The Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials and clinical practice. The ESD is a daily electronic diary assessing symptom severity; the EIS is a weekly electronic diary assessing symptom impact. This study explored the importance of symptoms (ESD items) and impacts (EIS domains), perspectives on scoring algorithms, and clinically important difference (CID) thresholds to inform clinical trial score interpretation.Endometriosis patients in Germany (n = 8) and the US (n = 17), and expert clinicians (n = 4) in Germany, the US, Spain, and Finland participated in semi-structured qualitative interviews comprising structured tasks. Interview transcripts were analyzed using thematic analysis techniques.Quality and severity of endometriosis-associated pelvic pain varied considerably among patients; some experienced pelvic pain daily, others during menstrual bleeding (dysmenorrhea) only. Patients and clinicians ranked “worst pelvic pain” as the most meaningful pain concept assessed by the ESD, followed by constant and short-term pelvic pain. Preferences for summarizing daily pain scores over the 28-day menstrual cycle depended on individuals’ experience of pain: patients experiencing pain daily preferred scores summarizing data for all 28 days; patients primarily experiencing pain during selected days, and their treating clinicians preferred scores based on the most severe pain days. Initial CID exploration for the “worst pelvic pain” 0–10 numerical rating scale (0–10 NRS) revealed that, for most patients, a 2- or 3-point reduction was considered meaningful, depending on baseline severity. Patients and clinicians ranked “emotional well-being” and “limitations in physical activities” as the most important EIS domains.This study informs the use of the ESD and EIS as clinically relevant measures of endometriosis symptoms and their impact. Findings from the ESD highlight the importance of individual-patient assessment of pain experience and identify “worst pelvic pain” as the most meaningful symptom assessed. Aggregating scores over the 28-day menstrual cycle may inform meaningful endpoints for clinical trials. Diverse EIS concepts  are meaningful to patients and clinicians, emphasizing the importance of evaluating the impact on both to comprehensively assess treatment efficacy and decisions.Not applicable. Qualitative, non-interventional study; registration not required. Endometriosis is an estrogen-dependent disorder characterized by the presence of endometrial-like tissue outside the uterus, which induces a chronic inflammatory reaction , 2. It aIn clinical trials, treatment effect is generally assessed by investigating change in endometriosis associated pelvic pain (EAPP) such as non-menstrual pelvic pain, dysmenorrhea, and dyspareunia , 12. ConThe measures of interest in this study, the ESD and EIS, were developed in accordance with scientific standards including FDA Guidance for Industry  and the The ESD is a daily electronic diary which assesses the experience of endometriosis symptoms over the past 24 h mostly reported on a 0–10 NRS. The EIS is a weekly electronic diary comprising items assessing the impact of endometriosis symptoms on patients’ daily lives over the past 7 days using a 5-point VRS , 19. TheAs a daily-completed, multi-item measure, patients’ daily responses to individual ESD items can be aggregated using multiple different scoring approaches. For example, data can be combined using scores either from every day or from selected days according to the relevance to the concept of interest, such as average pain or worst pain and summarized as either frequency, mean, range. For Patient Focused Drug Development, the priority of these endpoints for hierarchical testing should be patient informed , 23. TheThis study sought to generate additional insights from patients with endometriosis and treating clinicians to inform the implementation of the ESD and the EIS in endometriosis clinical trials, especially informing clinical endpoint selection and score interpretation. The specific objectives of this study were to understand: (1) the ESD items and EIS domains that would inform the most meaningful clinical trial endpoints; (2) preferred scoring algorithms for aggregation of the daily responses of the ESD “worst pelvic pain” item; and (3) clinician and patient perspectives of meaningful change in the ESD “worst pelvic pain” score.This was a multinational qualitative interview study conducted with patients with endometriosis and clinical experts treating patients with endometriosis. Qualitative and quantitative data were collected in the interview.Four clinicians, one each from the US, Germany, Spain and Finland, were recruited via an in-house clinician database and by contacting national endometriosis associations. Eligibility criteria required the clinicians to be in clinical practice and regularly treating ≥ 5 patients with endometriosis per month. No formal ethical approval was required for the clinician interviews, but all participants provided written informed consent.Patients were recruited from three clinical sites in the US and one clinical site in Germany through referral from clinicians participating in the ESPARIOS clinical trial (NCT02203331). Patients were referred based on pre-defined eligibility criteria, which were designed to allow comparability between the ESPARIOS study population and future endometriosis clinical trial populations. Patients were eligible for inclusion if they were a premenopausal female ≥ 18 years of age with their endometriosis diagnosis confirmed by laparoscopy or laparotomy within 10 years of the interview, and had experienced EAPP within 4 weeks of the interview. All patients provided informed consent and ethical approval of the protocol was received .Interviews were conducted in line with accepted industry best practice –28. ClinTo explore ESD item/EIS domain importance, clinicians were asked to allocate 100 points across each measurement concept or domain in a constant sum scaling task. Clinicians provided two distributions, one to represent the clinician perspective, and a second to represent their perception of the patient perspective  and 0–10 NRS 7 (severe EAPP) . This inClinicians were asked, which values of the ESD “Worst overall pelvic pain” 0–10 NRS they considered to represent for “mild,” “moderate,” and “severe” pain and to discuss the clinical meaningfulness of scores > 4 and > 7. To facilitate discussion, study participants presented with a blank 0–10 NRS  were interviewed. All worked within university hospitals and were involved in endometriosis diagnosis, treatment, and patient management. Overall, 25 patients with endometriosis from the US and Germany participated; demographic and clinical characteristics are presented in Table  were intExperiences of EAPP varied considerably between patients, with some patients experiencing pain every day and others only experiencing pain around the time of their menstrual period or during intercourse. Examples of patient pain profiles  are shown in Table “It summarizes all the pain.” (US-16)“[It’s the most important] because if I can't fix that, then I can't do my daily stuff.” (US-04)“[This is] most important because I feel like this is a daily issue.” (US-06)Patients and clinicians gave similar importance to each item of the ESD Table . “Worst “I obviously think the constant pain is [most important] because […] it’s constant pain, it’s all the time.[…] It makes me unhappy, it makes me irritable.” (US-03)“I can feel it every day, hour or minute. It is just always present.” (DE-03)“Worst constant pelvic pain” was assigned the second highest priority overall for both clinicians and patients; one clinician described this pain type as “the most disabling for a woman.” Fourteen of 25 patients (56%) considered “Worst constant pelvic pain” as one of the top two most important pain types due it being a permanent “frustrating” presence in their lives and the type of pain most likely to interfere with their daily activities:“Well, the constant I can deal with ‘cause I know it’s going to be there.” (US-11)“Worst short-term pelvic pain” received mixed views from patients and clinicians. Some patients ranked “Worst short-term pelvic pain” with high importance due to the severity and unpredictability of this pain type. Others considered the short-lived nature of the pain comparatively easier to cope with and thus of lesser importance:“I have a pretty good pain tolerance. So, I know if I can just breathe through it for a minute, it goes away.” (US-04)“This is the worst thing for me.[…] It is the most limiting for me, the fact that it is random or unpredictable, and it just shuts me off and kills any nice moments.” (DE-05)“I may be sitting at my desk at work when all of a sudden the stabbing pain kicks in and I pinch my fingers on my desk and curl up with pain.” (DE-07)Other patients considered this item to be less important because they could anticipate their “Worst constant pelvic pain”, and had learned how to cope with it:“[Bleeding days] are the days where I am in the most pain and the most incapacitated.” (US-03)“I put ‘Pain associated with bleeding’ [as rank] 7 because for me I never really had pain with bleeding, so that to me is not a factor.” (US-01)“I think [‘Pain due to sexual intercourse’] is just very important to me because that's something that I would like to give [my husband].[…] It's frustrating because I can't give him that one particular thing that he really desires as much as he would like.” (US-02).There was some variability between the importance that patients assigned to the “Pain associated with bleeding” concept and “Pain during sexual intercourse” item. Patients who did not experience pain during sexual intercourse or did not experience differences in pain during bleeding days compared with non-bleeding days ranked these items of a comparably lower importance Table . CliniciPatients and clinicians interviewed both ranked “Avoidance of sexual intercourse” and “Pain medication usage” as ESD items of minor importance to them. However, some patients rated “Pain medication usage” highly due to concerns related to addiction or side effects.“When I don’t feel good, I am in a bad mood. It’s easy for me to be irritable or stressed out. And so, that affects my family and it affects work.” (US-13)“When I'm not in a good mood I don't want to be around people. I'm a social butterfly so people don't understand when I don't want to be around them because I'm in pain.” (US-02)Clinicians mostly agreed with patients on the relative importance of the different EIS concepts Table . Patient“Ok. My first one I put as most important was physical activities, which is my exercise, the exercise, like six days a week, so for me, even if I’m all day in my job. So for me that is the most important, because if I don’t exercise, and if I take out two days of exercise, I get crabby, it’s like I just need that stimulation or something.” (US-01)“I want to be able to go out and play with my son without needing to come in and sit down. I want to be able to sit through a movie […] I will have to change positions five hundred thousand times because it gets uncomfortable.” (US-03)“Limitations in your physical activities” also ranked highly in the patients’ ratings:, suggesting, if they could not move, they could not work, socialize, or take part in leisure activities.This ranking was echoed by clinicians. One clinician noted that “one thing is a consequence of the other,” and another clinician stated that if patients can go about their physical activities, they have “fewer emotional problems”.“I want to be able to work continuously and not have to miss shifts and miss out on money. I do still have bills. But when it happens I have no choice but to leave.” (US-11)“Sleeping; oh my goodness, yeah. I've been asleep and it's like a sharp—it hits me, it wakes me up out of my sleep. So, yeah, that's—it's not fun.” (US-05)The EIS “Other limitations” domain includes items assessing social and leisure activities, paid work or study, household activities, difficulty concentrating, and/or difficulty sleeping. Of these items, patients considered difficulty sleeping and an inability to work or socialize as important items.“That would make me happier, number one it would make my husband happier, make my family happier […] because when you have two happy parents you would be happier.” (US-03)“It’s not that it’s not important, but everything else came prior.” (US-16)Overall, patients and clinicians considered “Limitation in sexual activities” as comparably less important to other domains. Clinicians described “Limitation in sexual activities” as not of high importance to some patients. However, for some patients this was a very important concern due to the impact on their partner as well as themselves.Overall, patients expressed mixed preferences regarding the four different scoring algorithms proposed for the “Worst overall pelvic pain” 0–10 NRS for aggregating the daily scores over a 28 day period. Individual preferences seemed dependent on the patient’s own pain profile. Patients’ and clinicians’ perceived advantages and disadvantages of each algorithm are presented in Table Patients and clinicians described “mild”, “moderate”, and “severe” pain related to the0–10 NRS. In general patients and clinicians reported the mild/moderate boundary to be at approximately 4 and the moderate/severe boundary to be at approximately 7 on the 0–10 NRS . Some patients noted that as they were conscious of pain, their mood would be affected.In general, clinician perceptions of scores of 7 on the 0–10 NRS were more severe than those provided by patients; clinicians considered scores of 7 on the 0–10 NRS to be severely limiting and to require immediate medical attention. Patients, however, reported that this level of pain was just “the start of a peak” (US-15) and would subsequently get considerably worse. Some patients reported considerable physical limitations at a score of 7 on the 0–10 NRS and described reducing their activities to only those that were most necessary. Scores of 7 were also described as a turning point in patients’ moods, with patients feeling miserable and withdrawn. A summary of patient descriptions of each point on the 0–10 NRS is presented in Table Clinicians described the minimum score change on the 0–10 NRS that would be considered meaningful following treatment for endometriosis to be dependent on the baseline score, as “it all depends on what level you are coming from” (Clin-GER) Table .Table 7P“On level 8, I cannot do anything, but on level 5, I could do almost everything although I would constantly feel right on the borderline to taking pain medication. I imagine that being on level 5, I might be free of pain at some points by taking pain medication.” (DE-06)When discussing meaningful change from a score of 5 on the 0–10 NRS, most patients described a 2-point reduction as being meaningful. One patient described a change in score from 5 to 3 as “life-changing” (US-03) and another commented that “even though it might not be fun, I could go to work normally and lead a regular social life” (DE-04).When discussing meaningful change from a score of 3 on the 0–10 NRS, some patients commented on the limited opportunity for meaningful change a score of 3 on the 0–10 NRS was already considered representative of “mild” pain. Other patients concluded that if their pain were “only” at a score of 3 on the 0–10 NRS, treatment would need to remove pain entirely in order to make a meaningful difference.“…I mean if I was at a 3 every day I’d be great.[…] A 3 I wouldn’t even notice.[…] Any change would be fine…” (US-01)“Well I guess level 2 would be fine… but really if it were me personally, I wouldn’t go on a 12-week treatment if I were on pain level 3. I feel that the effort I would put into that treatment would be more than the difference between levels 0 and 3." (DE-08)Patient ratings supported this statement. When discussing meaningful change from a score of 8 on the 0–10 NRS, most patients perceived a 3-point reduction as being meaningfulThe findings from this study supplement prior validation studies of the ESD and EIS , 19, 20 Participating patients had varied experiences of EAPP, including dysmenorrhea and dyspareunia, in line with previous findings , 15, andPatients and clinicians prioritized “Worst overall pelvic pain” as an important measurement concept, regardless of whether it was associated with menstrual bleeding, with sexual intercourse, or neither. This finding is comparable with qualitative studies in other endometriosis patient populations that have identified both non-menstrual pelvic pain and pain during menstruation as important symptoms of endometriosis for a treatment to address , 34. TheWhen assessing the impact of EAPP, in line with previous findings, , 16 the Overall, all scoring algorithms used to aggregate the daily ratings over the 28-day menstrual cycle were found to have potential advantages. In addition, some general preferences by clinicians for selecting a subset of days within the 28-day cycle was observed in concordance with an understanding that pain levels frequently vary during the menstrual cycle and that days where the most severe pain was experienced might be most important to women with endometriosis. Patients did not identify a single “best” scoring option: those who experienced pain daily tended to prefer an aggregation of scores from all days within the 28-day cycle; those whose pain did not occur daily or whose pain varied in severity throughout the month generally preferred a score that included only the most severe days. Definitions of those “most severe pain days” were explored to understand the appropriateness of proposed scoring algorithms. Most patients considered a “severe” level of pain as ≥ 7″ on the 0–10 NRS, consistent with findings in the literature . PatientThe final objective of this study was to explore the changes in “worst pelvic pain” scores that patients understand as clinically meaningful . In general, patients and clinicians identified a greater degree of improvement as meaningful for higher baseline pain levels than for lower baseline pain levels. Slightly greater than the minimal clinically important difference of 10 mm on the 100 mm VAS for assessing endometriosis-associated pelvic pain presented by Gerlinger et al. , a 2-poiPatients frequently described the relationship between EAPP and physical limitations and the relationship between EAPP and impact on emotional well-being. These findings, and those reported elsewhere , 38, 39,As a major limitation of this study it must be noted that cognitively complex themes were discussed with patients who are not expected to have a background in this type of research. Additionally, the topic of meaningful differences on the ESD scale might have been difficult to conceptualize for any participants who had not experienced recent changes in pain. Also a difference in familiarity with the ESD and EIS existed, depending on whether patients had participated in the clinical study BAY98-7196/15832, or not; this was mitigated by all participants completing the ESD for 7 days prior to interview and the EIS once before and on the day of the interview. However, no obvious differences in findings between these two subgroups emerged. Qualitative exploration can be influenced by the researchers’ personal biases; this was mitigated by using highly experienced interviewers and the formal structure in tasks removed some elements of interpretation. Although patients and clinicians from several countries were included, the small sample sizes did not allow comprehensive cultural comparisons. Furthermore, the small sample size and the heterogeneity in endometriosis symptoms experienced means that results are not universally generalizable and should be considered in the context of other relevant qualitative and quantitative studies. An area for further exploration may be to investigate the importance of dyspareunia and limitations on sexual activities, given the polarization in importance ratings demonstrated by women in this study.The ESD and EIS provide clinically relevant assessments of endometriosis symptoms and the impact of endometriosis on patients’ lives. Insights from patients and clinicians highlight the importance of “worst pelvic pain” as measured by the ESD, and suggest that aggregating scores over the 28-day menstrual cycle can support efficacy assessments in endometriosis treatment trials. A reduction of 2–3 points on the ESD “worst pelvic pain” 0–10 NRS was considered meaningful to most patients, but patient interpretations of meaningful change were also reported as being dependent on baseline pain severity. Findings from this study highlight the importance of assessing the impact of treatments on physical limitations and emotional well-being of patients to fully understand treatment efficacy.Additional file 1. Examples of completed ranking tasks and material used for cognitive exploration tasks.


We aimed to determine the serum concentrations of some inflammatory and oxidative stress biomarkers in relation with pain intensity and quality of life in patients with myofascial pain syndrome (MPS) compared to healthy controls. This study is a case–control study. The participants were selected from MPS patients who referred to rehabilitation outpatient clinics of the Tabriz University of Medical Sciences, Iran.Serum hs-CRP , phospholipase A2 (PLA2)  and malondialdehyde (MDA)  levels were significantly higher and serum total antioxidant capacity (TAC)  and superoxide dismutase (SOD)  levels were significantly lower in the MPS patients compared to healthy controls. Serum high-sensitivity C-reactive protein (hs-CRP) level was significantly and positively associated with resting , activity  and night pain  intensities, pressure pain threshold (PPT)  and pain duration . Serum TAC level was significantly and negatively associated with resting pain intensity . Some scales and subscales of quality of life were positively correlated with serum TAC level and negatively associated with serum hs-CRP and PLA2 levels. Myofascial pain syndrome (MPS) is a chronic painful dysfunction that can distress any striated muscle in the human body . MPS is The primary aim of this study was to compare serum concentrations of important inflammatory biomarkers and oxidative stress between primary MPS patients and age and body mass index (BMI) matched healthy controls. The secondary aim of this study was to determine the correlation between these biomarkers with clinical findings, and quality of life exists.The present study was a case–control study. Patients with the primary MPS attending the university rehabilitation outpatient clinics and satisfying inclusion criteria [ > 4) and normal neurologic examination], were involved via simple random sampling from October 2018 to May 2019. The exclusion criteria were fibromyalgia, cervical radiculopathy, metabolic diseases like hypothyroidism and diabetes mellitus, and previous injection for MPS treatment within the last 6 months before the enrollment.The control group was a sample of healthy subjects, matched for age (± 2 years) and BMI selected randomly from the other outpatient clinics of the same university. The exclusion criteria were the presence of systemic diseases, chronic pain, or psychiatric disorders. The ratio of the case to the control group was 1:1. The study was carried out following the principles of the Declaration of Helsinki. Written informed consent was achieved from all participants.Based on a previous study by Koca et al.  and TAC 2) [The demographic data of participants were gathered through face to face interviews by a general characteristics questionnaire containing demographic and medical information. BMI was calculated by dividing the weight (kg) by the square of height (m2) . The phy2) . Three c2) .VAS was used to measure the pain observed by the subjects in the last 24 h through a 0–10 cm scale. Each patient was instructed to represent their perceived resting pain, night pain, and pain intensity with the activity which ranged from ‘0’ (no pain) to ‘10’ cm (worst imaginable pain). The VAS is a simple and commonly applied method for the evaluation of pain intensity . This ra2. An electronic pressure algometry device was placed perpendicularly on the location of the trigger point to increasing compression pressure against the muscle under examination by 1 kg/cm2/s [The least force exerted which persuaded pain was inspected using PPT through the pressure algometry method. Estimation precision was distinguished at 1 kg/cmkg/cm2/s .The validated Persian version of the 36-item questionnaire SF-36 was used to evaluate the quality of life in participants .Serum high-sensitive C-reactive protein (hs-CRP) (μg/mL) was measured by the Monobind hs-CRP Elisa kit. The Luminex-based immunoassay using the Serum Phospholipase A2 kit  was used to measure phospholipase A2 (PLA2) as described by Hsu et al. . MeasureAll statistical analyses were performed using the statistical package SPSS . An independent sample t-test or Mann–Whitney U test was done to inspect the differences in inflammatory markers and oxidative stress indices between patients with MPS and non-MPS controls. Unadjusted linear regression was run to assess the association between inflammation and oxidative stress biomarkers with pain intensity and quality of life. A P-value ≤ 0.05 was considered statistically significant.A total of 96 patients with MPS were evaluated for eligibility. Of these, 11 were excluded due to the disagreement of participation in this study or lack of inclusion criteria. Finally, 85 participants were studied in this. Distribution of demographic variables like age, weight and BMI, serum levels of biomarkers, and subscales of quality of life are presented in Tables Data were more analyzed to determine the association between serum concentrations of biochemical indices with clinical findings and quality of life by Pearson/Spearman correlation. The analysis also performed in controls concerning the correlation of the biomarkers and the quality of life Table .Table 3CIn this study, we showed that circulating plasma levels of inflammatory indices of hs-CRP and PLA2 and also MDA as an oxidative stress marker are higher and the plasma level of SOD antioxidant enzyme is lower in patients with MPS in comparison with healthy subjects.Although serum concentrations of inflammatory and oxidative stress indices have been researched in different pain disorders, data in MPS patients are few. Human studies suggest a probable pathogenic role of the cytokines in pain . Koch etDuring the inflammatory response, an increase in the amount of oxidative stress also contributes to the pain. Reactive oxygen species (ROSs) and reactive nitrogen species (RNSs) can, directly and indirectly, induce sensitization and activation of nociceptor receptors . The accBased on our findings, higher serum concentrations of hs-CRP and lower serum level of TAC was associated with higher pain intensity and duration in patients with MPS. These findings suggest that key symptoms of MPS may partly be the consequence of systemic inflammation.Pain experimental models established pro-nociceptive properties of cytokines . In the We found that, there were significant and negative correlations between some scales and subscales of quality of life and serum concentrations of hs-CRP and PLA2 in MPS patients. In return, TAC concentration was directly correlated with some scales and subscales of quality of life in the patients. In healthy controls, TAC and SOD concentrations were directly and hs-CRP, PLA2, and MDA concentrations were negatively correlated with scales and subscales of quality of life.Previous studies have evaluated the association between inflammation and quality of life in other disorders –34 and cThe association between mental conditions and the endocrine and immune systems, especially inflammation may be somewhat explained by the hypothalamic–pituitary–adrenal (HPA) axis function. Given that acute psychological stress can induce an inflammatory response , stress The findings of this study may theoretically impact clinical practice by suggesting a novel approach to symptom treatment in which systemic inflammation is recognized as a key therapeutic object.Patients with MPS had significantly higher concentrations of hs-CRP, MDA, and PLA2 and lower concentrations of SOD in comparison with healthy subjects. In these patients, higher concentrations of hs-CRP and lower concentrations of TAC were associated with higher pain intensity and duration and lower scores of some scales and subscale of quality of life. The serum level of PLA2 was also associated negatively with some scale and physical health subscale scores of quality of life in MPS patients. Additionally, serum concentrations of SOD and TAC were positively and serum concentrations of PLA2, MDA, and hs-CRP were inversely associated with different scale and physical and mental health subscale scores of quality of life in healthy matched controls.Our study has a relatively small sample size. Additionally, the case–control design limits the capability to causality assessment of how inflammatory and oxidative stress biomarkers implements in predicting MPS. Moreover, the serial examination of biomarker levels for assessing dynamic alterations was not examined. Lack of dietary intake assessment of micronutrients with anti-inflammatory and anti-oxidative properties is another limitation. Furthermore, we did not execute subgroup analysis based on the levels of stress and other psychological elements that may be accountable for the raise in the biomarker concentrations. Finally, we studied a particular group of MPS . Thus, external validation may not be applied to other patients with MPS.


IntroductionIn this prospective study, we aimed to determine if there was a link between pain on propofol injection (POPI) and various hemogram parameters and ratios.MethodsThe study was designed to include 100 consecutive male patients undergoing surgery in a tertiary hospital in February 2017. Preoperatively collected data included patients’ age, weight, height, hemogram parameters (white blood cell (WBC) count, neutrophil count, lymphocyte count, platelet count, mean platelet volume (MPV), platelet distribution width (PDW), plateletcrit (PCT), hemoglobin, and hematocrit). All patients’ hemograms were performed using the same device. The neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, and systemic immune inflammatory score (SII) were calculated from this data.Patients received prior information that pain would be questioned during propofol injection. The pain was grouped between 0 and 3 .Patients were questioned by the anesthesiologist about their level of pain at five-second intervals until loss of consciousness occurred. The same anesthesiologist also used the McCririck and Hunter’s verbal rating score (VRS) to evaluate pain. The patients’ heart rate and blood pressure were also recorded after induction.ResultsAn extremely significant correlation was found between the presence of POPI and neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR) and SII ratios (p<0.001). All three parameters were found to be significant in predicting the presence of POPI. The higher area under the curve (AUC) was found for SII.The cutoff value for SII’s prediction of POPI was calculated to be 479,000, with a sensitivity of 68% and a specificity of 68%. Patients with an NLR of >497000 had a 4.63 times higher risk of POPI .ConclusionOur study is the first to show that POPI can be predicted by using NLR, PLR, and SII. Our data also support other studies that have reported a relationship between the inflammatory biomarker NLR and pain perception. Propofol is the most frequently used hypnotic agent in anesthesia induction and total intravenous anesthesia (TIVA) . Pain onDespite many studies on the management of POPI, data are scarce with regards to any correlation with patient demographics and the ability to predict POPI .In recent years, studies have demonstrated a link between some values and ratios obtained from a hemogram and the diagnosis, follow-up, or survival rates of certain pathologies . The neuIn this prospective study, we aimed to determine if there was a link between POPI and various hemogram ratios (neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII).The study was designed to include 100 consecutive male patients undergoing surgery in a tertiary hospital in February 2017. Informed consent was obtained from all patients. Male patients classified as American Anesthesiology Association (ASA) physiological score I or II, aged between 18 and 40 years due to undergo general anesthesia for elective orthopedic, abdominal, urological, ear-nose-throat, or plastic surgery procedures were included in this study. Subjects with chronic diseases, such as diabetes, hypertension, hypo or hyperthyroidism, vitamin B12 or vitamin D deficiency, leucocytosis, leucopenia, or other hematological, biochemical, or serological abnormalities, those with chronic medication use, and those using non-steroid anti-inflammatory drugs in the previous week, steroid use in the previous six months (including steroid creams), those with upper respiratory tract infections within the last three weeks, and those with routine alcohol intake were excluded from the study, as these conditions may affect the results of hemogram parameters. Patients with a history of psychiatric illness and those who required the use of a sedative due to serious preoperative anxiety were also excluded, as these patients’ perception of pain may have been affected.Preoperatively collected data were patients’ age, weight, height, hemogram parameters , platelet distribution width (PDW), plateletcrit (PCT), hemoglobin, and hematocrit). All patients’ hemograms were performed using the same device . NLR, PLR, and SII were calculated from this data. We calculated SII from the equation, SII = Platelet (P) x Neutrophil (N) / Lymphocyte (L), where P, N, and L are the preoperative peripheral blood platelet and neutrophil and lymphocyte counts per liter, respectively.Patients underwent routine monitoring . Intravenous access was performed on the dorsum of the hand with a 20 gauge cannula. A face mask was used to deliver 6 lt/min of fresh oxygen and fraction of inspired oxygen (FiO2) for three minutes before induction.Patients received prior information that pain would be questioned during propofol injection. The anesthesiologist used the McCririck and Hunter’s verbal rating score (VRS) to evaluate pain. Pain was grouped between 0 and 3 . A solution of 200 mg/20 mL 1% propofol and 2 mL 2% lidocaine (40 mg) was prepared in a 50 mL injector. Basal heart rate and blood pressure were measured and propofol infusion of 18.3 mL/min was commenced and continued until a dose of 2.5 mg/kg was achieved. The patients were questioned by the anesthesiologist about their level of pain at five-second intervals until loss of consciousness occurred. The patients’ heart rate and blood pressure were also recorded after induction.A blinded individual compared hemogram parameters and ratios to pain perception scores. SPSS 16.0  was used for statistical analysis. Parameters were compared using the independent samples t-test for normal distribution; otherwise, the Mann-Whitney U test. An intergroup comparison was performed using the analysis of variance (ANOVA) test. Cut-off levels for parameters (sensitivity and specificity) were calculated using the receiver operating characteristic (ROC) curve analysis. p <0.05 was regarded as statistically significant.Of 100 patients, eight were excluded due to leukocytosis, thrombocytopenia, and other hematological problems, seven due to chronic alcohol use, five due to psychiatric pathologies, and one due to preoperatively detected arrhythmia. The average age of the remaining 79 patients was 35.1±7.8 years and the average body mass index was 26.04±2.81.When POPI was evaluated using VRS, 25 patients had no pain, 31 had mild pain, 14 had moderate pain, and nine had severe pain. The patients’ distribution of VRS scores, demographics, and hemogram parameters are shown in Table An extremely significant correlation was found between the presence of POPI and NLR, PLR, and SII ratios p<0.001). Area under the curve (AUC) for NLR, PLR, and SII in regards to the presence of POPI is shown in Figure . Area unThe cutoff value for NLR ‘s prediction of POPI was calculated to be 1.64, with a sensitivity of 77% and specificity of 48%. Patients with NLR of >1.64 had a 3.23 times higher risk of POPI .The cutoff value for PLR‘s prediction of POPI was calculated to be 121000, with a sensitivity of 56% and a specificity of 52%. Patients with NLR of >121000 had a 1.46 times higher risk of POPI .The cutoff value for the SII prediction of POPI was calculated to be 479000, with a sensitivity of 68% and a specificity of 68%. Patients with an SII of >497000 had a 4.63 times higher risk of POPI .While our study did not find a correlation between any individual hemogram parameter and POPI, three ratios calculated from these parameters  were found to be significantly higher in patients with POPI.POPI is a clinical problem that must be managed by anesthesiologists. Literature reports that POPI can be seen in up to 90% of patients, especially when the injection is made to small diameter veins such as those on the dorsum of the hand ,15. ManyHanci et al. reported that POPI differed at different times of the menstrual cycle in women . They obNLR, PLR, and SII are cheaply and easily available biomarkers calculated from hemogram parameters that have been shown to be useful in the differential diagnosis of various pathologies as well as predictors of disease survey and treatment response ,13,20. TIn a study of ASA I-II patients due to undergo laparoscopic cholecystectomy, Persson et al. evaluated the relationship between postoperative pain intensity measured using VAS and opioid consumption during venous cannulation and propofol injection . The autThere are many limitations to this study. First, a study evaluating the relationship between NLR, PLR, and SII and smoking found that these ratios and indexes are significantly higher in smokers . We did Our study is the first report to show that POPI can be predicted by using NLR, PLR, and SII. Our data also support other studies that have reported a relationship between the inflammatory biomarker NLR and pain perception.


Low back pain (LBP) affects approximately 51% to 57% of hospital nurses and nurses’ aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.We conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to 2 groups: intervention group, where patients received LED photobiomodulation therapy 3 times a week for 2 weeks, and the sham group, where patients had sham therapy 3 times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a multidimensional fatigue inventory, fear-avoidance beliefs questionnaire, and the Oswestry disability index. The outcome measures were assessed before therapy and 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. Our results will be useful for patients, working nurses, nurses’ aides, and other healthcare workers with chronic low back pain.NCT04424823 The annual LBP prevalence among hospital nurses and nurses’ aides in Europe is between 51% and 57%, and new high-risk groups include home and long-term care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers; hence, identifying ways to reduce the prevalence of long-term LBP and thus prevent absences associated with LBP among healthcare workers is crucial.Low back pain (LBP) is the leading cause of disability in both low-income and high-income countries and is associated with large direct and indirect healthcare costs. Chronic low back pain (CLBP) is defined as back pain lasting more than 12 weeks. CLBP may be associated with true radicular symptoms in patients with canal or foraminal compromise or pseudoradicular leg pain where the pain does not fall into a particular dermatomal pattern. CLBP is generally assumed to be due to the following:Back pain is generally self-limiting. However, a significant percentage of patients develop chronic back pain.1.Dysfunction of the motion segment of the spine , in which varying degrees of discal degeneration based on MRI are noted2.Non-specific CLBP, which may not show significant degenerative changes in MRI.–11 with an annual prevalence ranging from 45% to 77%. Persistent LBP in nurses causes considerable functional and work disability and is a strong risk factor for long-term sickness absence and dropout from profession at the early stages of their career. Thus, prevention of persistent LBP in nurses is a priority.Previous studies worldwide have documented a higher LBP prevalence in nursing personnel than in other occupations,–19 Photobiomodulation therapy consists of applying a non-ionized form of light, which includes light amplification by stimulated emission of radiation or commonly known as laser, light-emitting diodes (LED), and other lights with a broader spectrum, ranging from visible to infrared.  Light energy exerts biochemical, bioelectrical, bioenergetic, and biostimulatory effects. Mechanisms by which light therapies have been shown to relieve pain include increases in microcirculation and nitric oxide synthesis, enhanced release of endorphins, modulation of nerve transmissions, and modulation of key mediators of inflammation, such as inhibitory cyclooxygenase and prostaglandin E2. Because it promotes tissue healing and produces anti-inflammatory and analgesic effects, light therapy is commonly used to treat musculoskeletal conditions.–26 Moreover, light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed onset muscle soreness. A previous systematic review and meta-analysis including 221 studies and 7 randomized controlled trials demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). Foley et al showed that 830-nm LED phototherapy significantly reduced adverse advents in return to play of university athletes with a wide range of injuries. Currently, few studies have investigated the use of bright light or LED therapy in Carvalho et al showed that LED therapy in lateral decubitus position and with flexion exercises of the lower limbs for the treatment of L4-L5 and L5S1 lumbar disk herniation with radiculopathy showed better therapeutic performance for radicular pain, gait claudication, and functional disability. In addition, Hsieh and Lee showed that treatment with hot-pack therapy and 890-nm light therapy is associated with reductions in the severity of disability and fear avoidance beliefs in patients with CLBP. The use of 890-nm light therapy was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain in 2002. Moreover, previous studies have shown that 890-nm light therapy reduces pain without detrimental systemic cardiovascular effects.Photobiomodulation therapy (PBMT) is a non-pharmacological intervention often used in the treatment of musculoskeletal disorders, such as LBP.Thus, this double-blind randomized controlled trial aimed to evaluate the effect of LED PMBT on pain, fatigue, fear avoidance beliefs, and function in individuals, particularly nurses, with NSCLBP. We hypothesized that LED PMBT 3 times a week for 2 weeks would be effective in reducing pain and fear of pain among female nurses with NSCLBP.22.1The study protocol is in accordance with the 2013 SPIRIT  Statement . Figure Participants were randomly allocated to 2 groups: intervention group (participants received LED light therapy) or sham group . The LED and sham interventions were performed using the same device and the same irradiated sites 3 times a week  for 2 consecutive weeks. To ensure blinding of patients, the device was set to produce the same sounds and display the same information during both therapies. Furthermore, because the device produces a non-significant amount of heat, the participants could not determine whether active or shame light therapy was administered. The group assignments were not revealed to the participants.2.2Male and female nurses aged 18 to 65 years with a clinical diagnosis of NSCLBP based on history and clinical examination were included in this study. No restrictions were imposed with regard to race. The exclusion criteria were as follows: severe skin diseases ; LBP associated with nerve root compromise ,38; serious spinal pathologies, such as fractures, tumors, and inflammatory and infectious diseases; decompensated heart disease or metabolic disorders; previous spinal surgery; and pregnancy. Relevant concomitant care and interventions which is same as previous treatment that are permitted.The inclusion criteria included the following: male or female registered nurses aged 18 to 65 years with non-specific chronic LBP, which is defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs, and persistent LBP for at least 3 months.Moreover, patients with CLBP were allowed or asked to withdraw from the study if patient makes such a request; the patient develops a serious disease, such as stroke or heart disease; and the patient experiences an adverse effect related to the whole body vibration exercise.2.3 with an estimated standard deviation of 1.84 points. A statistical power of 80% was considered for the 2 outcomes, with an α level of 5% and a possible sample loss of up to 15%. Therefore, a total of 148 patients were required for this study.Sample calculation was performed to detect a 1-point difference for the outcome pain intensity ,Step 1 – Recruitment of study participants. Patients received information regarding the objectives and procedures, and those who agreed to participate were asked to sign a written informed consent prior to participation.Step 2 – The participants were blinded to the study group allocation. The therapists were aware of the participants’ group assignment.2.4Prior to the initiation of treatment, the patients were randomized to their respective intervention groups. The randomization was generated by a computer program  and performed by a researcher not involved in the recruitment or evaluation of the patients.2.52 and 14 mW/cm2, respectively. The LED device  was designed in Silicon Valley, United States, and was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain. Parameters of the LED phototherapies used in this study are described in Table Patients were submitted to photobiomodulation therapy with wavelengths of both 630-nm and 850-nm for RED and near-infrared LEDs, with power density set to 8 mW/cm2.6Age, sex, education level, marital status, work status, smoking, and drinking habits, and comorbidities were recorded for all participants, and their body mass index was calculated.2.7The outcome measures were assessed before, 2weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed. The investigator who performed the therapy was blinded to the allocation of each participant.Primary outcome measures included the following:1.Lumbar active range of motion assessments, which included forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.2.A 100-mm visual analog scale (VAS), which was used for LBP assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.3. was measured. A longer chair-rising time represents greater physical function limitations.Chair-rising time, wherein the time required for participants to rise 5 times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support,Secondary outcome measures were assessed with:1. The MFI contains 20 visual 5-point Likert statements that cover different aspects of fatigue, including general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher MFI score indicates greater fatigue.A multidimensional fatigue inventory (MFI), which was used to assess fatigue.2. The FABQ is a 16-item questionnaire with 2 subscales: the FABQ physical activity subscale, which contains 4 items that assess fears, avoidance attitudes, and beliefs regarding general physical activity, and the FABQ work subscale, which contains 7 items that assess fears, avoidance attitudes, and beliefs regarding occupational activity. Higher scores in the physical activity  and work  subscale evaluations indicate greater fears, avoidance attitudes, and beliefs.A fear-avoidance beliefs questionnaire (FABQ), which was used to measure fear-avoidance beliefs regarding physical activity and work.3. The ODQ contains 10 questions . Considering that certain cultural differences may be inherent in a questionnaire that was originally developed for a Western population, severity in the ODQ in our study was classified into 5 categories based on the total scores, according to a previous study on CLBP conducted in a Taiwanese population, as follows: minimal disability (0–11), moderate disability (12–22), severe disability (23–32), crippled (33–43), and bed bound (≥44).An Oswestry disability questionnaire (ODQ), which was used to evaluate the extent of the effect of LBP on the participants’ ability to manage activities of daily living.2.8t tests were used to compare the differences in the data between the treatment and placebo groups according to demographic and baseline variables. Paired t tests were used to compare the effects between the intervention and sham groups based on the primary and secondary outcome measures. The level of statistical significance was set at P < .05.Results of our evaluations are expressed as mean ± standard deviation. Chi-squared tests or 3,41,47 Theoretically, light therapy should be an effective treatment for NSCLBP. However, the evidence for LED PMBT is inadequate, and the effectiveness of LED in LBP remains to be established. We evaluated the short-term effect of LED therapy using a LED-based device on NSCLBP in this prospective, double-blind randomized placebo-controlled study. This study revealed that LED therapy could be an effective alternative treatment for NSCLBP by reducing pain and fatigue and improving fear-avoidance beliefs, function, and quality of life.Recently, a trend toward the use of LED light-therapy devices for pain relief among medical practitioners has emerged because of the lower costs in the irradiation of large-surface areas compared with treatments using laser-based light-therapy devices.3.1LED therapy is easy to perform, non-invasive, and has no obvious side effects. The limitations of this study include difficult recruit busy working nurse for complete treatment and follow up.The authors would like to thank the assistant of the department of nursing of National Taiwan University Hospital Hsin-Chu Branch.Conceptualization: Wei-Tso Chia.Data curation: Ying-Hao Su, Shih-Fang Chin.Formal analysis: Wei-Tso Chia, Yu-Ching Chou.Funding acquisition: Wei-Tso Chia.Investigation: Yen-Po Lin, Shih-Fang Chin.Methodology: Ying-Hao Su, Wei-Tso Chia.Resources: Wei-Tso Chia.Supervision: Wei-Tso Chia.Writing – original draft: Yen-Po Lin.Writing – review & editing: Ying-Hao Su, Wei-Tso Chia.


The item ‘hip pain’ is widely used in questionnaires related to Spondyloarthritis and/or Ankylosing spondylitis (AS), either in clinics with patients being physically present or remotely, as the hip joint is known to affect AS in particular. Patients in clinics often claim to have hip pain. However, by stating “hip” they are referring to variable structures located in the hip region not necessarily related to hip joint itself.To assess which structure(s) patients mean when referring to hip pain.A diagram used as a proforma for patients to indicate the site of ‘hip pain’ following a detailed history and examination was used. Radiological imaging was utilised for those patients with multiple sites or clinically unclear causes of “hip” pain.From 54 patients 7 different anatomical sites described which were: Trochanter, (27.2%), hip joint (20.8%), iliac crests , lumbar spine (8.3%), sacroiliac joint (6.9%). More than 1 sites in the same patient: (17.5%). Diagnoses were: Trochanteric bursitis (27%), osteoarthritis of hip and spine, (25%), enthesitis (22%), sacroiliitis (6.7%), synovitis (5%), fibromyalgia (3.4%), and hip dislocation (1.6%). More than 1 diagnosis in same patient: 9.3%.’hip pain’ as an item used in questionnaires must be interpreted with caution. The aim was to: 1) assess the varying anatomical locations and disease processes underlying in the reported as ‘hip-pain’ complaint; and 2) evaluate the use of the term ‘hip pain’ in PAMs used to diagnose and assess disease activity in AS.8 All patients (new and follow up) presenting with ‘hip pain’ during a one-year period (August 2014 to September 2015) age 18 and above were included. All patients were recruited by 3 independent clinicians aware of the study, in rheumatology clinics at King George’s Hospital, North East London (Essex).This was a prospective study registered as a scientific audit under the section “Clinical practice evaluation” of the audit proforma. As such, no consent was required.Figure 1). Schematic representation of the hip area produced by author LR. Radiological imaging was utilized, for those patients with multiple sites or clinically unclear causes of “hip” pain, to confirm or exclude the clinical diagnosis for the pain.After detailed history and examination performed on each patient, an accurate description of the site referred to as “hip” was recorded on a proforma designed for the purpose of the study  were assessed with 14 of the 54 patients (25.9%) indicating more than one site for their hip pain, resulting in a total of 72 anatomical sites.The Mean age for the cohort was 57.6 years (SD ±14.1). From the total of 54 patients, 40 patients (74%) indicated 1 site for the source of ‘hip pain’, while 14 indicated more than 1 site . Radiological evaluation was required for 40/54 (74%). Out of those, 23 patients had X-rays (57.5%), 13 patients had ultrasound (32.5%), 4 patients (10%) had magnetic resonance imaging (MRI). In the remaining 14 patients, the diagnosis was clinical, and no radiological evaluation was required.Table 1. The most common area was the trochanter . Pain related to the actual hip joint itself occurred in 20% of cases (n=15).In total, 7 separate anatomical locations were indicated as the source of the complain of ‘hip pain’ shown in Table 2). Hip pain that could be associated with inflammatory rheumatological causes was seen in less than half of cases . The second most common diagnosis was osteoarthritis .There was a wide range of diagnoses following the complaint/statement of ‘hip pain’ by the patients, with trochanteric bursitis being the most common  . It seems reasonable to presume that in the general population this incidence would be much lower.4 use ‘hip pain’ to attempt to diagnose inflammatory arthritis through questionnaire remotely. We feel this should be utilized with caution as we have shown patient reported ‘hip pain’ to be diagnostically and anatomically varied. In addition, the majority of patient-reported ‘hip pain’ is not secondary to an inflammatory process, even in the rheumatology clinic.Some PAMs10 To a proportion of patients, English is not their native language. To avoid confusion and with the aim to bypass potential language barriers, we used a diagram of the region. Patients were asked to draw on the diagram the exact site of pain.Bias of the study may be related to the multi-ethnic population attending the hospital in which the audit has been carried out as stated before.Self-reported ‘hip pain’ as a diagnostic aid for Ankylosing Spondylitis or Spondyloarthritis related to inflammatory back pain should be used with caution.PAMs that use ‘hip pain’ to monitor disease activity are at risk of skewed results due to its heterogeneous diagnostic, anatomical & semantic nature.


We aimed to assess the level of patient's satisfaction and associated factors regarding postoperative pain management. P value ≤0.2 in the bivariable analysis were a candidate for multivariable logistic regression. A P value ≤0.05 was considered as significantly associated with patient's level of satisfaction at 95% CI.  An institution-based cross-sectional study was conducted from April to May 2018 at the University of Gondar, and comprehensive specialized hospital data were collected through semistructured questionnaire and chart review. Level of satisfaction was measured using five-point Likert scale. Statistical analysis was done using SPSS software version 23. Both bivariable and multivariable logistic regression analyses were done. Variables of  A total of 418 patients were included in this study with a response rate of 98.58%. The overall proportion of patients who were satisfied with pain management services was 72.2% (95% CI: 67.7–76.6). ASA1 (AOR = 3.55: 95% CI = 1.20–10.55) and ASA2 patients (AOR = 3.72: 95% CI = 1.04–13.28), absence of postoperative pain (AOR = 1.86: 95% CI = 1.02–3.39), peripheral nerve block done (AOR = 9.14: 95% CI = 3.93 20.86), received analgesic before request (AOR = 6.90: 95% CI = 3.72–12.83), and received systemic analgesics (AOR = 6.10: 95% CI = 1.17–33.91) were significantly associated with the level of satisfaction.  The level of patient satisfaction with postoperative pain management was considerably low. Hence, it is vital to implement time-interval pain assessment method during the first 24 hours of postoperative period and treat accordingly based on the WHO pain ladder. Moreover, we suggested that all patients who underwent major surgery should receive peripheral nerve block as part of multimodal analgesia to decrease the incidence and severity of post op pain. Globally, postoperative pain is one of the major concerns in surgical patients and many studies have been done through different methods to assess patient satisfaction with postoperative pain management and associated factors –3.Satisfaction is a general psychological condition that results from emotional surrounding expectations coupled with the prior feeling of consumers toward the consumption experience . PatientStudies suggested that pain management can be affected by multiple factors such as gender, age, preoperative expectations, information given prior to surgery, ASA status, preoperative pain medication, type of anesthesia, type and duration of surgery, communication of staffs with patient, and experience of pain relief –11. PatiUntreated postoperative pain may have an effect in the clinical and psychological status of the patients. In addition, it creates a burden to health institutions by increasing costs and prolonging hospital stay. In addition, untreated acute postoperative pain may change to chronic pain with sequelae of decreased quality of life with different clinical sequels –18.Despite different methods of postoperative pain control have been provided to surgical patients, there had been lack of evidence that examined patients' satisfaction with the quality of postoperative pain management in the study area. Therefore, we aimed to assess the level of patient's satisfaction and identifying factor that could affect postoperative pain management.Institution-based cross-sectional study was conducted from April to May 2018 at the University of Gondar Comprehensive Specialized Hospital, northwest Ethiopia. The University of Gondar Comprehensive Specialized Hospital is a referral and teaching hospital which is found in Gondar town, about 738 km northwest from Addis Ababa, capital of Ethiopia, and 230 km from Ethiopia–Sudan boarder. The hospital is estimated to serve over 5 million people around the area and according to the annual report of the hospital, more than six thousand patients were operated on per annum.Sample size was calculated using a single population proportion formula. In a previous study done in Jimma University Specialized Hospital, it was shown that satisfaction rate was 50%, 5% of accepted difference, and CI of 95%:n = is the required sample size, Z = critical value for normal distribution at 95% confidence level (1.96), W = 0.05 (5% margin of error), α = the level of significance = best estimate of the population proportion, and 10% of nonresponse rate was added. Therefore, based on the abovementioned assumptions, 424 participants were enrolled in this study. All consecutive surgical patients were included until the calculated sample size was reached.Assumptions Data were collected through patients' chart review, interview, and five-point Likert scale. Questionnaires including five-point Likert scale were translated to local language (Amharic language) and pretest was done on 43 patients (10% of the estimated sample size) and amendment was done before the actual data collection.s, s−alpha) test of this instrument was 0.97. The questionnaire was modified from the American Pain Society satisfaction survey, American Pain Society patient-outcomes questionnaires–modified [Data was collected at 24 hours after operation. Two junior anesthetists were involved in data collection after receiving training and supervised by the principal investigator. The level of patient's satisfaction was measured using five-point Likert scale  and checklist. The reliability coefficient  –25. Pati(1) Sociodemographic Factors. Sex, age, BMI, and level of education.(2) Preoperative Factors. Previous surgical history, preoperative pain, treatment and previous side effects of pain medication, preoperative information of postoperative pain management, and disease status.(3) Surgical Related Factors. Body site of surgery, type of surgery, type of anesthesia and analgesia, duration of surgery, surgeon, and intra- and postoperative pain.Data clean-up and cross-checking were done before analysis. The coded data were entered to Epi Info software version 7 and exported to SPSS version 23. Bivariate and multivariate logistic regression analyses were used to control the possible confounding factors and to identify factors associated with patient's satisfaction. The cut-off point for statistical significance was <0.2 and 0.05 for bivariate and multivariate logistic regression analyses, respectively. The relationship of nominal data with satisfaction was analyzed by using cross tabulations. Categorical data were presented as numbers and frequencies (percentages). Patient's satisfaction through five-point Likert scale was dichotomized in to satisfied and dissatisfied groups based on demarcation threshold formula.2. The majority of the study participants, 64.4%, 87.1%, and 55%, underwent abdominal procedure, major surgery, and emergency surgery, respectively. More than fifty percent (54.1%), 45.9%, of patients were operated on under general anesthesia and 54.1% were operated on under spinal anesthesia , were females. Most of the respondents, 311 (74.4%), were in the age group of 18–39 years and the mean age ± SD was 33.5 ± 13.2 years and the mean ± SD of BMI was 22.2 + 3.0 kg/mesthesia .The overall of patients who were satisfied with pain management service was 72.2% (95% CI: 67.7–76.6). The highest satisfaction score was with communication and the way of response to reports of pain (76.6%) whereas the lowest score was with preoperative information and general care .Multivariate analysis showed that ASA status, postoperative pain, nerve block, receive analgesics, and analgesics before request were the significant factors associated with patient satisfaction in postoperative pain management .Previous studies showed that the level of patient satisfaction was not associated with postoperative pain severity, since the majority of the patients were considered satisfied, even though they had moderate-to-severe pain. In contrary, other studies showed that satisfaction was associated with postoperative pain management –29.In the current study, the overall proportion of patients who were satisfied with pain management services was 72.2% (95% CI: 67.7–76.6). This finding was low compared with other studies , 30–33. In the current study, we found that disease status has an association with the level of satisfaction, ASA1 patients were 3.5 times more likely to be satisfied compared with ASA3 and ASA4 patients (AOR = 3.55 (1.20–10.55)) and ASA2 patients were 3.7 times more likely to be satisfied compared with ASA3 and ASA4 patients . A study conducted in Australian patients showed that ASA3 and above were associated with patients' dissatisfaction in postoperative pain management survival in univariate odds ratio analysis. However, after adjustment, ASA status was no longer in associated with patients dissatisfaction .Patients who received a postoperative regional analgesic technique generally had lower pain scores and a higher level of satisfaction , 37–41. From 418 patients, 15 (3.6%) had not received analgesics; among them, only 5 (33.3%) patients were satisfied whereas 10 (66.6%) patients were dissatisfied. When compared with patients who had received analgesic versus patients who had not received analgesics, patients who had received analgesic were 6 times more likely to be satisfied (AOR = 6.1: 95% CI = 1.17–33.91). Furthermore, in the other studies, it was shown that patients who had received analgesics postoperatively were highly satisfied compared with nontreated patients , 42.In the current study, 149 (35.6%) patients had pain immediately after the operation. Those patients were 1.8 times less satisfied when compared with those who did not have pain immediately after the operation (AOR = 1.86: 95% CI = 1.02–3.39). Several studies conclude that patients' satisfaction with postoperative pain management was associated with the patients' actual pain experience , 34, 43,Another factor associated with patient satisfaction in postoperative pain management was using analgesic before request. Patients who received analgesics before request were 6.9 times more likely to be satisfied compared with those patients who had not received analgesics before request or totally did not receive analgesic (AOR = 6.90: 95% CI = 3.72–12.83). This finding is also in line with the other study and could be the association between pain management and patient's satisfaction .The overall level of patient's satisfaction with postoperative pain management was considerably low as compared with other studies. ASA status, presence of pain immediately after operation, peripheral nerve block, administration of systemic analgesics, and analgesic before request were significant determinant factors for patients' level of satisfaction. Hence, it is vital to implement time-interval pain assessment method during the first 24 hours of postoperative period and treat accordingly based on the WHO pain ladder. Moreover, we suggested that all patients who underwent major surgery should receive peripheral nerve block as part of multimodal analgesia to decrease the incidence and severity of post op pain.Dichotomized Likert data leads to loss of information and the space between each choice cannot possibly be equidistant. The study did not include patients discharged before 24 hours, and after 24 hours, the level of satisfaction was not assessed.


Chronic postsurgical pain (CPSP) can be caused by peripheral nerve injury (PNI) resulting from surgical procedures and has a significant neuropathic component. This prospective, single‐arm study was conducted to document the effectiveness of 10‐kHz spinal cord stimulation (10‐kHz SCS) as a treatment for patients with CPSP.Subjects with CPSP who were refractory to conventional medical interventions and reported pain scores of ≥5 cm on a 10‐cm VAS underwent trial stimulations lasting up to 14 days. Epidural leads were implanted at locations appropriate for the primary area of pain, and trials resulting in ≥40% pain relief were considered successful. Subjects with successful trials underwent implantation with a permanent 10‐kHz SCS system and were followed for 12 months after implantation.Of the 34 subjects who underwent trial stimulation, 1 was withdrawn early and 29 (87.9%) had a successful trial and received a permanent implant. After 12 months of treatment, the mean VAS score decreased by 6.5 cm, the response rate was 88.0% (22/25), and 18 subjects (62.1%) were remitters with VAS scores sustained at ≤3.0 cm. Scores for all components of the short‐form McGill Pain Questionnaire 2 were significantly reduced, including affective descriptors of pain. Pain catastrophizing and vigilance, patient function, physical and mental well‐being, and sleep quality all improved over the course of the study. No neurologic deficits reported in the study.10‐kHz SCS is effective and tolerated in patients with CPSP, and further study of its clinical application in this population is warranted. Chronic postsurgical neuropathic pain (CPSP) is a chronic pain syndrome recognized by the International Association for the Study of Pain (IASP) and the World Health Organization (WHO). CPSP is a diagnosis of exclusion defined as pain developing after surgery or tissue injury (including burns) and persisting for at least 3 months after the trauma occurred.Neuropathic CPSP has been associated with more intense, persistent, and impactful painPulsed radiofrequency treatment has reduced pain in postsurgical settings, but studies showing long‐term efficacy are lacking.Studies evaluating paresthesia‐based SCS in CPSP have reported effective pain relief in some cases. Preclinical studies have demonstrated that low‐frequency SCS can modulate genes upregulated after PNI in an amplitude‐dependent fashion, increases paw withdrawal thresholds, and suppresses allodynia, explaining the potential mechanism of analgesia in this pain condition.Despite the unmet need for effective nonpharmacologic treatments for CPSP, published data regarding this pain condition are sparse. Many published studies of patients with CPSP only included those with complex regional pain syndrome, and the larger population with CPSP has not been examined in detail. Therefore, this study was conducted to evaluate 10‐kHz SCS for the treatment of likely neuropathic CPSP and included neurological assessments before and after stimulation. Unlike other neuromodulation methods tested, 10‐kHz SCS is paresthesia independent, which avoids the burdens associated with paresthesia mapping and the discomfort associated with this sensation.This was a single‐arm, prospective, multicenter, post‐market study. The Western Investigational Review Board reviewed and approved the investigational plan, amendments, and informed consent forms before implementation, and the study complied fully with the U.S. Code of Federal Regulations and recommendations guiding physicians in biomedical research by the 18th World Medical Assembly, Helsinki, Finland. The study design and patient flow are shown in Figure Eligible subjects were affiliated with, or referred to, the clinical investigation sites and were diagnosed with chronic, focal, neuropathic pain following surgery involving the trunk or the limbs limited to 1 to 2 dermatomes with an average intensity of ≥5 cm on a 10‐cm VAS over 7 days. All subjects had scores of ≥4 on the Douleur Neuropathique 4 (DN4) neuropathic pain diagnostic questionnaire, a threshold that captures patients with a ≥70% chance of having neuropathic pain.All eligible enrolled subjects underwent trial stimulations lasting up to 2 weeks. Investigators placed octapolar leads in the epidural space based on each subject’s pain location Figure . The leaTrial stimulation resulting in at least 40% pain relief were deemed successful, and these subjects underwent implantation with a permanent 10‐kHz SCS system . A threshold of 40% pain relief exceeds the minimum clinically meaningful improvement for VAS scores (≥30% pain relief)Outcomes were assessed before beginning the trial stimulation (baseline) and at follow‐up visits. The primary outcome, pain intensity, was assessed using VAS scores. In contrast to the trial stimulation, subjects with permanent implants were classified as responders if their VAS scores declined by 50% or more, a commonly used threshold.Pain characteristics were evaluated using the short‐form McGill Pain Questionnaire 2 (SF‐MPQ‐2).Routine standard of care neuro‐assessments were performed at baseline, at the end of the trial stimulation, and after 3 and 12 months of stimulation. Results were documented as “maintenance,” “improvement,” or “deficit” for sensory, motor, and reflexes. To maintain consistency, the same investigator conducted the neuro‐assessments at all time points.t‐tests with a fixed variable (post‐implantation measurement time) and a random variable (subject). The threshold for statistical significance was P ≤ 0.05. All statistical analysis was performed using Microsoft Excel 2016 . Safety results were reported in the intent‐to‐treat population , and efficacy results were reported in the per‐protocol population (subjects who received an implant and completed 3‐month follow‐up).All outcomes were analyzed using descriptive statistics. Categorical variables were reported as counts and percentages, and continuous variables were reported as means ± standard error of the mean (SEM) intervals, as appropriate. To determine the statistical significance of longitudinal results, baseline measures were compared to follow‐up values using 2‐tailed paired In all, 34 study subjects, including 21 women (61.8%), enrolled in this study and underwent trial stimulation, and their demographic information is summarized in Table n = mild, n = 3 moderate). These AEs primarily involved the implantation procedure or the device itself. A total of 15 serious adverse events (SAEs) were observed in 9 subjects (26.5%) during the study. All but one of them were unrelated to the study, device, or the procedure. The single procedure‐related SAE (implant site infection) was resolved when the device was explanted. Neuro‐assessments revealed no deficits in neural functioning after the trial stimulation, nor after 3 months or 12 months of 10‐kHz SCS treatment. Interestingly, 9 of 28 subjects (32.1%) and 9 of 24 subjects (37.5%) demonstrated improvements in neuro‐assessments at the 3‐month and 12‐month follow‐up visits, respectively.A total of 6 study‐related adverse events (AEs) were recorded during the study, and 6 subjects were affected . After 12 months, the mean scores for neuropathic pain and affective descriptors of pain were 3.7 points and 3.4 lower than at baseline, respectively (P < 0.001 for both comparisons).Pain intensity was also assessed using the SF‐MPQ‐2, and the results are displayed in Figure n = 15, PCS total score ≥ 30), PCS scores decreased from a mean of 41.0 at baseline by 22.9 points after 3 months (P < 0.001) and 30.5 points after 12 months of stimulation (P < 0.001) , the magnification score decreased by 5.9 points , and the mean helplessness score decreased by 14.8 points . The mean PVAQ scores of all subjects, as well as the mean scores of both the Attention to Pain and Attention to Changes in Pain subscales, decreased from baseline throughout the course of the study .Subjects’ perceptions of pain were assessed using the PCS and the PVAQ, and the results are summarized in Figure ) Figure . By end y Figure . The meaThe study subjects were surveyed about their satisfaction level with 10‐kHz SCS therapy. After 3 months, 27 of 28 subjects (96.4%) were satisfied or very satisfied with their treatment, and 23 of 25 subjects (92.0%) were satisfied or very satisfied after 12 months.The patients’ and clinicians’ perceptions of 10‐kHz SCS treatment was assessed using the PGIC and CGIC. At 12 months postimplantation, 88.0% (22 of 25) of the subjects were reported to be “better” or “a great deal better” as assessed with both the PGIC and CGIC.P < 0.001). After 12 months, PDI scores exceeded the minimal clinically important difference of 8.5 to 9.5Multiple tools, including the GAF, PDI, and SF‐12, were used to assess subject quality of life, disability, and well‐being, respectively. The mean GAF score increased 17.9 points (24.4%) after 12 months of treatment, and the PDI score declined from 42.8 ± 2.3 at baseline to 13.8 ± 2.6 , while the score for awakening during the night due to pain decreased from 7.1 ± 0.5 to 1.3 ± 0.3 , and the score for awakening in the morning due to pain decreased from 8.2 ± 0.4 to 2.2 ± 0.6 .Sleep was assessed using the PSQ‐3, and patients reported improvement on all 3 questions. The mean score for trouble falling asleep decreased from 7.1 ± 0.5 at baseline to 1.8 ± 0.5 after 12 months of treatment (These results support the safety and efficacy of 10‐kHz SCS as a treatment option for CPSP. The safety results observed in this study demonstrated that the therapy does not introduce any unanticipated AEs. Study‐related AEs occurred in 7 subjects (20.6%), and no neurological deficits were observed.In order to define a homogenous patient population, CPSP was defined by 3 criteria to produce a homogenous patient population while remaining independent of the location of pain: (1) pain caused or exacerbated by a surgical procedure; (2) pain limited to 1 or 2 dermatomes; and (3) pain likely to be neuropathic, as defined by a DN4 score of 4 or more.Pain intensity showed rapid and continued improvement throughout the study period, and the responder rate compares favorably to previous studies of 10‐kHz SCS in other pain conditions, including the SENZA‐RCT randomized controlled trial, which reported response rates of 84.5% for back pain and 83.1% for leg pain, and other real‐world and prospective studies.To examine whether the population of patients with CPSP was indeed homogenous in pain etiology and response, the results from the entire cohort were compared to a subgroup analysis of the 10 patients with chronic postsurgical knee pain, and their reported pain scores before and after stimulation were very similar to the entire cohort. At 12 months, the responder rate in permanent implant patients (per‐protocol population) with postsurgical knee pain was 77.8%, and the remission rate was 66.7%, which was comparable to the overall rate of 62.1%, which suggests that 10‐kHz SCS is similarly effective in patients with CPSP, regardless of pain location.Treating patients with 10‐kHz SCS also avoids some of the complications associated with alternative nonpharmacologic treatment options. Dorsal root ganglion stimulation presents risks similar to those of conventional SCS, but differences in the devices themselves and the implantation techniques may contribute to greater risks for dural puncture, neurologic injury, migration, and component damage associated with the former.Secondary endpoints, including patient function, mental health, well‐being, and sleep quality, also showed significant and sustained improvement, demonstrating broad benefits from this therapy. Affective descriptors in the SF‐MPQ‐2 questionnaire were significantly reduced after stimulation, demonstrating improvements in not just pain sensation but also the emotional component of pain.It is recognized that greater patient attentiveness to pain and greater levels of catastrophizing can lead to higher pain intensity, greater emotional distress, greater levels of disability, and higher levels of healthcare use.The mechanism of action of 10‐kHz SCS was demonstrated using animal experiments, namely by primarily reducing central sensitization through modulation of inhibitory interneurons in the superficial dorsal horn.This study was designed to prospectively evaluate 10‐kHz SCS as a treatment option for CPSP, as defined by the IASP and WHO, and these results support further investigation of this treatment to address unanswered questions. Subjects in this study were selected for presenting with probable neuropathic pain using DN4 scores, but only about 30% of patients with CPSP present with neuropathic pain features, depending on the type of surgery.As an observational study, subjects were not randomized and there was no control group. The historical data presented is intended to provide context for the results and compensate somewhat for the lack of randomized controls. Moreover, the effect of selection bias was addressed by enrolling subjects in a variety of institutions, including a single‐physician practice, large multi‐physician practices, and a large research institution. Also, identical neuro‐assessments were not performed across all subjects. Although improvements in range of motion and sensation were reported, the results could not be compared between subjects since the neuro‐assessments were carried out only in the painful dermatomes in question. The study also did not collect information on opioid usage. The results need to be cautiously interpreted because sample size was small, and subjects had varied postsurgical peripheral nerve injury conditions.This is the first prospective study of 10‐kHz SCS in patients with CPSP, and the results support this therapy as a promising treatment option. The pain relief and responder rate in patients with permanent implants were comparable to 10‐kHz SCS studies in patients with chronic back and leg pain. Findings from the current study would encourage further studies into 10‐kHz SCS as a viable alternative for this unmet need in chronic pain.Dr. Gupta is on the scientific advisory board for Vertos Inc; consultant and speaker for Nevro Corp., Vertos Inc, and Foundation Fusion Solutions LLC; and received research grants from BIOTRINK, Sollis Therapeutics Inc, Allergan, Axsome Therapeutics Inc, SPR Therapeutics Inc, Nalu Medical Inc, and Vertiflex Inc. Dr. Scowcroft is a consultant for Nevro Corp. Dr. Kloster is a member of preceptorship faculty for Nuvectra, Vertos, Flowonix, and Vertiflex. Dr. Guirguis is a consultant for Boston Scientific and Avanos and received research grants from Abbott, Boston Scientific, and Neuros Medical. Dr. Carlson is a consultant for Nevro, Abbott, Saluda, Boston Scientific, Vertiflex, CornerLoc, and PillNurse. Dr. McJunkin is a consultant for Nevro Corp. and received research grants from Saluda Medical, Neuros Medical, Nevro, Abbott, and Stimgenics. Dr. Subbaroyan is employed by Nevro Corp. Drs. Chaiban and Israel have no conflicts of interest to disclose.The study was sponsored by Nevro Corp.J.S. was responsible for conception and design planning, conduct, data analysis, and interpretation. M.G., J.S., D.K., M.G., J.C., T.M., G.C., and A.I. were involved in conduct, reporting, acquisition of data, and interpretation of data. All authors reviewed and approved the final manuscript.Table S1. Inclusion criteria.Table S2. Exclusion criteria.Table S3. Location of patient pain and surgeries.Figure S1. Study design schematic.Figure S2. Subject function improved after initiation of treatment.Click here for additional data file.


To evaluate the efficacy of radiation therapy in alleviating pain and improving the quality of life (QoL) with validated questionnaires in patients with painful bone metastases (BoM).This prospective, observational study recruited 167 patients with painful BoM who were treated with palliative radiotherapy (PRT) from February 2015 to February 2018. After the first clinical assessment, the patients filled out specific questionnaires and underwent a fast radiotherapy treatment within 48 hours. The patients were followed up for eight weeks.The median age was 66.30 years. The most common primary cancer was lung cancer (31.1%). The most often prescribed scheme was 8 Gy in one fraction (70%). The patients experienced significant pain response and improved QoL compared with baseline, especially in the first two weeks after radiation. Overall, reduced pain and drug score were reported at two weeks of PRT in 68 (51.5%) and 37 (28%) of patients, respectively.PRT is an effective treatment option for patients with painful BoM. Bone metastases (BoM) are a common health issue, as the bone is the third most common metastatic site of cancer . It is tIn 1991, Bruera et al  validateThe aim of this study is to present our experience in treating and following up patients with painful BoM and to estimate the efficacy of PRT in improving QoL with validated instruments and in alleviating pain response with visual analogue scale (VAS) as well as the pain and drug scores. Finally, we aimed to assess whether a single or fractional radiation dose was better at improving QoL and relieving pain.The participants of this prospective, longitudinal, observational study were recruited among all patients with painful BoM who were referred for PRT in the radiotherapy department of Virgen de las Nieves University Hospital (HUVN) in Granada, Spain from February 2015 to February 2018. This hospital is one of the two public hospitals in the city of Granada, serving a population of over 487 000 people. The inclusion criteria were a proven histological diagnosis of a solid tumor, painful BoM of any bone site that was not previously irradiated, and age older than 18 years. The medical treatment of pain was performed in the pain care unit. Mild pain was treated with a non-steroidal anti-inflammatory drug; acetaminophen, ibuprofen, and indomethacin. Moderate to severe pain was treated with opioid therapy; with mild narcotics tramadol and codeine and strong narcotics fentanyl , methadone, and morphine.Patients with BoM were closely monitored for eight weeks, during which QoL and pain were assessed. After a clinical assessment, PRT was evaluated, and a scheme for RT delivery was outlined on a day-care basis. Following this, a pre-treatment computed tomography simulation was done, and clinical target volume and planning target volume were determined according to recommendations . The patQuality of life was evaluated with the EORTC-QLQ-C15-PAL, a validated questionnaire for QoL research in cancer patients that consists of 15 questions with answers on a four-point scale. Patients had to choose the response that best described their state, from 1  to 4 (very much). Overall QoL was rated from 1 (very poor) to 7 (excellent) . We alsoQualitative variables at each cut-off point of the follow-up are expressed as frequency and percentages. The significance of the change of the dependent variables during the follow-up was assessed with the Friedman’s non-parametric test. Survival after diagnosis was estimated with the Kaplan-Meier method. For survival analysis, the start date was considered the date when the individual was considered a palliative patient and the end date was the date of death or the end of the study (February 2018). Statistical analyses were conducted using the SPSS statistical software package, version 24.0 .The median age was 66.30 years . Ninety-nine patients (59.3%) were male. A total of 149 patients underwent out-patient treatment, and the average time from the first assessment to the first RT dose received was 2 days . Regarding PRT, 120 (71.9%) patients received single fraction therapy (SFRT), while 47 (28.1%) received multiple fraction therapy (MFRT). The most frequently prescribed scheme was 8 Gy in one fraction (70%), followed by 20 Gy in 5 fractions (15.6%). The most common site of radiation was the spine (50.9%) .P < 0.001). There was also a significant pain reduction as evaluated by VAS   received a single-fraction dose of 8 Gy, whereas one patient received 20 Gy in 5 fractions and one 15 Gy in 5 fractions . Twenty < 0.001) .Out of 132 patients evaluated at 2 weeks after PRT, 70 (53%) reported partial pain relief as assessed by VAS and 68 (51.5%) as assessed by pain score . MoreoveOur study found pain mitigation and QoL improvement after RT in patients with metastatic bone disease, especially during the first month after radiation. There was no difference between patients who received SFRT and those who received MFRT. This study is the study with the largest number of patients with BoM (167 patients) that used validated QoL instruments , as well as VAS and pain and drug scores.BoM is a common problem in patients with tumors and a major cause of disability. Our study presents clinical and evaluative research focused on patients’ outcomes. After one month, 77% of the patients were still alive. After two months, however, only 52% of the patients were still alive and participating in the study. After three years of the study, most of the patients died. The main reasons for not completing the follow-up questionnaires were drastic health deterioration or death. Data were missing for a considerable proportion of patients, most commonly the patients who left the follow-up in the middle of the study.Most of studies have shown that PRT provides pain relief for about 60% of patients in a median of two to three weeks ,26. We oPatients with BoM need a rapid pathway that provides prompt RT delivery in the most comfortable setting. In a previous study conducted in our department, the mean delay from RT unit consultation to RT initiation for BoM was 11 days . The meaAccording to Chang et al , a radiaPalliative patients are specific patients that need all the care that we can offer. They need to be free from pain and distressing symptoms and to feel supported by their health care team. Although patients with BoM generally begin the treatment early enough, a rapid pathway not only accelerates the treatment delivery and enhances the quality of medical service, but also encourages patients to opt for this treatment method.The study has some limitations, mainly the small number of patients. However, all patients were assessed on a similar basis with validated instruments. In addition, data were gathered from patients with clinical records and treatment sheets, increasing the data reliability.Our study also introduced the after-treatment use of validated questionnaires: EORTC-QLQ-C15-PAL, ESAS, VAS, and pain and drug scores. In Spain, RT as a treatment option for painful BoM has been applied for years, but there has been a lack of follow-up protocols that use validated QoL questionnaires. This study confirms the effectiveness of the protocol we have used in our center. This model not only improves the QoL and reduces pain, but also makes the work more complete, faster, smoother, and more satisfactory for the patients and working team. Therefore, we believe that our present findings can facilitate the introduction of similar models in other hospitals.