To determine the changes in each of the five dimensions of the EuroQol 5-dimension index associated with community-based physiotherapy.Four thousand one hundred and thirty-six patients that received community-based musculoskeletal physiotherapy across five NHS centres completed the EQ-5D on entry into the service and upon discharge. Patients were categorised on symptom location and response to treatment based on their EQ-5D index improving by at least 0.1 (“EQ-5D responders”). For each symptom location, and for responders and non-responders to treatment, the mean (± SD) were calculated for each dimension pre- and post-treatment as well as the size of effect.p < 0.05) in all symptom locations for EQ-5D responders (d = 0.26–1.58) and in ankle, knee, hip and lumbar symptoms for EQ-5D non-responders (d = 0.17–0.45). The self-care dimension improved (p < 0.05) in all symptom locations for EQ-5D responders (d = 0.49–1.16). The usual activities dimension improved (p < 0.05) across all symptom locations for EQ-5D responders (d = 1.00–1.75) and EQ-5D non-responders (d = 0.14–0.60). Despite the pain/discomfort dimension improving (p < 0.05) across all symptom locations for both EQ-5D responders (d = 1.07–1.43) and EQ-5D non-responders (d = 0.29–0.66), the anxiety/depression dimension improved (p < 0.05) from higher starting levels in EQ-5D responders (d = 0.76–1.05) with no change seen for EQ-5D non-responders (d = − 0.16 to 0.06).The mobility dimension improved (Clinicians should not assume that a patient presenting with pain but expressing high anxiety/depression is unlikely to respond to treatment, as they may show the best HRQoL outcomes. For patients presenting with pain/discomfort and low levels of anxiety/depression, the EQ-5D index is perhaps not a suitable tool for sole use in patient management and service evaluation. Health-related quality of life (HRQoL) outcomes are often used to evaluate healthcare interventions  and servIn musculoskeletal healthcare, EQ-5D has been used to evaluate services such as aquatic exercise therapy , posturaWhilst an overall measure of HRQoL using the EQ-5D index is useful for evaluating the effectiveness of community-based physiotherapy intervention, no studies have explored changes in the individual dimensions of EQ-5D that contribute to the EQ-5D index. By investigating how each dimension interacts over the course of physiotherapy management, and how these changes differ based on the anatomical site of pain/injury, useful information could be derived to predict outcome of physiotherapy intervention. This study aimed to determine the association between community-based physiotherapy and changes in EQ-5D dimension scores in terms of their relative contribution to improved HRQoL.Patients receiving community-based physiotherapy from one of the five National Health Service centres  between January 2012 and April 2016 were eligible to be included in the sample. All patients were registered with a general practitioner (GP). Entry to the service was via referral from their GP, or through self-referral via a telephone assessment and advice service. For those patients that could not use the self-referral service  could only enter the service through GP referral. Patients entering the service completed a pre-intervention EQ-5D. Those unable to understand the English language sufficiently to answer the questions without the need for an interpreter did not complete a pre- or post-intervention EQ-5D and were excluded from this study, due to only the English language version of the EQ-5D being licenced for use within the service. The mean new-to-review ratio across these centres within this period was 1:2.38. The patient population used in this study was the same as reported on previously [On first entry into the service, patients were categorised according to symptom location. Thirteen symptom location categories were used, including the foot, ankle, knee, hip, sacroiliac (region where the spine meets the pelvis), lumbar (lower back), thoracic (middle-upper back), neck, temporomandibular (jaw), shoulder, elbow, wrist, hand, as well as generalised pain and “other disorders not otherwise stated”. Physiotherapy-based management was subsequently provided to patients in a community setting, appropriate to their symptoms. Patients received interventions that typically included lifestyle advice, exercise therapy, manual therapy, taping, soft tissue techniques, electrotherapy and/or acupuncture. The most appropriate intervention was determined according to patient need, evidence-based practice and national and local clinical guidelines, using shared decision making. Episodes of care usually involved an initial telephone triage assessment and treatment assessment followed by face-to-face appointments, if required.The study was approved by the Northumbria University Ethics Committee as a retrospective study.The EQ-5D was administered upon first entry into the physiotherapy service and was subsequently requested from patients at discharge following the completion of treatment. Within each of the five dimensions, a patient will receive an integer score from 1 to 5, where a score of 1 indicates the best outcome  for that dimension , as those patients had their post-treatment EQ-5D within CATS which, therefore, did not make this a valid representation of community-based physiotherapy management. Sacroiliac pain, temporomandibular pain and general pain categories were removed from the dataset due to having very low patient numbers, and the other disorders not otherwise stated category was also removed as it did not pertain to any specific symptom location.d < 0.20), small (0.20 < d < 0.5), moderate (0.5 < d < 0.8) or large (d > 0.8).For each symptom location, mean (± SD) score for each of the five EQ-5D dimensions were calculated before and after treatment. Paired samples t tests were used to determine the significance of any difference between pre- and post-treatment. Cohen’s d effect sizes were also calculated for each pairwise comparison to provide an indication of the magnitude of effect between pre- and post-treatment. Cohen’s d effect sizes were calculated by the change in mean between pre- and post-treatment divided by the mean standard deviation. Effects were defined as trivial (n = 4832), 28,285 patients had a first EQ-5D recorded, of whom 5547 patients also had an end of episode EQ-5D recorded, who were included in the analysis. Those without a follow-up score  were either discharged after their telephone assessment only as a one-stop shop, or failed to return the EQ-5D score after discharge if seen face to face. Four hundred and sixty-five patients were excluded as they returned more than two EQ-5D scores, as the data management system only retaining the first and last score. Of the 5547 patients with both a pre- and post-treatment EQ-5D, a further 1275 were excluded as they did not meet the remaining inclusion criteria. Due to very small patient numbers, those with temporomandibular pain (n = 4), generalised pain (n = 4), sacroiliac pain (n = 24) and other disorders not otherwise stated were excluded. This left a final sample for analysis of 4112 patient records.Overall, 33,117 patient records were obtained. After removal of duplicates  than EQ-5D non-responders (1.89–2.44), but showed reduced post-treatment pain/discomfort (1.27–1.51) when compared to EQ-5D non-responders (1.76–2.23). Of all five dimensions, pain/discomfort has been reported as being the most frequently problematic dimension across a range of musculoskeletal conditions . The facThe anxiety/depression dimension reduced in EQ-5D responders, with large effect magnitudes in symptom locations except the shoulder (moderate effect). EQ-5D non-responders reported no change in anxiety/depression, with trivial effect magnitudes across all symptom locations. Pre-treatment anxiety/depression dimension scores were higher in EQ-5D responders than EQ-5D non-responders. Following treatment, the anxiety/depression dimension was lowest in EQ-5D responders. These data suggest that if patients present with higher levels of anxiety/depression, they are, in fact, more likely to show improved HRQoL than those who present with less anxiety/depression. This finding contradicts the findings of Bergbom et al , who obsThe anxiety/depression dimension scores at presentation for EQ-5D responders are still relatively low, so may not represent true clinical depression in most patients in a physiotherapy cohort compared to those reported in previous studies as showing poor outcome and poor adherence to treatment. The lower levels of depression in the EQ-5D non-responders could be considered as very low, though Shaw et al.  found thThe mobility dimension showed the greatest improvements in EQ-5D responders that received treatment for lower limb and low back conditions, showing large effect magnitudes. In EQ-5D responders receiving treatment at other symptom locations, only small to moderate improvements in the mobility dimension were observed. In EQ-5D non-responders, improvements with small effect magnitudes were observed for lower limb and wrist symptoms, and only trivial effects for trunk and upper limb symptom locations. Mobility is sometimes assessed using functional tests such as the 6-min walk test , which nThe self-care dimension improved in EQ-5D responders, with moderate to large effect magnitudes observed in all symptom locations except the foot . In EQ-5D non-responders, most symptom locations showed no change in the self-care dimension, and patients receiving treatment for ankle, hip and elbow symptoms reported small declines in the self-care dimension. When completing the EQ-5D outcome, patients indicate their ability to wash themselves and to get dressed . Having In EQ-5D responders, improvements in the usual activities dimension  than in EQ-5D non-responders. These data suggest that those patients presenting with increased pain/discomfort and/or anxiety/depression may have the greatest capacity for improving their overall HRQoL. It must be noted, however, that the majority of patients reported only slight to moderate pain/discomfort and either no or slight anxiety/depression. This suggests that the EQ-5D dimensions may not be sufficiently sensitive to identify improvements in HRQoL in these patients. Herdman et al.  reportedThe fact that many patients reported no pain/discomfort on the EQ-5D pain/discomfort dimension (i.e. score of 1), especially with the lack of improvement in overall HRQoL for many of those patients, raises the question as to whether it is economically appropriate for them to receive intensive physiotherapy. This would be in line with the approach of the STarT Back stratification tool for low back pain . It coulIt must be remembered that the individual EQ-5D dimensions are not validated as individual outcome measures. Multi-dimensional HRQoL measures are also not as effective as joint-specific outcomes in the evaluation of treatment outcome . The preIn conclusion, following a community-based physiotherapy intervention for musculoskeletal conditions, the pain/discomfort dimension scores improved across all patients and all symptom locations yet was not necessarily linked to improved HRQoL. Patients that showed the greatest improvement in overall EQ-5D index presented with worse pain/discomfort and/or anxiety/depression, as measured by the respective EQ-5D dimensions. Clinicians should not, therefore, assume that a patient with worse pain and anxiety/depression is unlikely to respond to treatment, as they may, in fact, show the best outcomes in terms of HRQoL. The EQ-5D index, however, is not sensitive enough for the evaluation of patient presenting with low levels of pain/discomfort and/or anxiety/depression, so is perhaps not a suitable tool for sole use in patient management and service evaluation. The findings suggest that additional validated pain and anxiety/depression outcomes could be used to compliment EQ-5D to better capture the experiences of patients and identify patients that might respond best to treatment.


When divided into 24-h periods, differences were demonstrated for the 24–48 and 48–72 h periods but not the 0–24 h period. Pain scores did not differ statistically. Conclusion: Opioid naïve obstetric patients who undergo non-emergent repeat cesarean delivery demonstrate lower opioid consumption in the postoperative period. Providers should be aware of this potential difference in order to better educate patients and provide adequate pain management. Highlights: The study reviewed differences in opioid consumption between primary and repeat cesarean deliveries. All patients received the same protocol for spinal dosage and pain management. Repeat cesarean deliveries were associated with lower opioid consumption.Background: Cesarean deliveries represent a large percentage of deliveries worldwide. Patients undergoing repeat cesarean deliveries are known to have increased risks for surgical complications. However, little is known regarding potential differences in pain. We sought to compare postoperative opioid consumption and pain scores in opioid naïve patients undergoing primary versus repeat non-emergent cesarean delivery. Methods: This was a retrospective cohort study. Patient inclusion criteria included: having a non-emergent cesarean delivery, receiving a spinal procedure for surgical anesthesia without general anesthesia, and following the same postoperative pain management protocols. Exclusion criteria included: history of opioid tolerance, illicit drug use, or prior, non-obstetric, major abdominal surgery. The primary outcome marker was total morphine equivalents consumed 0–72 h post-procedure compared between the primary versus repeat cesarean delivery groups. Secondary outcome markers were opioid consumption and pain scores in 24-h period increments for the first 72 h postoperatively. Results: 1617 patients were screened. 217 primary and 377 repeat cesarean deliveries met criteria for comparison. Reduced opioid consumption was demonstrated for the total opioid consumption 0–72 h for the repeat cesarean delivery group (median = 35) compared to the primary cesarean delivery group (median = 58),  There are 1.23 million cesarean deliveries (CD) performed in the United States each year, accounting for 32% of all deliveries ,5. LittlModern practitioners must be judicious in their opioid administration as one in 300 CD patients become chronic opioid users . A stateTo date, no study has investigated whether there are differences in acute (0–24 h) to subacute (24–72 h) postoperative pain scores and opioid consumption between primary versus repeat CD. One might suspect that repeat CD patients consume more opioids due to scar hyperalgesia, which has been associated with increased pain scores in these patients . AlternaThe methods are presented following the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) checklist methodology .This study was approved by the Loma Linda University Medical Center Institutional Review Board (IRB # 5170140) as a retrospective cohort study. The Institutional Review Board waived the requirement for written informed consent given the retrospective chart review study design. The cohort included all obstetric patients who underwent non-emergent CD between 2015 and 2017 at a tertiary academic hospital in the United States and received the same intraoperative anesthesia and postoperative pain management. Intrapartum CD were also included in the study. Postoperatively, all patients during the study period received a protocolized pain management strategy. Within 1 h post-surgery all patients were prescribed acetaminophen 1000 milligrams (mg) intravenously (IV) × 1, Toradol 30 mg IV × 1, fentanyl 25 micrograms mcg IV q5 min as needed, “pro re nata" (PRN), and Dilaudid 0.2 mg IV q15 min PRN. Subsequently patients were prescribed acetaminophen 650 mg per os (PO) every 6 h (q6h) scheduled, Toradol 30 mg IV q6h or ibuprofen 600 mg PO q6h scheduled, and oxycodone immediate release 5 mg PO q6h PRN. Scheduled opioids were provided after patient request and the reported failure of PRN dosage. All patients could refuse scheduled pain medication and PRN medications were provided after patient request. Spinal dosage and postoperative pain management protocols were developed from a multidisciplinary committee approval. Subject inclusion criteria were as follows: (1) 18–60 years of age; (2) (ASA) II; (3) underwent primary or repeat CD at study institution; (4) and received a spinal for surgical anesthesia using the following intrathecal medications: 0.15 mg morphine, 20 mcg fentanyl, and 13.5 +/− 1.5 mg hyperbaric bupivacaine; (5) opioid naïve before the CD. Opioid naïve was defined as recommended by the US Food and Drug Administration (FDA) definition as patients who do not meet the below definition of opioid tolerant, and who have not taken opioid doses at least as much as those listed for opioid tolerance for one week or longer. Exclusion criteria were: (1) ASA >2; (2) opioid allergy; (3) taking any home medication of opioid antagonist or opioid agonist/antagonist within the past two years; (4) history of pain disorder or substance abuse; (5) previous history of major abdominal surgery; (6) emergent procedure; or (7) opioid tolerant. Opioid tolerance was defined as recommended by the US Food and Drug Administration (FDA) definition as patients who are taking, for one week or longer, at least: 60 mg oral morphine/day, 25 µg mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of any other opioid . PatientAll variables were regarded as independent and included morphine equivalents and pain scores. Opioids administered for each patient 0–72 h post-procedure were noted and then converted to morphine equivalence as per a previously validated equivalency calculator . Totals All information was collected from the review of the electronic medical record . The entirety of the patient’s health record is stored on this platform at the study institution, including clinical notes, diagnostic studies, vital signs, and all patient assessment notes).All data were reviewed and confirmed by two research personnel at different time points to improve accuracy.Based on our institution’s historical distribution of primary to repeat CD, we determined a ratio of repeat to primary of 1.75. This ratio was applied for our power analysis. A significant difference for our primary outcome marker was set, a priori, at 10 mg of morphine equivalents opioid consumption over 72 h. Support for this threshold was based on previous data demonstrating a statistical difference between comparisons within a range of 7 mg to 16 mg . With thThe primary outcome marker was a comparison of total morphine equivalents consumed 0–72 h post-procedure between the primary versus repeat CD groups. Secondary outcome markers were opioid consumption in 24-h period increments and pain scores in 24-h period increments for the first 72 h postoperatively between primary versus repeat CD. Continuous variables were summarized using both median and interquartile range. The Mann–Whitney test was used for comparisons between continuous variables. A Chi-Squared test was used to analyze count data. All analyses were performed with R. . A spearman rank correlation was performed to evaluate the association between opioid consumption and pain scores.Between the period of August 2015 and May 2017, we screened 1617 patients with 594 patients meeting inclusion/exclusion criteria. Full details regarding patient enrollment are reported in the Consolidated Standards of Reporting Trials diagram . There wp < 0.005). Additionally, opioid consumption was also significantly reduced at the 24–48 and 48–72 h periods in repeat CD compared to primary CD (p < 0.005)  . A revie< 0.005) . The maj< 0.005) . Of note< 0.005) . FinallyThis study demonstrated a reduction in opioid consumption between patients undergoing repeat versus primary non-emergent CD without showing a difference in postoperative pain scores. These findings are of interest given the high rate of patients undergoing repeat CD procedures. Currently, repeat CD is regarded differently than primary CD in terms of surgical risk but often not regarding postoperative pain management. These findings suggest that postoperative pain management could be regarded differently for patients undergoing repeat CD versus primary CD. The development of pain post-CD is widely variable. Multiple factors have been associated with this development including higher body mass index, longer operative time, general anesthesia vs. spinal, age, marital status, hospital stay, and age . This prIndeed, the use of analgesic therapies for the post-CD patient is complex. Additionally, the postpartum period is a known period of anxiety for the mother. Studies have demonstrated anxiety to significantly contribute to increasing pain sensation in women for both non-obstetrical ,18 and CThis study has several limitations. First, the retrospective study design prevents the standardization of several data points, such as pain score assessment or patient providers. Also, we were not able to differentiate opioids that were ordered per the PRN protocol vs. those provided in a scheduled manner after physician evaluation. Additionally, the comparison groups consisted of different patients and the possibilities of confounders do exist. While this study included only non-emergent, ASA I-II, opioid naïve, CD patients, other confounders are possible. Specifically, the race of the study patients was not captured. For reference, review of our census for labor and delivery admissions for the study time-period demonstrates the following: White Non-Hispanic—46%, Black Non-Hispanic—5.2%, Hispanic—37.5%, Asian and Pacific Is—7%, Other—4.2%. Similarly, there may be a bias in that if a patient experienced significant postoperative pain after their primary CD they may opt out of a repeat CD at the study institution or undergo a trial of labor after CD instead. Importantly, no repeat CD patient was included in the study if they received the primary CD during the study period. Finally, while the study period was targeted such that the spinal dose and postoperative pain orders were standardized, further comparison regarding intraoperative management including providers was not evaluated. It is the authors’ hope that our findings support future prospective studies that account for these confounding variables. This retrospective study demonstrated an association with opioid naïve obstetric patients undergoing non-emergent repeat CD to have lower opioid consumption in comparison to similar patients undergoing primary CD. This information could help providers better educate patients and manage postoperative pain optimally without overprescribing opioids.


Introduction: The diagnosis of sleep bruxism is challenging due to the difficulties involved. Sleep bruxism can lead to clinical consequences, including pain in masticatory muscles, limitation of jaw mobility, headache, and the spectrum of symptoms associated with damage to the teeth and oral mucosa. Currently, only video-polysomnography can definitely diagnose sleep bruxism. Due to the risk of painful temporomandibular disorders (TMD) in sleep bruxers, early diagnosis of pain in the temporomandibular region using questionnaires is recommended. Therefore, this study aimed to assess the relationship between the intensity of sleep bruxism and the occurrence of pain related to TMD.Materials and Methods: This study was conducted on the patients of the Clinic of Prosthetic Dentistry operating at the Department of Prosthetic Dentistry at the Wroclaw Medical University. Based on a positive medical history, a thorough examination for the diagnosis of probable sleep bruxism was carried out in the enrolled patients. Eligible patients were then subjected to a video-polysomnographic study. Each patient was asked to complete the TMD Pain Screener questionnaire to assess the occurrence of pain in jaw and temple area.Results: The results of the study showed that increased bruxism episode index (BEI) was statistically significantly correlated with increase of all types of bruxism episodes—phasic, tonic, and mixed—in all the studied patients; a significant correlation was also found with respect to division of patients into studied and control groups. The study also showed that there was no statistically significant difference between BEI values and scores of TMD Pain Screener. In all the studied patients, a higher BEI was not found to be correlated with the occurrence of TMD-related pain assessed by TMD Pain Screener; similarly, no correlation was found with respect to division of patients into studied and control groups.Conclusions: The occurrence of TMD-related pain is not related to the intensity of sleep bruxism. TMD Pain Screener may be used as an auxiliary tool in the diagnosis or risk of occurrence of TMD-related pain, whereas in the case of sleep bruxism, it has only limited diagnostic value.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03083405 Bruxism is a common phenomenon, and is estimated to occur in 8−31% of the population without division into subtypes and without significant variation in relation to gender . The occThe origin of bruxism is multifactorial –3. It isThe widely accepted definition of bruxism was created in 2013 in an international consensus  and the Due to the difficulties involved, diagnosis of SB is challenging. SB can lead to clinical consequences, including pain in the masticatory muscles, limitation of jaw mobility, orofacial pain, headache in the temporal region, and the spectrum of symptoms associated with damage to the teeth and oral mucosa. Currently, only video-polysomnography can efficiently diagnose SB. According to the guidelines of the International Classification of Diseases-10-Clinical Modification (ICD-10-CM), during sleep, repeated contractions of the masticatory muscles occur in patients with SB are called as a rhythmic masticatory muscle activity .Due to the risk of pain related to temporomandibular disorders (TMD) in sleep bruxers, early diagnosis of pain in the temple and jaw area using questionnaires is recommended. One of the questionnaires used for diagnosis is TMD Pain Screener . This stThe study population consisted of patients of the Prosthetic Dentistry Clinic operating at the Department of Prosthetic Dentistry at the Wroclaw Medical University. Based on a positive medical history and thorough examination following the guidelines of the ICD-10-CM of the American Academy of Sleep Medicine, probable SB was diagnosed in the patients.This study was approved by the Ethical Committee of the Wroclaw Medical University (ID KB-195/2017). Written informed consent was obtained from all the participants of this study.The selection of patients for video-polysomnography was based on a medical interview with particular emphasis on the presence of severe systemic diseases and psychoemotional disorders, physical examination for the presence of TMD, and interview and physical examination for the presence of sleep disorders with particular emphasis on grinding of teeth at night and, if possible, confirmed by partner. In addition, each patient was subjected to physical extra- and intraoral examination for an accurate assessment of the condition of teeth and oral mucosa in terms of symptoms indicating the presence of bruxism and with the use of Tooth Wear Index developed by Smith and Knight. After verification of the identified symptoms in accordance with the guidelines of ICD-10-CM, the diagnosis of bruxism was carried out.Criteria for inclusion of a patient for further examination were as follows: age above 18 years, lack of severe systemic (including genetic) diseases, lack of severe mental illness and significant mental (including genetic) disabilities, positive diagnosis of SB based on the criteria of ICD-10-CM, lack of contraindications for polysomnographic examination, and consent to participate in the study.The exclusion criteria except inverse to inclusion included: the presence of SB caused by a diagnosed disorder or as a side effect to intake of a drug or medication; use of medicines that significantly affect the function of the nervous and muscular systems.A one-night polysomnographic examination with video recording was carried out in each of the included patients using Nox A1  in the Sleep Laboratory at the Wroclaw Medical University. Examination took place between 10.00 p.m. and 6.00 a.m., taking into account the preferences and sleeping habits of the patient. Before the tests, the electrodes were arranged in a standard manner as recommended by the manufacturer. A modification relative to the standard distribution of electrodes included placing only bipolar leads for electromyographic recording from the masseter muscles. In agreement with the manufacturer's recommendations, a modification was made by placing the electromyographic electrodes on both sides of the origin and insertion of masseter muscles.Each of the polysomnography examinations included electroencephalography, electrocardiography, electrooculography, and electromyography from the chin area and bilaterally from the regions of the masseter muscles, motion recording of abdominal and thoracic breathing activity, assessment of body position, as well as audio and video recording. An additional recording tool, NONIN WristOx2 3150 pulse oximeter , was used which enabled the recording of the level of saturation, pulse, and plethysmographic data. The restoration of the full polysomnographic record was possible, thanks to the device Noxturnal developed for sleep recording and analysis .Bruxism was assessed according to the ICD-10-CM guidelines based on the electromyographic recording of masseter muscles and audio and video recordings. Episodes of rhythmic activity of masseter muscles, which were often accompanied by grinding sounds and characteristic movements in the orofacial region occurring after a minimum of 3 s break from the last muscle activity, were qualified as episodes of bruxism. Based on the types of contractions, episodes were classified as phasic (lasting 0.25–2 s), tonic (lasting more than 2 s), or mixed .The participants were divided into study group (bruxers—bruxism episode index (BEI) ≥ 2) and control group (non-bruxers—BEI < 2) according to the BEI .https://ubwp.buffalo.edu/rdc-tmdinternationa). It allows an easy assessment of the occurrence of pain in the temporomandibular area in patients over the last month. The survey consists of three questions. Questions 1, 2, and 3a are called as “short screener,” while questions 3b−3d are called as “long screener”. Answers are scored as follows: “a”−0 point, “b”−1 point, and “c”−2 points. The maximum number of points given for a “short screener” is 4, while for a “long screener” it is 7. The questionnaire also allows screening of pain associated with TMD.Each of the qualified participants was asked to fill in TMD Pain Screener. This questionnaire has been validated by the International Network for Orofacial Pain and Related Disorders Methodology . Selected elements of the database were then subjected to statistical analysis.p < 0.05 were considered statistically significant. The shapes of the data distributions and deviations from the shape of the normal distribution were analyzed with the Shapiro–Wilk test.A statistical analysis of the obtained data was carried out using the statistic program Statistica 13.1 . The level of statistical significance was assumed at α = 0.05, i.e., the results of statistical tests that appeared with a probability of The following principle was adopted in the analyses: first, the use of parametric methods was preferred. If the data did not meet the assumptions of the parametric methods , they were further transformed. If the data met the assumptions after the transformation, parametric methods were used for the analyses. If the data still did not meet the assumptions after the transformation, non-parametric methods were used for the analyses, and the analyses were performed on the original (untransformed) data.t-test for unrelated samples. This test verifies the hypothesis that there are no differences between means in the compared groups.In additional analyses, the determined BEI was divided into two groups: BEI value up to 2 (“ <2”) and BEI value of 2 and above (“2+”), corresponding to the control and test group, respectively. The preferred analytical approach for the study of differences between the groups was Student's t-test are as follows:distributions of data in the compared populations are normal, andin both the compared populations, there is the same variance (variances are homogeneous).The assumptions of Student's U test was used to analyze the differences between groups. This test is a non-parametric equivalent of the Student's t-test and verifies the hypothesis that the medians in both the compared groups are not equal or, in other words, that two randomly selected samples come from the same population. For some comparisons, the size of groups differed from the size of the starting study and control group due to incorrect or incomplete filling of the questionnaires by the patients.If the assumption regarding homogeneity of variance was not met, the analysis of significance of differences between means in both the groups was carried out using Cochran–Cox test. In the case of a significant breach of the assumption about the normality of the data distribution, the Mann–Whitney There were 77 patients included in the study (56 women and 21 men). All the patients subjected to polysomnography were Caucasians, aged 18–63 (mean age 34.8 ± 10.8). Of the 77 patients, 58 were included in the studied group and 17 in the control group.W = 0.8745, p < 0.0001). Therefore, the BEI values were subjected to a logarithmic transformation, after which the data distribution was not found to differ significantly from the normal distribution . Similarly, the distribution of data of phase contraction differed statistically significantly from the normal distribution . However, even after applying the logarithmic transformation, the data distribution was found to deviate from the normal distribution .The distribution of BEI data deviated from the normal distribution (rs(77) = 0.79, p < 0.00001]. The increase in BEI was accompanied by an increase in the number of phasic episodes . Similarly, the distribution of data of phasic episodes in the “BEI 2+” group differed statistically significantly from the normal distribution .The distribution of data of phasic episodes in the “BEI < 2” group deviated from the normal distribution , and the number of phasic episodes was statistically significantly higher in the “BEI 2+” group . Therefore, the BEI values were subjected to a logarithmic transformation, after which the data distribution was not found to differ significantly from the normal distribution . Similarly, the distribution of data of tonic episodes differed statistically significantly from the normal distribution . However, even after applying the logarithmic transformation, the data distribution was found to deviate from the normal distribution .The distribution of BEI data deviated from the normal distribution (rs(77) = 0.81, p < 0.00001]. The increase in BEI was accompanied by an increase in the number of tonic episodes . Similarly, the distribution of data of tonic episodes in the “BEI 2+” group differed statistically significantly from the normal distribution .The distribution of data of tonic episodes in the “BEI < 2” group deviated from the normal distribution , and the number of tonic episodes was statistically significantly higher in the “BEI 2+” group . Therefore, the BEI values were subjected to a logarithmic transformation, after which the data distribution was not found to differ significantly from the normal distribution . Similarly, the distribution of data of mixed episodes differed statistically significantly from the normal distribution . However, even after applying the logarithmic transformation, the data distribution was found to deviate from the normal distribution .The distribution of BEI data deviated from the normal distribution (rs(77) = 0.77, p < 0.00001]. The increase in BEI was accompanied by an increase in the number of mixed episodes . Similarly, the distribution of data of mixed episodes in the “BEI 2+” group differed statistically significantly from the normal distribution .The distribution of data of mixed episodes in the “BEI < 2” group deviated from the normal distribution , and the number of mixed episodes was statistically significantly higher in the “BEI 2+” group . Therefore, the BEI values were subjected to a logarithmic transformation, after which the data distribution was not found to differ significantly from the normal distribution .The distribution of BEI data deviated from the normal distribution . Therefore, the data of TMD Pain Screener were subjected to a second-degree power transformation. Due to the fact that the raw data of TMD Pain Screener contained 0 values, each value was increased by a fixed value 10 before the data were raised to power. However, even after applying the transformation, the data distribution was found to significantly deviate from the normal distribution . The non-parametric Spearman rank correlation test was used to analyze the strength and significance of the BEI and the scores of TMD Pain Screener. The analysis showed no significant relationship between BEI and TMD Pain Screener  . In contrast, the distribution of data of TMD Pain Screener in the “BEI 2+” group differed statistically significantly from the normal distribution . Due to the violation of the assumption about the normality of the data distribution in the “BEI 2+” group, the Mann–Whitney U test was used for analysis. The analysis showed that both the groups did not differ significantly in terms of the results of TMD Pain Screener   .Presented study showed that increase in BEI is associated with increased number of all types of muscle contractions. The number of phasic, tonic and mixed episodes was statistically significantly higher in bruxers than non-bruxers. Authors used TMD Pain Screener to assess the relationship between the intensity of SB and occurrence of pain related to TMD. Analysis showed no statistically significant relationship between intensity of SB and TMD Pain Screener scores taking into account all studied material and when dividing it into studied and control group. Summarizing, study showed that intensity of bruxism is associated to muscle activity, but not to pain related to TMD.Bruxism during sleep is inextricably linked to the function of the masticatory muscles in two ways: it is caused by the increased activity of muscles, or it acts as a possible important risk factor for the occurrence and severity of pain related to TMD, the essential component of which are the disorders of muscle origin. The consequences of bruxism during sleep related to muscle pain are very common and sometimes severe –3, 13–16Lobbezoo et al. indicate that the possible negative clinical implications of bruxism are often related to the type of electromyographic activity, and not the number of episodes . Other aIn the present study, the authors verified the activity of masticatory muscles during sleep both quantitatively and qualitatively. BEI was used in the quantitative assessment, and the classification of episodes as phasic, tonic, and mixed was applied in qualitative assessment. The analysis showed that the increase of BEI was statistically significantly correlated with increase in the number of all types of electromyographic pathways, and thus, the types of episodes. This result suggests that increase in specific type of muscle activity could be associated with more frequent conditions contributing to pain related to TMD.Many scientific teams have investigated the relationship between the comorbidity of TMD and bruxism. Blanco Aguilera et al. attempted to determine the correlation between SB and pain in temporomandibular region based on the sensitivity, age, and gender of patients and clinical subtypes of TMD. They reported that the occurrence of bruxism during sleep correlated positively with age below 60, female sex, more intensification of pain symptoms, and muscular as well as articular TMD. The study supports the hypothesis of bruxism as a risk factor for more frequent TMD. However, the study does not indicate a more frequent occurrence of the muscular disorders than the articular disorders . In a clIn the present work, to examine the relationship between the intensity of SB and the occurrence of pain caused by TMD, TMD Pain Screener, a questionnaire validated by the International Network for Orofacial Pain and Related Disorders Methodology, was used . TMD PaiBerger et al. conducted a study analyzing the association between TMD-related pain and specific diagnoses of bruxism, both based on questionnaires. Patients were asked to fill an anonymous questionnaire, consisting of three questions, to verify the presence of TMD-related pain and the two forms of bruxism. In this study, the authors also showed that there was no statistically significant association between SB and TMD-related pain . A majorThe limitation of the study was lack of adaptive night and providing only one-night polysomnography. The study was conducted in such way due to the lack of foundation of the adaptive night by the Polish National Health Service.The occurrence of TMD-related pain is not related to the intensity of SB. TMD Pain Screener may be used as an auxiliary tool in the diagnosis or risk of occurrence of pain related to TMD, whereas in the case of SB, it has only limited diagnostic value.JS analyzed the data and wrote the manuscript. HM and MW created the research concept, edited the manuscript, and finally revised it before submission. MM-Z recruited patients for the study and collected data. AW collected the references. GM and EW finally revised the manuscript before submission. All authors read and approved the final manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


IntroductionThe optimal surgical treatment of isolated lumbar foraminal stenosis has not been defined. Minimally invasive decompression of the foramen from a far lateral tubular decompression (FLTD) approach has been shown to not only have minimal morbidity but also highly variable success rates at short-term follow-up. It is important to quantify improvement and define the demographic and radiographic parameters that predict failure in this promising, minimally invasive surgical technique. This study investigates pain and disability score improvement following FLTD at 12 and 24 months and investigates associations with failure.MethodsAll patients who underwent lumbar FLTD by a single surgeon at a single institution from September 2015 to January 2018 were included in this prospective case series. Visual analog scale (VAS) for back pain and leg pain and Oswestry Disability Index (ODI) were collected preoperatively and at the 12- and 24- month follow-ups. Outcomes between visits were fitted to a linear mixed-effects model. The univariate analysis investigated demographic, radiographic, and operative associations with subsequent open revision.ResultsA total of 42 patients were included in this study. Back pain , leg pain , and ODI  demonstrated significant improvements at the 12-month follow-up. Back pain , leg pain , and ODI  improvements were maintained at 24-month follow-up. Four patients (9.5%) required subsequent open revision. Subsequent open revision was associated with prior spine surgery (RR=2.85 (2.07-3.63), p=0.045) and scoliosis ≥10° (RR=6.33 (4.87-7.80), p=0.013).ConclusionBack pain, leg pain, and ODI showed significant improvement postoperatively. Improvement is maintained at two years. Prior spine surgery and scoliosis ≥ 10° may be relative contraindications to FLTD. Foraminal stenosis causing radicular leg pain affects 8%-11% of lumbar spinal stenosis patients . The optThe purpose of this study was to investigate one- and two-year outcomes following far lateral tubular decompressions (FLTD) of the lumbar neuroforamen, as well as the patient and surgical factors associated with failure. We hypothesized that patients undergoing FLTD would demonstrate a significant improvement from presurgery to the 12-month follow-up and maintain the improvement at the 24-month follow-up.This study was conducted at a single academic medical center with prospective data collection beginning in September 2015. Outcomes were collected at 12-month intervals as the standard of care. All aspects of the study were approved by the institutional review board. Consecutive patients with symptomatic degenerative lumbar foraminal stenosis who underwent FLTD by the senior author were included in this study.Patient selectionInclusion criteria for this study were patients ≥18 years of age with symptomatic foraminal stenosis who underwent elective microdecompression of the lumbar spine. Patient selection for surgery was based on the preoperative evaluation by the senior author and the persistence of neurologic deficits after at least 90 days of conservative non-operative treatment . Selection criteria included the absence of a lytic spondylolisthesis at the affected level. Degenerative spondylolisthesis was not a contraindication to this approach. Magnetic resonance imaging (MRI) selection criteria included radicular symptoms that anatomically correlated with MRI evidence of nerve root compression in the foramen. The foramen size was not measured; instead, the nerve root was visualized on axial and sagittal T2 imaging throughout its course: If the root itself was compressed in the mid-zone or exit zone of the neuroforamen, the pathoanatomy was deemed amenable to far-lateral decompression. If significant lateral recess stenosis also involved this nerve root, patients were treated with a dual surgical approach: a tubular decompression laminotomy of the lateral recess combined with the far lateral approach.Surgical techniqueThe surgical approach used was slightly different than the previously published techniques in that oblique fluoroscopy was used to approach the neuroforamen from a more lateral approach, sometimes up to 9 cm off midline ,8. This Data collectionVisual analog scale (VAS) for back and leg pain and Oswestry Disability Index (ODI) were collected preoperatively and at 12-month intervals as the standard of care for all patients undergoing lumbar nerve decompression. Baseline scores were collected during preoperative office visits. Postoperative outcomes were either collected during follow-up office visits or via a standardized telephone script.ODI is a composite score of the responses to 10 independent questions . In casePatient demographics  and operative details were retrieved from the institutional electronic medical records. The operative time reported is the operative time per level; i.e. two-level decompression operative times were reduced by a factor of two. Spondylolisthesis, scoliosis, coronal wedge angle, and segmental lordosis angle measures from preoperative standing lumbar spine X-rays were assessed by a single reviewer. The coronal disc wedge angle of the operated segment was recorded as per the method used by Haimoto: “coronal angle between the line parallel to the lower endplate of the superior vertebra and the line parallel to the upper endplate of inferior vertebra” . A positStatistical methodsAll computations and statistical analyses were performed in R . A linear mixed-effects model was fitted to outcomes and preoperative scores, controlling for differences between patients. Pairwise differences were investigated with a post-hoc Tukey test for multiple comparisons. This methodology allowed for an investigation of whether pain and disability scores demonstrated improvement from pre-surgery to 12-month follow-up, whether the improvement was maintained at 24-month follow-up, and whether there was any deterioration between 12-month and 24-month follow-up. A p-value of 0.05 was considered significant for outcomes improvement.Patient demographic, radiographic, and operative factors were compared between those who did and did not require subsequent open revision. These comparisons were quantified with a Mann-Whitney U test for continuous variables and with Pearson’s Chi-Square Test for categorical variables.A total of 42 consecutive patients who underwent FLTD were included in the study. Given the prospective nature of the data collection, 28 patients were eligible for two-year outcomes inclusion and 14 patients were eligible for only one-year outcomes inclusion. Four patients (9.5%) underwent multi-level FLTD. Eight patients (19.0%) had simultaneous discectomy. Two patients (4.8%) required a dual surgical approach  to address lateral recess stenosis. A summary of patient characteristics is presented in Table Back pain , leg pain , and ODI  demonstrated statistically significant improvements at the 12-month follow-up. Back pain , leg pain , and ODI  improvements were maintained at 24 months. No outcomes deteriorated between the 12-month and the 24-month follow-up  required subsequent open revision decompression and fusion. These four patients underwent isolated FLTD during the first year of the study investigation, with dates of surgery ranging from December 2015 to May 2016. No patients since then have required subsequent open revision. The subsequent open revisions were performed at a median of 9.5 months after index microdecompression (range two months - 24 months). Three of the four patients had complex spine pathologies (i.e. occult pars fracture) and a history of prior spine surgery . The fourth patient had 15° of lumbar spine scoliosis and required a multi-level decompression.Six patients (17.6%) required a subsequent minimally invasive procedure after isolated FLTD. These cases were not considered failures, as patients acknowledged and accepted that this may be warranted. Moreover, these patients generally experienced initial relief, with symptoms recurring months or even years later. Subsequent microdecompression was performed at a median of 17 months after index microdecompression (range seven months - 24 months). Three of the six patients exhibited pathology recurring at the same level and side but inside the canal at the lateral recess rather than outside the foramen. One patient was an elderly patient with multiple prior surgeries who did not improve clinically. The remaining two patients developed pathological problems at a level different than that of their initial presentation.Subsequent open revision was associated with prior spine surgery (RR=2.85 2.07-3.63), p=0.045) and scoliosis ≥10° (RR=6.33 (4.87-7.80), p=0.013; Table .63, p=0.The present study highlights both the benefits and challenges of utilizing FLTD, a minimally invasive, same-day surgery to treat symptomatic degenerative lumbar foraminal stenosis. Significant reductions in back pain, leg pain, and ODI were demonstrated postoperatively and maintained at two years. The current literature defining minimum clinically important differences  suggests that the improvement observed in this study is not only statistically significant but also clinically significant . PatientNumerous studies have described paramedian or far-lateral decompression techniques with varying results -8. Kim eFrom a clinical standpoint, foraminal stenosis remains a challenging problem to address, particularly utilizing minimally invasive techniques. Continued movement of the segment with disc bulging and facet hypertrophy may well contribute to the recurrence of symptoms. In a registry study of MIS transforaminal decompressions by Sclafani et al., the authors reported a revision rate of 2% for those undergoing discectomy and 28% for those undergoing decompression from bony foraminal stenosis . FurtherThe statistical significance of the VAS and ODI score improvements is likely reflective of a clinical significance, with the ODI minimum clinically important difference estimated to range between 2.92 to 15.36, depending on the calculation method . Chung eThis case series is limited by the small sample size. Large database studies aside, this is characteristic of studies investigating minimally invasive decompressions. A control group was not included for analysis. Ideally, a non-surgical group would serve as a control, however, this has the potential to compromise patient care and may introduce selection bias to the study. As such, this study aimed to describe outcomes at one-year and two-year follow-up rather than to demonstrate superiority to non-operative management or other surgical techniques. Furthermore, all procedures were performed by a single surgeon; however, we believe the technique is reproducible, and that this limitation does not affect the generalizability of the results. A strength of this study is the prospective nature of the data collection, which allows for the identification of predictors of failure using a novel technique.In patients with symptomatic degenerative lumbar foraminal stenosis who underwent FLTD of the lumbar neuroforamen, back pain, leg pain, and disability scores showed consistent improvement at two years. Based on our reported outcomes and complications, prior spine surgery and scoliosis ≥ 10° may be considered relative contraindications to this technique. Continued outcomes collection at five years postoperatively will better describe the long-term outcomes of this approach.


Functional tests are widely used to measure performance in patients with chronic musculoskeletal pain. Our objective was to determine the Minimal Clinically Important Differences (MCID) for the 6-min walk test (6MWT), the Steep Ramp Test (SRT), the 1-min stair climbing test (1MSCT), the sit-to-stand test (STS), the Jamar dynamometer test (JAM) and the lumbar Progressive Isoinertial Lifting Evaluation (PILE) in chronic musculoskeletal pain patients.A single-center prospective observational study was conducted in a rehabilitation center. Patients with upper-limb, lower-limb or neck/back lesions were included over a period of 21 months. We used the anchor-based method as a reference method, supplemented by the distribution-based and opinion-based approaches, to determine the MCIDs.838 chronic musculoskeletal pain patients were included. The estimation method and thelesion location had a significant influence on the results. MCIDs were estimated at +75m and +60m for the 6MWT , +18 steps for the 1MSCT (lower-limb and neck/back lesions) and +6kg for the JAM (upper limb lesions). The anchor-based method could not provide valid estimations for the three other scales, but distribution and opinion-based methods provided rough values of MCIDs for the SRT (+39w to +61w), the STS (-5 sec to -7 sec) and the PILE (+4kg to +7kg).The above MCID estimations for the 6MWT, 1MSCT and JAM can be used in chronic musculoskeletal pain patients participating in vocational multidisciplinary rehabilitation programs or in therapeutic trials. The use of specific anchors might give better estimations of MCIDs for the three other scales in future research. The prevalence of chronic (more than 3 months) musculoskeletal pain is higher than 20% in industrial countries . It contIn clinical research, small improvements in patient-reported outcomes may be statistically significant, but clinically irrelevant. The concept of “Minimal Clinically Important Difference” (MCID) was introduced by Jaesche et al. in 1989 to study the clinical importance of such improvements . The MCIThree general approaches are currently used to determine the MCID of a clinical scale : anchor-- In the anchor-based method, the change in the outcome measure is compared with a subjective anchor variable completed by the patient. For example, patients are asked to rate their perceived global evolution from before to after the treatment with a 7-level Global Rating of Change (GRC) from − 3: “much worse”, to + 3: “much better” [ better” . The bin better” . Additio better” , 19. Oth better” . For thi- In the distribution method, the change in the outcome score is compared with a measure of variability. For example, the Standard Error of Measurement (SEM) is the score’s variation due to unreliability. The distribution method is useful to evaluate in cases where the anchor technic is inappropriate or produces lower MCID values. The MCID should be at least equal to the SEM [ the SEM .- The opinion-based approach consists in gathering opinions of experts (or patients), using an iterative consensus approach like the Delphi method (see an example in [ample in ).Our main objective was to determine MCIDs for the 6MWT, PILE, SRT, 1MSCT, STS and JAM in chronic musculoskeletal pain patients presenting with upper-limb, lower-limb and neck/back lesions and undergoing a multidisciplinary functional rehabilitation program. A secondary objective was to compare MCIDs using the opinion-based methods with those obtained using the reference Anchor-based and the distribution-based approaches.A single-center prospective study was conducted in a 140-bed rehab center in the French-speaking part of Switzerland. All rehab inpatients of working age (18–65) and admitted for chronic musculoskeletal pain between May 2014 and January 2016 after an acute orthopedic injury of neck/back, upper limb or lower limb were considered for inclusion.Inclusion criteria were as follows: French-speaking working-age patients, able to understand and sign the study informed consent form, able to answer the questionnaires used in the study, suffering from chronic musculoskeletal pain (at least 3 months). Patients were excluded from the study if they met any of the following criteria: under legal custody (whatever the reason), more than one of the three defined lesion locations, severe traumatic brain injury at the time of the accident if any , spinal cord injury, injury severity graded ≥3 according to the Abbreviated Injury Scale  . The stuDuring their stay in the rehabilitation clinic, all patients received four to six therapy sessions a day, 5 days a week for 4–5 weeks. Sessions included physiotherapy , physical reconditioning , occupational therapy, vocational therapy and cognitive-behavioral therapies.The following functional tests are part of the systematic assessment made at intake and discharge in our rehab center. They all are easy to administer and have good psychometric properties.- The 6MWT measures the distance an individual is able to walk as quickly as possible in a total of six minutes on a flat surface [ surface .- The SRT is an incremental graded exercise test on a cycloergometer (70–80 rpm), were the load increases by 25 watts every 10 s until the patient’s exhaustion. The test ends when the pedal frequency falls under 60 rpm [- The 1MSCT: The patient is invited to walk up and down stairs (one step at a time) for 1 min, the score being the total number of steps climbed [ climbed .- The STS: The patient sits in a chair with his back against the back of the chair, and is asked to stand up straight as quickly as possible five times, without stopping in between. The score is the time required to complete the test [the test .- The Jamar Handgrip Dynamometer measures the maximum isometric grip strength. The dynamometer is set to the second handle position and the test is performed three times with both hands; the score is the average of the six measurements in kg [ts in kg .- The lumbar PILE involves lifting weights placed in a box from the floor to waist height (0-76 cm), four times in 20 s. The weight is increased incrementally by 2.5 kg/5 kg (women/men), starting with 5 kg/7.5 kg (women/men). The test is terminated (1) by the subjects themselves ; (2) by the examiner if the subject’s heart rate reaches 85% of the age-determined maximum heart rate; or (3) when the subject reaches the limit of 55 to 60% of his body weight [y weight .Patients with neck/back and lower-limb lesions performed the 6MWT, SRT, 1MSCT and STS, patients with upper-limb lesions performed the JAM, and all of the patients performed the PILE.All functional tests were performed at admission and at discharge (length of stay 31 ± 10 days).General and sociodemographic variables , pain location , Abbreviated Injury Scale, the Brief Pain Inventory , the HosThe 7-level (GRC) from − 3: “much worse”, to + 3: “much better”. All patients were specifically asked to answer the GRC with respect to the injury they were hospitalized for.Data at entry were collected before starting the therapeutic program. Records were collected electronically with a digital pen. Functional tests were done under the supervision of highly experienced physiotherapists, familiar with the tests through clear instructions and with chronic pain through regular training: 73% of our physiotherapists have received specific training in chronic pain management; regular complementary training seminars are organized at the clinic (at least twice a year) in addition to weekly multidisciplinary meetings in each hospitalization unit.In addition to the ROC reference technique, we calculated the SEM in cases where the ROC was not conclusive. The Delphi process was also used to fulfill the secondary objective.Evidence supports the use of a 7 to 11-point numerical scale  and the The SEM was calculated as the square root of the mean square error term from a repeated-measure ANOVA (intake and discharge), which has the advantage of not being influenced by systematic error , compared to other methods that rely on the Intraclass Correlation Coefficient . Since aThe Delphi process was conducted with 19 experts . Three rounds were organized: (1) gathering MCID values of each expert for the 6 scales; (2) 2nd estimation, knowing the 1st round anonymous results ; (3) 3rd estimation, knowing the 2nd round anonymous results and the arguments given by experts who gave the lowest and highest values for each scale.In the anchor-based and the distribution-based methods, different estimations of the MCID were made separately for upper-limb, lower-limb and neck/back lesions. As the SEM is the score’s variation due to unreliability, MCIDs smaller than the SEM were not considered valid. In the opinion-based method, a single estimation was made for each functional test. All statistical analyses were performed using NCSS 9 .Between May 2014 and January 2016, one thousand and forty-seven patients were admitted to the clinic for the management of chronic pain after trauma to a limb or spine, 838 patients were eligible for inclusion. Their baseline characteristics, GRC and functional scores at admission and discharge are reported in Tables Seven hundred and thirty five were male (88%), mean age was 44 years ±11, median duration of painful symptoms was > 1 year (401 days). Mean length of stay in the rehabilitation clinic was 31 days±10, 280 (34%) declared a significant improvement during the stay, as defined by a GRC between + 2 and + 3.r = − 0.40, p <  10− 6) and the Hospital Anxiety and Depression Scale . It was not influenced by age or sex.For each functional test and each lesion location, one ROC curve was drawn with the GRC as the condition variable and the score progression (intake-discharge) as the criterion variable. The optimal cutoff on the ROC curve was determined as the value that gave the highest Youden index (sensitivity+specificity-1), provided that both sensitivity and specificity were simultaneously ≥60%. Only MCIDs for the 6MWT, 1MSCT and JAM reached this condition Table . As an eSEM values for each functional score according to lesion location are also reported in Table Using the Anchor-based method, the MCIDs of the 6MWT and 1MSCT were estimated at + 75 m / + 18 steps (lower-limb lesions) and + 60 m / + 15 steps (neck-back lesions) and the MCID of the JAM was estimated at + 5 kg (upper-limb lesions). For the SRT, STS and PILE, only distribution-based and opinion-based estimations were relevant (sensitivity and specificity criterion not met for the anchor method): + 39w to + 61w, − 5 s to − 7 s and + 4 kg to + 7 kg, depending on the method and the lesion location. The above values may be used as a basis for interpreting clinical changes in a patient or in a group of patients participating in a therapeutic trial, and in determining the minimal sample size in a new trial.Distribution-based and Anchor-based estimations were close to each other in many cases. This is consistent with previous studies, in which MCIDs based on patients’ global rating as the anchor were close to the value of one SEM , 34. On as temporary substitutes pending availability of empirically established anchor-based indicators” [Some authors have argued that the anchor-based approach is the best choice because it is the only method that addresses the patient’s perspective. In a recent review of the literature on MCID estimations for the 6MWT, Bohannon et al.  only tooicators” . On the icators” . For allOur results showed that the lesion location also affected MCIDs. This result was not surprising at all because walking performance is more severely impaired in patients with lower-limb lesions than in those with neck/back lesions, and the former obviously expect a greater improvement in function directly related to their lesion. As anticipated, MCID estimations differed from previously published values in different groups of patients. For example, MCIDs of the 6MWT have been estimated at 20 m for patients with Duchenne muscular dystrophy  and at 2Parameters other than the disease may influence MCID estimations. For instance, the MCID for the JAM in stroke patients was lower if the motor deficiency affected the dominant hand (5 kg) rather than the non-dominant hand (6.2 kg) , and theIt is therefore crucial to estimate MCIDs in homogeneous groups of patients, and our very large population made it possible to produce separate MCID estimations for chronic musculoskeletal pain patients with lower-limb, upper-limb and neck/back lesions.r > 0.3). GRC scores also correlated strongly with changes in mood and pain scales, suggesting that pain and psychological improvements also contributed to patients’ satisfaction. Conversely, GRC scores correlated less strongly with scores improvement of SRT, STS and PILE, but we can assume that the MCIDs might have been estimated for these three scales with anchors specifically related to strength or endurance.This is the first study to attempt to estimate the MCID of six functional tests simultaneously and separately in patients with upper-limb, lower-limb and neck/back lesions. We used three different approaches, including the anchor-based approach with ROC analysis, which is considered the reference method by some authors –22. AlthThe main limitation of this study was a potential selection bias because all of our patients were of working age (18–65), mostly men and presented with lesion in only one area . It is more than likely that MCID estimations would have been slightly lower in an older population or might have differed in a predominantly female population. Another limitation is that we cannot guaranty that all patients specifically answered the GRC with respect to the lesion injury they were hospitalized for. For example, a patient presenting with a chronic low back pain and comes to rehabilitation for a leg injury could be influenced by the back pain when completing the GRC. If we had not included this kind of patients, we might have estimated more MCID values with the ROC technique, but we would have deviated from real-life conditions.Finally, we are aware that our way of evaluating the SEM is not ideal, because it is based on repeated measures with an intervention in between, but no data were available with repeated evaluations within a short time period. Moreover, it was not possible to implement such repeated evaluations in the therapeutic program of the patients, which is already very dense. However, our estimation is not penalized by a systematic bias  and is in line with Rousson’s recommendations .Tangent to this debate, and importantly, one should remember that the MCID is of limited value in the management of individuals taking part in multidisciplinary rehabilitation programs. By way of illustration, let us say that + 5 kg is a good estimation of the MCID for the JAM in patients with painful upper limb lesions. This only means that most patients who are satisfied with their clinical outcome after a multidisciplinary rehabilitation program have improved their grip strength by at least + 5 kg in this test. Now let us imagine that the main focus of a new rehabilitation program is grip strength to the detriment of other dimensions, like hand dexterity, bimanual activities, pain management, psychological support, etc. A high percentage of patients who reached this grip-strength MCID could be “globally unsatisfied” as their objectives in the other aspects were not met. This leads us to the opinion that the present estimations of MCIDs are not tailored for “all chronic musculoskeletal pain patients”, but for “chronic musculoskeletal pain patients participating in a vocational oriented multidisciplinary rehabilitation program”, where grip strength, walking speed or climbing stairs are only three aspects of many. In other words, these values should not be used to set goals at an individual level, unless the patient explicitly expresses a wish to increase grip strength, or walk or climb stairs faster.MCIDs were estimated at + 75 m and + 60 m for the 6MWT , + 18 steps for the 1MSCT (lower-limb and neck/back lesions) and + 6 kg for the JAM (upper limb lesions). Distribution and opinion-based methods provided rough estimations of MCIDs for the SRT (+ 39w to + 61w), the STS (− 5 s to -7 s) and the PILE (+ 4 kg to + 7 kg). The use of specific anchors might eventually give better estimations for these three scales. Future research is needed to estimate MCIDs for functional scales in older chronic musculoskeletal pain patients.


Type D personality (TDP) is a sign of tapered stress and compromises treatment outcomes including those of hip arthroplasty. The common dissatisfaction with total knee arthroplasty (TKA) is predicted by fear avoidance, pain catastrophizing and emotional lability, with poor quality of life (QoL) reflecting these strains. This study is the first to investigate the influence of TDP on TKA assuming (1) negative affect (NA) to be linked to fear avoidance and to increased dissatisfaction with TKA and (2) the expression of NA and social inhibition (SI) to not be stable over time. T-test and regression were used to compare the variables of interest between groups built based upon outcome severity.  We studied 79 participants using the brief symptom inventory-18, the pain-catastrophizing scale, the Tampa scale of kinesiophobia, the SF-36, and the WOMAC preoperatively and 12 months postoperatively. p=0.02) and knee function (p < 0.01) at follow-up. Contrarily, increased expressions of NA/SI at follow-up were predicted by NA (p=0.04) and rumination (p=0.05) at the baseline.  NA at follow-up predicted knee pain ( The present results suggest the postoperative increase of NA to be linked to dysfunctional outcomes of TKA due to an interaction with pain catastrophizing. Baseline self-rated physical health did not connect to the dissatisfaction with TKA 1-year postoperatively. Chronic pain is a widespread medical problem of an equifinal character usually involving psychological, psychosomatic, and psychosocial factors –3. The fGiven the reported association between TDP and catastrophizing, we speculate that it extends to pain catastrophizing lending an explanation for the association between chronic pain and TDP. Moreover, we speculate, based on prior research, this effect to be mainly accounted for by NA . On the t = 1.12, p=0.3), persistent dysfunction , and reactive TDP  did not differ from those without regarding age.Seventy-nine patients scheduled for elective primary TKA for osteoarthritis were included in the present study. 72% of the patients lived with a partner, 48% had attended junior high school or have had higher education, 8% of the patients had no training qualification, 13.33% had attended university, and 65.3% had made an apprenticeship, while 4% were unemployed, 56% received a pension, and 32% worked on a regular base. Written informed consent was obtained from all the patients. The study was approved by the local institutional review board. Participants were asked to fill in questionnaires assessing the variables of interest of psychopathological distress, type D features, kinesiophobia, and pain catastrophizing, as well as QoL. This study compares the data collected before the operation and after 1 yr of follow-up. The mean age of the participants was 66.28 (11.26) years. The groups with persistent pain . Cronbach's ged good . The WOMThe brief symptom inventory (BSI-18) , a shortα: total score: 0.87, PCS-Rumi: 0.87, PCS-Magni: 0.66, and PCS-Help: 0.78) [The pain-catastrophizing scale (PCS) is a 13-item rating scale comprising the subscales rumination (PCS-Rumi), magnification (PCS-Magni), and helplessness (PCS-Help). It assesses thoughts and feelings about pain experience on a 5-point Likert scale. The PCS has proven adequate to excellent internal consistency (Cronbach's p: 0.78) .α being 0.73 for its German version [The Tampa scale of kinesiophobia (TSK) is a thirteen-item rating scale rated on a 4-point Likert scale. Assessing fear of movement and re-injury, it is a valid and reliable instrument with Cronbach's  version . The TSKThe short form 36 (SF-36) assesses eight dimensions of subjective health and two summary scores  and knee function (WOMAC C) were dichotomized using the lowest tertile as the cut-off point, allowing for the comparison of the worst third with the remaining group reporting better results. Using severity tertiles is a proven procedure  for studχ2 = 20.84, p < 0.01) and between the dysfunctional taxon and not being married as well as living separate from one's partner . The persisting pain and the persisting dysfunction taxons were highly interrelated . The category of type D personality as assessed at baseline was linked to the persisting pain taxon  but lacked associations with the persistent dysfunction  and the reactive TDP taxon .The following primary outcomes (mean (SD)) need reporting: WOMAC A baseline/follow-up: 5.26 (2.21)/10.94 (10.63); WOMAC C baseline/follow-up: 5.02 (2.30)/44.84 (35.52); NA baseline/follow-up: 8.19 (6.06)/5.34 (4.61); SI baseline/follow-up: 6.87 (4.84)/8.58 (4.18); baseline BSI-total score 6.78 (7.66); baseline PCS total score 17.18 (12.24); and baseline TSK total score 21.05 (6.61). Sociodemographic aspects  lacked associations with the persistent pain taxon and with reactive TDP, but there was an association between the persistent dysfunction taxon and not working full-time  during the 1 yr follow-up, i.e., a group with rising NA/SI levels during the follow-up.The prevalence of primary TDP at the baseline was lower than that reported for other contexts, e.g., fibromyalgia coinciding with TDP in 57% , myocardStudy hypotheses: contrary to our expectations, we did not find TDP related to worse outcomes of TKA, although it has been reported to coincide with worse outcomes after hip arthroplasty , 19. RatHowever, kinesiophobia, as assessed by the TSK, was not linked to the algofunctional outcome 1 yr postoperatively, in the present study. In addition, kinesiophobia decreased during the follow-up, but 39% of the participants experienced the opposite regarding the dimensions of TDP. As our study hypothesis regarding the nonstability of TDP was confirmed, the question arose whether changes in TDP during a postoperative follow-up should be considered a sign of TDP being a mode of adaptation to the operation rather than a sign of being a prerequisite of dysfunctional adaptation. In fact, changing loads of TDP symptoms connected to a stressor are not in line with the view of TDP as a stable trait but suggest TDP to reflect a state altered through the stressor. Coyne and de Voogd  state thIn conclusion, the present results are indicative of a complex interaction involving rumination, the experience of pain, negative affectivity, and, not least, disability and its subjective impression. While the data do not allow for any causal explanations, they do have clinical implications and a seminal potential. TDP may not be a trait but seems to function as a state which is induced by surgery-related stress. Both, TDP and QoL, are not outcomes of surgery but reflections of the psychosomatic mechanisms involved in coping with TKA. Future research will face the task of identifying psychological markers indicative of a maladaptive potential and of testing psychotherapeutic interventions aiming at improving the patient's emotional, interactional, and adaptive competencies. Rumination and NA may be reasonable candidates for the early detection of maladaptive copers and worthwhile targets for psychotherapeutic interventions. Moreover, the worse the pain before the operation, the greater the expectation of the patient's dissatisfaction with TKA will have to be. This argues clearly for not delaying the operation under the acceptance of the worsening of knee pain, and it calls for a sufficient pain relief especially in the perioperative phase. As to the caveats of the present study, which is the first to report on TDP in TKA and therefore needs replication, its cross-sectional character and the limited sample size need to be mentioned. The sample is not representative of all patients undergoing TKA, and its generalizability is restricted by the lack of a control group.


Although intraoperative periarticular multi-drug injection has been used for postoperative pain control after total knee arthroplasty (TKA), the injection has the inherent shortcoming of limited acting time. This randomized controlled trial was performed to assess whether adding percutaneous periarticular multi-drug injection at the day following TKA would improve the postoperative pain relief.A total of 43 participants were randomly assigned to receive additional periarticular injection at 08:30, postoperative day 1 or no additional injection. The multi-drug solution including 40 mg of methylprednisolone, 150 mg of ropivacaine, and 0.1 mg of epinephrine was infiltrated into the muscle belly of the vastus medialis. In both groups, patients were treated with intraoperative periarticular multi-drug injection and postoperative intravenous and oral nonsteroidal anti-inflammatory drugs. We did not use any narcotic pain medications postoperatively. The primary outcome was the patients’ global assessment of postoperative pain at rest measured using a visual analog scale (VAS) and quantified as the area under the curve (AUC) of serial assessments until 20:00, postoperative day 5.p = 0.007). No wound complication or surgical site infection was observed in either groups.The mean AUC for the postoperative pain VAS at rest was 1616 ± 1191 in patients received the additional periarticular injection versus 2808 ± 1494 in those received no injection (mean difference, − 1192; 95% confidence interval, − 2043 to − 340; Adding percutaneous periarticular multi-drug injection at the day following TKA may provide better postoperative pain relief. Further studies are needed to confirm the safety of the percutaneous injection.UMIN000029003. Registered 5 September 2017.University Hospital Medical Information Network  Pain is severe after total knee arthroplasty (TKA) . MultimoSeveral investigators tried to add continuous intraarticular infusion to multimodal pain management including periarticular multi-drug injection , 7–10. HWe conducted a prospective, randomized, open-label trial to investigate the impact of the percutaneous periarticular multi-drug injection at the day following TKA on multimodal pain management for TKA. The hypothesis of this study was that the postoperative pain score would be lower in patients that received the percutaneous periarticular multi-drug injection.We did a single-center, two-arm, parallel group, randomized, open-label trial with 1:1 treatment allocation. The randomized controlled trial was approved by the institutional review board on 3 September 2017. Written informed consent was obtained from eligible participants. Before the onset of participant enrolment, the trial was registered as a randomized controlled trial titled “Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial” with the University Hospital Medical Information Network (UMIN) that is accepted registration by the International Committee of Medical Journal Editors (ICMJE).Patients were recruited between October 2017 and March 2018 from a single orthopedic clinic . We prespecified the inclusion criteria of this randomized controlled trial as patients older than 20 years of age and scheduled for TKA of the unilateral knee. We prespecified the exclusion criteria as below: (1) patients scheduled for revision TKA, (2) scheduled for TKA combined with implant removal, (3) having allergy or intolerance to one of the study drugs, and (4) having poorly controlled diabetic mellitus defined as hemoglobin A1c with levels over 7.0%. Patients were not excluded based on their primary disease to maintain generalizability.Patients were randomly assigned to receive either percutaneous periarticular multi-drug injection at the day following TKA or no injection. The randomization schedule was generated by an independent investigator (KK) who did not take part in surgery or the assessment of outcome, by means of a computer-derived random-number sequence. The investigator created the randomization sequence by permuted block randomization with a block size of 4 and a 1:1 allocation generated using a computer software . When a patient participated in the trial, the generated randomized number was assigned accordingly. Patients with even numbers were allocated to the group scheduled to receive percutaneous periarticular multi-drug injection at the day following TKA, and those with odd numbers were allocated to receive no injection.The pre- and postoperative medications were identical in both groups except for the percutaneous periarticular multi-drug injection at the day following TKA. We routinely performed intraoperative periarticular injection for the perioperative pain management. The multi-drug solution of the injection included methylprednisolone 40 mg  [1 mL] as corticosteroid, 7.5 mg/mL ropivacaine  [40 mL] as local anesthetics, 10 mg/mL morphine hydrochloride hydrate  [0.8 mL] as opioid, 1.0 mg/mL epinephrine  [0.3 mL], and 50 mg of ketoprofen  [2.5 mL] as non-steroidal anti-inflammatory drugs , ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at the day following TKA. The injection was performed at approximately 3 cm above the superior border of the antero-medial skin incision using 23-gauge needle with the knee extended  to 100 mm (indicating extreme pain). The VAS score was measured 1 day after surgery at 12:00 and 20:00, and 2, 3, 4, and 5 days after surgery at 6:00, 12:00, and 20:00. The measurement of VAS score at rest was performed during the hospital stay.The prespecified secondary outcomes of this study were postoperative level of pain during activity, range of motion of the knee, and complications. We defined the strongest pain experienced during physical therapy exercise on a day as the VAS score during activity. We also recorded the amount of the consumption of rescue analgesia during the study period. The data was collected from postoperative days 1 to 5.A total of 16 patients per group was needed to fulfill the minimal clinically important difference (MCID) of 20 mm in the point-by-point assessment of primary outcome , 5, withStudy protocol prescribed that missing data of the primary outcome were filled up by linear interpolation between two valid data. When the missing data did not lie between two valid data, the missing data were filled up by the medians of the treatment groups at the same measurement time.To compare the cumulative pain VAS score at rest after TKA, we quantified area under the curve (AUC) of each study patient. The calculation was performed as follows: we made a line graph for each patient in which VAS score was on the vertical axis and time after surgery was on the horizontal axis and we divided the area under the graph into a series of trapezoids. The sum of the areas of each of the individual trapezoids was calculated as the AUC , 11–13. P value for the effect of group, which means the effect of the additional periarticular injection, was assessed.The serial measurements of pain VAS scores were also analyzed applying repeated-measures analysis of variance to data obtained at each time point to establish whether there were significant differences over time between two groups . We applIn addition to statistical significance, the effect size of patient-reported outcomes should be assessed whether they are meaningful in the clinical setting . The VASt test for continuous variables and the Fisher’s exact test for categorical variables between the study groups. We assessed changes in the VAS scores during activity, the consumption of diclofenac sodium suppository as rescue analgesia, and the range of knee motion between groups using analysis of variance for a repeated-measures analysis of variance. All tests were two-sided. We considered P < 0.05 as statistically significant. All statistical analyses were done using R software.Patient demographics and baseline clinical characteristics were compared with Student’s n = 22 and n = 21, respectively). Table A total of 49 patients underwent unilateral TKA during the study period and were eligible for inclusion in the study. The flowchart presented in Fig. p = 0.007).Figure p < 0.001). Repeated measures analysis of variance with the Greenhouse-Geisser correction also showed that the effect of group  was associated with the difference of VAS at rest (p = 0.04).The sphericity was rejected with Mauchly sphericity test   Table . No sign3) Table .Table 3VNo wound complication was recorded in any study patient. There were no patients that developed surgical site infection. In addition, no cardiac or central nervous system toxicity was observed in any study patient.In this randomized trial, we evaluated the effectiveness of percutaneous periarticular multi-drug injection at the day following TKA as a component of multimodal pain management including intraoperative periarticular multi-drug injection. The percutaneous periarticular multi-drug injection was associated with significantly lower postoperative pain VAS score at rest. The mean pain VAS scores were under the threshold value of the PASS in the additional periarticular injection group in all assessment points. The difference of pain VAS score reached the MCID at 20:00, postoperative day 1. In addition, the pain VAS score during activity was less in the periarticular injection group.The cumulative postoperative pain VAS score was significantly better in the additional periarticular injection group than no additional injection group. However, the difference of the mean pain VAS scores between groups reached the MCID of 20 mm only at 20:00, postoperative day 1. We believe that this short-duration difference may be meaningful for patients undergoing TKA since the time point of 20:00, postoperative day 1 generally corresponds to the peak of rebounding pain after intraoperative periarticular injection , 5.Postoperative intraarticular local anesthetics through catheter has been applied to the multimodal pain management after TKA , 7, 8. TOur postoperative pain management regimen did not include any opioids. The United States is faced with the opioid epidemic , 16. TheThe most important limitation of our study is that the treatment team members and patients were not blinded. The non-blinding design is known to cause overestimation in randomized controlled trials . Second,The randomized, controlled design is the most important strength of our study. Another strength is the use of the remote method of randomization, in which the study institution is different from the site managing randomization schedule. We believe that the use of the AUC to analyses serial measurements of primary outcome may be the strength of this study since the AUC can avoid the serious problems associated with the use of comparisons at each time point when analyzing serial measurements on patients , 19, 20.The percutaneous periarticular multi-drug injection including methylprednisolone, ropivacaine, and epinephrine may have better postoperative pain relief than no additional injection after TKA. Further studies are needed to confirm the safety of the percutaneous periarticular multi-drug injection.