This sometimes reveals differences in perception between body sides that are not uncommon in chronic pain patients and may point to pain-associated nondermatomal somatosensory deficits (NDSDs) [From a methodological point of view, it might be considered as a disadvantage that the clothes peg test does not explicitly distinguish between PPdt and PPtt. Therefore, in a clinical setting it seems recommendable to consistently apply the clothes peg method to both anatomical sites (i.e. finger plus ear lobe) as they  (NDSDs) .normal values in the pain-free population are useful in order to have reference values. Such reference values have been recently become available for a variety of psychophysical and electrophysiological pain tests, including the electronic pressure algometer we used [There are no other studies on clothes peg algometry as a method of measuring pain. Therefore, there are currently no published data available with respect to the discriminatory performance of the clothes peg algometer in different forms of clinical pain entities reaching beyond those investigated in the present study. The observed difference in pain sensitivity between the orthopaedic and medical-psychosomatic pain patients is, however, suggestive for discriminatory diagnostic properties Table . Further we used ,14. Furt we used .To conclude, clothes peg algometry is both an easy-to-administrate and low-cost method for assessing patients' pain sensitivity where electronic pressure algometers are not readily available. Clothes pegs can easily be stowed away in a jacket pocket, they are ubiquitous worldwide and their clamping forces can easily be checked Figure . This siThe authors declare that they have no competing interests.NE and MLG are responsible for the whole clinical concept and examinations, and RvK and RC for the study design and the statistical analyses. MC supervised the study on a medical-methodological level. NK, BW, and EM performed the clinical tests. All authors participated substantially in the acquisition or the analyses of the data. All co-authors were involved in drafting or revising the manuscript and have approved its final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/12/174/prepub


Patient-centered care ideally considers patient preferences, values and needs. However, it is unclear if policies such as wait time strategies for hip and knee replacement surgery (TJR) are patient-centred as they focus on an isolated episode of care. This paper describes the accounts of people scheduled to undergo TJR, focusing on their experience of (OA) as a chronic disease that has considerable impact on their everyday lives.Semi-structured qualitative interviews were conducted with participants scheduled to undergo TJR who were recruited from the practices of two orthopaedic surgeons. We first used maximum variation and then theoretical sampling based on age, sex and joint replaced. 33 participants  were included in the analysis. 20 were scheduled for hip replacement and 13 for knee replacement. A constructivist approach to grounded theory guided sampling, data collection and analysis.While a specific hip or knee was the target for surgery, individuals experienced multiple-joint symptoms and comorbidities. Management of their health and daily lives was impacted by these combined experiences. Over time, they struggled to manage symptoms with varying degrees of access to and acceptance of pain medication, which was a source of constant concern. This was a multi-faceted issue with physicians reluctant to prescribe and many patients reluctant to take prescription pain medications due to their side effects.For patients, TJR surgery is an acute intervention in the experience of chronic disease, OA and other comorbidities. While policy has focused on wait time as patient/surgeon decision for surgery to surgery date, the patient’s experience does not begin or end with surgery as they struggle to manage their pain. Our findings suggest that further work is needed to align the medical treatment of OA with the current policy emphasis on patient-centeredness. Patient-centred care may require a paradigm shift that is not always evident in current policy and strategies. Access to hip and knee replacement, specifically reduction of wait times for these procedures, has been a concern of publically funded health care systems for the past decade or more. The UK and Canada are but two examples where health systems policies and initiatives have been implemented with attention to access, quality and cost containment ,2. WhileThe concept of patient-centred care is a term that has permeated the literature and government policy since the 1990s . The InsMost studies have explored the experiences of people with OA in relation to their referral for consideration of hip or knee replacement rather than solely on the impact of OA on their lives. Existing literature focuses on primary care physicians’ challenges in managing musculoskeletal conditions , tools tGiven this gap, this study sought to elicit and document the experiences of people scheduled to undergo total hip or knee replacement surgery, focusing on the impact of OA on their lives rather than on their decision-making or referral wait times to having TJR. We discuss how patients’ experiences of OA pose a challenge to the rhetoric of patient-centred care, based on the definition of the Institute of Medicine, National Academies of Science (US)  and suggThis research is part of an ongoing three year qualitative study with the primary purpose of investigating why people with OA do or do not engage in social and personal roles and instrumental activities of daily living after having a primary TJR. Each participant will be invited to take part in three interviews: (1) approximately one month prior to surgery; (2) nine months post-surgery; and, (3) 18 months post-surgery. For the purposes of this paper, only data from the preoperative interviews are used in analysis. A constructivist approach to grounded theory which guided sampling, data collection and analysis was adopted . This apThe data reached a point of saturation when no new information or themes were being generated, at which point interviewing stopped . Data saPotential participants were identified from the surgeons’ roster data and mailed an information letter describing the study and a consent form. A research associate followed up by telephone to answer any questions, screen for eligibility and arrange an interview time for interested participants. Patients were eligible for participation if they received a diagnosis of OA and were fluent in English; patients with rheumatoid arthritis or other illness that might limit activity and participation  were excluded. A semi-structured interview guide facilitated discussions with participants. The guide was piloted to determine if length and flow of questioning was appropriate prior to commencing the study. All questions were meant to be exploratory to allow differences between patients’ perceptions and experiences to emerge during the course of the interview. Preoperative interviews occurred about 1 month prior to surgery from November 2011 until July 2012 and took place in person in the participant’s home or a private room in the hospital or by telephone. The literature supports the use of both telephone and face-to-face interviews within the same study without compromising the trustworthiness of the findings . All preEach interview was digitally recorded and transcribed verbatim. Transcripts were imported into NVivo, a qualitative software program that helps organize and retrieve data . Four reWe have organized our findings around four main themes that emerged from patient experiences with care and which highlight potential challenges for existing care which need to be redressed. These are: 1) patients’ experience of multiple joint symptoms and multiple chronic conditions; 2) the experience of OA as a chronic disease; 3) concerns related to prescription pain management; and, 4) referral times to surgical consultation for consideration of TJR. These findings suggest that patients’ descriptions of their OA as a complex and chronic condition challenges the doctrine of patient-centred care delivery models that largely focus on wait times for surgical interventions.Patients described having multiple painful joints and other health conditions that both impacted and were affected by their OA. Many described this as progressive, with their OA pain being worse in one joint and then eventually becoming worse elsewhere:The right side is worse than the left side, but lately, for the past four or five weeks, I’ve been feeling the left side also being almost as equally sore as the right side. It’s like somebody has a knife in it and is twisting it. Painful joints included the opposite side knee and hip, as well as elbows, back, and toes. Involvement of multiple joints exacerbated patients’ pain experience:At this point the pain in my hip… you could cut the whole thing off right now from [hip] on down, because it just feels like it’s been thumped with baseball bats right from my ankles all the way up and in, and that’s how much it hurts. The participants in our study frequently revealed that other health conditions both impacted and were impacted by their OA. In some instances these health conditions were believed to have developed as a result of OA, but they were always described as related, as in the following account:I’d developed coronary problems and they would send me to rehab, and I will go there and they will make me walk and will make me do the bike and that, and then I’d be in excruciating pain. For three days, I’d be in bed because my hips would hurt so much. Participants also described having a variety of other health conditions, including high blood pressure, cardiovascular disease, diabetes, chronic obstructive pulmonary disease, asthma, varicose veins, and acid reflux. The experience of these additional conditions was often described as highly influential on the participants’ quality of life. Due to their complex health needs, participants reported that they were sometimes given contradictory advice by different physicians, as described in the following example:… the frustrating thing is one doctor is telling you, you have to lose weight and the next [specialist is] saying don’t move, you have to sit with your leg up. Well, who do you listen to? It’s frustrating. For the participants in our study, OA was described as a chronic, life-changing condition that had an impact on every aspect of their lives, from the moment they woke up to the time they went to bed. Participants described struggling with sleep because of their OA pain. Many patients also reported feeling fatigued; often, sleeplessness and fatigue were described by participants as being linked. Fatigue has been recognized as a serious and disabling symptom of several diseases, and recent work suggests this is the case with OA as well . One parThere’s been maybe three nights where I’ve just about been in tears. It’s like I’ve tried everything I can try, how come it won’t go away, but fortunately only three [nights I haven’t slept]. Participants described how OA pain negatively impacted their employment and several described having to reduce their duties at work to accommodate OA-related limitations. For many, OA pain also required the modification of duties on the job, or the elimination of some responsibilities entirely. Participants expressed a desire to continue to work, and would modify their physical activities by being “careful”, reducing hours, or eliminating duties as necessary.It just was very difficult to get through the work day. I mean, I was put on modified duties for such a long period of time because, well, my surgeon at the time… didn’t feel that I could ever return to regular duty … because of my knees being so bad…. Participants described feeling as though their OA was negatively impacting the size of their social sphere. People who previously engaged in regular social activities outside the home, such as going to the movies, skiing, etc., were unable to continue these activities in the same ways they once had. For many, the types of outings they used to enjoy became increasingly difficult as the pain of OA progressed, resulting in less time spent outside the home. Consequentially, participants’ social circles became increasingly limited, as their more home-centred life meant less interaction with those outside their immediate surroundings.Participants described the impact of their OA pain as permeating beyond their participation in everyday activities and into their relationships with family members. For some, the necessity to reduce or eliminate physical activities meant more than simply an inability to do the activity; it meant a change in the ways in which they could interact with loved ones. For participants whose marriages had regularly included activities such as dancing, having to give up this interaction with their spouse was particularly difficult. For others, the struggle with the constancy of OA pain rendered the maintenance of normal relationships with family members difficult. Participants who had previously been cheerful and happy people began to feel as though they needed to filter their daily interactions with family members in order to prevent the experience of pain from negatively impacting their interaction. This was described by one participant as the need to “think before I speak” instead of it “just coming out” .Overall we heard in participants’ accounts a strong sense that their lives were shrinking.My ability to do extracurricular things like my walking distance has shrunk. I can’t cross-country ski anymore. It’s just too painful and snowshoeing I can’t do. And sitting for long periods of time, it becomes very uncomfortable. I had to give up part of my job… everything seemed to shrink, what I could do and couldn’t do. Strangely enough, I understand how old people feel, how when you get to a certain age you start to narrow your social field and what used to be here at 20 is now here at 80, but for me I’m here at 40. You really do sense every option has a yes and a no and more often, the no is dictated by the amount of pain you want to feel, the amount of pain you know you are going to feel and whether or not you want to go through it. [OA] really does narrow your social circle. “I don’t like medication so I try to stay away from it. I try to manage [my OA pain] with as few pain killers as possible.”  There were many accounts of patients who were told by their primary care providers that they could not have prescription pain medication. As one participant described:Patients described their difficulties in obtaining adequate pain relief for their OA pain, as well as their own concerns about prescription pain management. Many patients were uncomfortable taking pain medication. The following sentiment was shared by many, He said, well take Tylenol for arthritis. I didn’t know you had anything else for [the pain], I just figured that was it. But then when I went one day I was nearly crying and I said, you’ll have to give me something for this. … well they want you to try Advil and Tylenol and Aleve and all that before they give you the Celebrex. That’s what the doctor told me, and of course none of them really did too much.”  The issue of pain management was complicated for participants. While they did not want to be in pain, at the same time they also had concerns around addiction and were often resistant to taking pain medication. The following example typifies this tension that was evident in several patient accounts:Participants described trying different medications for pain relief but finding them ineffective: “I’d been to [my doctor] a few times and told him I was in a lot of pain and he just said, just take the Tylenol. He only gave me Tylenol …. No that’s not true…he gave me … OxyContin or something, … And I took them and they worked. He only gave me maybe 15 or 20, I don’t remember how many he gave me … Anyway I go back to get more and he went, are you finished these? I went, yeah you gave me them. He said to me, they’re highly addictive. I said, yeah but they work. He said, no we can’t give you that so he gave me something else but it didn’t work. .It was not surprising that although TJR was not the central focus of their concerns some patients did not want to wait any longer for their TJR surgery. In particular, younger patients described how their physicians thought they should wait for referral to surgery, while they were instead more concerned with their current quality of life than with the risk of future revision surgery:[I used to think that] Maybe I’ll have a hip replacement 10 or 15 years from now. I didn’t think I would be here four years from now doing it. But, you know, it gets to the point where you’ve got to do something because you’re giving up doing too many other things. In the following account, the physician’s sense that the patient was not yet “experiencing enough discomfort” sharply contradicted her pain experience:I was quite disappointed [that I would have to wait for surgery] because I felt like I was having a fair bit of discomfort especially in my left leg. I was already taking prescribed anti-inflammatories and I had a prescription for Tylenol 3 to take PRN so yeah, I was disappointed that they weren’t going to be doing anything for quite a while. And I thought well maybe I’m just not experiencing enough discomfort and I had a fair ways to go. It kind of panicked me a little bit because I was working, still am, and I didn’t know how I was going to get through the next three, four or five years with the pain. Patients’ accounts of OA suggest that their experiences often involve the simultaneous existence of both multi-morbidity and pain in multiple joints. This does not align with the current policy emphasis on a single joint and access to surgery to replace that single joint, which has been adopted in many jurisdictions ,2. PatieWhen discussing the time leading up to surgery, many participants described using non-prescription pain or non-steroidal anti-inflammatory medications (NSAIDs), although the efficacy of such medication was described as variable. It was common for participants to feel that their doctor was not comfortable prescribing medication for pain management, instead preferring that the patient take over-the-counter remedies. While patients in our study expressed being fearful of addiction, this limits the pain reduction strategies available to them. The current controversy over the use of opioids for pain management likely underpins the prescribing reluctance of physicians (and patient fear). There is a rising concern with addiction amongst physicians  with somThe patients in our study often reported having a different assessment of readiness than their physicians who might encourage them to delay referral; this was especially true for those patients who were younger. Rotstein and Alter  take issOur findings suggest that health policies and strategies (such as the wait time strategy) cannot be considered patient-centred when they are not based in or representative of patient experiences. Developing models of care that are truly patient-centred may require a paradigm shift in how we conceptualize and deliver patient care for OA. Increasingly, the notion of shared decision-making is coming into use as a model for understanding and improving the role of the patient in clinical decision-making . Yet somAs with any qualitative study, our findings are based on the experiences of participants. Our participants received their replacement surgery in a large academic hospital in an urban area in Canada. We do not know the extent to which our participant’s experiences are generalizable beyond this setting. Additionally, our analysis did not include patients being treated for depression and/or who were identified as having addiction problems. These patients may have valuable insights to share regarding the analysis we have developed.Despite the fact that initiatives have achieved the goal of reducing wait times for hip and knee replacement surgery, the extent to which this goal and or its measurement truly aligns with the needs of OA patients remains unclear. Our findings suggest that further work needs to be done in order for the management of OA–of which TJR is an acute intervention in the context of the chronic pain and disability of OA– to align with the current policy emphasis on patient-centredness. We would argue that policy makers and clinicians need to be aware of and acknowledge the everyday work patients perform in struggling to manage their OA pain and/or mobility limitations in the context of multi-morbidity and of the significant impact of OA on their lives. This would facilitate formal designation of OA as a chronic disease and help create policy that would provide truly patient-centred clinical care and self-management supports with the potential to limit the often unrelenting impact of OA on people’s lives.The author(s) declare that they have no competing interests. This work was supported by an unrestricted operating grant from The Arthritis Society (Canada).Conceptualization of the project: AD, FW, AP, RJ, SJ, ES, JW Acquisition of funding: AD and FW Recruitment and data collection: VV, SB, MM Data analysis and interpretation: AD, FW, AP, RJ, SJ, ES, JW, VV, SB, MM Preparation of the final manuscript: FW, AD, VV, MM Approval of the final manuscript: AD, FW, AP, RJ, SJ, ES, JW, VV, SB, MM. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/13/531/prepub


Patients with chronic pain are found with highly variable clinical presentation and differing physical complaints. They are seen as a heterogenic group. Based on clinical observations, elderly patients seem to differ from younger patients with chronic pain. We examined whether there were systematic differences between young and old pain patients.As part of a routine evaluation of university hospital care, a newly developed psychosomatic treatment model for chronic somatoform pain disorders was examined. The basis for treatment efficacy was a target-oriented, specific somatic and psychological intervention that included a stable physician-patient relationship. Particular attention was paid to differences in treatment outcome with regard to changes in both physical and psychopathological symptom levels. We hypothesised that younger pain patients had higher psychological burden and benefitted more from our treatment than older pain patients.2=.108; model: p< 0.01).Overall, 179 inpatients (57.5% women) with chronic pain were examined (age between 16 and 79 years). The group as a whole yielded high scores on the somatisation dimension (SCL-90) and showed a considerable amount of psychopathological symptoms, such as depressive mood and anxiety (HADS) and a great emotional instability (FPI-R). Age differences were only found with regards to patients’ degree of aggression (SCl-90): younger patients showed higher aggressive tendencies than older ones (p< 0.05). The treatment offered helped patients in both age groups especially with regard to reduction of depressive mood  and anxiety levels . Regression analysis showed different age groups and gender as significant predictors of anxiety reduction under therapy (RResults show that younger chronic pain patients suffer more from a considerable amount of psychological distress than older ones, but our treatment approach was equally effective in both groups. However, age and gender differences, as well as the patient’s baseline level of anxiety influenced the outcome. These factors need to be studied in future research. Pain may present itself in different ways. It may be acute or chronic, somatic or psychogenic. How pain is perceived, experienced and managed depends not only on the organic pathology but also on the patients’ previous experiences, personal history, and personality structures. Chronic pain is a poorly understood condition and a challenge for both accurate diagnosis and adequate treatment. If pain becomes the central topic between physician and patient, it is often an indication for the beginning of a long journey of suffering.The primary concern for both physicians and patients is to localise the pain and its causes as quickly and reliably as possible. Assigning the manifest symptoms of the pain to a clear, underlying clinical cause is essential. Physicians’ diagnoses depend on the patient’s personal account and self-report; a comprehensive description of the experienced pain is thereby crucial.Thus, a thorough medical history, including both the patient’s subjective description of all symptoms and the physician’s comprehensive physical examination, are needed. Once the patient can describe his or her pain coherently in terms of its chronological development, localisation, intensity and quality, a specifically targeted physical examination can begin. Only if the pain’s quality, intensity and localisation can be linked to its morphological and pathological origins can an adequate treatment approach be offered. A successful treatment may lead to considerable mitigation or even complete alleviation of the experienced pain. If these conditions are provided, a supportive and stable future physician-patient relationship can be expected. Often however, the diagnosis, treatment and medical outcomes in pain patients are unsuccessful. Although there is a high variability among pain patients, based on clinical presentations, we want to specify whether systematic trends and differences could be found among different subgroups of somatoform pain patients.There are two groups of pain patients . A firstBoth verbal accounts of an experienced pain have the potential to compromise an adequate diagnosis. Given the complex mechanisms that underlie pain perception and its verbalisation, inadequate patient descriptions may lead to misinterpretation, frustration, anger or resignation on the part of the physician. This in turn can distort the diagnosis and may lead to the wrong treatment suggestions. Independently of biological, psychological and social factors, acute pain requires an immediate analgesic treatment, in order to alleviate suffering and prevent the pain from becoming chronic. However, despite successful treatment, pain is always affect-laden and relates to one’s previous experiences as well as to current circumstances. If a particular acute pain is accompanied by an existentially threatening event  in conjunction with previously established risk factors (such as trauma or addiction), it may undergo a rather prolonged process, eventually becoming chronic with a high propensity to develop into a somatoform pain disorder. Patients suffering from somatoform pain disorder do not perceive physical and psychological symptoms, such as restlessness, fear, anger, sadness, but instead experience and communicate these as physical pain.We have made remarkable progress over the last few years with regard to the management and treatment of acute pain. Standardised analgesic treatment helps patients to bear acute pain after injury, peri-surgical, during labour, during myocardial infarction, tumour and during palliative care. Important thereby is physicians’ sufficient knowledge of available and appropriate analgesics, adequate application, dosage and frequency of administration. In addition, most hospitals (in Germany) have now an established pain clinic, where patients who do not respond to first-line analgesic pain relief can be referred. However, despite our increasing understanding of pain and its management as well as better provision of treatment available, many treatment attempts still remain unsuccessful. Pain associated with considerable difficult life events can become unmanageable and in that prevent a rigorous diagnosis explaining the underlying causes for the acute or chronic pain. Without the inclusion of bio-psycho-social factors into the treatment model and the understanding of physician patient relationship such pain management will not be successful.The very first consultation shapes the physician-patient relationship and in that determines the nature and development of all future encounters. It offers the patient the opportunity to describe their experienced symptoms comprehensively. It is known that an accurate description of one’s experienced pain can be limited by or even be made completely impossible for a variety of reasons, including personal history, personality, peripheral and central pain processing ability, and other previous experience . Thus, mThey can have serious negative consequences for the quality and nature of the patient-physician interaction. Patients experiencing pain often expect to be treated quickly and effectively, with a wish that it leads to long lasting pain relief. In addition to other implicit or unconscious expectations, expectations and demands are also made by patients’ relatives, their socio-economic environment, their social insurance agencies and employer; all of which have an impact on the physician-patient relationship. Finally, the physician’s own ambitious aims should not be forgotten, as they play a pivotal role in the development and management of the interaction between both parties. Thus, it becomes clear that a complex mixture of conditions shape and equally strain the relationship between the physician and the patient. The first encounter between both and how the clinical assessment is carried out plays a pivotal role in the subsequent treatment approach. It determines all future expectations and within that sets the frame for a successful treatment. Whether or not the treatment of pain is successful depends on how supportive the interaction is being perceived by the patient. Thus a physician’s ability to adjust to the patient’s individual history and personality is of tremendous importance. A positive treatment alliance is a positive precursor, yet the very nature of pain often brings about particular challenges so that to date the treatment of pain patients remains a clinical challenge . Pain, w1. “Responder” are those, who respond to a therapy as usual (TAU) -pain management successfully.2. “Partial responder” are those who benefit from pain management but do not experience complete pain relief. They are, however, able to continue or adapt their lifestyle accordingly.3. “Non-responder” do not respond to TAU - treatment at all. The pain levels in the latter group remain unchanged and are often experienced as catastrophic. Medication does not work as expected and often leads to disagreeable psychotropic side effects, such as extreme sedation and euphoria, and thus carries high potential for a subsequent addiction. A somatic-morphological assessment cannot be made in the last group [Especially, the last group shows important consequences in the physician-patient relationship. The aforementioned expectations of a treatment resulting in immediate pain release has not happened, thus leading to feeling misunderstood and further feelings of disappointment, distrust, fear, helplessness, rage and hurt. These experienced secondary emotions change the patient-physician relationship. Thus, two diametrically opposed treatment processes may develop. Either an unreasonably invasive assessment procedure and treatment is carried out despite unsuccessful results, or physician and patient do not manage to achieve an adequate assessment procedure and subsequent treatment at all. Both, however, trigger a vicious cycle leading to the pain becoming chronic. These kinds of patients are often transferred to interdisciplinary pain conferences of university medical centres or psychosomatic in-patient treatments in German cities.The difficulties in treating chronic pain patients successfully led to the important clinical question of if particular sub-populations of pain patients - transferred to psychosomatic inpatient treatment - react differently as some have argued . Do age,We posed the following hypotheses within the clinical evaluation study: Firstly, we stated that younger pain patients have a significantly lower pain threshold (a) and more psychological (b) and management problems (c) than older pain patients. It follows that a psychosomatic treatment would be more effective for the former group. Secondly, we stated that our treatment approach had an effect on our pain patients as demonstrated in symptomatic change on the depression (a) and anxiety scale (b) of the HADS.Preliminary remark: All patients who experienced physical and/or psychological pain as their chief complaint for more than six months were given the acronym ‘pain patient’ in this article. Initially, we included all patients who expressed suffering from chronic pain and were referred to our unit for its treatment. All of them had an initial assessment that included a comprehensive physical examination and history-taking in line with a bio-psycho-social approach. Further diagnostic differentiation was carried out through examinations in different medical specialties of the university medical centre interdisciplinary in a second step.We conducted a retrospective analysis based on our clinical documentary system which we apply for all inpatients treated in our department. Questionnaires are handed to the inpatient at the beginning and at the end of treatment, consisting of a questionnaire battery suitable for psychosomatic patients. Results are calculated by a psychologist and also examined by the treating psychotherapist. Moreover, medical diagnoses of the inpatients are documented at beginning of treatment and after discharge of the patient.179 patients with chronic pain were treated at the psychosomatic unit of the university hospital Charité Campus Benjamin Franklin, Berlin between 2000 and 2008. Of these inpatients 115 were women and 61 were men with a mean age of 50 years (range 16–79 years). The average inpatient stay was 25 days (sd 10 days). Most patients had been seen at the hospitals’ interdisciplinary pain clinic, which receives referrals from general practitioners and specialist consultants  within the South-Berlin catchment area.All patients with chronic somatoform pain were included in the piloting of our treatment, independently of whether other diagnoses, such as chronic back pain, low back pain, functional gastro intestinal pain, muscle-skeletal pain, headaches or severe physical impairment were given. The diagnosis in accordance with the ICD-10 diagnostic criteria was carried out by an interdisciplinary workgroup, which consisted of psychosomatic clinicians, specialised pain therapists, internists, and neurologists.To understand differences of pain patients according age a median split was performed on the total number of patients in order to differentiate between two comparable age groups. This yielded a “young patient group” ranging from 16–49 years of age and an “old patient group” ranging from 50–79 years of age. In a second step we examined in a multivariate analysis the whole range of age and other factors like gender and psycho diagnostic variables. Given the small sample size of patients and the lack of questionnaire data to examine attachment styles, we focused in this first pilot study only on the two age groups.Psychiatric diagnoses were made following the ICD-10 diagnostic criteria at the first week of the inpatient treatment. All 179 patients were diagnosed with the diagnosis persistent Somatoform pain disorder ; 128 (71.5%) of the 179 patients SPD as the main diagnosis. The remaining 51 (28.5%) received a diagnosis of somatic disorder, with 32 (17.9%) being given SPD as primary, 17 (9.5%) as secondary and 2 (1.1%) as tertiary diagnosis. Additional psychiatric diagnoses we found in ICD-10 chapter F0 (n=1), F1 (n=39), F1 (n=2), F3 (n=50), F4 (n=47), F5 (n=24), and F6 (n=10). Within the inpatient treatment we were able to diagnose a small group of patients with a severe somatic disease whilst they were initially referred to us with a diagnosis of psychological pain.Out therapy model is described as an integrative, psychosomatic treatment. It is described in great detail by Wulsin et al. (2005) . TherefoAnxiety and Depression was assessed using the German version of the Hospital Anxiety and Depression Scale . The self-report questionnaire was administered pre and post treatment. The instrument consists of two subscales, one for anxiety and one for depression with maximum scores of 21 on each subscale. The HADS is a well established instrument to measure anxiety and depression in in-patients .Subjective impairment due to physical and psychological symptoms and the alteration of impairment were determined using the Symptom Checklist . The self-rated instrument consisting of 137 questions that patients are asked to score as either “true” or “untrue”. The answers are compiled into 12 scales or personality dimensions. These include: satisfaction with oneself, social orientation, need for achievement, inhibition, irritability, aggression, demandedness, physical complaints, worries about health, openness, extraversion and emotionality. With regards to the described personality traits of pain patients [. The selIn addition, a standardised questionnaire for collecting patient medical history was used. All measures were administered during the first three days of admission and once again, (with the exception of the SCL-90 ) during the last three days of their in-patient stay before discharge.Descriptive statistics are used for a detailed description of the patients. All data are presented as mean (M) and standard deviation (SD) or the absolute and relative frequencies for categorical data.Differences between the age groups were analyzed using the Mann-Whitney’s U test or Wilcoxon’s signed rank test for comparisons between different time points. The Chi square test was used for group comparisons involving categorical data. Fisher’s exact test was used for cases where more than 25% of the cells had an expected cell size of less than five.To test whether the age had an effect on depression or anxiety reduction a one way ANOVA was used. We controlled for gender and age in subgroups. Coefficients were considered significant if the respective p-values were less than α = 0.05.To examine predictors for depression and anxiety reduction, we conducted a logistic regression and included age, gender and severity of disease as independent variables in a multivariate model using stepwise inclusion of parameters.Calculations were done with SPSS 19.0. Coefficients were considered significant if the respective p-values were less than α = 0.05.Table Overall, psychological assessment at admission revealed high pathological scores in “physical complaints”, “emotional instability” (> 6.0 stanine on the FPI), “somatisation”,  and “depression” and “anxiety” (> 9.8 points on the HADS), but they were similar to those of normal control samples in the other examined psychological dimensions Table . In agreBased on clinical reports of the ward physicians, two thirds of the participants profited from treatment in relation to experienced pain symptoms and perceived psycho-education regarding possible causes. For a summary of the patient report, the pre and post treatment HADS was analysed. As shown in Table 2=.108) and was significant (p=0.005). The baseline effect was not significant for depression and the depression model showed no significance (R2=.017).Multivariate analysis where age, gender and diagnosis (somatoform vs somatic) were entered as covariates showed no significant changes of depression and anxiety scores. Regression analysis with the target variable changes of the depression/anxiety score during inpatient treatment showed no significant effects for age, gender and diagnosis. For anxiety, a significant effect of the baseline anxiety value was found . This model, including anxiety baseline, age group (19–49 years vs. more than 49 years) and gender explained 10.8% variance  were given a primary diagnosis of somatic disorder. Primary diagnosis was equally distributed across both younger and older patient groups. It could be argued that for no other disorders the bio-psycho-social diagnostic model and the acknowledgement of the complexity involved in the physician-patient relationship is of such importance, which might explain the diversity of diagnoses given to patients suffering with pain 8.5% were. It is pChronic pain patients signify a considerable problem in the health care system ,12.Our results have shown that the majority of these patients were women between 16 and 79 years of age. These results confirm findings from other studies, in that patients showed a high degree of somatisation, reported a considerable amount of physical as well as psychopathological symptoms, and scored high on depressive mood, anxiety and emotional liability. Nickel et al., 2010 [When we looked at the other dimensions of the age sub-groups, only marginal differences were found with regards to pain experience, psychological symptoms, and disease management.Differences between the two age groups were found with regards to reported levels of aggression, the mean duration of stay in hospital, and the mean consumption of analgesic medication. The significance of aggression in pain patients was also emphasised in studies about fibromyalgia patients .A newly-developed integrative, psychosomatic treatment model was piloted for a group of chronic pain patients that are routinely referred to our university clinic for in-patient treatment. 179 patients received the new treatment and preliminary results as to its effectiveness are outlined by a descriptive analysis of the patient group. Two-third of the patients with a primary diagnosis of somatoform pain disorder benefited from our treatment, as shown in a reduction of symptoms of depression and anxiety.Opposed to our expectations, both age groups benefited from treatment. No significant differences were found, which was surprising  given thAn additional note concerning psychodynamic aspects of pain treatment: The role of attachment was only integrated in the kind of treatment of pain patients. In this study, we could not demonstrate data for this important aspect ,18: It iLimitations of the study: The described therapy model is based on the long-standing experience of individual physicians working at our clinic, all of whom differ in their approach to diagnosing and treating pain patients. Within the scope of this preliminary evaluation, we were able to describe in detail only clinical patients. This does not allow generalization of the results to all pain patients. However, the diagnosis in accordance with the ICD-10 diagnostic criteria was carried out by an interdisciplinary workgroup. They consisted of psychosomatic clinicians, specialised pain therapists, internists, and neurologists. Given the large variability within the somatic disorders in general, we have only focused on ICD 10, F 45.4 as the main diagnosis. The heterogeneity with regards to somatic disorders as primary and psychiatric disorders as a secondary diagnosis in relation to gender and age effects  were thuInspite of these limitations we were able to describe sociological, clinical and psychological differences between age groups in our examined pain patients. Additionally we could evaluate effects of the in-treatment in both groups, which were not different. This clinical evaluation study has shown there are differences between age groups, gender and somatics compared to somatoform pain diagnoses groups in chronic pain patients. This will need to be evaluated in the next few years to find out the best treatment strategies for “non responder patients”. In these cases we need a common view on the subjective experience and the individual disease management of patients. Pivotal is the exploration of the patient’s experience of pain. In order to gain a better understanding of the experience of pain patients, we have found it important not only to pay clinical attention to the individual but also to differentiate between different subgroups. This view, in conjunction with the basic understanding of pain management, is needed when dealing with with each patient as an individual suffering from pain.The authors declare that they have no competing interests.BB drafted and wrote the manuscript, LE conducted statistical analysis, BKD and HCD conceptualized the study and revised the manuscript. All authors read and approved the final manuscript.


SI joint pain can mimic discogenic low back pain or even radicular pain. Patient presentations vary considerably and conditions may include low back, groin, and/or radicular pain, leading to the potential for inaccurate diagnosis and treatment. Despite the large number of patients with SI joint pain, treatment options have been limited to conservative care involving physical therapy and joint injections, radiofrequency rhizotomy, or traditional open SI joint arthrodesis surgery. The purpose of this retrospective study is to evaluate the safety and effectiveness of MIS SI joint arthrodesis via an ileosacral approach in patients refractory to conservative care.We report on the first 11 consecutive patients treated with a novel MIS SI joint fusion system by a single surgeon. Medical charts were reviewed for perioperative metrics and baseline pain scores recorded using a 0-10 numerical rating scale.Ninety one percent (91%) of patients were female and the average patient age was 65 years (range 45-82). Mean baseline pain score (SD) was 7.9 (± 2.2). Mean pain score at the 12 month follow up interval was 2.3 (±3.1), resulting in an average improvement of 6.2 points from baseline, representing a clinically and statistically significant (p=0.000) improvement. Patient satisfaction was very high with 100% indicating that they would have the same surgery again for the same result.The results of this small case series illustrate the safety and effectiveness of minimally invasive SI joint fusion using a series of triangular porous plasma coated titanium implants in carefully selected patients. Larger multi centered studies are warranted. Low back pain is exceedingly common in modern society, affecting well over 90% of adults at some point in their lives . Apart fDespite the large number of patients with SI joint pain, treatment options have been limited to nonoperative care involving physical therapy and joint injections, radiofrequency rhizotomy, or traditional open SI joint arthrodesis surgery. Open arthrodesis procedures reported in the literature require relatively large incisions, significant bone harvesting, and lengthy hospital stays; moreover, they may require non-weight bearing for several months -13.To address these challenges, a novel minimally invasive arthrodesis system has been developed . The surgical procedure involves placing a series of triangular, porous plasma spray coated titanium implants placed across the target SI joint. The objective of this surgery is to achieve arthrodesis through a permanent linkage across the joint, relying on bone ongrowth for permanent stabilization of the implant.The purpose of this retrospective study is to evaluate the safety and effectiveness of SI joint arthrodesis via a minimally invasive surgical (MIS) approach in patients refractory to conservative care.We report outcomes of the first consecutive 11 patients treated at a single, community based spine practice between April 2011 and July 2011. Medical charts were reviewed for peri-operative metrics, complications, pain scores  and satisfaction with surgery. As there were no experimental procedures performed in this case series and the data was collected without using personally identifiable information from medical records, no IRB or ethics committee review was required or obtained.Mean age at the time of surgery was 65 years (range 45-82) and nearly all patients were women 91%)  was performed in all cases by a single neurosurgeon.The procedure is performed by placing a series of 3 triangular shaped porous plasma coated titanium implants across the SI joint using intermittent fluoroscopy to monitor instrument and implant placement Figure . GeneralPain related to the SI joint was assessed pre-operatively and post-operatively at 12 months per standard procedure at our practice. Patients were asked to rate their pain using a 0-10 numerical rating scale with 0 representing no pain and 10 representing the worst pain imaginable. Satisfaction was assessed by asking the patient if s/he would have the same surgery again for the same outcome.We report on 11 consecutive patients who were treated with minimally invasive SI joint fusion. A total of 12 SI joints were treated: 8 right- and 4 left-sided. Average (± SD) operating time was 78 ± 32 minutes and blood loss was less than 50cc in all cases (Table Mean baseline pain score (SD) was 7.9 (± 2.2). Mean pain score at the 12 month follow up interval was 2.3 (±3.1). The mean (SD) change in pain score was 5.4 (3.4) points (p<.000). A clinically significant benefit, defined as a >2 point change from baseline, was observed in 8 (80%) patients . DespiteSI joint symptoms can present as pain in the SI joint, low back, hip, groin, or buttock. As a result, a careful and thorough clinical and physical exam must be performed to correctly identify the pain generator. Positive provocative physical examination maneuvers combined with 75% pain relief after imaged guided SI joint injection is a reliable method for diagnosing the SI joint as the pain generator ,16.Recent reports of MIS approaches to SI joint arthrodesis using screws show relatively good clinical results with room for improvement in outcomes and technique. Al-Khayer et al. reported on 9 patients using a single hollow modular anchorage (HMA) screw packed with bone graft . All patAdvantages of this reported MIS SI joint fusion implant technique include a small incision, relatively short operating time, minimal blood loss, bone and ligament preservation, and a relatively short period of immobilization. The triangular shape combined with an interference fit of the titanium implant used in this cohort was designed to minimize rotation, micromotion and avoid issues encountered with traditional screws. In our cohort of patients undergoing MIS SI joint fusion, clinical outcomes were favorable with 80% of patients experiencing a clinically significant benefit at 12-months. One patient did not report improvement in pain. This 72 year old female patient presented with a 20 year history of low back and SI joint pain with multiple back surgeries. She felt she was unable to distinguish SI pain from low back pain, which may have confounded the results of SI joint surgery. The other patient with previous back surgery had a substantial improvement in pain. Though this represents the results of two patients, one cannot assume any relationship between prior back surgery and clinical improvement after SI joint surgery.As with all surgical procedures, there are inherent risks. Possible risks of the reported procedure include implant malposition, nerve damage, loosening of implants, and failure to relieve symptoms. These risks are minimized with procedural training, implant design features and proper patient selection. Implant costs may be considered a disadvantage on the surface, however relief from chronic debilitating pain has the potential to save on disability related expenditures. Proper patient selection cannot be overemphasized to ensure a proper diagnosis and treatment plan in low back pain patients.Although our study sample size is small, the results of minimally invasive SI joint surgery appear promising. All patients presented with low back and SI joint pain. Favorable outcomes in these patients underscore the necessity to suspect the SI joint as a pain generator in patients with low back pain. Special attention should be paid to the SI joint after lumbar spine surgery to avoid the potential for inaccurate diagnosis and treatment. Furthermore, this minimally invasive approach significantly benefits the elderly population, who are not candidates for other conventional techniques due to poor bone quality, delayed healing and reduced mobility. This segment of the population is not likely to respond well to physical therapy alone in part because of the degenerative nature of SI joint disease. The MIS procedure described herein affords this segment of the population an opportunity to regain mobility, alleviate SI joint and low back pain caused by SI joint issues and experience an improved quality of life.When conservative measures fail, minimally invasive SI joint fusion using a series of triangular porous plasma coated titanium implants is a safe and effective treatment option in carefully selected patients.Donald Sachs: Consulting agreement with SI-Bone Inc., no stock or royalties. Robyn Capobianco: Part time clinical affairs employee at SI-Bone, Inc.DS performed all surgical procedures, performed data collection and interpretation and critical review of manuscript. RC was involved in drafting manuscript and data analysis. Both authors read and approved the final manuscript.


This review proposes a critical discussion of the latest studies investigating the presence of alexithymia in patients with fibromyalgia (FM) and its relation to other psychological disorders. The focus is on the most relevant literature exploring the relationship between FM, a chronic pain syndrome, and alexithymia, an affective dysregulation, largely observed in psychosomatic diseases. The articles were selected from the Medline/Pubmed database using the search terms “Fibromyalgia,” “Alexithymia,” and “Psychological Distress.” Of the seven studies fulfilling these criteria, one found no differences between FM patients and the control group, four found significant differences, with higher levels of alexithymia in the FM sample, while two showed unclear results. Overall, the majority of findings highlighted the high prevalence of alexithymia in FM patients. Future studies should clarify the role of alexithymia in FM, paying attention to two principal aspects: the use, as a control group, of patients with chronic pain conditions but a low psychosomatic component, and the use of other measures, in addition to the Toronto Alexithymia Scale (TAS-20), to assess alexithymia. The main aim of this review is to propose a critical discussion of the most recent studies investigating the presence of alexithymia in patients affected by fibromyalgia (FM) syndrome, and its relation to psychological disorders, frequently observed in these patients.Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, with an unknown etiology , 2010, wUsing the keywords “Fibromyalgia,” “Alexithymia,” and “Psychological Distress,” the Medline/Pubmed database was searched for studies examining the prevalence of alexithymia in FM patients published up to October 2012 which were then analyzed. In particular, target articles were searched using the following associations: fibromyalgia AND alexithymia, fibromyalgia AND psychological distress, fibromyalgia AND alexithymia AND psychological distress. Abstracts were checked and reviews, comments, and studies not concerning the relationship between fibromyalgia, alexithymia, and psychological distress were excluded. Seven studies were ultimately included in this review.Fibromyalgia is a syndrome characterized by chronic, widespread musculoskeletal pain with tenderness over specific trigger points . Its precentral sensitization syndrome,” caused by increased sensitivity in the central nervous system to pain signals , which measures the inability to distinguish between specific emotions, or between emotions and the bodily sensations of emotional arousal; difficulty describing feelings(F2), which assesses the inability to verbalize one’s emotions to others; and externally oriented thinking(F3), which evaluates the tendency of individuals to focus their attention externally and not on the inner emotional experience .To date, different studies have investigated the presence of alexithymia in FM patients, using distinct experimental procedures. Of the seven studies selected for the current review, three assessed alexithymia rates comparing FM patients to patients with other chronic pain conditions, one compared alexithymia levels comparing FM patients to healthy controls and three evaluated the prevalence of alexithymia comparing FM patients’ values to normative data from healthy populations. In all these studies, the assessment of alexithymia was based on the use of TAS-20 ], The results, at least partially contrasting, obtained in the studies mentioned above, might depend on different reasons. One could be related to the substantial individual differences in pain severity and disability in patients with persistent pain . In mostAnother possible reason could be the exclusive use of the TAS-20 for the assessment of alexithymia. In recent years, this instrument has been criticized for its inability to detect the most severe cases of alexithymia, the difficulty in replicating its factor structure, and its association with negative affectivity . FurtherThe presence of psychological distress, especially depression and anxiety, is a well-known aspect of FM syndrome and has been reported in many studies . At the These results reveal the strong link between alexithymia and psychological distress in FM syndrome, especially depression. So it is essential for further research to consider the impact of alexithymia trait and its possible relationship with psychological distress and psychiatric disorders.Fibromyalgia is a multifaceted condition in which many factors are involved in the onset and retention of the disease. Psychological features are some of the principal aspects that contribute to the disability caused by this pathology and it is therefore essential to investigate them. Alexithymia is an emotional dysregulation trait, largely observed in psychosomatic disorders  that couThe available studies show the high prevalence of alexithymic traits in FM patients, ranging from 15 to 20% . HoweverThe other possibility is to use a control group of patients with chronic pain conditions with a low psychosomatic component (such as rheumatoid arthritis patients). The differences observed in alexithymia levels may be influenced by variations in the experience of pain, usually rated as more severe in FM syndrome than in other chronic pain diseases . So to bThe authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Metastatic spinal tumors are common and major causes of pathological spinal fractures that result in severe pain, weakness, and progressive neurological deficits. This study aims to evaluate the efficacy of percutaneous vertebroplasty (PVP) in pain-relief in patients with spinal fractures due to metastatic spinal tumors.We evaluated 25 documented cases of metastatic spinal tumors with pathologic vertebral fractures who were suffering from severe pain and underwent vertebroplasty. Degree of pain was measured by visual analog scale (VAS). The symptoms were evaluated 24 hours and 2 months after vertebroplasty regarding the degree of pain relief.Complications such as leakage, embolism and infection were assessed.MeanVAS score was 8.23 before therapy in the patients that was reduced to 2.12 and 1 in the patients 24 hours and 2 months after vertebroplasty, respectively. The most common complication was cement leakage (44%) and there was no embolism or infection. Data was analyzed by SPSS version 18 software through ANOVA test with Greenhouse-Geisser correction and P-value of 0.00 was obtained in the patients 24 hours and 1 month after surgery.Considering significant decrease in the mean pain severity degree after the treatment, veretebroplasty seems to be significantly effective in pain relief in metastatic spinal tumors. Spinal metastases are common and can lead to radiculopathy, myelopathy, deformity, severe pain and pathologic fracture that result in spinal cord compression . Spinal Indications for surgical treatment include radiotherapy resistant disease, spinal cord compression, acute or progressive neurological deficits, previous radiotherapy of the spinal cord, spinal column instability, resistant pain despite previous therapies, and life expectancy of more than 3 months -13. VertPercutaneous vertebroplasty (PVP) is a minimally invasive procedure in reducing pain caused by spinal compression fractures and improve vertebral column’s strength and mobility ,25. VertSome complications such as PMMA leakage, rib fracture, spinal cord compression, infection, pneumothorax and cement embolism are reported to be associated with vertebroplasty. Most procedural complications are related to leakage of PMMA through cortical defects, with epidural compression of the neural elements; however most of these problems are clinically insignificant ,30.Pain is the most common symptom among patients with metastatic spinal tumors with spinal compression fractures -4. In thIn this prospective cohort study, we evaluated 25 documented cases of malignancies with secondary spinal involvement and vertebral body fractures at different sites. Our patients consisted of 11 males and 14 females with mean age of 53.5 (range 37 to 70 years). Severe pain was the main presenting symptom in these patients that had decreased their quality of life. The sites of pathologic fractures varied from T3 to L4 with major lumbar involvement and less thoracic fractures. All patients gave their informed consent in writing. Patients were evaluated by complete history, physical examination and radiological evaluation . The average pain was evaluated by using visual analogue scale (VAS) with scores ranging from 1 (no pain) to 10 (excruciating pain) before PVP.  The ViceThe patients were placed prone after induction of general anesthesia in operating room and single-plane C-arm equipment was used. Under strict sterile technique, the skin overlying the vertebral body to be injected was cleaned and draped. After a small skin incision, the disposable bone biopsy needle was inserted under fluoroscopic guidance and advanced until its tip reached the pedicle, then the needle was guided through the centre of the pedicle and into the vertebral body. A bilateral transpedicular approach was used only if there was inadequate instillation of cement with the unilateral approach under fluoroscopy. The PMMA bone cement was injected in different amounts from 3 to 6 mL considering the site and size of the fracture under lateral fluoroscopic control until the PMMA reached the posterior three-quarter of the vertebral body or the PMMA leaked into the disc space or paravertebral tissues . In caseOpen surgery was performed in 4 patients because of unstable vertebral fracture and deformity to keep spinal column’s strength and shape. The patients and their postoperative VAS pain scores were evaluated 24 hours after the surgery.In order to make further evaluation, the degree of pain was also measured 2 months after the procedure.Data was analyzed by SPSS version 18 software  through ANOVA test with Greenhouse- Geisser correction.PVP was performed on 25 patients for a total of 25 procedures at 6 treated vertebral levels. The patients included 14 women and 11 men with a mean age of 53.5 years (range 37 to 70 years). The patients had pathologic fractures secondary to metastasis. Many patients had undergone previous therapy for spinal disease.The sites of pathologic fractures varied from T3 to L4 with major lumbar involvement (72%) and less thoracic fractures (28%). The mean vertebral height lost before vertebroplasty was 7 mm. Four lumbar levels and 2 thoracic levels were treated. During the procedure, 6 mL cement was injected to 5 patients (8%), 5 mL was injected to 13 patients (52%), 4 mL was injected to 9 patients (36%), and 3 mL was injected to 1 patient (4%). 5 mL cement was injected to T4 (2%), 4 mL to T8 (3%), 4 mL to L1 (25%), 5 mL to L2 (15%), 5 mL to L3 (40%), and 4 mL to L4 (15%). The mean amount of cement injected per level in the patients was 4.5 mL and the total injection volumes ranged from 4 to 5 mL. The most vertebral involvement was L3. No infection or cement emboli occurred.P-value of 0.00 was obtained 24 hours and 2 months after PVP (P≤0.05) that was considered statistically significant. Mean VAS pain degree of these patients was 8.23 before PVP that was decreased to 2.12 and 1 in 24 hours and 2 months afterwards , lung cancer (36%) and prostate (10%) in decreasing order. Leakage, infection and embolism as three major adverse effects of the procedure were assessed and 11patients with leakage including 5 paravertebral, 4 discal and 2 epidural leakages were reported . There wVAS scores obtained 24 hours and 2 months after PVP from our series of 25 patients showed significantly better pain relief in the patients with pathological vertebral fractures due to metastatic spinal tumors by PVP.Medical therapy, surgery, and radiation are available treatments for metastatic diseases of spine. Surgical intervention is not usually the first line of therapy and mostly is used with goals of palliative pain control, neurologic function and spinal stability maintenance ,34. RadiPVP is a safe, effective and minimally invasive surgical technique with decreased overall surgical complications which is successful at improving pain and contributes to spinal stabilization ; it is aShowed vertebroplasty is safe and effective in the setting of severe back pain caused by vertebral body fracture that is unresponsive to other therapies, even in the presence of relative contraindications to the procedures.To date, percutaneous vertebral augmentation offers a minimally invasive approach for the treatment of pathologic vertebral compression fractures . PVP hasreported that PVP in metastatic fractures significantly decreased many patients’ back pain, reduced their intake of pain medications and was a safe procedure with no serious complications. Weill et al . reporteSome authors have correlated complications with excessive PMMA injection , whereasPVP significantly reduces the degree of pain in the patients with metastatic vertebral involvements.


To investigate the association of the change of painful physical symptoms (PPS) after 4 weeks, with the 6-month treatment outcomes of depressive symptoms in patients treated with duloxetine in clinical practice.Multicenter, prospective, 6-month, non-interventional study in adult outpatients with a depressive episode and starting treatment with duloxetine. Depression severity was assessed by the clinician (Inventory for Depressive Symptomatology [IDS-C]) and patient . Somatic symptoms and PPS were assessed using the patient-rated Somatic Symptom Inventory (SSI) and visual analog scales (VAS) for pain items. Association of change in PPS with outcomes of depressive symptoms was analyzed based on mean KUSTA scores  and achievement of a 50% reduction in the total IDS-C score after 6 months using linear and logistic regression models, respectively.Of the 4,517 patients enrolled , 3,320 patients (73.5%) completed the study. 80% of the patients had moderate to severe overall pain (VAS > 30 mm) at baseline. A 50% VAS overall pain reduction after 4 weeks was associated with a 13.32 points higher mean KUSTA score after 6 months, and a 50% pain reduction after 2 weeks with a 6.33 points improvement. No unexpected safety signals were detected in this naturalistic study.Pain reduction after 2 and 4 weeks can be used to estimate outcomes of long-term treatment with duloxetine. PPS associated with depression have a potential role in predicting remission of depressive symptoms in clinical practice. Depressive patients frequently report somatic symptoms including painful physical symptoms (PPS) accompanying their depression  . The cauIn 69% of depressed patients, painful or non-painful physical symptoms were the only presenting complaints in general practice ,11 and iIn a naturalistic clinical trial addressing long-term treatment of PPS and emotional depressive symptoms , it was Extensive data support the efficacy of tricyclic antidepressants (TCAs) for the alleviation of pain in chronic pain patients , and alsThe primary research objective of the present 6-month, observational study with duloxetine ('PADRE') was to investigate the association of an early improvement in PPS with long-term changes in depressive symptoms, which could be used as a predictor of long-term treatment outcomes in depression. Such a predictor could be helpful for an early adjustment of treatment to the individual patient .The present multicenter, prospective, non-interventional study (F1J-SB-B009) investigated the influence of early changes in PPS in depressed patients on long-term changes in depressive symptoms during treatment with duloxetine in clinical practice over a period of 6 months.The study was conducted at 693 centers in Germany. Initially, all psychiatrists/neurologists of the Lilly database  were contacted and finally 693 centers actively participated in the study. Outpatients (age ≥ 18 years) with a depressive episode (according to ICD-10) who were initiated to antidepressive treatment with duloxetine were allowed to enter the study. Treatment patterns were solely at the discretion of the physician and the patient.The study was approved by the appropriate ethics committee and notified to the German national authority . Patients provided written consent to the collection and release of anonymized data (according to the Declaration of Helsinki).Data were collected at baseline (i.e. prescription of duloxetine), after 2 weeks, 1, 3, and 6 months, or at early discontinuation of observation. The study was conducted from August 2005 until December 2007.Depressive symptoms were assessed using the daily self-rating KUSTA scale  . A high The Inventory for Depressive Symptomatology (IDS)  is an inChanges in painful and non-painful physical symptoms were assessed by the patient-rated Somatic Symptom Inventory (SSI) . The SSIThe outcome assessments were conducted at the visits in the physician's office, either by the patient  or by the investigator (IDS-C).Improvements are indicated by a decrease of the respective scores for IDS-C, VAS Pain and SSI, and by an increase of the Mean KUSTA score.Demographics and other baseline parameters, treatment decisions, concomitant use of analgesics, hospitalizations for depression, and tolerability data (adverse events [AEs]) were collected.For this study, about 4,300 patients were planned to be recruited. This sample size allows measurement of changes in pain using the VAS with adequate precision (10% of the standard deviation [SD]) in all subgroups derived from the combination of gender and baseline pain (≤ 30 or > 30 mm VAS ). It wasData analyses were performed using SAS version 9.1.3 statistical software. All analyses were exploratory; no confirmatory statistical tests were performed, or statements derived. Continuous variables were summarized using descriptive statistics  and binary or categorical variables using absolute and relative frequencies. A conservative test of whether mean changes over time were statistically significant was done by seeing whether the 95% confidence intervals for the means at the time points overlapped. To address the primary objective, the Mean KUSTA score and whether or not patients had achieved a ≥ 50% reduction in the total IDS-C score at the final visit were analyzed, using linear and logistic regression models, respectively. These models included the following variables:• Baseline score of the outcome variable• Gender, age, employment status, whether living alone• Number of weeks unable to work in the last 12 months• Currently unable to work• Duration of depression• Concomitant psychiatric/somatic diseases• Baseline psychotropic/permanent pain medication• Pain symptoms at baseline• Initial dose of duloxetine• Overall pain VAS at baseline• ≥ 50% overall pain VAS reduction at 4 weeks• ≥ 50% reduction in SSI painful symptoms subscore at 4 weeks• SSI painful and non-painful symptom subscores at baselineAll of these independent variables were included in a full model and then removed stepwise. Model calculation was repeated with 50% reduction in VAS for overall pain and SSI between baseline and 2 weeks instead of at 4 weeks. Post-hoc, this model was repeated for patients with clinically relevant (> 30 mm) baseline pain only.The effect of non-painful physical symptoms on outcomes was also investigated using regression methods. Model fit was checked by reviewing plots of residuals for the linear regression and the Hosmer-Lemeshow goodness-of-fit test for logistic models. Sensitivity analyses  were performed to check the robustness of the primary analysis.A further post-hoc analysis in patients with > 30 mm pain at baseline examined the predictive value of an early response in depressive symptoms  in conjunction with an early response in pain  and other possible predictive factors.Data quality was assured by implementing a data validation plan and double data entry. Data from incomplete scales  were excluded from statistical analysis for the respective visit and patient.A total number of 4,517 patients were enrolled into the study, 3,320 patients (73.5%) reached the endpoint at Visit 5 . Correspondingly, the IDS-C total score continuously decreased over time (p < 0.05). The development over time of all individual KUSTA items was similar to that of the mean KUSTA score. Details on the mean KUSTA score and IDS C score are given in Table VAS pain scores and SSI scores improved continuously over time during the study (p < 0.05) as shown in Table Categorical analyses of the proportions of patients with a reduction of ≥ 30% or ≥ 50% in VAS overall pain from baseline to 6 months are shown in Table The linear regression analysis showed that in the applied model, a 50% reduction in overall pain VAS during the first 4 weeks had the strongest association  of all variables assessed with the mean KUSTA score at 6 months. For patients with a ≥ 50% reduction in overall pain VAS during the first 4 weeks, the mean KUSTA score at 6 months was estimated to be 13.32 points higher than for patients without a ≥ 50% reduction. These results were supported by sensitivity analyses based on LOCF and repeated measures approaches. The results were similar for patients with baseline pain > 30 mm. All variables with a statistically significant effect in the regression analysis of the mean KUSTA score are given in Table In the logistic regression analysis of the response rate in the IDS-C total score (50% reduction [yes/no]), the IDS-C total score at baseline and the change in the overall pain VAS during the first 4 weeks had the strongest effect (p < 0.0001) among the factors included in the model.The odds ratio for the change in the overall pain VAS during the first 4 weeks was 3.00 (95% CI: 2.41-3.75). This indicates that for patients with a ≥ 50% reduction in their overall pain VAS during the first 4 weeks, the odds of achieving a 50% reduction in the IDS-C total score after 6 months is 3 times higher than for those who did not. Expressed as relative risks, the probability of achieving a 50% reduction in the IDS-C total score was 1.45 times higher for those patients with an early ≥ 50% reduction in their overall pain VAS.Further statistically significant factors were similar to those seen in the analysis of the mean KUSTA score.When performing the model based on 2-week data, the ≥ 50% reduction in overall pain VAS during the first 2 weeks was identified as a relevant factor in influencing the outcome of depressive symptoms after 6 months. Two-week data were associated with a 6.33 point improvement in the 6-month mean KUSTA score, compared with patients without a ≥ 50% pain reduction.The remission rate based on IDS-C  after 6 months was 45.9% for all patients. In a regression analysis, pain reduction  during the first 4 weeks was the factor most strongly associated with remission rate (p < 0.0001), with an odds ratio of 2.90 (95% CI: 2.38-3.52). The relationship between an early pain reduction after 2 and 4 weeks and the remission rate after 6 months is shown in Figure In a post-hoc analysis, the early reduction of depressive symptoms measured with the IDS-C scale was added to the linear regression models. Using the reductions during the first 4 weeks in patients with clinically relevant pain (> 30 mm VAS) at baseline, the ≥ 50% reduction in overall pain VAS  and the ≥ 50% reduction in IDS-C total score after 4 weeks  showed the strongest associations with 6-month KUSTA depressive outcomes. An analysis based on the 2-week results with a 20% reduction criterion also showed a strong association of the reduction in overall pain VAS  and the IDS-C total score  with 6-month KUSTA depression outcomes.During the observation period, 132 patients (3.1%) were hospitalized due to depression, the median duration was 23 days (range: 1 to 153 days).At least one treatment emergent adverse event (TEAE) was reported by 741 patients (17.2%). The most frequently affected system organ classes (at least 3% of patients with an event) were gastrointestinal disorders (395 patients [9.2%]), psychiatric disorders (200 [4.6%]), nervous system disorders (153 [3.5%]), and skin and subcutaneous tissue disorders (131 [3.0%]). The only TEAE that was reported by more than 3% of patients was nausea (226 patients [5.2%]).Serious TEAEs were reported by a total of 34 patients (0.79%). The only serious TEAEs reported by more than 2 patients were depression (6 patients [0.14%]) and diarrhea (3 [0.07%]). Serious TEAEs included one report of suicidal ideation; however, no suicide or suicide attempt was reported. Two patients had fatal TEAEs: renal cancer; cerebral hemorrhage.At each post-baseline visit, mean weight had decreased compared to baseline, but mean decreases were not greater than 0.23 kg below baseline at any time point.In the PADRE study, 80% of the depressed patients had moderate to severe overall pain at baseline. For all patients, the mean overall pain VAS score was 55.0 mm. This high pain intensity could partly result from the fact that depressed patients with pain syndromes could be overrepresented in this study because of the proven analgesic efficacy of duloxetine ,23. HoweFor 72.1% of the PADRE population, concomitant somatic diseases were documented most frequently 'muscle and skeleton diseases' (33.7%). The high prevalence of patients suffering from pain conditions may raise concern that common depression rating scales overestimate depressive symptoms in these patients, as they may score higher on somatic items because of their pain rather than because of their mood. However, Poole et al.  showed aThe main finding of our study is that early change in pain severity was strongly associated with a long-term reduction of depressive symptoms according to the mean KUSTA score. Pain responders also had a higher chance of achieving a 50% reduction in the IDS-C total score after 6 months.This association of an early improvement in pain with long term depression outcomes was already seen after 2 weeks, albeit, to a smaller extent than after 4 weeks. This is remarkable, considering that 72.9% of the patients started duloxetine treatment with a dose of 30 mg/day, which is lower than the recommended starting and maintenance dose.Patients with a VAS pain reduction of ≥ 50% after 2 and 4 weeks, showed also higher remission rates after 6 months than patients without a ≥ 50% pain reduction . Results showed that an early pain response had similar predictive value compared to early depression response for long term depressive outcomes as measured with the KUSTA scale.The main results of the PADRE study are in contrast to a recent publication , reportiOther studies support the association between early improvement in pain and long-term antidepressant response ,37. PoolThe results of the PADRE study are of interest in the context of other recent research ,38-42. EAs this was a large observational study in daily clinical practice, several methodological limitations such as the absence of monitoring or a high number of patients lost to follow-up were unavoidable and may lead to concerns with regard to data quality. However, this non-interventional approach reflects current treatment of patients with MDD by office-based psychiatrists and should therefore allow generalization of our results to clinical practice. Perhaps the most serious shortcoming of non-interventional trials is selection bias because of absence of randomization. Another limitation of the study is the lack of a control group, as only duloxetine-treated patients were included.Pain is a frequent and often severe concomitant symptom in depressive patients in clinical practice. Pain reduction after 2 and 4 weeks can be used to estimate long-term outcomes regarding successful antidepressive treatment with duloxetine.The present results emphasize the importance of PPS associated with depression because of their potential role in predicting and achieving depressive symptom remission.Edith Schneider, Harald Weigmann, Thomas Wagner, Deborah Quail, and Hans-Peter Hundemer are employees of Eli Lilly or Boehringer Ingelheim.Ulrich Hegerl is speaker/advisory board member for Lilly, Lundbeck, GlaxoSmithKline and Bristol-Myers Squibb.Michael Linden is consultant and speaker/advisory board member for Lilly and Lundbeck.This research was funded by Lilly Deutschland GmbH and Boehringer Ingelheim Pharma GmbH & Co KG.ES, UH, ML, TW, and HPH have participated in the study design, interpretation of results, and writing of the manuscript. DQ carried out the statistical analysis, participated in the interpretation of results, and writing of 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/1471-244X/11/150/prepub