N = 222) were recruited by e-mail, who in turn recruited their patients (N = 139). Therapists and patients were asked to rate the meaning of different areas of life before as well as during the COVID-19 crisis. The psychotherapists showed an overall higher rating of the importance of areas of life compared to their patients (p < 0.001). The rating of the importance of the domains of living was differently affected by the COVID-19 situation (p < 0.001). While the meaning of physical and mental health during COVID-19 was rated higher than before, the opposite was observed for work (p < 0.001). No differences were found for relationships and friends, as well as for hobbies. As no interactions between perspective (therapists vs. patients), area of life, and time point (before vs. during COVID-19) were observed, it can be concluded that the COVID-19 situation changed the subjective attribution of meaning concerning different aspects of life similarly in therapists as well as patients. While mental and physical health gained subjective importance, the opposite was observed for work.We assessed psychotherapists’ and patients’ ratings of their subjective perception of meaning related to different areas of life before the COVID-19 pandemic as compared to the time during the COVID-19 pandemic. In a quantitative cross-sectional study, Austrian psychotherapists ( The novel coronavirus disease COVID-19), a novel disease resulting in severe acute respiratory syndrome caused by coronavirus 2 (SARS-Cov-2), confronts humanity with an unquestionable, unprecedented crisis 9, a nove,4. ViktoThe COVID-19 crisis has not only explicitly questioned the capacity to survive—the most fundamental human need —but alsoBesides detrimental effects on economics, several previous studies highlight that many psychological problems emerged progressively during this state of public health emergency . A high In addition to consequences on mental health, the COVID-19 pandemic has been reported to be related to detrimental behavioral alterations and negative impacts on physiological health. In this regard, dramatic shifts in substance use , physical activity , and diet (poor diet and too high energy intake) have been reported, which likely also interact with mental health .Social behavior is also dramatically affected by the COVID-19 pandemic, as the reduction of social contacts is considered as one of the most important measures to fight the spread of the virus. In general, social behavior represents an important protective factor and has been associated with mental health, such as depression, stress, and anxiety , as wellTo summarize, the COVID-19 pandemic poses far-reaching challenges in almost all aspects of life. Following existential-humanistic psychology’s focus on dialectics and paradox , the ChiHowever, whether the COVID-19 crisis is associated with changes in the perception of the meaning of life  has not been investigated so far. Furthermore, whether potential changes in the perception of the importance of different areas of life due to COVID-19 differ among individuals with mental disorders (patients) as compared to those who are assumed to be well aware of a positive, mentally healthy lifestyle (psychotherapists) has not been investigated yet.This paper aims to examine the changes in the rating of the importance of certain areas of life in Austrian psychotherapists and patients during the COVID-19 crisis. In Austria, the first COVID-19 cases were reported on the 25 February 2020 and a nationwide curfew went into force from the 16 March 2020 until the 30 April 2020. After a peak of the daily confirmed COVID-19 cases at the end of March 2020 (>1000 confirmed cases per day), with the end of the lockdown, daily cases decreased and remained at a low level (<100 cases/day) until the end of June 2020. From July to August 2020, daily cases started to increase again . The surThe following research questions (RQs) were investigated:RQ1: Is there a difference in the subjective perception of the meaning of certain areas of life during the COVID-19 crisis as compared to the time before COVID-19 in psychotherapists and their patients?RQ2: Is there an age difference in the rating of the subjective importance of different areas of life before and during COVID-19?RQ3: Is there a gender difference in the rating of the subjective importance of different areas of life before and during COVID-19?To investigate our research questions, a quantitative cross-sectional study was conducted in the form of an online survey using the platform REDCap. The information about the survey including the link was sent by the Austrian Federal Association for Psychotherapy (ÖBVP) to their members at the end of June 2020. Additionally, e-mail addresses were exported from the official list of psychotherapists (around 9000 registered psychotherapists in July 2020) to contact them.The present study was part of a larger survey in which psychotherapists were asked to participate and also to invite their patients to participate if both experienced a switch in the psychotherapy format (either from remote psychotherapy to face-to-face psychotherapy or the other way around). Both surveys (therapists’ and patients’ versions) were open from the 26 June 2020 until the 3 September 2020. In total, 222 psychotherapists and 139 patients completed the survey. All the participating therapists and patients were included in further analyses, irrespective of whether they stated in the survey changes of the treatment format during psychotherapy.Therapists were offered continuing education credit points to compensate for the time spent conducting the survey and to motivate them to participate. Patients’ participation was voluntary, without incentives. Participants had to agree to the data protection declaration to start the survey (electronic informed consent). The principles outlined in the Declaration of Helsinki were followed and the ethics committee of the Danube University Krems (Austria) approved the study.Psychotherapists reported their age, gender, and level of qualification , as well as their therapeutic orientation.Patients were asked about their age, gender, and months receiving psychotherapy. No information was obtained regarding the therapeutic orientation of the psychotherapy the patients received, as patients were not matched to the therapists in the online survey to ensure anonymous data collection.To examine the patients’ mental health problems, the ICD-10 Symptom Rating (ISR)  was admiPatients, as well as therapists, were asked to rate their subjective perception of the meaning of six domains of living/values on a five-point scale from “not important at all” (coded as 1) to “extremely important” (coded as 5): (1) work, (2) relationships, (3) acquaintances, friends, (4) leisure time, hobbies, (5) physical health, (6) mental health.First, participants were asked to rank the importance of those areas of life before the current corona crisis and thereafter they had to rank them during the current COVID-19 crisis.For statistical analysis, the IBM SPSS  Statistics 26 software program was used.t-tests were applied.To analyze possible differences in sociodemographic characteristics between therapists and patients, chi-squared tests and Statistics for RQ1: Mixed ANOVAs were performed to investigate whether the subjective perception of meaning changed during COVID-19 vs. before COVID-19, whether the rating of the meaning differed among areas of life and between therapists and patients. Moreover, we investigated possible two- and three-way interactions between time point, areas of life, and perspective (patients vs. therapists). In this ANOVA, the subjective rating of the meaning was the dependent variable. There were two within-subject factors: the first was “change”  and the second was “area” (six levels: (1) work, (2) relationships, (3) acquaintances, friends, (4) leisure time, hobbies, (5) physical health, (6) mental health). There was one between-subject factor, that is, “perspective” . All main effects (ME) and interaction effects (IE) were examined. The Greenhouse–Geisser corrected values are presented. Bonferroni-corrected simple effects tests were conducted for significant ME and IE.Statistics for RQ2: To answer the research questions of whether age affects the subjective perception of the meaning of different areas of life before or during COVID-19 or the change in the subjective meaning during vs. before COVID-19, we calculated Pearson correlations.t-tests comparisons. Bonferroni correction for multiple comparisons was applied for results interpretation of RQ3, considering p < 0.0028 as significant (p < 0.05/18 t-tests).Statistics for RQ3: To evaluate potential gender differences, only female and male participants were included, as only one transgender patient participated in the study. Differences between female and male participants were calculated by p < 0.05 before Bonferroni correction.All statistical tests were performed two-tailed and the significance level was set to p < 0.001). Therapists already registered in the list of psychotherapists (n = 202) were on average 11.69 (SD = 9.41) years in the profession. The remaining 20 therapists were advanced psychotherapy students already allowed to practice psychotherapy under supervision.In total, 139 Austrian patients and 222 Austrian therapists participated in the online survey. There were no differences concerning gender between therapists and patients . Howevern = 49), humanistic 46.4% (n = 103), systemic 20.7% (n = 46), behavioral 10.8% (n = 24).The distribution of their psychotherapeutic orientations was as follows: psychodynamic 22.1%  months (range from 0 to 150 months). Analysis of the ISR revealed a global score of M = 1.14 (SD = 0.69), indicating moderate symptom distress . The fivDifferences between patients and therapists:p < 0.001).The rating of the meaning of life over all areas was higher in therapists  as compared to their patients   = 16.788; Differences between areas of life:p < 0.001). Bonferroni-corrected post hoc tests revealed that the area mental health  was rated highest, differing significantly from all other areas (p ≤ 0.002). The areas relationships  and physical health  followed. The area friends  ranked in the fourth place, differing from all other areas (p < 0.001). The lowest rankings were measured for the areas work  and hobbies , which did not differ from each other (p = 1.000).The meaning of the different areas irrespective of time point and perspective differed significantly  = 96.339; Changes during COVID-19 as compared to before COVID-19:p = 0.137).The overall rating of the meaning of life did not change from before COVID-19 to during COVID-19  = 2.216; Changes of the ranking of areas during COVID-19 as compared to before COVID-19:p < 0.001) as illustrated in A significant interaction was found between the change and the area  = 22.563; p < 0.001), the opposite was observed for physical health (from p < 0.001) and mental health (p < 0.001).Pairwise comparisons of each area between both time points revealed that the areas work, physical health, and mental health were rated differently before vs. during COVID-19. While the subjective rating of the meaning of work decreased during COVID-19 as compared to the times before the pandemic (Differences in the change of meaning of different areas during COVID-19 as compared to before COVID-19 between patients and therapists:p = 0.240) nor the area  = 1.987; p = 0.092).The perspective interacted with neither the change  = 1.383; p = 0.258. Descriptive statistics (mean and standard errors) for all areas and time points for psychotherapists and patients are summarized in No three-way interaction emerged between change, area, and perspective  = 1.332) Results of the correlation analyses to reveal potential age differences in the subjective meaning of different areas of life before COVID-19 and during COVID-19, as well as in the change from COVID-19 to the times before COVID-19, are summarized in r = −0.174) means that with the increasing age of the therapists, the subjective meaning of the importance of work decreased during COVID-19 as compared to the months before. Before the COVID-19 crisis, younger therapists regarded leisure time and hobbies as more important than older ones (r = −0.166), whereas no age effect for the subjective rating of the meaning of this area of life was found during COVID-19.Among therapists, a positive correlation between age and work was found before COVID-19 (r = 0.183), but not during COVID-19. This means that the older therapists were, the higher they rated the importance of work before COVID-19. The negative correlation between age and the changes in the meaning of work (r = −0.190) as well as during (r = −0.168) the COVID-19 crisis. Physical health was regarded as more important by older patients before the crisis (r = 0.194), whereas the increase in the importance of physical health decreased with increasing age (r = −0.170).Among patients, younger age was associated with higher importance of leisure time and hobbies before  = 3.214; p = 0.001). Women rated the importance of friends before the pandemic higher  than men . However, this was only significant when analyzed for the total sample (patients + therapists). For all other variables, no significant differences between male and female participants were observed when analyzed for the total sample (p ≥ 0.043). Separate analyses per perspective (therapists and patients) revealed no significant gender differences (p ≥ 0.003).Results for the This study evaluated whether the COVID-19 pandemic was associated with changes in the perception of the meaning related to different areas of life in psychotherapists and their patients. Additionally, potential associations with gender and age were evaluated.We were able to show that among patients and therapists, work was regarded as less important during the COVID-19 pandemic than before. During COVID-19, unemployment rates strongly increased in Austria. Furthermore, many people had to switch to short-time working, a state-regulated system that aims to support companies to avoid laying off any of their employees instead of reducing employees’ working hours, with the government making up some of the employees’ lost income. Therefore, our findings suggest that with the increase in job insecurity and reduced time spent with professional activities, the subjective meaning of work declined. However, it has to be noted that with the current survey, we cannot rule out whether the occupational status of the participants changed due to the COVID crisis. Our findings are also not generalizable to other countries with other social support systems. In this regard, it has been observed that the economic crisis in 2008 went along with increased suicide rates, except for countries with active supportive labor-market programs such as Finland and Sweden ,34. TherA study conducted on Hong Kongers during the SARS epidemic revealed that greater mental health awareness, positive lifestyle changes, and better social and family support were positive consequences within the broader suffering of SARS . A recenA public health emergency increases the awareness of our own mortality and the mortality of our friends and family. Additionally, the pandemic is associated with the uncertainty of who will fall ill and when the crisis will end . This suDuring these challenging circumstances, meaning might not always be readily apparent . In the Therefore, concerning the special situation around the pandemic, the role of the therapist might become more like a guide, accompanying the patient creating meaning and making sense out of this new situation context. As not only the patient, but rather the whole of mankind is undergoing this situation for the first time, understanding of its meaning should be shared between patient and therapist in a continuous, emergent, and idiosyncratic process. Being an expert for mental disorders and allocating diagnosis seems to be less relevant in this unprecedented situation. Therefore, existential therapeutic concepts, such as logotherapy and existential analysis, seem to be of particular importance, as the current state of the pandemic demands not only a categorical diagnosis of psychopathology, but also a special focus on the humanity shared between the patient and the therapists. In this regard, existential approaches might offer a path forward into the unsure future of the life after the pandemic .The following limitations have to be considered when interpreting the results: We performed a cross-sectional study, which implies that there might be a recall bias regarding the retrospective ratings of the psychotherapists and patients on the meaning of certain areas of life. A second measurement point before the COVID-19 pandemic would be necessary to investigate changes in the subjective rating of the meaning of different areas of life more accurately. Another major limitation is that no validated questionnaires were used to assess the meaning of the different areas of life. In future studies, standardized questionnaires for measuring values, such as the Valued Living Questionnaire (VLQ)  or the SOverall, the COVID-19 situation changed the subjective attribution of meaning concerning different aspects of life similarly in therapists as well as patients. While mental and physical health gained subjective importance, the opposite was observed for work.


Nowadays, trans-sacral epiduroscopic laser decompression (SELD) using slender epiduroscopy and laser is one of the preferred options for minimally invasive treatment in lumbar disc diseases. However, SELD is still in the initial stages of the global field of spine surgery, and the clinical outcomes in patients with lumbar disc herniation are not established yet. Therefore, the authors investigated patients undergoing SELD to report the clinical results.  Between November 2015 and November 2018, a total of 82 patients who underwent single-level SELD for lumbar disc herniation with a minimum follow-up of 6.0 months were enrolled. A retrospective review of clinical data was conducted. Clinical outcomes were evaluated using the visual analogue scale (VAS) for low back and leg pain and Odom's criteria. Also, surgical outcomes, including complications and symptom recurrences, and radiological outcomes were analyzed. p < 0.001). According to Odom's criteria, the success rate defined as excellent or good results at the final follow-up was 58.5%. There were no surgery-related complications such as neurologic deficits, infection, or epidural hematomas, except for transient mild paralysis in 3 patients and procedure-related nuchal pain in 2 patients. The rate of additional procedures was 17.0%  during the follow-up.  Low back pain and leg pain as determined by the VAS improved from an average of 5.43 ± 1.73 and 6.10 ± 1.67 to 2.80 ± 1.43 and 3.58 ± 2.08 at the final follow-up ( Our findings showed that SELD for lumbar herniated disc disease achieved less favorable clinical outcomes compared with those of previous studies. Further study is needed to clarify the influencing factors on the clinical outcomes of SELD. Epiduroscopy, also known as epidural spinal endoscopy, is defined as the percutaneous minimally invasive investigation of the epidural space with the assistance of a flexible endoscope through the sacral hiatus. It permits various clinical applications in the epidural space of the lumbosacral spine, such as epidural catheter placement and diagnosis, decompression of disc herniation, epidural adhesiolysis, delivery of epidural drug agents, and spinal cord stimulation electrode implants.Epiduroscopy has been steadily and dramatically developed over the last century, achieving various milestones during the epiduroscopic surgery era. The first real endoscope was invented by Adolf Kussmaul in 1868, which led to the milestone development of a flexible fiberglass endoscope in 1958 by Hirschowitz . Since tIn 1996, the United States Food and Drug Administration eventually approved Myelotec Myeloscopy , a modern epiduroscopic technique via the sacral hiatus, to visualize and treat spinal epidural pathology. After that, alongside small-caliber flexible optics and light sources, video-guided catheter and video systems, and laser technology, the present trans-sacral epiduroscopic decompression (SELD) technique was developed to treat the symptomatic pathology of the lumbosacral spine.Since 2000s, in the early days of SELD, some reports have suggested its clinical application in various lumbar spinal diseases to not only disc herniation but also adhesion or fibrosis around nerve roots, failed back surgery, and even spinal stenosis –15. BaseIn this paper, we reviewed the clinical, surgical, and radiological outcomes of SELD in patients with mild-to-moderate lumbar disc herniation with a follow-up of minimum 6 months.The study was approved by the Institutional Review Board of our institute (GAIRB2018-214).The indications for SELD were as follows: (1) magnetic resonance imaging (MRI) confirming mild-to-moderate soft disc herniation features concordant with the clinical symptoms and (2) persistent low back pain and/or radicular leg pain despite adequate conservative treatment or severe pain making daily life challenging. In addition, the contraindications for SELD were as follows: (1) cauda equina syndrome or severe paresis (motor grade 3 or less), (2) hard disc, (3) foraminal disc herniation which is inaccessible using SELD, (3) significant spinal stenosis or instability, (4) infection, (5) hemorrhagic diathesis, and (6) catheter-inaccessible anatomical abnormalities such as anomaly of sacral hiatus or peridural cyst.From November 2015 to November 2018, among the 116 patients who underwent SELD in a single institution, 82 patients were retrospectively enrolled in the final cohort. The study exclusion criteria were as follows: (1) multilevel procedure, (2) previous history of lumbar surgery, and (3) insufficient follow-up duration of 6 months or an incomplete medical record .Data were based on regular follow-up data obtained from the medical records, and patients who did not visit regularly or whose follow-up period was less than 6 months were contacted by phone to participate in clinical surveys and X-rays.The procedure was performed in the awakened state under local anesthesia using lidocaine with epinephrine over the sacral hiatus with monitored vital signs. Each patient was placed in the prone position on a radiolucent table with a Wilson's frame to decrease lumbosacral lordosis and intra-abdominal pressure.μm in diameter were advanced into the end of the catheter to visualize the epidural space and condense pathologic lesion.A 5 mm-sized tiny skin incision was made on the sacral hiatus, followed by a sacrococcygeal ligament puncture using a trocar under fluoroscopic guidance. After the advancement of the trocar to the S2-3 level, a video-guided catheter of 3.2 mm in diameter  containing two lumens (1.2 mm in diameter) was inserted through the trocar to the target level. Consequently, the video-guided catheter was advanced to the target level using bidirectional steering characteristics and the injection of radio-opaque dye via an infusion port, and fluoroscopic pictures were obtained to verify the position of the catheter in the ventral epidural space and confirm the outline of the herniated disc and flow obstruction caused by disc herniation and adhesion around the pathologic site. Through the video-guided catheter, the flexible epiduroscope of 1.0 mm in diameter  and the flexible fiber of a Ho:YAG laser of 550 The Ho:YAG laser generated by Litho  was used in this study because of its high-quality ablation of the hydrated disc without significant thermal injury to the neural structures . The lasUnder direct vision via a flexible epiduroscope, after confirmation that the tip of the catheter was located at the most inferior part of the herniated disc covered by the posterior longitudinal ligament, adhesiolysis around the target site and laser ablation of the herniated disc were performed. First, the bulging posterior longitudinal ligament was shrunk using a Ho:YAG laser at 2.5 W (0.5 J and 5 Hz), checking the patient's response. Once the patient tolerated the low-grade laser, the posterior longitudinal ligament was penetrated using the laser of 5 W (0.5 J and 10 Hz). Then, the herniated disc under the posterior longitudinal ligament was shrunk and decompressed by the high-energy laser of 8–10 W (0.8–1.0 J and 10 Hz). Protruded or ruptured discs were decompressed until the direct images confirmed a decompressed nerve root or thecal sac.As the herniated disc decreased, the epidural space between the dura and pathologic lesion became wider. Repeated epidurograms should show a flattened outline and free flow at the target site after sufficient decompression.The wounds were closed by one-point subcutaneous suture and skin tape.All procedures were performed by one surgeon.Demographic data and baseline characteristics, including age, sex, occupation, smoking status, alcohol consumption, body mass index, past medical history, previous history of epidural block, trauma history, surgical level, and preoperative symptom duration, were evaluated. Lumbar magnetic resonance imaging was performed prior to surgery, and preoperative state including surgery level, grade of disc degeneration using the Pfirrmann grade , disc heClinical outcomes were assessed using the visual analogue scale (VAS) scores of low back pain and leg pain. Data were collected preoperatively and at each follow-up visit . Patient satisfaction was surveyed using Odom's criteria at each follow-up visit .Surgical outcomes were evaluated using operation time; surgical failures; surgical complications, such as durotomy, neurologic deterioration, and surgical site infections; hospital length of stay; and return-to-work timing. Long-term surgical outcomes were assessed according to performance of additional procedures, including revision surgeries, nerve root blocks, and epidural blocks during the follow-up period.Plain radiography, including dynamic radiography, was performed at preoperation and 6 months after surgery to assess the change in lumbar alignment. Segmental angle and range of motion at surgery level, and total lumbar lordosis (measured using Cobb's method) were used to evaluate radiological outcomes.t-test, Friedman's test (a nonparametric multiple comparison test), one-way analysis of variance (ANOVA), independent t-test, and nonparametric Mann–Whitney U-test were used for univariate comparison according to characteristics of the factors. Kaplan–Meier survival analysis was used for the analysis of survival without additional procedures.Data management and statistical analysis were performed using SPSS version 23.0 . Pearson's chi square test, Wilcoxon's signed-rank test, the paired samples p values of <0.05.Results were expressed as means ± standard deviations, medians with ranges, or mean and 95% confidence interval (CI), and statistical significance was accepted for The 82 study subjects comprised 52 men and 30 women, with an overall mean age of 40.78 ± 15.24 years. The mean body mass index was 24.15 ± 3.99, and 6 patients (7.3%) had diabetes mellitus.The median duration of symptoms was 1.0 week . Twelve patients (14.6%) had a minor trauma history related to symptom aggravation, and 26 patients (31.7%) had a low back pain dominant symptom other than radicular leg pain. The median follow-up period was 23.0 months  .According to preoperative MRI, the surgical levels were the following: L3-4 in 6 patients, L4-5 in 22 patients, and L5–S1 in 54 patients. A high-intensity zone was revealed in 28 patients (34.2%), and the herniated disc volume was 0.30 ± 0.12 mL .p < 0.001, one-way ANOVA). Preoperation to 1-week postoperation, preoperation to 1-month postoperation, and preoperation to the final follow-up differences in VAS for low back pain were significant , but the differences between 1-week postoperation, 1-month postoperation, and the final follow-up of VAS for low back pain were not significant . Preoperation to 1-week postoperation, preoperation to 1-month postoperation, and preoperation to the final follow-up differences in VAS for leg pain were significant , but the differences between 1-week postoperation, 1-month postoperation and final follow-up of VAS for leg pain were not significant   and good in 40 patients (48.8%) at 1-week after the operation, excellent in 20 (24.4%) and good in 28 (34.1%) at 1-month after the operation, and excellent in 16 (19.5%) and good in 32 (39.0%) at the final follow-up. In other words, the success rate of the surgery (excellent or good according to Odom's criteria) was 61.0% at 1-week after operation, 58.5% at 1-month after operation, and 58.5% at the final follow-up. Odom's criteria distributions at all points of time after surgery were not significantly different (re test) .The median operation time was 50.0 minutes , the mean hospital stay was 3.60 ± 0.80 days, and the mean time return-to-work was 15.41 ± 6.92 days .Surgical complications occurred in 7 patients (8.5%), including 4 patients with transient headache or nuchal pain during the procedure, 2 patients with transient motor weakness, and 1 patient with dura puncture during the procedure. Fortunately, there were no surgical site infections or permanent neurologic deficits after the procedure. In addition, there was no perioperative morbidity related to the procedure, such as a cardiopulmonary problem or deep vein thrombosis.Eight patients (9.8%) underwent an additional epidural block or root block for persistent pain or pain recurrence during the follow-up, and the pain was appreciably relieved in all of these patients. Six patients (7.3%) underwent revision surgery at the index level due to aggravation of symptoms during their follow-ups (discectomy for 5 patients and fusion for 1 patient) .The 6-month procedure-free survival rate was 82.9%, and the mean overall time before an additional procedure, including a nerve block or revision surgery, was 25.86 ± 1.56 months  .All radiological findings, including disc height of index level, segmental angle of index level, range of motion of index level, and total lumbar lordosis, were not significantly different between the preoperation and the final follow-up .After the United States Food and Drug Administration approval of epiduroscopy, the concept of SELD was developed, and the literatures reported the clinical outcomes of SELD in not only disc herniation but also in spinal stenosis, adhesion, chronic low back pain, failed back syndrome, and cystic lesions in the lumbosacral spine , 19, 20.However, there were few reports about the clinical outcomes of SELD for disc herniation, and even if these existed, the follow-up duration was often short or there was a flaw in the reliability of the results. Several previous reports stated that the clinical outcomes of SELD were favorable even compared with those of open discectomy, as there was a significant decrease of low back pain or radiating leg pain, patient satisfaction higher than 70%, low rates of incomplete decompression, and a low recurrence rate , 22–25.However, according to this study, the clinical results of the patients were not all favorable. Although the mean VAS of low back pain and leg pain decreased significantly, the satisfaction and surgical failure rates were not all good. According to Odom's criteria, the patient satisfaction rate was 58.5%, and surgical failure rate, including additional nerve blocks or revision surgeries, was 17.1% during the follow-up period of a minimum of 6 months. This result was not favorable compared with not only the previous study of SELD but also the results of other surgical technique for lumbar disc herniation –25.The authors raise several hypotheses about the reasons for this discordance with previous studies. First, the effect of decompression after laser ablation might be lower than expected. Although the surgeon confirmed decompression of the lesion during the procedure, the objective reduction of the herniated disc could be minimal in immediate postoperative MRI . Also, bSecond, the learning curve of SELD of surgeons could affect the result. The result may be less favorable in the early stages of clinical application than in the later stages. Further study is needed to clarify the effect of surgeon's learning curve in clinical outcomes.Third, the selection of different patients could cause varied clinical outcomes. Even in the similar patients with single-level soft disc herniation, differences in detailed baseline characteristics such as demographic data, including age and past medical history, disc level, location of pathology, morphology of pathology, or disc degeneration could affect the clinical outcome. To clarify whether these baseline factors have a positive or negative effect on outcomes, further research is needed.This study has some limitations. Due to its retrospective nature, it was impossible to control all variations. Nevertheless, we tried to minimize errors by precluding the variables associated with results; for example, we excluded patients with multilevel procedures or previous histories of lumbar spine surgery and who received insufficient follow-up. Also, the number of patients in the final cohort was not large enough, and the study was conducted at a single center. However, this single center study could maintain the quality of follow-up and exclude the factor of the diversity of surgeons. Of course, further studies with large numbers of subjects are mandatory to confirm the clinical results and to clarify the influencing factors on the clinical outcomes of SELD.The clinical outcomes of SELD with a minimum 6 month follow-up were not favorable compared to those of previous studies, as patient satisfaction was 58.5% and additional procedure rate was 17.1%. According to these results, we believe that there could be several reasons for this variation in clinical outcomes, including a learning curve and baseline influencing factors on outcomes; thus further study with a larger cohort is needed.


Both groups received 30 sessions of TE (3 per week), and the PNE + TE group received eight face-to-face educational sessions. The measuring instruments used were the visual analogue scale, a standard pressure algometer, the Revised Fibromyalgia Impact Questionnaire, the Pain Catastrophizing Scale, the Hospital Anxiety and Depression Scale and the Health Assessment Questionnaire. Results: The PNE + TE group showed a statistically significant decrease on pain intensity compared to TE group at short term (p = 0.015). No between-groups differences were found for mechanical pain sensitivity, general fibromyalgia impact, pain catastrophizing, psychological distress or quality of life (p > 0.05). Conclusions: The combination of PNE and TE was more effective than TE for reducing pain intensity in the short-term. No differences were found for psychological distress, pain catastrophizing and quality of life after the intervention or at 3 months of follow-up.Background: We compared the effects of therapeutic exercise (TE) combined with pain neurophysiology education (PNE) to those of TE in isolation on pain intensity, general fibromyalgia impact, mechanical pain sensitivity, pain catastrophizing, psychological distress and quality of life in women with fibromyalgia syndrome (FMS). Methods: A feasibility study with a 3 month follow-up was designed. Thirty-two patients with FMS were randomly assigned to PNE + TE group ( Fibromyalgia syndrome (FMS) is a rheumatological disorder characterized by widespread pain and tenderness. Pain is the main symptom in FMS ,2,3 and Pharmacological treatments are widely used for FMS. Studies based on pharmacological interventions reported some adverse events, such as drug intolerance, secondary effects and several complications from continuous intake . In addiExercise has shown positive effects in patients with FMS ,15,16,17Pain neurophysiology education (PNE) is an educational intervention for patients with chronic pain. PNE uses neurophysiological information to teach patients that pain can be overprotective and completely real, even in the absence of tissue injury. The goal of PNE is to change patients’ beliefs, considered as a preliminary step to changing behavior ,20,21. PAlthough clinical guidelines recommend the combination of patient education and graded physical exercises, there is a lack of high-quality studies evaluating the effects of PNE combined with TE. Thus, the present study aimed to analyze the effects of TE combined with PNE compared to those of TE on pain intensity, mechanical pain sensitivity, catastrophizing thoughts and feelings, psychological distress and quality of life in women with FMS.A feasibility study conceptualized as a non-inferiority design with two intervention groups (PNE+TE group and TE group) was conducted with repeated measures. The study was carried out at the University of Valladolid, Faculty of Health Sciences. This study was developed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. All procedures were approved by the Clinical Research Ethics Committee of Burgos-Soria (CEIC 1903) and registered at clinicaltrials.org (NCT03641495). The selection and recruitment were conducted following the declaration of Helsinki and all patients provided written informed consent prior to enrolment.n = 36) were female patients diagnosed with FMS referred from medical doctors and from the fibromyalgia association FIBROAS  between January 2018 to September 2019.All participants (Inclusion criteria were: (1) woman diagnosed with FMS by a rheumatologist according to the latest American College of Rheumatology (ACR) classification criteria ; (2) age® 13.0 program. For the differences in mean values between groups, 2 cm was the minimum relevant change considered in the visual analogue scale (VAS). The standard deviation was based on a previous study in patients with FMS. Assuming a standard deviation of 1.8 and a between-mean difference of 2 cm, and estimating a two-tail test a level of significance of 0.05, a power of 0.8 and a follow-up loss rate of 15%, 16 participants were required for each group.The sample size calculation was based on pain intensity as a primary outcome using Minitabwww.random.org).Participants who fulfilled the eligibility criteria were randomly assigned to PNE + TE group or to TE group. Concealed allocation (ration 1:1) was performed by an external examiner using the Research Randomizer (Version 4.0) computer software . The PNE+TE group also received 8 sessions (once a week for 8 weeks) of an educational program based on PNE by a medical doctor expert in pain neurophysiology. The treatment adherence was registered with a list of attendance in each intervention group.Both groups received 3 TE sessions per week for 10 weeks. The sessions were carried out by a physiotherapist blinded to the group allocation. The TE program included an active warm-up including low intensity movements and dynamic stretching, a central part with aerobic training and strengthening exercises of the major muscles and a cool-down part including static stretching and respiratory exercises. Each session lasted 60 min.The active warm-up was performed at a light level of intensity, prior to the central part. The warm-up protocol was based on joint mobility exercises, active stretching and submaximal repetitions of the strengthening exercises designed for each session.In the central part, the aerobic exercises  were adapted to a gradual progression from low intensity to moderate intensity, equivalent to 40–60% of age adjusted maximum heart rate (220–age) . To achiThe cool-down part consisted of 3 sets of 30 s of static stretching of the major muscles trained and breathing techniques. The exercise protocol used is shown in The type of exercises and the intensity selected for each type of exercise were developed according to the findings described by Busch et al. . All theThe PNE+TE group received 8 face-to-face educational sessions. The sessions were carried out by a medical doctor. The PNE program was performed based on the recommendations described by Butler and Moseley . The sesThe topics explained during the education sessions included the characteristics of acute versus chronic pain, the purpose of acute pain, how acute pain originates in the nervous system, how pain becomes chronic and potential sustaining factors of central sensitization, such as emotions, stress, illness perceptions, pain cognitions and pain behavior. Acute nociceptive mechanisms were explained first and then were contrasted with central sensitization processes. Different examples and metaphors were used to clarify the contents. The education was presented verbally and visually. All the questions or doubts of the participants were answered during the educational sessions or at any moment during the rest of the study. The patients were encouraged to apply the new knowledge in daily life.Sociodemographic information, including gender, age, height, weight, body mass index (BMI) and years since diagnosis were registered for descriptive purposes. The primary outcome variables were pain intensity and mechanical pain sensitivity. Secondary outcome variables were general fibromyalgia impact, psychological distress, pain catastrophizing and quality of life. All the outcome variables were measured at baseline (T0), one week after the 10 week intervention (T1) and at the 3 month follow-up after T1 (T2). T1 was performed one week after finishing the intervention to avoid any related fatigue. Generalized pain intensity was recorded using a 10 cm visual analogue scale (VAS). The ends represented the extreme expressions in which 0 represented “no pain” and 10 “the most intense pain imaginable.” Patients were asked to report pain intensity in the last 3 days. The VAS has been widely used for assessing pain intensity in patients with FMS. This scale has shown an intraclass correlation coefficient (ICC) of 0.97 for patients with chronic pain . The Min2. The algometer score was calculated as the sum of the pain-pressure values obtained for each tender point [Mechanical pain sensitivity was assessed using a standard pressure algometer . The 18 tender points registered in the 1990 ACR criteria were measured . The tener point .The general fibromyalgia impact was assessed by a Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The FIQ-R assesses function, impact and symptoms related to FMS. The FIQ-R ranges from 0 to 100, with 100 indicating maximum FMS impact. This questionnaire has been shown to be reliable with an ICC superior to 0.7 .Pain catastrophizing was evaluated using the Spanish version of the Pain Catastrophizing Scale (PCS). This scale consists of 3 subscales assessing rumination, magnification and helplessness. Each item rated from 0 (no negative thoughts or feelings) to 3 (maximum negative thoughts or feelings). This scale has shown an ICC of 0.84 .Psychological distress was evaluated using the Spanish version of the Hospital Anxiety and Depression Scale (HADS) . This scThe quality of life was measured using the Spanish version of the Health Assessment Questionnaire (HAQ9). The scale assesses the difficulty in performing daily living activities . The HAQ consists of 20 items, each rated from 0 (no disability) to 3 (completely disabled). This scale has shown an ICC ranging from 0.87 to 0.99 .p > 0.05). Baseline demographic and clinical variables were compared between groups using a Student’s t test or the Mann–Whitney U test according to the normally distributed data or non-normally distributed data.SPSS software version 20.0 for Windows was used for statistical analysis . The statistical analysis was conducted according to intention-to-treat (ITT). Mean and standard deviations were calculated for quantitative variables. Normal distribution of the variables was analyzed using the Shapiro–Wilk test  was also calculated to estimate the magnitudes of the within-group differences. The magnitude of the difference was classified as small if the value of Cohen’s d ranged from 0.2 to 0.5; as moderate if it ranged from 0.5 to 0.8; and as large if Cohen’s d was greater than 0.8. Moderate and large magnitudes of effect size were considered indicators of appropriate statistical power [The group by time effects between both groups (PNE + TE and TE) and time points  were calculated using two-way repeated measures analysis of variance ANOVA. A al power .n = 16) or the TE group (n = 16). Four patients dropped out during the study for personal reasons. A flowchart of the recruitment and follow-up of participants is shown in p > 0.05).In total, 36 women were recruited, and 32 women (52.6 ± 10.4 years) diagnosed with FMS who met the inclusion criteria were enrolled in the clinical trial. They were randomly assigned to the PNE + TE group (p = 0.015) at T1. The PNE + TE group showed a greater decrease of pain intensity than the TE group . The between-groups difference was not maintained at T2 . No statistically significant between-group differences were found for the number of tender points , the algometer score , FIQ-R , PCS , HADS  or HAQ . After the intervention, the ANOVA analysis showed a significant group by time interaction for pain intensity (F = 6.64; The within-group change scores and within-group effect sizes for all the variables measured are shown in the To the best of our knowledge, this was the first study to investigate the effects of PNE combined with TE compared to TE in women with FMS. The results of our study showed that the PNE + TE group showed a greater improvement in pain intensity after the intervention compared to TE group. No between-groups differences were found for the number of tender points, mechanical pain sensitivity, impact of FM, pain catastrophizing, psychological distress or quality of life. Both groups reported improvements in the number of tender points, mechanical pain sensitivity and general fibromyalgia impact.Greater improvements were achieved for pain intensity at T1 and at T2 in the PNE + TE group. The change achieved for pain intensity in the PNE + TE group was higher than the MCID stated for patients with chronic pain . The numIt has been described that cognitions and emotions can modulate pain through descending pathways because they are directly connected to different brain areas, such as the limbic system . PatientGeneral fibromyalgia impact, pain catastrophizing, psychological distress and quality of life variables fluctuated somewhat over time, but no statistically significant changes between groups were found. The results of this study showed that PNE + TE is not more effective than TE for improving these variables. According to this, PNE may not contribute to greater benefits in these variables. These results achieved are in accordance with recent publications which concluded that education in isolation seems not to produce improvements in general fibromyalgia impact, pain catastrophizing and quality of life ,45.Although education is a promising approach that allows the therapist to interact and to explain certain information with different examples, the patients’ appreciation and understanding of the information should be assessed. The results reported in this study could be related to the nonspecific factors associated with the face-to-face sessions that were not measured, such as the patient’s emotional processing of the encounter with the healthcare professional, the quality of the therapeutic alliance, the empathic understanding from the clinician and treatment preferences ,47.From a clinical perspective, the results achieved in this study showed that the combination of patient education through PNE plus exercise therapy seems to produce better benefits in the short-term for pain intensity than exercise in isolation. These results are in accordance with the latest EULAR guidelines for the management of FMS . PNE seeSeveral limitations need to be considered. First, the small sample size included in the study, which makes difficult the extrapolation of the results. A larger sample could be more likely to determine differences between the two interventions in the variables that showed no statistical changes. Secondly, all patients were recruited from a fibromyalgia association and showed the motivation to participate in the study; other selection mechanisms should be applied. Third, there was a lack of a control group to control the changes when no intervention was applied; a lack of healthy control group to understand the effects of this program in healthy subjects; and a lack of PNE group who performed PNE in isolation to report the effects of the specific PNE intervention. Fourth, only women were included in the study, so results cannot be extrapolated to the male population. Fifth, a 10 week intervention could be not enough for the management of a chronic condition. Finally, only short-term and medium-term effects were assessed. Future studies should investigate the long-term effects of PNE combined with TE in the male population, and its inclusion in a multimodal approach.The results of this study showed that the combination of PNE and TE was more effective than TE for reducing pain intensity at short-term. No differences were found for psychological distress, pain catastrophizing and quality of life after the intervention or at 3 months of follow-up.


Preoperative anxiety and depression were evaluated by the Hospital Anxiety and Depression Scale (HADS), and the quantitative and qualitative dimension of early postoperative pain were evaluated by the McGill Pain Questionnaire Short Form (MPQ-SF). Furthermore, the postoperative analgesia protocol was recorded for each patient. Pain declined gradually during the first 24 h postoperative. Although preoperative anxiety had no correlation with the overall pain of postoperative Day 0, patients with a higher level of preoperative anxiety had significantly more intense and more unpleasant pain at 1 h post operation. In addition, depression influences both the intensity and unpleasantness of pain at different time points . Preoperative pain correlated with educational level, but not with age, BMI, gender, marital status, smoking and surgery type. In conclusion, preoperative anxiety and depression influence the early postoperative pain after bariatric surgery, and their preoperative identification is of major importance to enhance the implementation of fast-track postoperative protocols to prevent complications and prolonged hospitalization.Uncontrolled postoperative pain and prolonged immobilization after bariatric surgery have been associated with increased postoperative complications and prolonged hospitalization. The aim of our study was to evaluate the postoperative pain that follows bariatric surgery and identify any psychological factors that may affect the early postoperative perception of pain. The study included 100 patients with obesity (women,  When ng world ,7,8. Barng world . The obeng world  and the ng world ,12. Techng world .Currently, the most common bariatric procedures worldwide are the laparoscopic Roux-en-Y gastric bypass (LRYGB) and the laparoscopic sleeve gastrectomy (LSG) ,13. The Pain is a subjective experience that is characterized by its intensity and its quality characteristics. The quality characteristics of pain are described by words that reflect (a) the sensory qualities of pain in terms of temporal, spatial, pressure, thermal and other properties; and (b) the affective qualities of pain in terms of tension, fear and autonomic properties that are part of the pain experience . The senIdentifying the psychological factors affecting the postoperative perception of pain for this group of patients may lead to more efficient pain protocols, thus enhancing the implementation of fast-track bariatric protocols ,28,29. T2, laparoscopic bariatric procedure of LSG or OAGB, and patients with I and II physical status according to the classification system of the American Society of Anesthesiologists. The exclusion criteria were history of bariatric or other upper abdominal surgery, diagnosis of a psychiatric disorder, diagnosis of chronic pain, intraoperative placement of a drain, simultaneous cholecystectomy, and postoperative complication and reoperation. In total, 100 patients  were eligible to participate in our study. The sample size (n = 100) of the study was determined using the statistical software G*Power 3.1.9.6 for macOS  considering tail one, effect size 0.3, error probability alpha 0.05 and power (1-error probability beta) 0.93 for correlational analysis.The study was approved by the Institutional Human Subjects Review Board of our hospital. During a 2-year period (2016–2018), 250 patients with obesity underwent bariatric surgery at our Laparoscopic Bariatric Unit. Our inclusion criteria were as follows: age 18–65 years, BMI ≥ 30 kg/mPrior to the experimental procedures, the patients were informed in writing and orally about the surgical procedure and the survey protocol. After signed written consent was obtained, all patients were asked to complete a questionnaire about their medical history, socioeconomic status and the Hospital Anxiety and Depression Scale (HADS). In the intraoperative period, the researcher provided a questionnaire about the surgery and analgesia protocol. All patients were asked to complete the Greek version of the McGill Pain Questionnaire Short Form (MPQ-SF) ,31 durinThe research protocol predetermined the intraoperative and postoperative analgesia consisting of a bolus intravenous infusion of 1gr paracetamol plus 2 mcg/kg fentanyl 30 min before the animation. Postoperatively, the protocol consisted of an intravenous infusion (IV) of 1gr paracetamol every 6 h, in addition to a fentanyl solution (10 mcg/mL) infusion through a patient-controlled analgesia (PCA) pump, with a stable rate of 2.5 mL/h. Furthermore, the PCA pump allowed patients to self-administer small IV doses of fentanyl (2 mL) with a lockout interval of 10 min. The self-administrated fentanyl volume during the first 24 h was recorded for each patient.HADS is a tool to measure the feeling of anxiety (HADS-A) and depression (HADS-D) . It is uPostoperative pain was evaluated by using the validated Greek version of MPQ-SF ,31. The p < 0.05. Analyses were conducted using SPSS statistical software .Parametric (mean ± SD) and non-parametric statistics (median and interquartile range) described variables. Despite the use of variables described by ordinal scales, we presented data with both parametric and non-parametric statistics to have comparable data with the literature ,30. The The operations performed were LSG on 58 patients (58%) and laparoscopic OAGB on 42 patients (42%). The preoperative feeling of anxiety and depression was evaluated using the HADS. With respect to the preoperative level of anxiety, 76% of patients were assessed as having a normal level, 15% as having a border-line level and 9% as having an abnormal level. As for the preoperative depression level, 89% were assessed as having a normal level, 7% as having a border-line level and 4% as abnormal. The mean values of the sample’s preoperative anxiety and depression levels were both normal (0–7 points). The mean preoperative anxiety score was at 4.24 (out of 21), and the mean preoperative depression score at 5.78 (out of 21) .At POD #0, the NRS was 4.61 (out of 10), the PPI was 1.79 (out of 5), the sensory score was 6.32 (out of 33), the affective score was 2.81 (out of 12) and the SFMPQ total was 9.16 (out of 45) . Althougp = 0.042) and the average score on the Sensory (p = 0.048), affective (p = 0.049) and total emotional score SFMPQ (p = 0.043), with patients in more pain seeking extra analgesic drugs by using the PCA pump.The need for extra bolus infusions of the analgesic drug through the Patient Controlled Analgesia (PCA) pump during the POD #0 was recorded; patients’ attempts were 19.0 ± 14.7, while the amount of analgesic drug delivered from the attempts was 0.4 ± 0.3 mg. p ≤ 0.05) with all pain parameters’ ratings . Patients with a higher educational level experienced more severe pain both in terms of quality and intensity during the first 24 hours. Furthermore, the multiple linear regression analysis between the bolus infusions of the analgesic drug through the PCA attempts showed no association with all the above characteristics  with pain ratings for the first 24 postoperative hours. The educational level had a positive association  but extract an important influence on severity and unpleasantness of pain  at the 4th postoperative hour. Furthermore, patients with higher levels of preoperative depression report less severe unpleasantness (affective and SF-MPQ score) at the 24th postoperative pain measurement .Many studies have demonstrated a higher prevalence of psychological disorders among obese patients who are candidates for bariatric surgery ,34,35. IIt is well known that psychological factors play a role in the perception of postoperative pain ,25,36. TIn this study, pain control during the first eight postoperative hours was insufficient, with patients experiencing severe and distressing pain at the 1st postoperative hour decreasing to moderate pain 4 h after the surgery and persisting until the 8th postoperative hour. Furthermore, anxiety seemed to play a role on pain perception at the 1st postoperative hour, with patients with higher levels of preoperative anxiety experiencing more severe pain in terms of intensity and quality. This finding confirmed the results of previous studies showing that anxiety is a significant positive predictor of severe pain shortly after the operation ,38. MoreAn unexpected finding of our study was the impact of preoperative depression on the affective dimension of pain at the 24th postoperative hour measurement. Patients with higher levels of preoperative depression experienced less unpleasantness (affective component) of pain 24 h after the surgery. Moreover, it also influenced the total perception of pain in terms of pain sensation at this time point . Studies evaluating the experimental pain in depressive patients have reported equivocal results, with some describing increased or decreased pain thresholds  dependinAnother interesting finding is that patients’ educational level is an independent factor influencing the perception of quantitative and qualitative characteristics of pain, with patients with higher educational levels reporting more severe pain during the POD #0 after a bariatric surgery. This positive correlation was significant with all the MPQ-SF parameters. On the other hand, age, gender, BMI, marital status, smoking and type of surgery had no influence on postoperative pain. Our findings are supported by the results of other studies about bariatric surgery, which reported that gender, age, surgical technique and smoking are not related to postoperative pain ,45,46. HIn conclusion, preoperative anxiety and depression and a high educational level are factors influencing the qualitative and quantitative dimension of early postoperative pain during the first postoperative day (POD #0). The preoperative identification of these factors may be useful for designing personalized and time-dependent postoperative analgesic protocols to improve clinical outcomes. Furthermore, regular and systematic pain assessment during different time points at the POD #0 after bariatric surgery is essential for the efficient control of early postoperative pain. The efficient control of early postoperative pain enhances early mobilization and promotes the implementation of fast-track bariatric protocols. This strategy is of major importance due to the susceptibility of bariatric patients to postoperative complications.


In this randomised, controlled trial, the participants were randomly assigned to the experimental group or placebo group. The experimental group was assisted with manual therapy sessions based on connective tissue massage, whereas the placebo group was “treated” with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo. Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29) were completed before and after the intervention. In the experimental group , significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia (p < 0.001). Correlations showed a relationship between fatigue and sleep variables  and pain variables with the POMS anger-hostility subscale . Although the size of the sample could be a limitation, the study concluded that the application of manual therapy in fibromyalgia patients performed with moderate pressure for 15 min on the posterior cervical musculature decreased the perception of pain, muscle fatigue, and the state of tension-anxiety.Fibromyalgia is a condition characterised by chronic widespread muscle pain and fatigue, sleep disturbances, cognitive disorders, and mood disturbance. The purpose of this study was to determine the effectiveness of a manual therapy technique performed with moderate digital pressure in women with fibromyalgia ( Fibromyalgia (FM) is a chronic musculoskeletal disease of unknown aetiology and is characterised by pain diffused throughout the body and hyperalgesia. Patients with FM also have functional and emotional disorders, including persistent fatigue, sleep disturbances, paresthesia, cognitive disorders, and mood disturbance . Until 2In the absence of definitive pathology, the critical aspect for evaluating FM patients relies upon patients to report the presence and degree of symptoms . BecauseWhile fatigue is a common complaint for individuals with fibromyalgia, pain is the defining characteristic for diagnosing it . One of Poor sleep is reported by almost 80% of patients with fibromyalgia . EpidemiAnxiety, which is a key symptom in fibromyalgia, is associated with higher levels of pain and neuropsychological disorders in these patients . It is aSevere anxiety and/or depression can impede the ability to comply with nonpharmacological therapy, which is why interactions with chronic pain and fatigue can become cyclical and self-perpetuating. In FM, it is known that a negative mood can lead to a poor perception of physical health . DepressThe complex symptomatology of FM mainly involves three areas: aspects of physical health , pain regulation mechanisms (neuroendocrine system), and factors related to psychological well-being and mental health . DespiteRandomised controlled trials have shown that multiple nonpharmacological treatments such as psychotherapy, exercise therapy, education, and physiotherapy are effective in the reduction of FM symptoms . The maiManual therapy has been defined in different ways, one of them as the manipulation of soft tissues and joints using the hands and another as the systematic mapping of soft tissue with rhythmic pressure to prevent, develop, maintain, rehabilitate, or increase physical function or relieve pain . In physDespite this, Cimmino et al. has observed that massage is the therapeutic modality used by 75% of patients with fibromyalgia . HoweverThe application of different types of massage in FM patients, including connective tissue massage, has benefits in terms of improving FM symptoms, especially pain, anxiety, and depression , howeverFurthermore, with the intention to improve knowledge about FM symptoms and its management, the aim of the study was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in FM patients on the variables of fatigue, pain, sleep, anxiety, and mood. This was done to provide another alternative treatment to pharmacological therapies for FM patients and to provide new evidence on the effects of manual therapy in FM patients.This was a randomised clinical trial in which the participants were allocated to one of two groups: an experimental group or a control group in order to determine the effectiveness of a manual therapy technique performed with moderate digital pressure on the variables of fatigue, pain, sleep, anxiety, and mood in women diagnosed with fibromyalgia. The subjects were randomly assigned electronically by block design into two arms  using online computer software according to published recommendations . A resean = 14) were assisted with manual therapy sessions and those of the placebo group (n = 10) were treated with ultrasound sessions (US) performed without conductive gel and with the machine turned off as a placebo.Twenty-four female adult fibromyalgia syndrome patients aged 47 to 59 (53 ± 6) were recruited from local rheumatology practices in this randomised, controlled trial. The women studied had an average education level. They were recruited from public fibromyalgia associations in Alicante (Spain). All patients were chronic and they were interviewed and clinically evaluated in order to verify their eligibility by different physical therapists, using the same protocol and at the same time of day, both in the weeks of the intervention and in the week before and after the intervention (weeks 0 and 5). The participants of the manual therapy group (The present study was performed in accordance with the standards of the Helsinki declaration. The University Human Research Ethics Committee of Alicante University (Spain) granted approval to conduct a randomized trial (UA-2019-04-10) and all study participants provided written consent prior to the experiment. Furthermore, researchers kept confidential all participants’ personal data, codifying the personal information for that purpose. This study was also registered as a Clinical Trial in clinicaltrial.gov (Ref. NCT04158388).Only female adults were included in this study. Before the study period, women who were assessed by a rheumatologist to determine the fibromyalgia diagnosis according to the criteria established by the American College of Rheumatology fibromyalgia diagnosis criteria in 2016  were incThe intervention was performed in one month. Each group had two weekly sessions following the recommendations  for fourRecently, the Agency for Healthcare Research and Quality highlighted in its 2018 review update that chronic neck pain is one of the most common conditions in patients with chronic pain, the main characteristic of FM patients. Because Swedish massage is a massage that is characterised by general application, it is not recommended for FM patients .For that reason, the manual therapy group received a manual therapy treatment based on a digital manual therapy. This manual therapy was performed on the connective tissue at the back of the neck with moderate pressure following bibliographic recommendations ,35; thisFatigue was measured using the fatigue severity scale (FSS); a Likert scale consisting of nine items that assess fatigue severity and functionality . Items wR = 0.94, p < 0.001) than illiterate patients  before and after attending a rheumatology outpatient clinic [For pain perception, the visual analogical scale (VAS), commonly employed to assess the perception of somatic pain intensity, was used . Validatt clinic .Pittsburgh sleep quality index (PSQI) , validatAn abbreviated Spanish version of the profile of mood states (POMS-29) developed by McNair et al.  was used2) effect sizes for the time × group interaction effects were calculated. An effect of η2 ≥ 0.01 indicates a small, ≥0.059 a medium, and ≥0.138 a large effect. For those variables that showed significant main effects, post-hoc tests (Bonferroni) were performed. Furthermore, Pearson’s correlation test was used to establish relationships between the study variables. The level of significance was set at p ≤ 0.05. The effect size (ES) was calculated following the guidelines of Cohen [Statistical analysis of data was performed with JASP Team (2020) . For descriptive statistics (mean ± standard deviation) and inferential analysis, the Shapiro–Wilk test was performed to establish the normality distribution. Subsequently, independent sample t-tests were carried out to compare baseline values between groups. In addition, Levene’s test was conducted for equality of variances and analysis of covariance (ANCOVA) was applied  to analyse the effects of the intervention on outcomes. Eta squared  and placebo group (PG). Over the follow-up period, six participants withdrew from the trial, one from the MTG and five from the PG. Therefore, 24 women were included in the analysis. Both groups of women did not differ on demographic variables. All withdrawals were due to personal reasons .p = 0.038).p < 0.001; η2 = 0.093) in the pain scale. The post hoc analysis showed a decrease between pre- and post-intervention in the manual therapy group . In addition, inter-group differences were found  in favour of the manual therapy group. However, no significant effects were found in any other variable.re found  after thp = 0.046). A significant positive association was also observed between the pain variable and the anger–hostility subscale of the POMS . Except the significant associations between the POMS questionnaire and its own subscales, significant correlations between variables were not identified.The analysis of the correlations between all participants and each variable are shown in The aim of this study was to analyse the effectiveness of a manual therapy performed with moderate pressure on the variables of muscle fatigue, pain, sleep, and mood state in women with fibromyalgia. The effectiveness of a manual therapy in healthy people seems evident , howeverIn terms of the benefits of manual therapy for patients, it promotes restful sleep, decreases anxiety and depression, and reduces the immediate and delayed perception of pain ,26. RegaIt seems necessary to provide conclusive data to allow the use of manual therapy by health professionals as an alternative technique to other treatments with greater disadvantages such as drug treatments ,50. ThisIt is necessary to emphasise the importance of performing the massage with moderate pressure as described in the methodology and also to reach this pressure in an increasing way, as recommended by other authors . The sigBased on the results of the FSS, the state of fatigue was not significantly reduced after the intervention. Fatigue is a factor that can be associated with morning stiffness . The curOne of the main reasons why FM patients seek medical care is musculoskeletal pain, along with sleep disorders . As obseAlthough manual therapy has been shown to promote restful sleep in FM patients , no signPersons with chronic pain are more likely to have depressive symptoms than those without pain . FM patiLimitations of this study include the small sample size and the short-term assessment. In addition, while all attempts were made to standardize the delivery of the massage routine provided in this study, we did not control for the amount of pressure provided. This would be an important consideration for future studies, given that there is evidence that different amounts of pressure can elicit unique responses ,53. In oThis investigation suggests that manual therapy with digital moderate pressure for 15 min on the posterior cervical musculature decreases the perception of pain in women with FM. In this sense, it seems that this technique could be considered as another alternative to pharmacological therapies for the treatment of FM.


Recently, ultrasound- (US-) guided selective nerve root block (SNRB) has been reported to have similar effects compared to fluoroscopy- (FL-) guided cervical epidural steroid injection (CESI). There is no published study comparing the therapeutic efficacy and safety of interlaminar- (IL-) CESI and transforaminal- (TF-) CESI with US-guided SNRB. Our retrospective study aimed to compare the mid-term effects and advantages of the US-guided SNRB, FL-guided IL-CESI, and TF-CESI for radicular pain in the lower cervical spine through assessment of pain relief and functional improvement. n = 44) or FL-guided IL (n = 41) or TF-CESI (n = 37) were included in this retrospective study. All procedures were performed using a FL or US. The complication frequencies during the procedures, adverse event, treatment effects, and functional improvement were compared at 1, 3, and 6 months after the last injection.  Patients with radicular pain in the lower cervical spine who received guided SNRB (P < 0.05). Furthermore, the treatment success rate at all time points was not significantly different between groups. Logistic regression analysis revealed that the injection method (US- or FL-guided), cause, sex, age, number of injections, and pain duration were not independent predictors of treatment success. Blood was aspirated before injection in 7% (n = 3), 14% (n = 6), and 0% patients in the FL-guided IL, TF, and US-guided groups, respectively. In 2 patients of FL-guided IL and 7 of FL-guided TF group, intravascular contrast spread was noted during injection.  Both the Neck Disability Index (NDI) and Verbal Numeric Scale (VNS) scores showed improvements at 1, 3, and 6 months after the last injection in all groups, with no significant differences between groups ( Our results suggest that, compared with FL-guided IL and TF-CESI, US-guided SNRB has a low intravascular injection rate; it is unlikely that serious complications will occur. Also, US-guided SNRB requires a shorter administration duration while providing similar pain relief and functional improvements. Therefore, for the treatment of patients with lower cervical radicular pain, US-guided SNRB should be considered as a prior epidural steroid injection. Cervical radiculopathy is a common condition with an annual incidence of 83 per 100,000 , 3. In gRecently, various study groups, including ours, have shown the reliability of ultrasound (US) guidance for cervical selective nerve root block (SNRB) –7. BecauSince Galiano et al.  reportedTo the best of our knowledge, no published study has compared the therapeutic efficacy and safety of FL-guided IL-CESI and TF-CESI with those of US-guided SNRB. Accordingly, the aim of this retrospective study was to evaluate and compare the mid-term (6 months) effects of US-guided cervical SNRB and FL-guided TF-CESI/IL-CESI on pain and function in patients with lower cervical radicular pain. In addition, safety and procedure times were assessed as secondary outcomes.This was a retrospective comparative review of chart data. Patient privacy and data confidentiality were maintained throughout the research process. The institutional review board of the corresponding author's affiliated university approved the study. The approval included a waiver of informed consent because there was no direct contact with the study population and all patient identifiers were removed from the dataset on initial collection.Potential study participants were patients who received US-guided SNRB or FL-guided TF-ESI/IL-ESI at our outpatient rehabilitation department and pain clinics between 2015 and 2017. On the day of the procedure, before injection, all patients were requested to fill out self-assessment questionnaires regarding their baseline information . The electronic clinical records and questionnaire responses were retrospectively reviewed for the collection of data and determination of compliance with the inclusion criteria for the study.We selected patients aged >18 years who received US-guided SNRB or FL-guided TF-ESI/IL-ESI for the treatment of lower cervical radicular pain that lasted for at least 3 months. Cervical radicular pain was diagnosed on the basis of clinical profiles, medical examinations, and the confirmation of disc herniation or spinal stenosis via cervical computed tomography or magnetic resonance imaging. None of the patients had responded to conservative treatments administered for at least 4 weeks, including analgesic use  or opioids) and physical therapy. The score for self-reported neck pain on the Verbal Numeric Scale (VNS) was at least 5 points, with symptoms present on most days for at least 3 months. The exclusion criteria included psychiatric disorders, neurological deficits, cervical myelopathy, laboratory results suggestive of inflammatory disease or rheumatoid disorders, and a history of cervical spine surgery.US-guided SNRB or FL-guided TF-ESI/IL-ESI is commonly used for the treatment of symptomatic lower cervical radicular pain at our institution. The patient is provided detailed information about the procedure and the expected benefits and risks, following which consent is obtained.The procedures were performed by two physicians . All treatments were performed as outpatient procedures. Accuvix XQ®  with a 612 MHz linear probe was used as the US instrument –6. The pThe FL-guided TF-ESI procedure was performed by the same physician. All treatments were performed on an outpatient basis. The patient positioning and disinfection procedure for the injection site were identical to those described for US-guided SNRB.The fluoroscopic apparatus KMC 950  was adjusted such that a proper oblique and well-defined view of the intervertebral foramen was obtained. Following the application of 1% lidocaine for local anesthesia at the targeted area, the distal 5 mm end of a 22 G Spinocan® needle  was bent by approximately 15°20°. The angulated needle end was carefully tilted toward the posterior side until it contacted the medial surface of the superior articular process, which formed the posterior side of the targeted foramen. When the needle end contacted the superior articular process, the needle was rotated by 180° and advanced forward for 2-3 mm under continuous FL guidance. The depth of the fluoroscopic apparatus was adjusted under the anteroposterior view for location of the needle end at the center of the articular pillar. Cerebrospinal fluid and blood absorption tests were performed for the detection of possible blood traces in nontargeted areas. For confirmation of shadowed contrast of the foramen, nerve root, epidural space, and other related structures, fluoroscopic images were continuously monitored during injection of the nonionic contrast medium Omnipaque 300 . Then, 1 ml of 1% lidocaine was injected once the needle was repositioned for vessel infusion, the images of the nerve root showed appropriate shadowed contrast, and the contrast medium was not identified within any proximal vessel. The patients were monitored for the onset of clinical manifestations, such as mid-neck and contralateral arm pain, metallic taste, dizziness, tachycardia, full-body paresthesia, auditory changes, slurred speech, and motor ataxia for 1 to 2 minutes after the injection . On confFor FL-guided IL-CESI, the patient was placed in the prone position. A pillow was placed under the chest for shoulder elevation, which helps in widening the IL space by flexing the spine. The KMC 950 (KOMED) was used for all injections. The skin of the posterior neck was prepared and draped in sterile fashion, and the epidural space between C5 to C7 and T1 was entered. A 22 G Spinocan® needle (BRAUN) was then advanced into the posterior epidural space via a midline approach. If the needle was just posterior to the spinolaminar line on the lateral view, it was advanced very carefully by twirling and opening of the ligamentum flavum with intermittent injection of Omnipaque 300  until it spread smoothly in the epidural space. When the contrast material was spreading in the epidural space, needle advancement was stopped and the location of the needle tip in the epidural space was confirmed by an additional test injection of contrast agent. Then, 3 cc of the treatment drug, which comprised 2 ml of dexamethasone (10 mg) and 1 ml of 0.5% lidocaine, was injected into the epidural space .The patients were scheduled to receive two consecutive therapeutic injections, with a 2-week interval between injections. If the initial injection resulted in significant symptom reduction (VNS ≥ 50%), the second injection was omitted. If there was no pain relief or the pain worsened, or if the patient satisfaction rating was equal to or below “fair,” the second injection was not considered. If the patient satisfaction score was “good” despite a VNS score improvement of <50%, the second injection was scheduled.Because none of the patients had shown any improvement with medications such as analgesics (NSAID or opioid) and physical therapy for 4 weeks, we did not set any limit for continuation of previous exercise programs and drug therapy or return to work. No specific physical therapy, occupational therapy, bracing, or other specific intervention was utilized.A standardized chart abstraction form was used for the extraction of data regarding demographics, treatments, pain severity, analgesic use, and functional assessments. A nursing personnel not involved in the procedure conducted follow-up interviews during a hospital visit at 1, 3, and 6 months after the last injection.Primary outcomes included Neck Disability Index (NDI) scores and VNS scores for pain, which were recorded before injection and at 1, 3, and 6 months after the last injection. The degree of physical disability was measured using NDI, which is the most widely used questionnaire survey for the assessment of cervical spine abnormalities. NDI was first developed for evaluation of the degree of limitations in the daily lives of patients with severe cervical pains, particularly those with whiplash trauma . It inclThe patient satisfaction score was calculated using a five-point scale at 2 weeks after the first injection: <0, no effect at all; 1, bad; 2, fair, 3, good; and ≥4, excellent. The meaning of each satisfaction level was as follows: excellent, “satisfied with the treatment result as expected”; good, “not as much as expected but willing to try this treatment next time when pain redevelops”; fair, “had some effect but not enough to choose the same treatment next time when pain redevelops”; and bad, “same effect as that of the prior treatment or worse” .Patients with a VNS score improvement of >50% and NDI score improvement of >40% were categorized as responders , 12. PatThe procedure duration was also recorded. For US-guided SNRB, the procedure duration was defined as the time interval between contact of the US probe with the patient's skin and completion of injection , 14. ForFinally, we reviewed the charts for immediate adverse events such as vasovagal reaction, facial flushing, and brief severe neck pain within a few minutes after injection. The patients were handed a questionnaire at the end of the procedure, which had to be completed within 48 h and returned at the 2-week follow-up visit.P value of <0.05 was considered statistically significant.Pearson's chi-square test and one-way analysis of variance (ANOVA) were used to compare variables such as sex, age, body mass index (BMI), number of injections, analgesic use, anticoagulant use, and the pain duration among the three groups. At each time point , VNS and NDI scores were compared using repeated measures ANOVA with Bonferroni's correction for post hoc comparisons. Pearson's chi-square test was used to test differences in proportions, while one-way ANOVA was used to compare the procedure duration among groups. Univariate and multivariate logistic regression analyses with Pearson's chi-square test were used to determine whether the injection method, age, sex, analgesic use, and the number of injections were independent predictors of treatment success. All statistical analyses were performed using SAS Enterprise Guide 4.1 (4.1.0.471). A A total of 227 patients, including 81, 78, and 68 who received US-guided SNRB, FL-guided IL-CESI, and FL-guided TF-CESI, respectively, had received injections during the study period. From these, 69 (30.3%) patients were excluded because they did not complete and return the follow-up surveys. Another 36 (15.8%) were excluded on grounds of the exclusion criteria. Eighteen patients (7.9%) who had previously undergone surgeries and six (2.6%) with underlying rheumatoid arthritis were also excluded. 12 (5.2%) patients were excluded as other causes. Eventually, 122 (53.7%) patients, including 44, 41, and 37 who received US-guided SNRB, FL-guided IL-CESI, and FL-guided TF-CESI, respectively, were included .The average age of patients in the US-guided SNRB, FL-guided IL-CESI, and FL-guided TF-CESI was 52.9 ± 11.9, 54.8 ± 10.3, and 56.0 ± 9.8 years, respectively, with no significant differences among the three groups. Moreover, there were no significant intergroup differences in sex, BMI, the number of injections, the etiology , target nerve root, analgesic use, anticoagulant use, and the pain duration .n = 36) in this group. In the FL-guided IL-CESI and FL-guided TF-CESI groups, eight and seven patients, respectively, had received repeat injections, and one and two patients, respectively, had undergone surgery at 1 month. Thus, the 1-month treatment success rates were 78% (n = 32) and 75.7% (n = 28), respectively. At 3 months, nine, eight, and four patients had received repeat injections in the US-guided SNRB, FL-guided IL-CESI, and FL-guided TF-CESI groups, respectively, with corresponding treatment success rates of 61.4% (n = 27), 58.5 (n = 24), and 64.9% (n = 24). At 6 months, two patients had received repeat injections and one had undergone surgery in the US-guided SNRB group, one patient had received repeat injections and two had undergone surgery in the FL-guided IL-CESI group, and five patients had received repeat injections in the FL-guided TF-CESI group (n = 24), 51.2% (n = 21), and 51.4% (n = 19), respectively , sex, age, the number of injections, and the pain duration were not independent predictors of treatment success  or TF-CESI (382 seconds) group.n = 6), 13.5% (n = 5), and 0% patients in the FL-guided IL-CESI, FL-guided TF-CESI, and US-guided SNRB groups, respectively. Intravascular contrast spread was noted during injection in seven patients in the FL-guided IL-CESI group and eight in the FL-guided TF-CESI group.Immediately after the procedure, five patients in the US-guided group, three in the FL-guided IL-CESI group, and four in the FL-guided TF-CESI group experienced vasovagal reactions, while three, three, and four patients, respectively, developed a transient headache. Overall, at the 2-week follow-up session, two patients in the US-guided group, two in the FL-guided IL-CESI group, and three in the FL-guided TF-CESI group reported transient pain exacerbation (in the head or upper limbs) at 48 h after the procedure. No patient reported headache suggestive of postpuncture syndrome, and no cases of infection or hematoma were recorded during the 2-week follow-up period. Blood was aspirated before injection in 14.6% (In this retrospective study, US-guided SNRB, FL-guided TF-CESI, and FL-guided IL-CESI resulted in clinically meaningful and significant improvements in all parameters at the end of a mid-term period of 6 months after the last injection, with treatment success rates of 54.5%, 51.2%, and 51.4% in the US-guided SNRB, FL-guided TF-CESI, and FL-guided IL-CESI groups, respectively. The treatment success rates at 1, 3, and 6 months after the last injection were comparable among groups. However, the duration of US-guided SNRB was shorter than that of the FL-guided procedures. We speculate that the greater efficiency conferred by US guidance stems from the inherent difficulties related to FL. Pain control and functional improvements were similar in all three groups. To the best of our knowledge, this is the first study to compare the treatment efficacy and the injection efficiency with regard to the procedure duration among US-guided SNRB, FL-guided IL-CESI, and FL-guided TF-CESI over a 6-month follow-up period in patients with lower cervical radicular pain.ESI is currently used for the treatment of cervical radicular pain . Two appAs mentioned earlier, FL-guided TF-ESI has been associated with rare but devastating complications, including paralysis and death . The injAlthough US guidance can help in avoiding intravascular injections, it may not be able to detect such injections . To prevIn the present study, the treatment effect was similar for all three methods. It is hypothesized that the injected drug may not enter the lesion sufficiently during US-guided SNRB because the target point is more distal than that for FL-guided injection; this can reduce the effectiveness of the treatment. Jee et al.  reportedAnother main advantage of US-guided SNRB, in addition to no radiation exposure, is direct real-time visualization of vessels and nerves, which is particularly beneficial for injection in areas packed with a multitude of vulnerable vessels and other vital soft tissue structures that are compacted in a small area and are often in the path of the projected needle trajectory , 32. In However, US-guided SNRB also has several disadvantages compared to the FL-guided methods. First, Although US may assist in avoiding intravascular injections, it is not clear if it can help to detect such injections –9. To soThis study has several limitations. First was the retrospective design. Although patients were selected on the basis of extensive inclusion and exclusion criteria, there may have been heterogeneity in the selected sample. Nevertheless, patient demographics and the clinical and imaging parameters before treatment and at each follow-up visit are documented in a standardized format in the case records of patients receiving injections at our institution. Second, we could not entirely prevent the use of other treatments such as medication and physical therapy during the follow-up period. Third, we did not use FL to confirm appropriate injection of the drug into the targeted area during US-guided SNRB, and this could have affected the results. Further studies that address these limitations are necessary.In summary, the findings of this study suggest that the outcomes of US-guided SNRB and FL-guided IL-CESI/TF-CESI for lower cervical radiculopathy are similar in terms of pain reduction and functional improvements. However, US-guided SNRB is not associated with radiation exposure and requires lesser time. Thus, it helps clinicians in identifying and avoiding vessels in and around the injection trajectory. Accordingly, US-guided SNRB could be considered as the first choice of treatment for lower cervical radicular pain. However, although intravascular events can be avoided by using the US-guided approach, confirmation of the absence of small critical vessels may not be possible with the current US technology. Further studies are necessary to clarify our findings.