Patients with chronic pain often complain about cognitive difficulties, and since these symptoms represent an additional source of suffering and distress, evaluating the cognitive status of these patients with valid and reliable tests should be an important part of their overall assessment. Although cognitive impairment is a critical characteristic of pain, there is no specific measure designed to detect these effects in this population. The objective was to analyze the psychometric properties of the “Test Your Memory” (TYM) test in patients with chronic pain of three different origins. A cross-sectional study was carried out on 72 subjects free of pain and 254 patients suffering from different types of chronic pain: neuropathic pain (104), musculoskeletal pain (99) and fibromyalgia (51). The construct validity of the TYM was assessed using the Mini-Mental State Examination (MMSE), Hospital Anxiety and Depression Scale (HADs), Index-9 from MOS-sleep, SF-12, and through the intensity  and duration of pain. An exploratory factor analysis was also performed and internal reliability was assessed using Cronbach’s alpha. After adjusting for potential confounders the TYM could distinguish between pain and pain-free patients, and it was correlated with the: MMSE ; HAD-anxiety  and HAD-depression scales ; MOS-sleep Index-9 ; and the physical  and mental components  of SF-12. The exploratory structure of the TYM showed an 8-factor solution that explained 53% of the variance, and Cronbach’s alpha was 0.66. The TYM is a valid and reliable screening instrument to assess cognitive function in chronic pain patients that will be of particular value in clinical situations. An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage”, the concept of pain has shifted from the passive to the active, assuming cognitive processes underlie pain perception. In fact, it is currently recognized that perceiving pain is the result of complex and dynamic interactions that both encode and process nociceptive signals, influencing normal cognitive function and placing additional demands on overall attentional resources [Chronic pain (CP) has attracted significant attention in the last 30 years due to its prevalence and its impact on patients’ lives . Indeed,esources .When cognitive function has been assessed in CP patients, they appear to experience a mild impairment, most often reflecting poorer performance in memory tasks and executive functions –9. HowevNevertheless, when assessing this situation it is important to note that the scales used to assess cognitive functioning have not usually been specifically validated in CP patients. Moreover, those used are very broad, complex and time-consuming, sometimes requiring specialist health professionals to administer them , a challThe Test Your Memory (TYM) scale was developed recently as a screening test to assess cognitive function in different groups of dementia patients. TYM proved to be useful to distinguish dementia from non-dementia cases, detecting almost all of the Alzheimer disease dementia cases with a cut-off ≤42/50 in the index paper . It is sTherefore, we set out to analyze the criterion, discriminant and structural validity, and internal reliability of this questionnaire in patients with CP of three different origins: neuropathic pain, musculoskeletal pain, and fibromyalgia.This cross-sectional study included male and female patients between 18 and 60 years of age who attended the chronic pain unit at the university hospital in Cádiz (Spain). All the patients included had suffered chronic non-malignant pain for at least 3 months and they were divided into three separate groups in accordance with the cause and characteristics of the pain: musculoskeletal pain (MSK); neuropathic pain (NP); or fibromyalgia (FM). These groups were established according to the clinical examination carried out by pain specialists with extensive experience. MSK and NP cases were confirmed by objective tests such as electromyography, x-ray and advanced imaging, and were scored according to the ICD-10 criteria. In the case of FM, the American College of Rheumatology (ACR) 1990 classification criteria  were useAll pain patients and control subjects were able to read and write, they were mentally and physically capable of participating in the study and they provided their written informed consent. Individuals already diagnosed with any type of dementia or those in the control group with an MMSE <24 or a score other than zero in the Visual Analog Scale were excluded from the study.The study was conducted in accordance with the Helsinki Declaration, using Standard Working Procedures and Protocols, and it was approved by the Clinical Research Ethics Committee at the University Hospital “Puerta del Mar” in Cádiz, ensuring adherence to the norms of good clinical practice.Socio-demographic data and clinical variables  were recorded using a structured questionnaire and by consulting the patients’ clinical records. Information was collected on the pharmacological drugs being consumed by the patient at the time of the evaluation that might affect cognitive function, only recording whether the patient was taking certain drugs or not. The information regarding the specific effects of drugs on cognitive function was based on a list already drawn up using the technical data sheets of the products registered by the Spanish Agency for Medications and Healthcare Products. The intensity of pain experienced at the time of the evaluation was assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (the worst possible pain), and this was categorized as mild (<4), moderate (4–7) or severe (>7) pain  . Informawww.tymtest.com). Importantly, it has been shown that the TYM is very sensitive and specific to detect cognitive impairment and dementia.The translated and adapted Spanish version of the TYM test  was usedThe adapted and validated Spanish version of the Mini-Mental State Examination (MMSE)  was alsoThe Medical Outcome Study (MOS) Sleep scale  was usedDepression and anxiety were evaluated using the 2 sub-scales of the Hospital Anxiety and Depression scale (HADs) . The SpaThe adapted Spanish version of the SF-12 v.1, by Alonso et al. , was alsAll the information was collected on paper in the pain unit of the hospital by a previously-trained psychologist who was not the physician responsible for the clinical assessment of the patient. The study subjects performed the TYM test first, followed by the MMSE. Between the performances of both instruments, the administration of all the other instruments was performed. The testing procedure, in an isolated environment, lasted 1–1.5 h for each patient.A descriptive analysis of the demographic and clinical characteristics of the subjects was performed . In addition, the proportion of patients that obtained the lowest (floor) and the highest (ceiling) scores for the TYM and MMSE scales was calculated. The Kolmogorov-Smirnov test was used to determine the normality of the variables.The homogeneity or internal consistency of the TYM was assessed using Cronbach’s alpha coefficient, and it was considered acceptable when alpha was ≥0.6 . The corTo establish the structure of the TYM in the CP population, an Exploratory Factor Analysis (EFA) followed by Varimax rotation was performed. To determine the best solution for the number of factors, we first used the Kaiser rule, which involved dropping all components with eigenvalues <1 . In addiThe literature often emphasizes that cognitive function in patients with chronic pain is affected by repeated factors. Thus, it appears that an altered state of anxiety or depression, or poor quality sleep leads to worse cognitive performance. In light of these results, we proposed to consider the cognitive function as a construct consisting of all those previously described associations. In other words, we assumed that in these patients with pain, certain circumstances will condition the results of the cognitive function scores. This assumption was reflected in different hypotheses that have been used to assess the validity of the "cognitive function" construct assessed through the TYM scale.We established 14 hypotheses (H). Thus, given that CP can provoke emotional changes (anxiety and depression) and sleep alterations , and given that these disorders are known to produce a deterioration in cognitive function in other patients –38, we hThe evaluation of the construct validity also included an analysis of the discriminant validity in defined subgroups of patients, hypothesizing that lower TYM scores would be obtained from patients with CP compared to the control group  (H8). SiThe MMSE reference questionnaire was used to evaluate criterion validity, considering that this scale should be closely related to the TYM score, a hypothesis tested with the Spearman’s rank correlation test.To analyze each hypothesis and eliminate the potential confounders related to differences in sex, age, academic level, anxiety and depression scores, quality of sleep, treatment with drugs that potentially affect cognitive function, and cardiovascular risk factors between the case and control and between the tree groups of CP patients, the scores of TYM and MMSE were adjusted by these variables prior to the comparisons.All the analyses were performed with the SPSS statistical package (Ver. 21).A total of 336 subjects were recruited onto this study from November 2010 to April 2012. Of the individuals approached, six were excluded as they reported no pain at the time of the evaluation (VAS = 0), three refused to participate and one could not complete the test due to visual impairment. Thus, a final cohort of 254 subjects suffering CP  than with the other domains  performed on the TYM extracted 10 factors with eigenvalues >1 (Kaiser’s criterion), which explained the variability of 60.5%. However, according to the scree plot, from the eighth factor onwards the graph tended towards the horizontal . TherefoAnalyzing the validity of the construct, significant correlations were found between the adjusted TYM scores and the anxiety  or depression HAD scales , as well as with the MCS  and PCS  of the SF-12, and with index 9 in the MOS scale . There was also a significant negative correlation between the TYM score and pain intensity , although no correlation was observed between TYM and the duration of pain .Analyzing the discriminant validity, patients with CP obtained lower adjusted average TYM scores than the control subjects , although no differences were found in the scores between the three groups of patients who suffered pain of different origins . ConversThis study demonstrates that the TYM is an adequate screening tool to explore cognitive function in CP patients, confirming the valuable psychometric properties of the instrument. Indeed, this represents the first study to analyze the structure of this TYM scale.The results supported 11 of the 14 hypotheses proposed as constructs in the validation process, including the assumption that significant differences between cases and controls would exist in cognitive performance. They showed a narrow difference between the groups, demonstrating, as expected, that the impairment of cognitive function most frequently reported in patients with CP is mild, and therefore the difference with subjects without pain should not be too large. Studies that have previously used screening measures such as the Mini Mental State Exam (MMSE) ,46, or tThe two-way relationship between pain and affective disturbances has been largely addressed in the literature and multiple explanations have been proposed to justify these different pathways . HoweverSeparating pain-related effects on cognition from the effects of emotional distress is one of the main difficulties in studying pain-cognition interactions. Most pain patients suffer from depression, anxiety, stress, anger or a combination of these and related factors, all of which affect cognitive functioning directly or indirectly, via apathy, medication effects, fatigue, and disordered sleep . NotablyPain intensity was correlated with the TYM test score, with lower scores among patients with severe pain. Similar findings were established in a mixed population of pain patients, where those who reported high intensity pain performed worse in a demanding attentional task than subjects with low intensity pain . This waThere is a wealth of evidence that sleep-dependent mechanisms affect the neural plasticity leading to the consolidation of learning and memory . This inOur study demonstrates a relationship between poorer cognitive performance and a worsening in the mental and physical HRQL  components. Prolonged pain negatively affects mental health and the ability to perform everyday tasks, which translates into a poorer perception of the patient's physical and mental status . HoweverIn relation to the structure of the TYM for pain patients, the 8 factor structure was still the most relevant due to the distribution of the items for the different factors and despite the loss of variance that could be explained. It is significant that 3 of the 8 factors described in the EFA matched the naming, calculation and visuospatial ability domains of the original scale . MoreoveFinally, it should be noted that the TYM is a self-administered test that is easy and quick to use (administered to pain subjects in 10 min on average), and it has more features than the MMSE. One is the multi-task feature that opens the test to greater variability in terms of the results and the exploration of more cognitive aspects than with the MMSE test. Another advantage of the TYM is that the ceiling effect is weaker than with the MMSE. These features are particularly relevant given that the cognitive impairment observed in CP populations is generally milder than in other populations studied.One strength of this study is that it used rigorous diagnostic criteria to analyze 3 distinct groups of patients with CP. Likewise, the tools with which the TYM was compared, including the HAD, MOS-sleep and SF-12, have psychometric properties appropriate to patients with pain. Moreover, the TYM scores were adjusted to many variables common to CP patients with known effects on cognitive performance, including educational level, drug consumption and cardiovascular risk factors, which were taken into account in the validation process. This study demonstrates the usefulness of an instrument that overcomes the limitations that have become evident in the different studies where patients with CP have been assessed with tests that have not been validated with such patients, which may result in lower statistical power and potential bias. Considering these variables, a more accurate estimation of the test results was performed.In terms of the possible limitations of the study, no cut-off point has been established for the scale, although an analysis using cut-off values was considered somewhat dubious due to the paucity of studies in patients with CP . NonetheThis is the first study to assess the psychometric properties of the TYM in patients with CP of 3 different origins. The results obtained show that the TYM is a valid and reliable tool to screen the mild deterioration or decline in cognitive function frequently reported in patients with CP. When coupled to its ease of use, the TYM test is clearly an interesting alternative to apply to CP patients in regular clinical practice.S1 Data(XLSX)Click here for additional data file.S1 Table(DOC)Click here for additional data file.


We have previously shown that medication overuse is prevalent among individuals self-medicating regular headache.In this study we evaluated self-medicating headache patients from a broader perspective, exploring the interplay between headache and concomitant pain conditions, pain-related disability and pain medication use. Identification of subgroups of patients could be helpful to tailor intervention strategies.A hierarchical cluster analysis was used to group 1021 self-medicating headache patients according to their (1) sociodemographics, (2) pain characteristics, (3) pain-related disability and (4) pain medication use. Patients were recruited in 202 Belgian community pharmacies and fulfilled the following inclusion criteria: aged ≥18 years, purchasing an over-the-counter systemic analgesic, experiencing pain ≥1 full day/month and suffering from headache.Three subgroups were identified. Group 1 comprised patients with low socioeconomic status, low self-rated health, on average four concomitant pain conditions, high pain frequency, high disability, and high rates of medication overuse. Group 2 included older patients with a mean of two other pain syndromes, and low disability but high pain intensity. Group 3 comprised young highly-educated patients diagnosed with migraine, having on average one concomitant pain condition, low pain frequency, low disability but high pain intensity, and low rates of medication overuse.We have identified three subgroups in a large sample of individuals self-medicating headache. The marked differences across the three groups stress the importance of a holistic assessment of headache patients and the need for tailored strategies to reduce the risk of medication-overuse headache in primary care.No conflict of interest.


Despite the widespread use of subcutaneous methotrexate in treating pediatric rheumatic disorders, the amount of pain associated with the injections has not been quantified. Our study aims 1) to quantify the amount of pain associated with subcutaneous injections of methotrexate, 2) to explore predictors of pain, 3) to determine the frequency of patient-reported clinical adverse effects of methotrexate, and 4) identify coping strategies of patients and caregivers.Patients aged 4–17 years with rheumatologic diseases who were receiving weekly subcutaneous methotrexate injections for at least 4 weeks were invited to participate in this prospective cohort study. They were trained to use the Faces Pain Scale – Revised (FPS-R) and Faces, Legs, Arms, Cry, Consolability (FLACC) tools to rate pain associated with the injections. All patients underwent focused interviews exploring their experiences with methotrexate injections.Forty-one patients consented to the study. The mean age was 11.2 years (SD = 3.9 years) and 68% were female. Most patients were diagnosed with JIA (73%). Mean duration of methotrexate therapy was 2.5 years (SD = 2.1 yrs). All but one of the patients used methotrexate 25 mg/ml solution for injection in 1 cc or 3 cc syringe with 30 gauge ½” needle. Median amount of pain was 2/10 on the FPS-R and 1/10 on the FLACC. Higher intensity of pain was significantly associated with presence of side effects (p = 0.004), but not duration of therapy (p = 0.20) or age (p = 0.24). Most participants (61%) experienced at least one adverse effect; nausea (56%) and vomiting (34%) were the most common symptoms reported. Patients and caregivers reported using ice (34%), comfort positions (51%), rewards (49%), reassurance (54%), distraction (51%), and analgesic medications (22%) to cope with the injections.Subcutaneous injections of methotrexate are associated with a mild amount of pain. Presence of side effects may amplify the amount of perceived pain. Clinicians can apply this knowledge when counseling patients and family members about methotrexate therapy. Methotrexate has been an important component of treatment for paediatric rheumatologic conditions for over twenty years , 2. AccoProcedural pain in paediatric populations is a concern for clinicians due to its association with greater pain and anxiety in subsequent painful events, increased adult pain sensitivity, and long-term avoidance of medical treatment , 5. For Recognition of the negative consequences of inadequately controlled paediatric pain has generated increased interest in pain assessment and management for young patients . A largequantify the amount of pain associated with subcutaneous methotrexate injections,investigate the factors that influence the amount of perceived pain and identify effective pain management strategies used by patients and families, anddetermine the frequency of clinical adverse effects of subcutaneous methotrexate and effective treatments as reported by the patients and families, andidentify coping strategies of patients and caregivers.Given the negative long-term effects of repeated exposure to procedural pain and the vulnerability of the paediatric rheumatology population using subcutaneous methotrexate, our study aimed to address gaps in the existing literature by investigating the following objectives:Observational prospective cohort study.All patients at the Children's Hospital of Eastern Ontario Rheumatology Clinic with appointments scheduled between June and August 2013 were screened for their eligibility to participate in this study.Patients were invited to participate in the study if they were between the ages of 4 and 17 and were currently receiving subcutaneous injections of methotrexate for at least 4 weeks.The primary outcome was the amount of pain associated with subcutaneous injections of methotrexate.The secondary outcomes were the 1) predictors of injection-induced pain, 2) patient/family-reported side effects associated with subcutaneous methotrexate, and 3) effectiveness of treatments for these side effects.Clinical Interview. A research assistant conducted a standardized focused interview with the patient and family members to ask about their experience with subcutaneous administration of methotrexate. The interview consisted of 18 questions which were developed specifically for this study based on a review of the literature. The interview required approximately 10 minutes to complete.Chart Review. Charts were reviewed to gather information pertaining to medical diagnoses and therapy.Pain Measurements:a/Faces Pain Scale – Revised (FPS-R). This scale consists of six gender-neutral faces depicting “no pain” to “most pain possible”. The child is instructed to point to the face that represents how much pain he/she feels. Ordered faces are scored 0-2-4-6-8-10. This instrument has demonstrated validity and reliability in recording self-reported pain in children between the ages of 4–17 [ of 4–17 , 13.b/FLACC Behavioral Scale. This observational scale comprises five items, namely, (F) Face; (L) Legs; (A) Activity; (C) Cry; and (C) Consolability. Each of these five behavioural categories is rated on a scale 0 to 2 to provide an overall pain score ranging from 0 to 10. This tool is valid and reliable for children aged 4–18 [ged 4–18 , 15.Participants were taught to how to use the FPS-R to self-report pain, while caregivers were instructed in the use of the FLACC scale to rate their children's pain. One copy of each scale was provided for each of the next two methotrexate injections to increase the accuracy of the assessment. Participants then returned the completed scales via mail or electronic messaging to a single, secure address. An electronic messaging reminder was sent four weeks after the interview if the scales had not already been submitted. Descriptive statistics were used to analyze the demographics of the patient population and the frequency of the outcomes of interest. The Intraclass Correlation Coefficient was calculated to determine the level of consistency between the FLACC score and Faces Pain Scale. A Bland-Altman plot was also constructed to analyze agreement between instruments. Simple and multiple linear regression were conducted to determine the association between both the FLACC score and Faces Pain Scale and age, presence of side effects, and duration of treatment. All analyses were conducted using SPSS v. 21 and R v. 3.0.2.This study was approved by the Children's Hospital of Eastern Ontario Research Ethics Board (REB Protocol No 13/98X).Of the 42 patients who met the inclusion criteria for this study, 41 consented to participate (participation rate 97.6%). The mean age was 11.2 years (SD = 3.9 yrs) and 68.3% of participants were female. Most of these patients were diagnosed with JIA . Weekend days were the most popular for injection administration . In most families, the child's mother was responsible for administering the injection , followed by the father . Only 12.2% of patients regularly injected the medication themselves. The upper arm was the preferred site of injection in 70.7% of patients. Approximately 19.5% of caregivers reported preparing their children for the injection by "counting to three" in advance; the remaining participants did not receive warning before needle insertion.The set of pain scores from the first injection was used in statistical analyses. Of the 29 patients who completed the pain scales, the median amount of self-reported pain on the FPS-R was 2/10; 18 (62.1%) patients reported nil to mild pain (FPS-R score 0–2), and 9 (31.0%) reported moderate pain (FPS-R score 4–6). Two participants reported severe pain  rated the pain 3/10 or less , but not with duration of therapy (p = 0.45) or age (p = 0.33). Multiple linear regression adjusting for all three variables demonstrated that the presence of side effects was independently associated with a 2.1 unit higher FLACC . Age  and duration of therapy  were not significantly associated with FLACC scores.Participants were asked if they made past or current attempts to reduce the pain associated with the injections through any combination of various pharmacological and psychological techniques. The majority of participants (80.5%) tried at least one method. The frequency of use and reported efficacies of these methods are described in Table Participants were asked to describe changes in pain intensity of methotrexate injections over the course of therapy. While 7/41 patients (17.1%) reported that the pain has worsened over time, 12/41 patients (29.3%) reported decreased intensity. An additional 19/41 (46.3%) of patients reported no change in pain intensity throughout the course of therapy, and 3/41 (7.3%) of participants were unable to identify any consistent trend.Most participants  experienced at least one clinical adverse effect Figure . The twoThe timing of onset and the duration of clinical adverse effects were also recorded Table . AnticipOf 19 patients who had used oral methotrexate in the past, only 26.3% felt that the oral form was better tolerated. The remaining patients either favoured the subcutaneous route , had no preference , or were undecided .The participants within our study reported mild pain associated with the weekly subcutaneous methotrexate injections (2/10 on the FPS-R). Interestingly, approximately a third of patients and a third of caregivers reported no injection pain (FPS-R or FLACC score of 0). Compared to other studies that have used the FPS-R to measure pain associated with analogous procedures, our participants reported a relatively low amount of pain. For example, Berberich and Landman  measuredThough the median amount of pain reported in our study is relatively low, it is important to note that some children experienced moderate to severe pain with the injections. For example, two of the participants recruited for this study refused to regularly receive the injections due to the associated discomfort. Within our study, 92.7% of participants reported missing less than one dose of methotrexate per month. The rate of reported paediatric adherence to methotrexate therapy  within the existing literature is difficult to assess due to various operational definitions for adherence. However, adherence seems to vary from 82% to 95.9% between studies , 21. TheFamilies who participated in this study reported using a variety of techniques to alleviate the pain associated with injections. Interestingly, two thirds of our patients who tried ice to cool the skin prior to or immediately after injection found this intervention effective despite a systematic review of physical techniques to reduce injection pain that found inconsistent evidence to support the benefit from ice application  and subsApproximately half of our participants reported using comfort positions, such as hugging or hand-holding, to reduce to the injection pain. Two thirds of these patients reported experiencing some degree of pain relief. This is in keeping with prior research reports showing benefits of hugging children during painful procedures , 25. In Another common technique our families used to reduce pain involved providing rewards, either in the form of food treats (including sweets), toys, or enjoyable activities. Most of our patients reported experiencing pain relief due to the promise of reward. While there is no comparative study on the effects of promised future rewards on pain, a recent Cochrane review of randomized control studies investigating the use of oral glucose or sucrose for pain relief during needle-related procedures found these techniques did not reduce pain scores in school-aged children . This diSystematic reviews have reported that distraction is an effective coping method used to alleviate paediatric needle-related pain –29. As eWe found that experiencing nausea or vomiting in association with the methotrexate injections was associated with higher pain scores on the FPS-R and FLACC. These gastrointestinal symptoms are the most common side effects associated with methotrexate therapy and have been linked to a reduced health-related quality of life . It is pGiven this association, adequate control of these symptoms is desirable for alleviating injection-associated pain and its long-term consequences. Results of our study suggest that dimenhydrinate has only a very limited role in treatment of methotrexate associated nausea and vomiting, and perhaps ondansetron should be the treatment of choice in this situation. There is some evidence that psychological intervention may be beneficial to managing anticipatory nausea and vomiting when methotrexate is prescribed for JIA .Due to the observational nature and relatively small size of our study, we are unable to strongly recommend for or against particular methods of pain relief. However, each of the techniques described above provided relief for at least some participants. The low cost and low risk of these interventions justifies their trial. The small size of our study also prevented stratification of participants by age, rheumatologic condition, and anxiety. Further research is needed to determine whether the results generalize to different populations within these categories.This study provides detailed information on the amount of patient-perceived pain with subcutaneous injections of methotrexate and potential pain aggravating factors. In addition, the paper explores patients' and caregivers' perception of methotrexate-associated side effects and their coping strategies. We hope the results will help clinicians counsel patients and families starting weekly methotrexate injections. The possible association between the presence of gastrointestinal side effects and higher reported amounts of pain warrants further study. Careful management of these adverse effects may help to avoid the negative long-term consequences of inadequately managed procedural pain.We obtained a consent from patients and guardians to participate in the study. We did not obtain a consent for publication of this report as it was not required by our REB.


Post-herpetic neuralgia (PHN) is the most common complication in herpes zoster (HZ) patients.We performed a longitudinal, prospective study in 108 general practices throughout Italy to assess how many immunocompetent patients aged ≥50 years with newly diagnosed HZ develop HZ-associated pain, its duration and management over 6-months. HZ-associated pain was assessed by a direct question to the patient and by self-assessment of the worst pain felt in the previous two weeks on a visual analogue scale (VAS), a score ≥3 was taken as pain. PHN was defined as pain reported during the study period persisting for ≥3 months. Quality of life (QoL) was measured using the SF-12 questionnaire.At enrolment, 370 of the 413 patients (89.6%) reported HZ-associated pain which was still present in 20.6% and 9.2% of patients after three and six months, respectively, despite many patients receiving recommended anti-viral therapy. The overall QoL scores were lower than those in healthy Italians of similar age; scores for patients with HZ-associated pain were lower. The presence of >50 vesicles and VAS score ≥3 at enrolment, and being male were significantly associated with PHN at three months.These results suggest that HZ and PHN represent an important burden of disease in the elderly. There is a need for interventions that can prevent and reduce the burden of HZ to help improve the quality of life of the elderly. These data may be useful as baseline epidemiology data for the assessment of the impact of the VZV vaccine in Italy, after its implementation.The online version of this article (doi:10.1186/s12879-014-0637-6) contains supplementary material, which is available to authorized users. Varicella zoster virus (VZV) is a herpes virus that infects nearly all humans in temperate regions resulting in a highly contagious primary infection of varicella, usually in childhood . After tThe immune system declines with age (immunosenescence); the decline of VZV-specific T-cell-mediated immunity is thought to be involved in this reactivation . The incHerpes zoster is characterized by a, usually painful, unilateral vesicular rash, generally limited to a single dermatome, corresponding to the sensory ganglion from which the latent VZV was reactivated . The mosPain may occur during three distinct phases of the disease:prodromal pain: often occurs prior to rash onset;acute pain or neuritis: begins with the rash and usually disappears within 2 to 4 weeks;chronic pain i.e. post-herpetic neuralgia (PHN): most commonly defined as pain occurring or persisting for ≥3 months after rash onset.HZ-associated pain is debilitating and often has a substantial, negative impact on patients’ normal life and health, particularly among the elderly whose activities and basic tasks of daily living can be impaired and anxiety and depression can occur ,13]. In. In13]. The annual HZ incidence is similar throughout Europe, increasing with age from around 1–4/1 000 in adults aged <50 years to about 7–8/1 000 in those ≥50 years, up to 10/1 000 at >80 years . After tIn Italy, there are insufficient data on the burden of HZ and PHN because there is no HZ-specific national surveillance system. In one nationwide study the annual incidence of general practitioner (GP) visits for HZ was 4.1/1 000 persons aged ≥15 years; 19.6% presented with PHN and 26.1% presented ≥1 complications . One stuIn the perspective of a VZV vaccine to prevent and reduce the severity of HZ becoming available in Europe, it was decided to obtain baseline data on the occurrence of PHN in a multicenter, longitudinal, prospective, observational study involving general practitioners (GPs) throughout Italy, the HER.O.E.S. Study – HERpes zoster Outcome: Epidemiological Study. The primary objective was to assess the percentage of patients with HZ that have HZ-associated chronic pain and its duration.This study was conducted in compliance with the Declaration of Helsinki , Good Epidemiological Practice Guidelines and Italian national regulations ,28]. Th. Th28]. The co-primary objectives of the six-month study were:to assess the percentage of patients with HZ who developed HZ-associated chronic pain and how long the pain lasted.to collect disease management data from diagnosis to resolution of the acute symptoms, and data on the management of HZ-related pain.The secondary objectives were to assess quality of life (QoL) in the patients with HZ/PHN using the SF-12 instrument and to assess HZ-related pain intensity using a visual analogue scale (VAS). We also recorded the presence of clinical variables that have been identified as risk factors for HZ and assessed the patients’ care pathway and their disease progression during the study period.Patients aged >50 years old with a new clinical diagnosis of HZ, who were immunocompetent and who signed an informed consent form were enrolled in the study. Each patient was expected to attend four visits at 0, 1 (± 15 days), 3 (± 21 days) and 6 (± 30 days) months. Patients could be excluded from the analysis for one visit for non-respect of the time window, but included in the analysis for a subsequent visit, if it occurred within the time window.At the initial visit (V0), descriptive information was collected: socio demographic data, clinical description, medical history. The patients were asked if they had HZ-associated pain at the visit and their quality of life was assessed using the physical component summary (PCS-12) and the mental component summary (MCS-12) scores from the SF-12 questionnaire. The scores ranged from 0  to 100  . A scoread hoc monitoring visits during the study.The presence of allodynia, itching, paresthesia and malaise were all assessed by the physicians during the clinical examination at corresponding study visit. Data were collected using an electronic case report form (eCRF) which enabled a real-time quality control of the data at entry. In addition, a clinical research assistant telephoned the GPs monthly and also performed In HEROES, PHN (primary outcome) was defined as pain that persisted for more than three months after rash onset assessed by the patient replying ‘yes’ at a study visit when asked by the GP about the presence of HZ-associated pain. This assessment mode was chosen to be pragmatic, since physicians do not use tools to measure pain systematically. For the secondary outcome, HZ-associated pain was assessed with a score ≥3 on the VAS, reflecting the worst pain the patient had felt during the two-weeks prior to the visit.Based on information obtained from a questionnaire survey conducted on 317 GPs throughout Italy in 2008 that collected data on the number of patients with HZ they treated annually and how many had PHN, and other published data,  we assumThe descriptive analyses were performed with SAS , V9.2. The recorded or derived variables were summarized as frequencies (absolute or relative) or means or medians with their associated distribution . For all clinically-relevant variables, 95% confidence intervals (CIs) were calculated. Analyses were stratified on gender, age group , and presence of pain at the respective visit.Variables present at the initial visit associated (p = 0.25) with PHN at 3-months in univariate analyses were included in a multivariate regression model to identify PHN predictive factors (p ≤ 0.05). The fit of the final model was assessed using the Hosmer and Lemeshow goodness-of-fit test. The estimated β coefficients and the corresponding 95% CIs were calculated. Odds ratios and the corresponding 95% CIs were also calculated.A total of 108 of the 147 GPs who accepted to participate in the study included at least one patient. These 108 GPs were from 21 local health units localized in 12 Italian regions. Their regional distribution was similar to the national distribution (data not shown). They enrolled 435 patients with a new diagnosis of HZ from 27 March 2009 to 5 July 2010 of whom 413 were included in the study  presented with a rash and 77% had <50 vesicles. The rash was mainly localized in the thoracic dermatome area (59.1%) followed by cervical (15.0%), lumbar (13.8%), cranial (12.6%) and sacral segment (11.1%) dermatome areas, respectively  received an oral antiviral  for a median duration of 6.0 days. Oral antiviral treatment was initiated a median of two days after rash onset (mean = 3.4 days); 70% of the patients initiated oral antiviral treatment within three days after rash onset. Topical antiviral treatment was administered to 9.4% of patients .Only 23% of the patients received pain therapy for a median duration of 12.5 days (mean = 3 days); analgesics  (n = 48), nonsteroidal anti-inflammatory drugs (NSAID)s (n = 36), anti-epileptics (n = 29) or psycho-analeptics (n = 12).Among the 104 patients who worked at the initial visit, 36 took sick-leave due to their HZ episode for: 1 to 5 days (53%); 6 to 10 (33%); and more than 10 days (14%). At the 1-month visit, 33 patients reported that they had taken sick-leave, 2 at the 3-month visit and 1 at the 6-month visit.About 12% of the patients (n = 52) consulted ≥1 specialist during the study . None of the patients were hospitalised due to HZ.Overall, 370/413 (89.6% 86.2-92.3]) patients reported HZ-associated pain at the initial visit with a mean score of 5.8 ± 2.4 (Table -92.3) paThe mean VAS score for patients who reported pain at each visit decreased from 5.8 (median 6) at enrolment to 3.7 (median 3) at the six-month visit. The percentage of patients with a VAS score ≥3 was 81.7% [77.6% - 85.4%] at the initial visit; 49.7% [44.5% - 54.9%] at the 1-month visit; 22.4% [18.1% - 27.2%] at the 3-month visit and 15.2% [12.0% - 20.0%] at the 6-month visit . Multivariate analysis, including these variables, showed that the presence of >50 vesicles (OR = 2.595 [1.267-5.314]), a VAS score ≥3 (OR = 4.599 [1.181-17.907]) and being male (OR = 2.017 [1.006-4.042]) were significantly associated with PHN (p < 0.05) , although the majority of patients received antiviral treatment.All the patients included had a rash even if the presence of rash was not an inclusion criterion, suggesting that the GPs diagnosed HZ based on the presence of the typical rash. We cannot exclude erroneous diagnosis since there was no laboratory confirmation. In the pivotal HZ vaccine clinical trial in adults, 5–6% of the clinical diagnoses were not confirmed in the laboratory . SimilarIn HEROES, the patients enrolled do not seem to have suffered from severe disease as none were hospitalised. In Italy, the HZ hospitalization rate has been reported to be 5.6 per 100,000 patients and 10.3 per 100,000 for those with PHN . The stuWe observed a higher incidence of HZ-associated pain than that observed in the placebo group of the pivotal study (12% for PHN 3 months); however, the percentage of men was higher in the pivotal study and the subjects were older (≥60 years) so the age distribution was different . In a FrThe percentage of patients with PHN reported in retrospective database studies ranged from 6.9% to 32% ,25],,-39]. Re. Re39]. The presence of >50 vesicles, a VAS score ≥3 and being male were identified as variables that were associated with PHN at three months. The first two variables have been reported previously to be associated with a higher risk of developing PHN at three months suggesting that PHN is probably linked to more severe acute episodes of HZ . HoweverMost of the patients (91.5%) in HEROES received antivirals as recommended, which is similar to that reported in other studies ,16],,[With the predicted ageing of the European population in the coming decades, the number of people affected by HZ and its related complications, including PHN, can also be expected to increase . PreventThese data suggest that there is an important burden of disease in the elderly due to HZ. There is a need for interventions that can prevent and reduce the burden of HZ to help improve the quality of life of the elderly. These data may be useful as baseline epidemiology data for the assessment of the impact of the VZV vaccine in Italy, after its implementation.


Orthotic treatment of patients with degenerative deformations of the spine is a complex endeavor. It is a great orthopedic technical challenge to effectively reduce the accompanying pain and to help patients regain and keep their mobility. Due to difficult therapies and poor compliance, a surgical intervention to brace the spine is usually the first therapeutic choice.This article presents two cases in which individualized torso orthoses were successfully used to treat patients with degenerative diseases and disorders of the sagittal line as well as three dimensional deformities of the spine. Using torso orthoses allows treatment of these patients with as few invasive measures as possible without losing maximal functionality. Treatment of patients with degenerative deformations of the spine and of adult scoliosis patients with chronic back pain is challenging. Accompanying orthotic services, which are mandatory in many cases, are complicated and compliance is often poor. Consequently, a surgical intervention to brace the spine is the first therapeutic choice in many cases.Therapy of adult scoliosis patients with degenerative deformations of the spine and the accompanying chronic pains will usually improve their quality of life considerably. A stationary intensive rehabilitation is required to make these improvements permanent.Yet in some cases the back pain and the degenerative deformations remain even after such treatments and may require a back brace. Modern orthoses are technically and biomechanically adapted to the patient and can ease the pain - or even eliminate it completely. They support and relieve the spine and contribute to an optimization of the body statics with three dimensional adapted designs. Patients use them either during specific activities or permanently , 2.According to the SOSORT guidelines of 2006 and 2011, Scoliosis Intensive Rehabilitation (SIR) and orthoses are medically indicated for adult scoliosis patients with chronic pain if the therapeutic effect of the orthosis is established , 4. TherFurthermore a reduction of adult scoliosis by specific physiotherapeutic treatment is reported . But it One of the major tasks at hand was the development of an orthosis construction which really satisfied functional demands and would lead to a distinct improvement for the patients. To achieve this, empirical data was necessary. It was provided by monitoring more than 200 male and female adult scoliosis patients with chronic pains who have been treated with several orthotic systems for 7 years. These treatments took place as part of an intensive care program or were conducted as outpatient treatment in a specialized rehabilitation center. At first, results were mainly unsatisfactory due to immature orthosis constructions. The side effects caused by the orthosis were unacceptable compared to the improvements for the patients and rarely improved their situation significantly.This resulted in the development of the sBrace orthosis construction  which emThis case report presents evidence for orthopedic technical options to reduce pain and improve quality of life for adult scoliosis patients.To gather statistical data, patients from different international institutions were selected for a survey (including our patients in case 1 and 2). These patients documented the whole period of treatment, the longest case covering 9 years, the shortest only 1 year. Activities causing pain and the intensity of the pain were recorded using a scale of 0–10 . The quality of life was likewise measured .As the patients were treated in different institutions all around the world it was not possible to gather standardized reports of the treatment. The periods of use of the brace were decided by the patients themselves, so that they usually used it to perform specific activities or to counter acute pain. All patients were outpatients and received physiotherapeutic treatment.The intensity of pain before using the orthosis averaged 7,88. During the period the patients received orthotic treatment this value was reduced to 2,63.All patient in the survey were unable to perform business, household or leisure activities or could only perform them with restrictions. When using the brace the performance of all these activities was made possible or at least improved.The intensity of pain when sitting, standing or lying could be reduced significantly by the use of the orthosis: from an average of 5,50 to 2,25 when sitting, from 8,00 to 5,25 when standing and from 5,25 to 4,25 when lying Figure .Side effIn three cases a surgical intervention could be avoided by the use of the brace.The patient in this case was a 65 year old woman who had a spinal fusion operation. Her body did not tolerate the implants and they had to be removed. Following the operations and recuperation the original situation was restored: The diagnosis was degenerative scoliosis concomitant with kyphosis of the lumbar vertebral column and pseudarthrosis between L5 and S1.The patient Figure  had multThe independent handling of daily routines was impossible without stabilizing the lumbar spine and easing the pain. In this phase the patient assessed her quality of life and her social life as 3 on a scale of 1 to 10.In this case the back brace had to be able to stabilize the spine in the affected lumbar segment in order to stop and reduce the stenosis of the spinal canal. This could only be achieved by changing the body statics. At the same time it had to keep the body in a pain-free position. Furthermore a correction of statics and a normalization of the sagittal profile was targeted. The functionality of the thoracolumbosacral orthosis (TLSO) had to be ensured in standing, lying and sitting position without any restriction of mobility.The patient was equipped with a sBrace L TLSO trunk orthosis module Figures  and 5. TIn the next step the brace was fitted to the patient according to the indication. Thus brim courses were defined and pressure zones cushioned. By this customization the trunk orthosis module was made into a lightweight rigid TLSO in frame construction. The flexibility of the frontal area was defined by the layout of the orthesis. In this case the mobility remained completely unrestricted.Judging from the comparison of clinical photography the sagittal profile of the patient was improved considerably  brace, and a founding member of the SOSORT.


Patients who sustain a motor vehicle accident may experience long-term distress, even if they are uninjured or only slightly injured. There is a risk of neglecting patients with minor or no physical injuries, which might impact future health problems. The aim of this study was to explore patients’ subjective experiences and perspectives on pain and other factors of importance after an early nursing intervention consisting of “caring touch”  for patients subjected to a motor vehicle accident with minor or no physical injuries.A mixed method approach was used. The qualitative outcomes were themes derived from individual interviews. The quantitative outcomes were measured by visual analogue scale for pain , sense of coherence (SOC), post-traumatic stress (IES-R) and health status . Forty-one patients of in total 124 eligible patients accepted the invitation to participate in the study. Twenty-seven patients completed follow-up after 6 months whereby they had received up to eight treatments with either tactile massage or healing touch.p < 0.001) and IES-R (p 0.002) had decreased 6 months after the accident whereas the EQ-5D index had increased (p < 0.001). There were no statistically significant differences of the SOC or EQ-5D self-rated health scores over time.Patients reported that caring touch may assist in trauma recovery by functioning as a physical “anchor” on the patient’s way of suffering, facilitating the transition of patients from feeling as though their body is “turned off” to becoming “awake”. By caring touch the patients enjoyed a compassionate care and experience moments of pain alleviation. The VAS pain ratings significantly decreased both immediately after the caring touch treatment sessions and over the follow-up period. The median scores for VAS (In the care of patients suffering from a MVA with minor or no physical injuries, a caring touch intervention is associated with patients’ report of decreased pain and improved wellbeing up to 6 months after the accident.NCT02610205. Date 25 November 2015.ClinicalTrials.gov Id:  Motor vehicle accidents (MVAs) are common and 1.24 million people die each year as a result of road traffic crashes and between 20–50 million more people suffer from non-fatal injuries worldwide  highlighThe aim of this study was to explore patients’ subjective experience and perspectives on pain and other factors of importance after an early nursing intervention consisting of “caring touch”  for patients subjected to a motor vehicle accident with minor or no physical injuries.The study was conducted as a single-arm longitudinal observational study, combining qualitative and quantitative perspectives, i.e. a mixed-methods design. The rationale for combining quantitative and qualitative methods was to provide a comprehensive exploration of the research question . The stuA recruitment of potential study patients was made up from a list of incoming patients, inclusion criteria were; 18 years and above, literate in Swedish and cognitively intact, arriving at the emergency department following an MVA, and who upon medical examinations were given an injury severity score (ISS) between 0–3 and subsequently discharged straight home. ISS is a 0–8 point scale rating injury severity, where a rating of 0 indicates no physical injury, 1–3 represents minor physical injuries; and 8 corresponds to a life-threatening injury .Patients were invited to participate based on a convenience sampling procedure. Initially, the sample of participants was estimated in relation to the possibility of having a control group receiving conventional care only. However, due to logistical barriers in the clinical setting it was not possible to include a proper control group. The patients were informed about the study by mail during the week after the MVA, and those interested in participating in the caring touch intervention were asked to contact the author (FA) by phone or mail and subsequently completed a written informed consent form during the first encounter with the therapist.In this study we explore patients experience of a caring touch and not the treatment per se. Touch can be very private and intimate, and for this reason the patients could choose between tactile massage, which requires direct contact with the patient’s skin using a vegetable oil, or healing touch, which can be performed without direct contact with the patient’s skin. In this way, patients who were ambivalent about having their skin touched directly could choose the fully-clothed option. All of the participants choose to receive tactile massage in the beginning of the treatment period and ten percent of the participants later decided to try the treatment with healing touch. The caring touch was provided by nursing staff in a special treatment room with soft lighting and music, with the patient lying on a massage table. The tactile massage was performed by three assistant nurses certified in tactile massage with the same qualifications. Healing touch was given by a nurse certified at level four (of five) in Healing Touch. These two particular touch therapies were selected due to the fact that they were already being provided at the emergency department. The caring touch was adjusted to suit each patient and lasted for 20–60 min (mean = 45 min), once a week, for a maximum of eight treatment sessions altogether. The tactile massage, i.e. a soft tissue massage, was intended to stimulate touch receptors in the superficial layers of the skin and underlying tissues, without applying direct pressure or stretching to the muscles . The masThe healing touch was based on an established procedure, during which the therapist applied a light pressure to the feet, ankles, knees, hips, stomach, heart area, arms, throat, forehead and scalp  with theData was collected from September 2012 through May 2014 with a hold-up during June to August, and during Christmas, due to the therapists’ vacation. The questionnaires were administrated at inclusion and at follow-up by mail after 6 months. VAS pain ratings were measured before and after each treatment. Individual interviews were conducted after 3 months.The first author (FA) conducted the interviews in a closed meeting room at the hospital, 3 months after the patient’s first hospital visit. The time span was set to allow the patients to conclude their treatments with caring touch. The interviews, which lasted up to 60 min, were conducted in Swedish, digitally recorded and transcribed verbatim by the first author. An open-ended question was used to initiate the interviews: “Please tell me what you experienced when you had your motor vehicle accident” with an additional question, “Please tell me what you experienced when you received the caring touch”. During the interviews, there were continuous follow-up questions like “could you please explain further” and “could you give me an example”. During the interview, questions like “do I understand you right when you said…” were asked for clarification.The interviews were analysed using Systematic Text Condensation (STC), based on Giorgi’s psychological phenomenological analysis . ApplyinThe quantitative outcome was current level of pain measured by VAS, ranging from 0 (no pain) to 100 (worst imaginable pain) . PatientFurther exploratory outcomes were sense of coherence (SOC), constructed by Antonovsky on the basis of a salutogenic model. The Sense of Coherence scale was of interest since this instrument capture the patients’ experiences of comprehensibility, manageability, and meaningfulness which we assumed could be linked to patient recovery. SOC, a 13-item rating scale, developed using the subscales of comprehensibility, manageability, and meaningfulness. Total scores of 21–59 indicate low sense of coherence, 60–74 an average sense of coherence, and 75–91 high sense of coherence . AdditioData from VAS pain ratings and questionnaires was manually transferred from paper into an electronic database before statistical analysis. Summary characteristics of patients were presented as proportions, mean, median, standard deviation and/or min-max values. Change scores of VAS pain ratings, SOC, IES-R and EQ-5D over time between baseline and follow-up after 6 months were analysed for patients with complete data. Considering rating scales and ordinal types of data, and the relatively small sample sizes, non-parametric statistical analysis, i.e. the Wilcoxon signed-rank test was employed for assessing change scores over time. All p-value calculations were conducted with a 5 % significance level. An additional descriptive analysis was conducted for VAS pain ratings before and after each treatment session with caring touch. Computational software included STATA 13, StataCorp, USA and Microsoft Excel 2011, Microsoft, USA.In total, 124 eligible MVA patients were invited to participate in the study, and 41 patients accepted to participate. The flow of patients through the study is detailed in Fig. n = 29/41; 70 %) in the study. Three months after study inclusion 25 patients volunteered for interviews and 27 patients completed the questionnaires after 6 months. Additional characteristics of the patients are given in Table A larger proportion of women accepted to participate n = 29/4; 70 % ina way of suffering, caring touch as a bodily anchor, enjoying compassionate care and moments of pain alleviation.Four themes emerged from the qualitative data; “You know you get a shock, you just stand shivering” and feelings of surprise and panic, as well as experiencing that time stops and perceptions become clearer and stronger: “My heart was beating, I was shaking, could not think clearly, I was terrified”. This could also be expressed as a surrealistic feeling of being in a movie, not really aware of what is going on: “I was not prepared, everything was so strange. I don’t know… everything got blurred it was like being in a film or something”. Some experienced instant feelings of anger towards the person responsible for the accident: “I became very angry at the person who caused the accident!” and thoughts of fear of being disabled or even dying came up: “I thought I would die or become a package… it was the most horrifying experience I have ever had”. Trying to be practical and take control over the situation, patients said: “Clearly I did not care about myself, my first thought concerned the car, I am unemployed and no car and I need to pick up my son, that’s what I thought about…”. Later, patients experienced their bodies “waking up”, feeling pain, numbness or stiffness in their body, a body which was changed: “I had bruises after the belt, and I did not recognize my body, it was difficult to take a shower and look at myself, it felt very uncomfortable”.In the beginning of the trauma, some patients experienced their body as “turned off”, and then slowly coming “awake”. This theme includes the first reaction of unreality when the accident happened: Patients reported a sense of energy loss and a feeling of fear. Weakness appeared and pain started to invade the body.“When I arrived at the emergency room, I realized that I might be severely injured… I cried and laughed… everyone was so nice, they stayed with me the entire time…they were really nice”. But when all the examinations were completed, and it became clear that they had not sustained any physical injuries, some of the patients experienced that they were no longer of interest to the staff. They were put in a corridor or a small room without any way of getting the staff’s attention: “But when the x-ray was finished and it was clear that I was OK, they put me in a small room and nobody cared about me any longer”. Patients felt that they suddenly became unimportant and they felt forgotten, abandoned and alone, without any way of getting their needs met: “You were put in a small compartment and you were “nobody”… They pulled down the curtain and then “you”, the patient, the victim disappeared… I felt abandoned”. Later discharged home in many cases alone with fearful thoughts: “It was so scary, when I was back home, my God do I dare to move…will I lose my mind…what about my neck!…?” Many of the patients suffer from pain 3 months after the accident and find it obstructed from being physically active. The pain disturbs their sleep and they feel physically weak and have trouble concentrating. Some patients also felt a lot of frustration and bitterness, that the person who caused the accident had got away too easily. This could be voiced as identifying the other person involved in the accident as responsible: “I did not cause the car accident. It was the woman’s fault…she shouldn’t have turned, turning was prohibited! …she got away too easily, I took the beating so unfair…”. Almost all of the patients experienced an intensified awareness of traffic, both physically and mentally. They tended to look more often in their rear-view mirror, expecting someone to collide with them. Some patients got severe, traffic-related problems in terms of their heart rate increasing, as well as feeling stress and anxiety. Most of them drive more carefully today: “You are very frightened afterwards when you drive, you look carefully at every car…I just sit and look if the car behind me is slowing down or not, I am terrified!”.Taken to hospital, patients felt secure in the trauma room, experienced the staff as professional, trusting and caring: “This massage is about the soul, after the accident the soul is damaged, the body is there…it is about your soul and your mind, and massage helps that part, of course helps against pain, but most of all it’s the part touching your soul, you relax, you forget, you become as you once were”. Caring touch involves dimensions of the body and soul. During a trauma, patients experienced their body and soul as being “scattered”. Patients became aware of this disconnect between body and mind during the caring touch treatments: “And then the treatment put together all the scattered pieces of my puzzle back”, and gave them a feeling of wholeness: “It gives a feeling of coming together…the soul gets back into the body again”. They could feel where their body started and ended. For one patient, the invitation letter and the caring touch treatments were expressed as life-saving: “When I got this invitation letter…it was the turning point in my life …because I had lost everything after the accident…I felt I had no force in life…and then came this letter…this was the turning point…oh, yes God!”A common experience for all the patients was the disappearance of negative thoughts and pain when receiving caring touch: “To just meet the therapist more or less like a newborn and she was the midwife, the beloved, so secure”. Patients felt closely connected to the therapist, and being embraced by her safe hands, this made it possible to hand over responsibility: “I know I will relax during the treatment and I hand over my body to her…I know she will take care of it”. The caring touch treatment provided an opportunity to rest, feel relaxed and in harmony without pain: “Just this…her energy flows into…yes, transfers…when she touches you… you regain strength”. After the caring touch treatments, different perceptions of the body were experienced: “I remember the first time I received massage, I felt a tingling in my body, and I felt, Oh God! I am starting to feel joy! And it was so…it was so striking…God, I felt happy”.The therapist was important to the patients, and was described as creating a sense of security, a midwife who was letting the body rest in a moment of no responsibility: “You forgot the pain totally, just when she presses just a little, it is not like ordinary massage, it feels really comfortable in the area where you have your pain. Yes, the pain decreases, you forget the pain…at the outset I took painkillers and was to some extent relaxed from the beginning. But then I tried the massage with fewer painkillers, and I felt that I could relax without medicine”.To some patients, pain totally disappeared during the caring touch treatments and for some hours afterwards. Some of the patients were even able to decrease their intake of analgesics: There were 27 patients that had complete VAS pain ratings at follow-up after 6 months. The results indicate both clinically and statistically significant improvements in VAS pain scores over time  of the patients that were originally included received at least 5 (range 1 to 8) treatments with caring touch. This corresponds to a majority  of patients completing the study at follow-up after 6 months. A chart describing the before and after treatment pain ratings for these patients is depicted in Fig. The patients additionally rated their pain on VAS before and after each treatment session with tactile massage or healing touch. The results indicate a decreased pain during the caring touch treatment. Approximately half  concluding that supporting people after a trauma should include strengthening their sense of security, strengthening their confidence, strengthening fellowship, creating tranquility and increasing their sense of hope . When diThe patients in the current study were conveniently invited to participate. This resulted in an unbalanced group in terms of gender which limits the generalizability of the findings. In addition, the lack of a control group makes it difficult to generalize about the specific effect of the intervention itself. However, the trend of predominant female participation has also been seen in a previous study of MVA . Women aThe VAS pain outcome measure was highly applicable in terms of its long-term established use in the clinical emergency care setting. The IES-R is a common instrument in trauma research as well as SOC and both are preferable to use in further studies of motor vehicle accident patients . When inSustaining a MVA with minor or no physical injury can imply emotional and physical reactions. Therefore it is not surprising that a caring touch intervention during first weeks following the accident was associated with positive result, both in terms of improved pain ratings (VAS) and in lived experiences by interviews. Caring touch seems to responding to the need of the individual, who, when experiencing dissociation, may regard caring touch as a physical anchor, holding the self together and creating bodily boundaries. However, even if the results of caring touch may have positive outcomes there is a need to be aware of the potential impact of the therapist in the patient-provider relationship.The research project was approved by the Regional Research Ethics Committee in Stockholm, Sweden (Dnr 2010/514-31/2). Ethical principles have been performed in accordance to the Declaration of Helsinki, usefulness in relation to risks, integrity, non-malfeasance and respect for human dignity were considered. Patients were assured that they could withdraw from the study at any time and that it would not affect their care. Patients received oral and written information about the study and were informed about the nature and purpose of the study and the intended use of data.Written informed consent to participate and for results to be publish at group level was obtained from all participants.The data were coded and only the research group was permitted to have access to the data.


Background. Direct intra-articular injection of low doses of local anesthetic (IALA) after closure of the joint capsule remains controversial for pain control after total knee arthroplasty (TKA). Methods. A retrospective study comparing patients receiving IALA with high doses (0.5% bupivacaine 60 mL) of local anesthetics or FNB in addition to intravenous patient-controlled analgesia with opioids for pain management after TKA was conducted. The primary end point was to compare the analgesic efficacy and early ambulation between the two groups. Results. No significant differences between the two groups in pain intensity, cumulative opioid consumption, incidences of opioid-related side effects, the time interval from the end of operation to the first time the patient could walk assisted with a walker postoperatively, and postoperative hospital stay were identified. Three patients in the IALA group but none in the FNB group walked within 12 hours after the end of operation. Summary. IALA with high doses of local anesthetics provides comparable analgesic efficacy as single-shot FNB after TKA and might be associated with earlier ambulation than FNB postoperatively. Postoperative pain management for total knee arthroplasty (TKA) is a challenge for clinicians. Inadequate pain relief after TKA may hinder early rehabilitation , delay dAt our hospital, the acute pain service team has been used to provide a single-shot FNB in combination with intravenous patient control analgesia (i.v. PCA) with opioids for postoperative pain management for TKA. Since 2010, some patients received IALA for pain management after TKA while others still received FNB. The aim of this study was to evaluate the analgesic efficacy of IALA by comparing IALA to FNB in terms of their pain intensity, opioid consumption, opioid-related side effects, and time to ambulation after TKA.After approval from the institutional review board of Chang Gung Memorial Hospital (102-3855B), patients using i.v. PCA for postoperative pain control after knee surgeries between January 2010 and December 2011 were identified from the acute pain service database and their medical records were retrieved from hospital database. Only those patients who received unilateral primary TKA for knee osteoarthritis were included in the analysis. The exclusion criteria included age less than 18 years, use of opioids for more than 2 weeks prior to the surgery, operation under spinal anesthesia or peripheral nerve block, a history of alcohol or drug abuse, and use of dual therapy of IALA and FNB for postoperative pain management. Only patients who received the TKA under general anesthesia were included since the analgesic duration from spinal anesthesia and peripheral nerve block after operation can vary significantly. At our institution, the postoperative pain after TKA was managed with an ultrasound-guided, single-shot FNB with 0.2% levobupivacaine 25 mL in addition to i.v. PCA constituted with fentanyl on arrival to the postanesthetic care unit (PACU), and i.v. PCA was discontinued on the second postoperative day. Acetaminophen 500 mg 4 times a day and NSIADs were prescribed at the surgeons' discretion during hospital stay. At the PACU, additional opioids or ketorolac 30 mg i.v. could be administered if the intensity of pain was identified as equal to or more than moderate on a verbal severity scale . All patients were given intravenous ondansetron 8 mg at the end of operation and were instructed to use i.v. PCA if his or her pain was equal to or more than moderate in severity. In the morning of first and second postoperative day (POD1 and POD2), the acute pain service personnel recorded the cumulative consumption of fentanyl from i.v. PCA, pain intensity, and the presence of opioids-related side effects including nausea, vomiting, dizziness, drowsiness, pruritus, and respiratory depression if any. The rehabilitation protocol began on POD1. Since 2010, some patients received 60 mL 0.5% bupivacaine injected into the knee joint (IALA) by the surgeon after closure of the joint capsule before wound closure. Enrolled patients were grouped into IALA group and FNB group, depending on the pain management modality facilitated. The initial search included 182 medical records, of which 88 were excluded based on the exclusion criteria, leaving 39 patients in the IALA group and 55 in the FNB group.The demographic and clinical data recorded for analysis included gender, age, body weight, height, body mass index (BMI), preoperative comorbidities, American Society of Anesthesiologist physical status, history of alcohol or drug abuse or chronic opioid use, surgical approach, implanted prosthesis, intraoperative opioids, use of analgesics including ketorolac and opioids in the PACU, fentanyl consumption from i.v. PCA on POD1 and POD2, use of acetaminophen or NSAIDs in the ward, presence or absence of nausea, vomiting, dizziness, pruritus, and respiratory depression, and postoperative hospital stay. Pain intensity was assessed by verbal severity scale and recorded as 0–4 . The amount of all opioids consumed in the PACU and via i.v. PCA was converted into i.v. morphine equivalence using the equianalgesic conversion ratios of meperidine : morphine = 75 : 10 and fentanyl : morphine = 0.1 : 10 , 20. TheTo evaluate the impact of analgesic techniques on rehabilitation, the time interval from the end of operation to the first time the patient could walk assisted with a walker between the two groups was compared. The first time a patient could walk assisted with a walker after the operation was the most consistently documented landmark of rehabilitation progress in the medical records. A time interval less than 12 hours was considered as early ambulation, which was also compared between the two groups.t-test was used to compare the continuous variables in the two groups. A two-tailed P value of less than 0.05 was considered significant.Statistical analysis was performed using the SPSS software package . Fisher's exact test was used to analyze the categorical data due to small expected counts, and 2-sample independent P < 0.001) (P = 0.0018)  (< 0.001) . All pat< 0.001) . Slightl 0.0018) .P < 0.0001) (P = 0.07)  . There w 0.0001) . No sign 0.0001) . Three p = 0.07) .Our analysis revealed that after TKA, IALA group and FNB group displayed similar pain intensity and cumulative opioid consumption in the first 2 days after operation. There were no significant differences in the incidences of opioid-related side effects, the time interval from the end of operation to first time walking assisted with a walker postoperatively, and postoperative hospital stay. A few patients in the IALA group walked within 12 hours after their operation while no patient in the FNB group did so. To our knowledge, this is the first report comparing the analgesic efficacy of IALA to that of FNB for pain management after TKA as well as their impacts on early ambulation. Our result suggested that IALA could be as effective as FNB in pain relief after TKA. Given that FNB is superior to i.v. PCA alone for pain reduction after TKA , IALA isGiven the paramount importance of early rehabilitation and early ambulation after TKA, the ideal analgesic technique should provide adequate pain relief while preserving muscle strength. Therefore, LIA has been suggested as the preferred analgesic technique for TKA, considering its comparative analgesic effect to FNB in the absence of motor blockade . IALA, oAs the rehabilitation protocol in our hospital began on the POD1, time at which the motor blockade from a single-shot FNB with 25 mL 0.2% levobupivacaine had mostly dissipated, no difference was observed between the two groups in the time interval from the end of operation to postoperatively first time walking. However, albeit not statistically significant, a few patients in the IALA group but none in the FNB group could walk with a walker within 12 hours after operation, suggesting the superiority of IALA in preserving muscle power. To compare the impact of IALA on early ambulation to that of FNB, prospective studies incorporating immediate or shortly after operation rehabilitation protocols are needed.Although the difference in intraoperative opioids administered was statistically significant between the two groups, its clinical significance was questionable. It seemed unlikely that this small difference, less than 2 mg in morphine equianalgesic dose, would exert significant impact on postoperative analgesia. Unexpectedly, postoperative use of NSAIDs in the ward between the two groups was statistically significant, which might be related to the preference of the attending physicians. Whether this difference contributed to the trend towards more cumulative opioid consumption in IALA group as well as its impact on pain relief and rehabilitation remained to be explored.As with all retrospective studies, our analyses had a number of limitations, including post hoc selection of study variables, a lack of predetermined sample size, expectation bias, and missing data. The pain intensity was not rated by the visual analog scale or numeric rating score which might have revealed subtle but clinically significant difference in pain intensity. Our reviewed medical data did not record pain intensity during specific rehabilitative motion, which was especially relevant after TKA, even though the cumulative opioid consumption might reflect the intensity of pain during rehabilitation. Because the hospital discharge criteria were not standardized, the impact of different analgesic techniques on postoperative hospital stay could not be determined in current analysis. Additionally, as the use of NSAIDs was not standardized either, the extent of opioid-sparing effects was difficult to interpret. The reviewed medical records did not contain detailed information regarding the progress of rehabilitation; therefore the impact of analgesic techniques on rehabilitation could only be addressed by measuring the time interval from the end of operation to the first time walking assisted with a walker postoperatively. However, as ambulation was one of the most important components evaluated during rehabilitation after TKA, the time a patient was capable of walking assisted with a walker for the first time could be a valuable indicator of short-term outcome. There could be some time lag between the actual occurrence and the documentation of the time when a patient could walk with a walker for the first time after operation; nonetheless, this time lag was assumed to be comparable between groups. Finally, there was no consistent recording of functional recovery in the reviewed medical records; therefore, the impact of analgesic techniques on long-term functional outcomes could not be assessed.Our retrospective analysis revealed that intra-articular injection of high dose local anesthetics provided similar analgesic efficacy as FNB and might be associated with early ambulation. Further studies are mandatory to confirm our findings in a prospective randomized controlled manner incorporating a rehabilitation protocol that is installed immediately or shortly after the operation to evaluate the impact of IALA on early ambulation after TKA. The pharmacokinetics of local anesthetics should also be determined before this practice can be widely recommended.


Previous research suggests that pain arising on the left side of the body may be associated with greater emotional distress and use of healthcare services than right-sided pain. Migraine is a highly prevalent condition in which lateralized pain is a core diagnostic feature.We sought to evaluate whether patients with exclusive or predominant left-sided migraine pain experienced higher levels of distress or healthcare use compared with those with right-sided pain.We extracted medical record information for a random sample of 477 patients with migraine seen in 2011 at the John R. Graham Headache Center. Information was collected on patient demographic characteristics, comorbid affective spectrum and other selected psychiatric diagnoses, ED visits and healthcare contacts. Using a scoring system, we categorized patients as having exclusive, predominant, somewhat or no right or left lateralized pain.Of the 228 patients with some degree of lateralized head pain, almost twice as many experienced right vs left lateralized pain (47% vs 29%). With one exception (PTSD), there were no statistically significant differences between the groups in measures of affective spectrum disorder comorbidities or healthcare use.Taken as a whole, our data do not support the view that left-sided head pain is more distressing than right-sided pain. Although lateralization of head pain is useful in making a diagnosis of migraine, it does not have additional clincal implications. Additionally, its absence does not rule out a diagnosis of migraine, since in our sample roughly half of patients with migraine had bilateral pain.No conflict of interest.


Arthritis at the trapeziometacarpal joint of the thumb is common. Several surgical options exist showing favorable results. We report the outcomes after interposition of allograft knee meniscus for thumb trapeziometacarpal arthritis.Twenty-three patients (25 thumbs) had surgery for thumb trapeziometacarpal arthritis using knee meniscal allograft tissue. Eleven thumbs had a minimum follow-up of 24 months, 2 thumbs had a minimum of 12 months, and 12 thumbs had less than 6 months. Disabilities of arm, shoulder, and hand (DASH) questionnaire scores, pain levels, grip strength, pinch strength, range of motion, and radiographic measurements were performed.Between the preoperative and 24-month follow-up measurements, patient pain levels were reduced. There was a significant improvement in DASH scores. Comparisons between preoperative and postoperative strength measurements showed increase in grip strength and key pinch strength. Trapeziometacarpal subsidence was 5.5 %, and subluxation index measurements decreased 3.9 %. There was no clinical or radiographic evidence of foreign body reaction and no other complications occurred.The results of meniscal allograft arthroplasty are comparable to other surgical techniques for trapeziometacarpal arthritis with respect to pain, outcomes, strength, oppositional motion, complications, surgical time, cost, and return to work. The results suggest that meniscal allograft arthroplasty is a viable option in the surgical management of stages II and III arthritis of the TM joint. Further follow-up and clinical studies are warranted. Arthritis at the trapeziometacarpal (TM) joint of the thumb is a common problem encountered by hand surgeons. The prevalence of symptomatic TM joint arthritis is approximately 25 % of women and 8 % of men . PatientNonoperative management includes oral non-steroidal anti-inflammatory drugs, corticosteroid injections, and splinting. When symptoms persist, surgical treatment is recommended.A variety of surgical procedures have been reported for the treatment of stages II–III TM arthritis of the thumb Table . As indiThe hypothesis for this study was that the use of knee meniscal allograft tissue is a viable option for the surgical treatment of TM arthritis of the thumb.The procedure design for meniscal allograft arthroplasty (MAA) was tested and refined using a cadaver model in the laboratory. Human Investigation Committee (HIC) approval was obtained from our Institutional Review Board.Between 2009 and 2012, 25 consecutive MAA procedures were performed by the same surgeon (PSS) on 23 patients with stage III basal joint arthritis using an allograft knee meniscus transplanted into the thumb TM joint  (stage III). All patients were initially treated nonoperatively for a minimum of 6 months with splinting, oral anti-inflammatory medications, and with intra-articular steroid injections. Activity modification was encouraged.The disabilities of arm, shoulder, and hand (DASH) questionnaire was utilized as a preoperative outcomes measure of the patient’s symptoms and functional status , 28.Pain was evaluated using a visual analog scale (VAS) with 0 representing no pain and 10 representing the highest degree of pain. The visual analog scale measurements were recorded at maximal loading in key pinch as reported by Nilsson et al. . The oriAdditional preoperative data for all patients included grip strength using a Jamar dynamometer  and tip, key, and palmar pinch strength of the involved hand using a pinch meter . Preoperative range of motion data for all patients included carpometacarpal (CMC), metacarpophalangeal (MP), interphalangeal (IP), and oppositional (OPP) range of motion. OPP was measured by assessing the thumb tip ability to touch an anatomic landmark at the base of the small finger.Anesthesia consisted of a regional block induced prior to surgery along with sedation. A long-acting pain pump was used for all patients in the series, but is no longer currently used as it is felt not to be necessary. A dorsoradial incision was made obliquely over the TM joint Fig. . The supAttention was then shifted to preparation of the meniscal allograft for insertion in to the thumb TM space. The graft tissue was placed in a normal saline bath for 5 min to allow it to thaw. A minimum meniscal graft height of 5 mm was a prerequisite for use. The meniscal horns were removed from the tibia fragment (when present) Fig. . The allThe base of the graft was then inserted into the TM joint Fig. . The sutPostoperative management included thumb Spica casting applied 1 week postoperative and continued for 6 weeks, followed by 6 weeks of thermoplastic splinting and occupational therapy. The 6-week immobilization period was instituted for comparison with other procedures described in the literature. The authors currently use a 3-week period of casting followed by 3–6 weeks of splinting. Occupational therapy is no longer routinely prescribed, and is currently used only when deemed necessary.Data was collected preoperatively and at 3 months, 6 months, 1 year and 2 years postoperative. Recorded data included DASH scores, pain level, grip strength, tip, key and pinch strength, CMC, MP, IP, and OPP range of motion.Radiographic analysis of the space between the metacarpal base and proximal trapezium without stress were calculated preoperatively, immediately postoperative (less than 2 weeks), and at latest follow-up. Measurements of the thumb TM joint space were indirectly measured by calculating the trapeziometacarpal index (TMI) as previously described , 46, 53.Subluxation the thumb TM joint (S) along with the subluxation index (SI) was measured as described by Trumble et al. .P values and 95 % confidence intervals were calculated for the differences between pre- and post-surgical values with p values less than an alpha of 0.05 considered statistically significant. The statistical analysis used SAS 9.2 for Windows system and R software for the pain graph.A Gamma statistic was used to assess the strength of the association between pain and time. A 95 % confidence interval for this statistic was calculated. p = 0.002). Preoperatively, pain scores of severe and moderate levels predominated (96 % out of 23 patients), and then gradually changed over 24-months follow-up where 91 % had no pain or mild pain  at 24-months follow-up , tip 57.3 %), key (31.4 %), and palmar (33.8 %) pinch strength. These were not statistically significant  but was not statistically significant. All patients were able to touch their thumb tip to the base of the small finger MCP joint at 6-month follow-up Table .The mean TMI values were found to significantly decrease from preoperative to latest follow-up by a mean of 3.2 mm (5.5 %). Mean SI values decreased by 0.2 mm (3.9 %), but were not statistically significant  required revision surgery after a significant postoperative injury. These findings are comparable to previous studies. LRTI and HDA have reported up to 9 % complication rates including temporary paresthesias in the superficial branch of the radial nerve, superficial pin tract infection, and deep infection , 33, 34.Reports using synthetic materials including silicone, polyurethane, polytetrafluoroethylene (Gore-Tex), and polypropylene (Marlex) have been associated with foreign body reactions and have largely been abandoned , 36, 48.Surgical time for MAA averaged 78 min. This compares favorably to average surgical times reported by Sandvall et al.  for LRTIThe results of this study suggest that MAA may be indicated for high- or low-demand patients, as all employed patients, including an auto worker and a nurse anesthetist returned to their previous occupations within 6 months of surgery. Long-term studies comparing MAA to LRTI and/or HDA in an active male population may be useful to further address the impact of metacarpal subsidence or lack thereof in this subpopulation.With the acknowledged limitations of this study having low patient numbers and short-term follow-up, the results of MAA are comparable to other surgical techniques for TM arthritis with respect to pain, outcomes, strength, oppositional motion, complications, surgical time, cost, and return to work. These results support the use of this technique in the surgical management of stages II and III arthritis of the TM joint. Further follow-up clinical studies are warranted. Refinement and simplification of the surgical technique and shortening of the time of immobilization to accelerate the rehabilitation schedule are areas we intend to explore in the future.


Background. The contribution of apathy, frequently recognized in individuals with neurodegenerative diseases, to chronic low back pain (LBP) remains unclear. Objectives. To investigate levels of apathy and clinical outcomes in patients with chronic LBP treated with tramadol-acetaminophen. Methods. A retrospective case-control study involving 73 patients with chronic LBP  treated with tramadol-acetaminophen (n = 36) and celecoxib (n = 37) was performed. All patients were assessed using the self-reported questionnaires. A mediation model was constructed using a bootstrapping method to evaluate the mediating effects of pain relief after treatment. Results. A total of 35 (55.6%) patients met the criteria for apathy. A four-week treatment regimen in the tramadol group conferred significant improvements in the Apathy scale and numerical rating scale but not in the Rolland-Morris Disability Questionnaire, Pain Disability Assessment Scale, or Pain Catastrophizing Scale. The depression component of the Hospital Anxiety and Depression Scale was lower in the tramadol group than in the celecoxib group. The mediation analysis found that the impact of tramadol-acetaminophen on the change in apathy was not mediated by the pain relief. Conclusions. Tramadol-acetaminophen was effective at reducing chronic LBP and conferred a prophylactic motivational effect in patients with chronic LBP. Apathy is broadly defined as a loss of motivation and manifests in behaviors such as diminished motivation, poor persistence, lack of interest, indifference, low social engagement, blunted emotional response, and lack of insight . Apathy Chronic low back pain (LBP) patients have shown higher ratings of pain intensity and more comorbidities such as depression, panic/anxiety, and sleep disorders . Psycholμ-opioid agonist activity of tramadol conceivably plays a role in mood improvement  and 16 points [celecoxib group] with a standard deviation of 5.0) estimated that 33 patients would be needed in each group to provide a 95% chance of detecting such a reduction at the 0.05 level of significance. Mediation analysis was used to evaluate the direct effects of tramadol-acetaminophen on the change in apathy and the effects mediated by the pain relief, along with their standardizing coefficient (b), using bootstrapping (with 2000 replications) and 95% confidence intervals (CIs). An indirect effect  was considered significant if the CI did not contain zero.Normally distributed variables were compared using Student's P = 0.37) and pain duration (P = 0.47). In the present study, 35 (55.6%) patients met the criteria of apathy based on the Starkstein Apathy Scale. There were no significant differences between the two groups in terms of mean Apathy Scale scores (P = 0.47), NRS (P = 0.08), RDQ (P = 0.92), PDAS (P = 0.56), HADS , and PCS (P = 0.99) scores.The mean duration from symptom onset to consultation was 50 months (range 3 to 240 months); the mean age at the time of examination was 71 years (range 36 to 95 years) . In the P < 0.05). The NRS was significantly lower in the tramadol group than in the celecoxib group after treatment (P < 0.05), suggesting enhancement of internal pain control by tramadol-acetaminophen . No significant difference was found between the treatment groups in the mean HADS anxiety scores (P = 0.48) after four weeks of treatment, while a significant difference was found in the mean HADS depression score (P < 0.05), suggesting that tramadol-acetaminophen treatment has an antidepressant effect. There was no significant difference between the groups in the PCS scores after four weeks of treatment (P = 0.35).The Apathy Scale score was significantly lower in the tramadol group than in the celecoxib group after treatment . On the other hand, the bootstrapping method showed that the 95% CI contained zero (95% CI: −1.669–0.287), indicating that the effect of tramadol-acetaminophen on the change in apathy was not mediated by the pain relief. The results of mediation analysis showed that tramadol-acetaminophen was associated with the change in apathy directly, not through pain relief.A mediation model to test whether the effect of the tramadol-acetaminophen on the change in apathy is mediated by the pain relief was constructed . The dirP = 0.18). The adverse events related to the study medication for both groups are summarized in Fourteen (38.9%) patients reported adverse events during tramadol-acetaminophen treatment, and nine (24.3%) patients reported adverse events during celecoxib treatment. The difference in the overall incidence of adverse events between the treatment groups was not significant   and ParkBecause most pain conditions involve several different pathways, analgesic therapy with a single agent may be inadequate to relieve chronic pain. Combination analgesics with two or more agents may have synergistic analgesic effects and may provide more effective pain relief for a broader spectrum of pain . Dosagesμ-opioid agonist effects and weak inhibition of serotonin and norepinephrine reuptake [μ-opioid agonist activity plays a role in mood improvement [Pincus et al.  reportedreuptake . This μ-rovement , 14. We Patients with chronic pain frequently complain of depression and sleep problems. Depressive conditions may lead to reductions in the pain threshold ; therefoThe triad of pain, mentioned above, causes functional impairment in many areas of life . The meaP < 0.05). The results of the current study suggest that tramadol-acetaminophen in tablet form may represent an attractive alternative treatment option for chronic LBP patients with depression or apathy.The current study had some limitations. First, the dose of tramadol-acetaminophen was changed at the one-week visit from two tablets per day to four tablets per day unless side effects were experienced or adverse events occurred. In contrast, patients in the celecoxib group remained on two celecoxib tablets per day 200 mg/day) for the entire duration of the study. Thus, the incidence of adverse drug reactions may be attributed not to the drugs themselves, but rather to the difference in dose. Second, the present study included patients with LBP caused by various degenerative lumbar diseases consisting of a high proportion of lumbar canal stenosis. To evaluate the outcomes of tramadol-acetaminophen more precisely, it would be desirable to study patients with specific lumbar diseases. Third, the Japanese translation of 14-item Starkstein Apathy Scale was used in this study. The AES, Neuropsychiatric Inventory (NPI) , and its00 mg/day