Two additional logistic regression models also showed that depression  and functionality  can significantly predict the classification of chronic SP as centrally sensitized. Patients who were classified as centrally sensitized (n = 10) were found to have significantly worse functionality, psychological factors , and pain intensity (p < 0.05). Catastrophizing, depression, and functionality are predictive factors of CS symptoms in patients with chronic shoulder pain. Health care providers should adopt a precision medicine approach during assessment and a holistic rehabilitation of patients with unilateral chronic SP.The recognition of central sensitization (CS) is crucial, as it determines the results of rehabilitation. The aim of this study was to examine associations between CS and catastrophizing, functionality, disability, illness perceptions, kinesiophobia, anxiety, and depression in people with chronic shoulder pain (SP). In this cross-sectional study, 64 patients with unilateral chronic SP completed a few questionnaires including the Central Sensitization Inventory, the Oxford Shoulder Score, the Tampa Scale for Kinesiophobia, the Hospital Anxiety and Depression Scale, the Pain Catastrophizing Scale, the Brief Illness Perception Questionnaire and the “arm endurance” test. On the basis of three constructed linear regression models, it was found that pain catastrophizing and depression (model 1:  In chronic shoulder pain (SP), similarly to other chronic musculoskeletal disorders, several studies have confirmed that the extent of tissue damage may not be related to the occurrence or intensity of SP. Therefore, only a diagnosis of structural pathology in people with SP may not provide adequate information for schema therapy in clinical practice ,2,3. Modern pain neuroscience has given us new insights into understanding chronic pain, including the role of central sensitization (CS) in the presence and amplification of chronic pain experiences ,5. CS isPain is always a personal experience that is influenced to varying degrees by biological, psychological, and social factors” [. It has been suggested that increased chronic pain and disability are associated with amplified levels of psychosocial distress in people with chronic SP [In an effort to understand why only a subgroup of chronic pain patients presents CS, researchers have studied the influence of psychological factors on chronic pain. The revised definition refers that “factors” . Psycholfactors” ,25,26. Hfactors” ,27. It hronic SP , althougronic SP . CS seemronic SP ,30,31,32Psychosocial and cognitive behavioral factors such as incorrect illness perceptions, pain catastrophizing, anxiety, depression, and fear-avoidance play a role in the transition from acute to chronic pain ,34 and cIn the current study, the main aim was to examine associations between symptoms of CS and pain catastrophizing, functionality, disability, illness perceptions, kinesiophobia, anxiety, and depression in people with chronic SP. Second, this study aimed to compare the above-mentioned outcome measures between patients presenting and those not presenting symptoms of CS to a clinically relevant degree in a sample of patients having unilateral chronic SP. The present study is a cross-sectional study concerning patients with chronic shoulder pain who present or not symptoms of CS and follows the STROBE guidelines . The ethA total of 66 participants who suffered from chronic SP were recruited from an orthopedic clinic. Chronic SP was defined as unilateral SP lasting for 3 or more months, with a pain intensity of at least 3 on a 0–10 numerical pain rating scale (on most days of the last 3 months) and the presence of at least 2 positive provocation tests  . SP condExclusion criteria included: traumatic musculoskeletal shoulder pain, SP considered to be originated from the cervical region, systemic diseases , fibromyalgia, neurological dysfunction, cancer, shoulder surgery, participants with SP after fracture, being pregnant or given birth in the preceding year, overconsumption of alcohol or any other recreational drug, an inability to provide informed consent, and/or incomplete questionnaires’ responses. Patients were required to continue with the usual care at least 6 weeks prior to study participation to obtain a steady state. The sample of our study was calculated on the basis of the “rule of 10” for regression models .Initially, patients were invited to complete a demographic form. Then, they completed a few questionnaires in random order and performed a functional task. The symptoms related to CS were assessed using the Central Sensitization Inventory (CSI-Gr). The CSI contains a “part A” of 25 statements related to current health symptoms, indicative of CS . A mean score of 40 is the cut-off value for CS . The samSelf-reported questionnaires included the Oxford Shoulder Score (OSS), the Tampa Scale for Kinesiophobia (TSK), the Hospital Anxiety and Depression Scale (HADS), the Pain Catastrophizing Scale (PCS) and the Brief Illness Perception Questionnaire (BIPQ). All self-reported questionnaires have been cross-culturally adapted in Greek and used in previous studies ,47,48,49Self-report functional ability was assessed with the Oxford Shoulder Score in Greek . The OxfThe self-reported Tampa Scale for Kinesiophobia is a 17-item questionnaire developed to investigate fear of movement or re-injury . Each quThe assessment of anxiety and depression was performed using the Hospital Anxiety and Depression Scale (HADS) in Greek. The HADS scale has been adapted culturally and used by a sample of patients that were treated in a general hospital, as well as in community volunteers . The weiThe Brief Illness Perception Questionnaire (B-IPQ) in the Greek version was used to assess patients’ perception of the disease. It studies the cognitive and emotional perceptions of patients about their condition, including consequences, duration of development, self-management, control through treatment, personality, understanding of illness, and worries and emotions on a continuous scale from 0–10 in 8 items. Respondents also had the opportunity to list the 3 most important causal factors in their disease. Its original form has shown good indicators of control-reassurance reliability and predictive validity . The queCatastrophic thoughts were estimated with the Pain Catastrophizing Scale . The PCSThe functional task included the arm endurance test. This test measured the time the patient could hold both arms horizontally out to the side depicting small circles. The test was stopped when the time was more than 90 s or participants’ fingers did not remain above a line level with the elbow when the arm was dependent .To prevent test order effects, the order of questionnaires’ measures was randomized. Furthermore, self-reported measures were completed by using an e-application to collect data optimizing study feasibility, minimizing loss to follow-up, and ensuring data protection. The outcome measures were administered only once.s) were used for examining correlations between the CSI and the other dependent variables, depending on the normality of the data. Three multiple regression analyses  were performed for the prediction of the CSI score. The first multiple regression analysis (model 1) included the predictor variables that were relevant to the psychological condition of the patients . The second multiple regression analysis (model 2) included the predictor variables that were relevant to the functional condition of patients . The third multiple regression analysis (model 3) was a further analysis of the influence of catastrophizing on CSI by using as predictors its three dimensions . After the completion of the multiple regression analyses, the CSI was dichotomized on the basis of the known cut-off scores which classified the patients either into a central sensitization group or a non-central sensitization group . Then, two logistic regression analyses  were performed for the prediction of patients’ pain mechanism . The first logistic regression analysis (model 4) included as the predictors variables those relevant to the psychological condition of the patients . The second logistic regression analysis (model 5) included as the predictors variables those relevant to the functional condition of patients . In this study, it was preferred to construct different models, instead of one that would include all the predictors, as this approach offers the opportunity to understand and discuss better the different roles of functionality and psychology for the prediction of central sensitization. Comparisons of demographic, psychological, functional, and pain characteristics between patients with CS and without central sensitization were performed with independent t-tests when data was parametric, Mann-Whitney U-tests when data was non-parametric, and χ2 when data was nominal. The significance level was set at p = 0.05. All data analyses were performed with the Statistical Package for Social Sciences (SPSS), version 26.0.The normality of data was examined by using the Kolmogorov–Smirnov test. For descriptive characteristics, means (M) and standard deviations (SD) were used as measures of central tendency and dispersion, respectively. Pearson or Spearman correlation coefficients   .p < 0.001, R = 0.57, R2 = 0.33, adj. R2 = 0.30). During its construction, HADSanxiety , TSK , and BIPQ  were successively removed, whereas only PCS and HADSdepression remained as important predictors . During its construction, the functional test  was removed, whereby only OSS remained as the important predictor . During its construction, rumination  and magnification  were successively removed, whereby only helplessness remained as the significant predictor  = 18.45, p = 0.000, Nagelkerke R2 = 0.43, overall correct prediction 87.5%). During its construction, BIPQ (p = 0.98), TSK (p = 0.70), PCS (p = 0.36) and HADSanxiety (p = 0.12) were successively removed, whereby only HADSdepression remained as the significant predictor  = 10.22, p = 0.001, Nagelkerke R2 = 0.26, overall correct prediction 84.4%). During its construction, the functional task (p = 0.46) was removed, and OSS remained as the significant predictor   .This study examined the relationship between symptoms of CS and a battery of psychological and cognitive behavioral factors such as kinesiophobia, anxiety, depression, pain catastrophizing, incorrect illness perceptions, and functionality in patients with unilateral chronic SP. The results revealed that pain catastrophizing, depression, and functionality were strong predictors for CS symptoms in chronic SP (in two different models). When CSI was used to classify the patients either to a central sensitization group or a non-central sensitization group, based on known cut-off scores , only depression and functionality remained as strong predictors (in two different models). Furthermore, statistically significant differences were found between tested subgroups with higher levels of maladaptive cognitive-behavioral factors and poorer shoulder function in the CS group. According to the cutoff scores of kinesiophobia and pain catastrophizing, mentioned in the methodology, the CS group had clinically meaningful differences in relation to the non-CS group.Pain catastrophizing was one important CS predictor found in the current study. Pain catastrophizing is one of the most important features of the Fear Avoidance Model (FAM) which was created 25 years ago to explain the development and persistence of disability presented in a subgroup of chronic low back pain patients . This moFollowing an injury, pain acts as a protective mechanism to prevent further injury. This mechanism includes the reduced functionality of the area and the initiation of cognitive and emotional processes such as fear of movement, which have been established by previous experiences. Probably the context in which the injury takes place but also the presence of psychological distress leads to a vicious circle where destructive thoughts decrease the ability to disengage from pain. Studies in patients with chronic musculoskeletal pain have shown differences in the structure and function of their brain compared to the control group . The mesAlthough catastrophizing seems to play a role in maintaining or enhancing pain, it is interesting to see which aspect of catastrophizing predicts the symptoms of CS more strongly. In model 3 of the present study, the three aspects of catastrophizing were introduced as predictors . Only helplessness was an important predictor. Helplessness refers to the feeling of inability to manage pain. In the PCS, items 1, 2, 3, 4, 5, and 12 refer to helplessness and include statements such as “It’s awful and I feel that it overwhelms me” or “There is nothing I can do to reduce the intensity of the pain” ,61. PrevAdditionally, the second important CS predictor found in the current study was depression. Pain patients present depression with a mean occurrence rate of approximately 50% ,65, a peThere are a number of proposed mechanisms for deciphering this kind of relationship, such as similar molecular characteristics   or commoLastly, the third important CS predictor found in the current study was self-reported shoulder functionality. Difficulty in performing daily activities can be the result of attention to pain or/and an avoidance behavior . AlthougIn chronic SP patients, although the existence of psychosocial and cognitive behavioral factors has been reported and their significance in treatment results or even in the post-operative prognosis has been documented ,83,84,85Following previous studies, it seems that there is a subgroup of patients with unilateral chronic SP that presents incremental levels of CS symptoms. In the current study, this subgroup represented 15,6% of the sample. Compared to the non-CS group, these patients did not differ in age or gender; however, they presented higher pain, disability, and cognitive behavioral states. Similar subgroups have been identified in some other chronic musculoskeletal disorders such as in patients with low back pain , non-traThe results of the present study support the biopsychosocial framework within which clinicians should assess and treat chronic SP patients. There is strong evidence that chronic pain patients should be treated holistically, in view of their psychosocial, and cognitive behavioral states. These factors influence their symptoms (pain and function), and they are considered detrimental to the success or failure of any therapeutic schema. A lot of patients are undergoing surgery to manage chronic SP, even without any substantial tissue damage, to find a solution to their extensive chronic pain and disability even in daily activities. However, in a subgroup of patients, surgery or drugs not only failed to provide positive effects but also aggravated symptoms ,91. In fAlthough the sample size seems to be sufficient for the examination of correlations and the construction of regression models, the examination of differences between the CS and the non-CS group was not supported by a sample size calculation. Furthermore, the CSI contains questions about symptoms and signs related to CS; however, it is not adequate by itself to provide a diagnosis of CS . TherefoIt seems that there is an important subgroup of patients (15.6%) with unilateral chronic SP that presents incremental levels of CS symptoms. Τhe presence of CS has been associated with a poor outcome when used classical treatments . The results of the present study support the biopsychosocial (lifestyle) framework within which clinicians should assess and treat chronic SP patients. Factors such as catastrophizing, depression, and functionality may play an important role in the success or failure of any therapeutic schema. The findings of our study are in agreement with other studies of patients with chronic low back pain  and kneeSymptoms of CS were significantly associated with psychosocial and cognitive behavioral factors whereas pain catastrophizing and depression seemed to be the most influencing factors in patients with unilateral chronic SP. Patients with unilateral chronic SP and symptoms of CS presented higher scores in kinesiophobia, anxiety, depression, illness perceptions, and pain catastrophizing, and lower scores in shoulder function. From the above results, unilateral chronic SP should not be considered as a musculoskeletal problem only, but clinicians should adopt a precision medicine approach during assessment and a holistic rehabilitation of patients with unilateral chronic SP.


AT T1, the SPADI score decreased by half in both groups, and the improvement remained stable at T2. A multiplicative effect (Time × Treatment) was demonstrated . An improvement in the NRS score was measured at T1, and it remained stable at T2, a multiplicative effect was also reported . The main results of this pilot study provide evidence that UGN plus BEN increases functional performance and reduces shoulder pain in individuals with CTS. Moreover, the tendon calcification dimension at the baseline and the percentage of drainage of the lesion were associated with a functional performance recovery and pain reduction detected after intervention.Calcific tendinopathy of the shoulder (CTS) is the most common cause of shoulder pain. Conservative treatment is considered as the first therapeutic choice for CTS. The main objective of this study was to assess the effect of US-guided needling (UGN) compared to UGN plus Biocompatible Electrical Neurostimulation (BEN) in the treatment of the CTS. Pilot, prospective, non-interventional, monocentric, and observational study of patients treated for calcific rotator cuff tendinopathy and shoulder pain. Patients’ selection, enrollment and interventions were conducted at the Chiparo Physical Medicine and Rehabilitation outpatient facility. Forty adult patients (aged 40–60 years) with a diagnosis of CTS in the acute and colliquative phase were recruited and enrolled into the study. Participants were assessed for self-perceived pain through the Numerical Rating Scale (NRS), and for functional limitation through the Shoulder Pain and Disability Index score (SPADI) at baseline (T0), after 15 days (T1), and after 40 days (T2). As a possible confounding factor between the two treatments’ response, the dimension of the tendon calcification was also assessed by US-examination. Through the study, both groups improved their perceived functional performance of the arm ( Calcific tendinopathy of the shoulder (CTS) is the most common cause of shoulder pain. It is characterized by the presence of calcium-hydroxyapatite crystal located within the tendons of the rotator cuff . CTS maiClinically, the CTS presents with a different grade of severity and pattern of symptoms depending on the stage, size, and location of the calcifications. The clinical picture is characterized by referred pain localized in the anterior region of the shoulder or radiated to the posterior area of the scapula or upwards to the neck. The presence of pain is characteristic in the reabsorption/colliquation phase of the calcification ,4. The hTherefore, the main objective of this study is to assess the effect of UGN (standard of care), compared to UGN plus BEN (treatment group), in the treatment of calcific rotator cuff tendinopathy and shoulder pain.This was a pilot, prospective, non-interventional, monocentric, observational study of patients treated for calcific rotator cuff tendinopathy and shoulder pain with UGN plus BEN , compared with UGN-alone (UGN-A).The study design was conceptualized at the University “G. d’Annunzio”. The patients’ selection, enrollment and the interventions were conducted at the Chiparo Physical Medicine and Rehabilitation outpatient facility, Lecce, Italy.Between March 2019 and November 2020, adult patients aged 40 to 60 years, with a diagnosis of CTS, in fluid calcifications, hypo or anechoic, without acoustic shadowing, were recruited and enrolled into the study (stage III according to Sconfienza classification) . Among tEnrollment was offered to adult subjects over 18 years of age, affected by calcific tendinopathy of the shoulder rotator cuff in the hyperalgic and colliquative phase of calcification, with ultrasound features of without acoustic shadowing and blurred margins of the calcification. Participants were willing and able to give informed consent for the participation in the study.Patients were excluded if they had: (1) a poor compliance in attending the follow-up visits; (2) a diagnosis of rupture of any shoulder rotator cuff tendon; (3) a diagnosis of diabetes mellitus; (4) hypertension not well pharmacologically controlled; (5) drug hyper-sensibility; (6) a diagnosis of epilepsy; (7) a diagnosis of coagulopathies; (8) a current diagnosis of neoplasms; (9) an established pregnancy; (10) shoulder skin infections around the intervention area; (11) high temperature detected on the day of the procedure; (12) an implanted pacemaker; (13) a previous or current history of panic attacks. Moreover, subjects with the following comorbidities were also excluded: fibromyalgia, seronegative entesoarthritis, rheumatoid arthritis, or if they were on oral anticoagulant therapy or chronic use of opioid drugs.The study was developed following the Good Clinical Practice (GCP) guidelines. It was conducted within the ethical principles outlined in the Declaration of Helsinki, and with the procedures defined by the ISO 9001-2015 standards for “Research and experimentation”. Written informed consent was obtained at baseline from all participants. The data collection and the procedures applied are parts of the standard clinical routine, therefore, the normal ethics committee clearance was not required.The sample size of 40 patients was calculated with a Control group Event Rate (CER) of two points on the NRS score outcome and a CER of three points on the Visual Analogue Scale outcome. In addition, 0.05 α-error (Type-I), 0.20 β-error (Type-II).All subjects underwent a clinical and anamnestic evaluation; an US examination of the shoulder was performed, as well as a disability evaluation assessed by the Shoulder Pain and Disability Index (SPADI) questionnaire ,18. The Pain was assessed by the use of the Numerical Rating Scale (NRS score)  that varBoth groups underwent the mini-invasive procedure of percutaneous ultrasound-guided lavage of the intratendinous calcifications of the shoulder. The subjects were positioned as semi-seated on the seat with the arm flexed at 90° of the elbow and internal rotation of the shoulder. Following disinfection of the supradeltoid skin surface, a subacromial intrabursal ultrasound anesthesia was performed using 3 cc of lidocaine (2%) with a 22 G 40 mm needle inclined at 60° from the skin surface, with a visual check of the progression of the needle until the sub-acromial border . SubsequWithin the 48 h following the percutaneous treatment, patients started a daily BEN treatment, consisting of ten sessions of 20 min each, with the LIFE-Stim™  variable frequency electrical transcutaneous analgesic modulation device. The treatment was administered regularly, and titrated up to remain perceived as ‘strong but comfortable’ during use. Patients were seated with the upper limb positioned in a neutral position of internal rotation and elbow flexion. The two pairs of electrodes of channel 1 were positioned in the anterolateral region of the deltoid with the red electrodes proximally and the black electrodes positioned more distally. Conversely, the first pair of electrodes of channel 2 was placed in the posterior lateral area of the deltoid, with the red electrode placed at the posterior edge of the acromion process and the black electrode placed 5 cm posteriorly. The second pair of electrodes of channel 2 was placed parallel to the first pair, but 8–10 cm lower .® software, rel. 9.4, SAS Institute Inc., SAS Campus Drive, Cary, NC, USA), and p-value for differences was considered statistically significant for a value less or equal to 0.05.Data were reported as mean ± standard error (S.E.) for continuous variables and as absolute number and percentage for dichotomous variables; differences between groups were assessed with analysis of variance and chi-square test, respectively. To take into account the role of potential confounders, multivariate models were also conducted. To assess the variation in SPADI score and NRS score during the study, Linear Mixed Models (LMM) were applied . Interce by time . Data wep-value = 0.85). No statistically significant differences could be found for sex between the two groups; females were 11 (55.0%) and 13 (65.0%) for treatment and control, respectively . The treatment group reported at baseline, a higher functional limitation, recorded with the SPADI score , and a higher level of NRS score self-reported pain (p = 0.04), compared to the control group  were enrolled, 20 for each group. The mean age for the study population was 40.3 ± 6.0 ; as matter of fact, at T1 follow-up the SPADI score was practically reduced by half in both groups, and the improvement remained stable at T2. A multiplicative effect was demonstrated by the statistically significant interaction for time and treatment . Moreover, 4.5% in the SPADI score is attributable to differences between groups (ρ = 4.5%), whereas 44% of the within-person variation in SPADI score is associated with linear time ; moreover, from T0 to T2 assessment, a statistically significant reduction in the dimensions for all the patients enrolled in the study  was found . Lastly, 5 patients (12.5%) out of the 40 enrolled showed a percentage of lesion reduction ranging from 35% to 45%, while 13 (32.5%) patients showed a percentage of lesion reduction above the 60%.At the baseline, the calcification sizes were very similar  and the self-reported pain NRS score  independently from group treatment and evaluation time; for the same variables there was no multiplicative effect for the interactions.The tendon calcification dimension was associated with both perceived functional performance of the arm by mean of SPADI score , with benefits lasting in the long period (40 days), compared to standard of care. Percutaneous lavage of calcific tendon is a simple approach which requires a trained operator to perform the procedure. In addition, a minimum of 40% drainage of the initial dimension of the calcific lesion is sufficient to produce a beneficial clinical effect.


Neck pain and cervical disc degeneration (CDD) are common findings. Valid data on correlation between clinical scores and radiological grade of CDD in patients with mild to moderate clinical disability are not available. The study has been designed to investigate the correlation between clinical and radiological outcomes in these patients.A cohort of 150 patients who suffered from mild to moderate cervical spine dysfunction symptoms from September 2020 to May 2021 was enrolled. We evaluated functional status using Japanese Orthopaedic Association scores (JOA), the visual analog scale, and the Neck Disability Index. We assessed the CDD with magnetic resonance imaging-based grading systems. We analyzed relationships between radiological grades of CDD and clinical symptoms along with demographic data.P < 0.05) and the scores of Nakashima (P < 0.05) were positively correlated with the duration of symptoms, and the severity of the CDD increased with aging (P < 0.01). Moreover, we correlated patients’ JOA scores with the current scoring and grading systems, especially the grades of Miyazaki (P < 0.01) and the scores of Nakashima (P < 0.01).One hundred thirteen patients  were finally included. CDD occurred most at the C5–C6 level, with 56.93% of higher grade III from Miyazaki. The grades of Miyazaki (Increasing grades of CDD paralleled decreasing JOA scores in the population studied. Cervical disc degeneration (CDD) is a progressive condition that exists along a continuum of pathologic process, leading to neck pain, disability, and dysfunction symptoms , 2. The Degeneration is associated with decreases in the proteoglycan and water in the nucleus pulposus and its demonstrated nucleus intensity, nucleus structure, distinction of nucleus and annulus, and disc height , 5. GradHowever, previous studies did not investigate the association between grading of CDD and clinical symptoms, and it remains unclear to what extent these changes are responsible for the clinical symptoms of the patient.The present study was conducted to investigate the correlation of current radiological grading systems of CDD and clinical outcomes in patients with mild to moderate cervical spine dysfunction symptoms.This study was approved by the Medical Ethics Committee of our Hospital (Ethics Number: KY2020134) and registered in the Chinese Clinical Trial Registry (Registration Number: ChiCTR2100047228). All patients gave written informed consent. From September 2020 to May 2021, we enrolled a total of 150 patients with neck pain. Subjects who underwent cervical 3.0T MRIs with satisfactory signal-to-noise ratio were included. The exclusion criteria were as follows: history of cervical spinal surgery or trauma, age < 19 years or > 65 years, ankylosing spondylitis, imaging evidence of concurrent myelopathy, and spine fracture. After excluding 33 subjects who refused the examination of cervical 3.0T MRI, two subjects with unsatisfactory signal-to-noise ratio, and two subjects whose MRI data were not available, 113 patients were included in the final analysis. Baseline demographic data were recorded.The functional status was assessed by an independent physician using Japanese Orthopaedic Association (JOA) scores , visual We performed sagittal T1, T2‐weighted and axial T2‐weighted cervical MR imaging for each patient to evaluate disc degeneration. The grading of disc degeneration was primarily based on Pfirrmann grades , Miyazakr values in the range 0.2–0.39, moderate 0.4–0.69, and strong 0.7–1. A P value of < 0.05 was considered statistically significant [All statistical analysis was performed with IBM SPSS version 25.0, and values were expressed as mean ± standard deviation (SD). The reliability of the measurements was assessed by examining the intraclass correlation coefficients (ICC) . For intnificant .A total of 113 participants were included in this study, consisting of 35 men and 78 women. Baseline demographic data and cervical clinical scores are presented in Table A total of 678 cervical discs of the 113 patients were evaluated. C5-6 were the most severely degenerated segments, and the details are summarized in Table r = 0.30–0.61, P < 0.01)  and total Nakashima scores  .The relationships between radiological grading of CDD and clinical factors are summarized in Table 01) Fig. . Additio05) Fig. . There wThis is the first study to investigate the association of current radiological grading systems of CDD and clinical outcomes in patients with mild to moderate cervical spine dysfunction symptoms. We found that there was a significant negative correlation between the current radiographic grading systems and the JOA scores.CDD occurs throughout life and has been measured by physical and biologic mechanisms , 31. AbuImpairment of discs, muscles, and joints can cause pain in the cervical spine . It has The findings of this study must be seen in light of its limitations. One limitation was that the sample size was small. Therefore, a larger number of patients should have been enrolled to define the association more clearly. The second limitation was that, compared with X-rays, MRI may not gold standard for the assessment of cervical sagittal balance, which was defined as the distance between C2 plumbline and the posterior upper corner of C7 . HoweverFocusing on CDD, this study has analyzed the correlation of current radiographic grading systems and clinical outcomes in patients with mild to moderate cervical spine dysfunction symptoms. Increased grading of in CDD paralleled decreased JOA scores in the population under study.


The aim of the article is to present the first experience of applying a full-endoscopic posterior cervical foraminotomy and discectomy performed at Viet Duc University Hospital in Hanoi and describe the outcomes of such surgical intervention. This surgical series includes 20 patients underwent surgery through full-endoscopic posterior cervical foraminotomy and discectomy. The definitive diagnosis of the patients and the evidence for surgical treatment was radiculopathy due to lateral or intraforaminal disk herniation, foraminal stenosis, and lateral recess stenosis. Patients with discogenic cervical radiculopathy but with a contraindication to endoscopic posterior cervical foraminotomy and discectomy were not subject to surgical intervention. All patients underwent a CT and MRT examination of the cervical spine before and after surgery as complementary diagnostic methods. Besides radiological diagnostic methods, electroneuromyography and spondylography were performed with functional samples, i.e., with head tilts in the front and back, to eliminate segmental instability. The timing and degree of the root pain syndrome regression were assessed using a VAS scale  with a subsequent comparison of preoperative and postoperative performance. Immediately after the operation, all patients noted a complete or nearly complete regression of the pain syndrome. According to Lawrence3, among the total number of degenerative-dystrophic lesions of the spine, about 10% of the population suffer periodic compression pain in the cervical spine or the hand. A significant proportion of patients eventually need surgery4. The most common surgical methods in treating this pathology are anterior cervical discectomy and fusion (ACDF) and posterior cervical foraminotomy and discectomy (PCFD)6. At that, a posterior cervical foraminotomy is believed to be an effective technique that does not limit the range of motion in the cervical spine and minimizes the impact on degenerative changes in adjacent motor segments7. PCFD allows achieving adequate decompression and visualization of the outgoing nerve root in the region of the lateral recess and intervertebral aperture. In contrast to anterior discectomy, PCFD does not require stabilization9. Choosing the most optimal surgical treatment tactics for these pathologies is an urgent problem, which requires discussion. Minimal invasive PCFD has been used in clinical practice since the early 2000s11. The desire of specialists to minimize surgical aggression has influenced the evolution of endoscopic equipment, tools for effective bone resection and decompression, which predetermined the development of tube micro-endoscopy14 and percutaneous video endoscopy (full-endoscopic)18 in spine surgery. To date, a full-endoscopic method is the least invasive in spine surgery. Such operations on the lumbar spine have been proven to be safe and are performed routinely19. At the same time, the use of endoscopic methods in operations on the cervical spine is not so frequent. In 2007, Ruetten and co-authors20 reported on the experience of treating 87 patients with lateral hernias of the intervertebral discs of the cervical spine using a method of a full endoscopic PCFD with a 6.9 mm endoscope through a working cannula with an external diameter of 7.9 mm. Thus, the surgical intervention was performed using puncture access to the posterior structures of the cervical spine through a skin incision not exceeding 1 cm in length.The prevalence of discogenic compression syndromes at the cervical level is extremely high among people of working age and has a significant impact on their quality of life22. The authors point out the advantages of the full-endoscopic PCFD operative technique, which is the reproducibility of access, bright illumination of the operating cavity, and excellent visualization of anatomical structures in the liquid medium of the physiological solution of sodium chloride. Also, the possibilities of complete decompression of the spine under the targeted visual control have been established, which minimizes the risks of its damage, absence of necessity of stabilization due to complete safety of supporting structures, and no postoperative restrictions on the patient's activity23. However, the disadvantage of this technique is the inability to decompress the opposite part of the spinal canal and the technical complexity of the operation, which requires extensive experience of the surgeon in possession of not only microsurgical but also endoscopic techniques. When performing such interventions, the surgeon should be able to interpret the intraoperative radiological and video endoscopic picture as there are no indicators common for an open-access operation. Besides, such operations require the use of longer surgical instruments, which require working in cavities of small volume in conditions of constant irrigation with a physiological solution of sodium chloride, focusing on the video image at a changed angle of 25°–30° due to the form of the distal end of the endoscope. The above-described features of the method predetermine a long period of learning and the need for additional training of surgeons24.At present, some studies have been carried out to assess the efficiency of PCFD in comparison with the front percutaneous chiropractic endoscopic technique and the rear tube micro-endoscopy. The clinical results of the compared methods proved to be commensurate26.Full-endoscopic surgery of the cervical spine has recently tended to be widespread. It is largely due to the general trends of modern spine surgery and the health care system as a whole, which implies the minimization of surgical interventions, reduction in the number of bed days, smaller consume of medications, and quick restore of patients` ability to workHowever, in Vietnamese clinics, this surgical technique has not been used before.Therefore, the study aimed to (i) report the first experience with fully endoscopic PCFD performed at Viet Duc University Hospital in Hanoi; (ii) identify the indications for such surgery; (iii) describe the technique and evaluate the results of this surgical intervention.A study design is a prospective uncontrolled cohort study describing a comprehensive surgical series of full-endoscopic posterior cervical surgery foraminotomy and discectomy (PCFD) first performed at the Department of Spine Surgery, Viet Duc University Hospital, Hanoi, Vietnam. Full endoscopy (PCFD) was conducted in 20 patients  from February to September 2020. The group of patients included 18 primary surgery cases and 2 review cases. Two patients had previously undergone ACDF. After the operation, the development of radiculopathy caused by herniated intervertebral discs of the nerve roots was observed in patients, which resulted pronounced clinical symptoms. Afterward, PCFD was performed.This study was approved by the Ethics Committee of Viet Duc University Hospital (Minutes No. 2614 of 23 January 2020) and conformed to the Helsinki Declaration. All patients signed informed consent forms.Patients requiring full-endoscopic PCFD were selected according to preoperative diagnosis based on the established indications and contra-indications (inclusion and exclusion criteria) for such surgery.During clinical examination, complaints of patients were recorded, anamnesis data were assessed, and neurological status of patients was evaluated. In addition to the standard assessment of the neurological status, all patients received a CT and MRT scan of the cervical spine. CT is preferable for the detection of compression factors , while MRT is better in detecting the result of compression . Also, it allows obtaining an image of the entire cervical spine and determining the degree of stenosis of holes.The position of the intervertebral disc herniation and its density were determined based on the consolidated data. Afterward, the differential diagnostics of tumors of the spinal canal, traumas, inflammatory diseases, malformations, neuropathies, carpal tunnel syndrome, brachial periarthritis, and other dysfunctions was performed.27.Radiography of the cervical spine in the straight and lateral projections was employed to assess the degree of the existing deformity. Spondylography with functional tests (head tilted forward and backward) was used to identify segmental instability. Cervical spine instability was interpreted as a condition in which the range of motions exceeded the physiological one . Instability was assessed according to the White-Panjabi criteriaThe indications for full-endoscopic PCFD were as follows: unilateral monoradicular cervical pain syndrome due to lateral or foraminal ipsilateral single-level "soft" disc herniation in C2-C3 to C7-Th1 segments, secondary ipsilateral single-level foraminal stenosis with intervertebral joint hypertrophy.Inclusion criteria: radiculopathy due to (i) lateral or intraforaminal disk herniation, (ii) foraminal stenosis, (iii) lateral recess stenosis.Exclusion criteria: patients with discogenic cervical radiculopathy but having a contra-indication to endoscopic posterior cervical foraminotomy and discectomy: (i) axial neck pain; (ii) instability (5 and more scores according to White-Panjabi criteria); (iii) symptom due to central disc pathology; (iv) kyphotic deformity; (v) excessive ventral diseases.For surgical intervention, the endoscope Joimax (Germany) with an external diameter of 6.3 mm was employed. In addition to the optical system and fiber optic conductors, it contains an eccentrically located working channel for insertion of instruments with a diameter of 3.7 mm, as well as two channels with a diameter of 1.5 mm for irrigation and aspiration. The view angle of the endoscope was 30°. The outer diameter of the working cannula was 7.5 mm.A general anesthetic was applied. The patient was positioned on the abdomen with a slightly raised head end of the operating table to reduce the pressure in the epidural venous plexus Fig. . A slighThe surgeon and the operating nurse were on the access side. Screens of the X-ray C-arc monitor and the endoscopic facilities were placed opposite to them.Single intravenous antibiotics were injected just before the skin incision.The line of austral spurs was highlighted with a sterile marker on the patient's skin in the area of the surgery. According to the X-ray image, the level of surgical intervention was determined in the lateral projection, and perpendicular to the median line was made. The access point was perpendicularly shifted by 1.5–2 cm from the line of pinnacles towards the pathology.30. The stylet was removed from the needle and a string conductor was inserted. The needle was taken out.Under the control of fluoroscopy, a puncture needle 18G in diameter was introduced through the access point Fig. , the disThe skin incision was performed with a length of 8 mm. On a string conductor, tubular reamers of increasing diameter were introduced, on which a working cannula with a beveled cut with an external diameter of 7.5 mm was installed Fig. . The endHemostasis during the operation was achieved by regulation of pressure (about 150 cm H2O) of 0.9% sodium chloride solution supplied to the operating cavity through a special endoscope channel.31.Laminotomy and facetectomy were performed with a 3.0 mm diamond boron, from the “V-point” to the periphery Fig. . The “V-Bone resection is performed with preserved integrity of the yellow ligament, which is a measure of preventing damage to the dura mater and neural structures. The formed bone window has a rounded shape with a diameter of 4–8 mm.The yellow ligament was removed by Kerrison cutters, identifying the lateral edge of the dural sac and spine, located more cranial in the area of the formed bone window. The epidural plexus veins were coagulated with a bipolar radiofrequency electrode. The nerve root and intervertebral disk herniation material were mobilized with curved buttonhole and microspatula Figs.  and 6.FiAfter removal of the hernia by cutters, the degree of decompression of the nerve roots was assessed by its transmission pulsation. The working cannula and endoscope were removed. One nodal suture is applied to the skin. No draining of the wound was required.Wearing a soft cervical orthosis for seven days is recommended in the postoperative period.The timing and degree of regression of the root pain syndrome were assessed on a VAS scale  with a comparison of preoperative and postoperative performance. The VAS is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points on it: "no pain" and "the worst pain imaginable. The patient was suggested to draw a line perpendicular across the visual analog scale to the point corresponding to the intensity of his pain. A ruler was used to measure the distance (mm) from "no pain" to "the worst pain imaginable", getting a score of 0 to 100. According to the distribution of scores, the following classification was applied: no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), severe pain (75–100 mm). Neck pain (VAS-Neck) and arm pain (VAS-Arm) was evaluated separately.Evaluation of the operation outcome was carried out according to Odom criteria, representing a widely used 4-point scale for assessing clinical outcome after cervical spine surgery: excellent—no complaints referable to cervical disc disease and no functional impairment; good—intermittent discomfort without significant functional impairment; fair—subjective improvement but significant functional limitations; poor—no improvement or worsened condition. The scale was valided by a recent study.Social adaptation of patients after surgery was assessed using the NDI (Neck Disability Index). The questionnaire consisted of 10 questions that allowed assessing the degree of social adaptation and describing the possibility of performing usual activities . Each question suggested 6 possible answers, and patients were asked to choose the answer that best represents their current condition. The assessment was scored on a Likert scale from 0 to 5 . The total score ranged from 0 (no disability) to 50 . According to the distribution of scores, the following classification was applied: 0–4points (0–8%)—no disability, 5–14points —moderate disability, 25–34points (50–64%)—severe disability, 35–50 points (70–100%)—complete disability.Patients were interviewed preoperatively and on days 7, 14, 21, and 28 postoperatively.Continuous variables are presented as means ± standard deviation. For the VAS-Neck and VAS-Arm scales, the MCID  was calculated using the anchor method. The MCID for VAS-Neck was 28 mm , for VAS-Arm 26 mm . Preoperative and postoperative pain intensity scores according to VAS-Neck and VAS-Arm scales were compared on a boxplot graph.Statistical analysis was performed by used the program Excel for Windows.This study was approved by the Ethics Committee of Viet Duc University Hospital and conformed to the Helsinki Declaration.All patients signed informed consent forms.At clinical examination and based on patients' complaints, the prevalence of brachialgia symptoms is noted, often arising after physical activity or sharp head movement. Pain had a pronounced radicular nature, was spread respectively to the dermatomes, and usually was dependent on the position of the head and extremities. Pains in the neck area, shots to the scapula, shoulder, collarbone, the spread of pain on the ‘helmet’ type or the homolateral half of the head similar to hemicrania, and dizziness were reported as well. In some cases, hypesthesia with isolated reduction of tendon reflexes from adjacent muscles was observed. Less often, the reduction of power in the proximal parts of the upper limbs was observed, being, however, unilateral and inconstant.According to the preoperative imaging diagnostic data, the operated spinal level and the side of the pathology were established Table . In mostPain intensity values according to the VAS-neck before surgery in 15 (75%) patients were high (81.5 ± 2.1 mm), another 5 (25%) patients reported pain of moderate intensity (65.2 ± 4.2 mm). The mean pain intensity in neck of all 20 patients was 77.4 ± 7.7 mm.According to the VAS-arm before surgery, 60% of patients reported high-intensity pain (79.2 ± 2.1 mm); another 40% of patients had pain of moderate intensity (64.5 ± 3.6 mm). The mean pain intensity in arms of all 20 patients was 73.3 ± 7.9 mm.Three patients had nerve root palsy.Based on preoperative NDI scores, 11 (55%) patients had complete disability (40.1 ± 2.5 points) and the remaining 9 (45%) patients had severe disability (30.2 ± 2.5 points). The average NDI score for the entire sample was 35.7 ± 5.6.The average duration of the operation was 92 ± 7.6 min. A blood loss was reported at the minimum level. Intraoperative complications, such as postoperative hematoma or infection, were not observed. None of the patients required repeated surgery in the early postoperative period.Immediately after the operation, all patients noted regression of pain syndrome. But despite a decrease in pain intensity, 3 patients with nerve root palsy still reported high pain intensity according to VAS-neck and VAS-arm scales . According to VAS-neck scale, pain intensity decreased to moderate (53.4 ± 66 mm) in 9 (45%) patients and mild (38.0 ± 3.3 mm) in 8 (40%) patients. The mean pain intensity score for all patients was 50.8 ± 14.2 mm. According to VAS-arm scale, 5 (25%) patients had moderate pain intensity (58.8 ± 5.3 mm) and 12 (60%) had mild pain intensity (36.4 ± 2.8 mm). The mean pain intensity index for all patients was 47.8 ± 15.8 mm. MCID was achieved in 12 (60%) patients based on VAS-neck scale (28 mm reduction in pain intensity) and also in 12 (60%) patients based on VAS-arm (26 mm reduction in pain intensity).When assessing the intensity of pain according to the VAS one month and six months after the operation, the tendensy to pain syndrome regression persisted. Thus, 17 85%) of patients on VAS-neck in a month after the operation reported pain sensations of low-intensity or no pain at all (26.8 ± 8.5 mm). Another three patients (15%) had moderate intensity pain sensations (49.7 ± 4.6 mm). According to VAS-arm scale, 18 (90%) patients had pain sensations of low-intensity or no pain at all (23.4 ± 9.1 mm), while the other 2 patients (10%) suffered from moderate pain (49.5 ± 3.5 mm). The mean VAS-neck and VAS-arm pain intensity scores were 30.2 ± 11.6 and 26 ± 11.8 mm, respectively. After 6 months, pain intensity scores according to both scales demonstrated a downward trend of 22.4 ± 11.7 and 19.5 ± 10.5 mm, respectively. Only 2 patients on the VAS-neck scale and 1 patient on the VAS-arm scale retained moderate pain intensity. MCID was not achieved in 1 patient on both scales. The nerve root paralysis remained unchanged to him. The dynamics of pain intensity on VAS-neck before and after surgery is illustrated in Figs. 5% of patAccording to the postoperative success rate based on Odom criteria Table , an exceOn the NDI scale, 16 (80%) patients had only mild signs of disability or no signs at all one week after surgery. In another 3 (15%) patients, the level of mild disability was reached after 3 weeks. At the fourth week after surgery, 19 (95%) patients reported no signs of disability  or ‘hard’ (osteophite or bone spike), which is decisive in the choice of surgical access. In the case of a ‘soft’ lateral or intraforaminal disk herniation and foraminal stenosis and lateral recess stenosis, full-endoscopic PCFD is evident, while osteophyte in this area can be more radically eliminated by a ventral approachThe findings of this research are well consistent with the above-described concepts and complement the already known favorable studies of endoscopic approaches.However, the need for a prospective large-scale examination by comparing full-endoscopic techniques with traditional methods is indisputable. Such a study will help to better define the role of endoscopic approaches compared to conventional cervical accesses in the treatment of cervical radiculopathy.The results obtained confirmed the safety and efficiency of full-endoscopic PCFD at soft lateral or intraforaminal disk herniation, as well as foraminal stenosis and lateral recess stenosis. With correctly chosen evidence for surgery, the clinical results of this type of operational intervention correspond to the previously described open and minimally invasive methods of treatment. At the same time, the described surgical technique provides much less tissue traumatization while accessing the operational area. Thus, the time a patient spends in the hospital reduces, and his or her ability to work restores quite fast as well. Also, a decrease in cases of postoperative local pain or muscle spasm and the need for pain meds in the postoperative period are reported. Full-endoscopic PCFD is a worthy alternative to open surgery methods and fits into the general concept of modern spinal surgery development. The main disadvantages are the complexity of training in endoscopic methods for surgeons accustomed to traditional open access, the limited direct field of vision, and a narrow working channel. The prospects for the treatment of discogenic compression syndromes at the cervical level are undeniable. However, due to the high-risk profile of the cervical spine, caution is required in such approaches.


Results: A total of 101 patients  years; BMI 28.3 (24.2–31.6)) were enrolled. Patient workflow was not hindered, and no adverse events were recorded. In 80% of cases, a score was successfully calculated, with 74% at the first, 5% at the second, and 1% at the third attempt. Feasibility was judged as 9.0 (±1.8) by the patients, and 8.9 (±2.6) by the investigators on a 10-point Likert scale. Conclusions: Ultra-sensitive phonocardiography was found to be feasible in acute chest pain patients presenting to a tertiary ED. Thus, the CAD score measured during routine waiting times could potentially serve as an additional tool in a diagnostic pathway for thoracic pain.Background: Thoracic pain is one of the most frequent chief complaints at emergency departments (EDs). However, a respective workup in cases without clear electrocardiographic signs is complex. In addition, after having ruled out acute coronary syndrome (ACS), patients are often left with an unclear etiology of their symptoms. Ultra-sensitive phonocardiography is already used to rule out stable coronary artery disease (CAD); however, its feasibility in an ED-setting remains unknown. Methods: We prospectively used ultra-sensitive phonocardiography via the CADScor Thoracic pain is one of the most frequent chief complaints in emergency medicine ,2. WhilePatients >40 years in stable cardiorespiratory condition presenting to the ED with the chief complaint of chest pain were screened.®System , a palm-sized portable device with an adhesive sensor applied to the patient’s chest  [Ultra-sensitive phonocardiography was prospectively performed using the CADScorl space) . The meal space) . The scol space) ,10, withl space) ,10,11,12Measurements were conducted during routine waiting times in a separate quiet room, a supine position, and after 5 min of rest. Results were blinded to patients and treating physicians or nurses. An overview of the measuring procedure can be found in ®System. The overall study population was stratified into subgroups concerning gender, CAD history, and CAD score details, which were then compared. Continuous variables are presented as means and standard deviations or medians and interquartile-ranges, and compared via a Kruskal–Wallis test. Categorical data are presented as counts and percentages, and compared using χ2-square test. Due to the pilot study character and the main outcome merely being feasibility, no sample size calculation was performed, and a team of experts decided upon 100 patients. Statistical significance was defined by two-tailed p-values of <0.05. Data analysis was performed using SPSS 22.0 .The primary study outcome was the utilization feasibility of the CADScorIn 80% of cases, a score was successfully calculated, with 74% at the first, 5% at the second, and 1% at the third attempt. The measurement was stopped by the patient in 9% of cases , and by the investigator in 10% . In 2% of cases, a measurement was not possible due to technical reasons including inconsistent data analysis by the device  or too weak sound signals.Feasibility was judged as 9.0 (±1.8) by the patients and 8.9 (±2.6) by the investigators on a 10-point Likert scale .Descriptive laboratory data are found in the We demonstrated sufficient feasibility of ultra-sensitive phonocardiography via CAD score in acute chest pain patients at a high-volume ED. Routine workflow was not hindered, no adverse events were noted, and a CAD score was calculated in ¾ of cases at the first attempt. Feasibility was rated high by patients and investigators, and the system suggested a high functionality even under the time- and place-restricting conditions of a busy ED. In times of overcrowded EDs with increasing additional duties, such as comprehensive intensive care, as well as the physical and emotional strain on the staff ,15,16,17Further research seems warranted in two major domains:First, a CAD score should be evaluated as a potential additional triage tool in chest pain patients—not (only) towards discrimination of ACS vs. non-ACS, but rather concerning its potential power to provide additional information on patients’ CAD status right from the start of their evaluation. This especially applies to those patients not being able to provide an estimation on their coronary artery status, or those in whom anamnesis is not sufficiently possible . Hints towards a CAD score potentially identifying sicker patients  should be investigated in future research as well.Second, and of higher priority, the CAD score performs very well in ruling out stable CAD. Applying this information, alternative diagnoses for the chief complaint of chest pain can become more probable after having already ruled out ACS via the known standard algorithm. Currently, many patients are discharged with provisional diagnoses of their complaints, for instance musculoskeletal thoracic pain or radiating gastric pain . HoweverA study setting with a larger sample size and specially designed to investigate the above-raised points should be aimed for in future research endeavors.Key points:Ultra-sensitive phonocardiography in chest pain patients presenting to an emergency department is feasible.The CAD score is already utilized to rule out stable coronary artery disease.®System could help to classify chest pain patients into those with and without coronary artery disease, making a specific further cardiovascular workup possible.After having ruled out acute coronary syndrome via a guideline-directed algorithm, the CADScorUltra-sensitive phonocardiography is feasible in acute chest pain patients presenting to a tertiary emergency department. Thus, a CAD score measured during routine waiting times could potentially serve as an additional tessera in a diagnostic pathway for thoracic pain after having ruled out acute coronary syndrome.


Both groups underwent the measurement of the duration of intervention, the consumption of analgesics and hypnotics, and their pain and comfort using a validated visual analogue scale (VAS 0−10). Results: The baseline characteristics were comparable in both groups, including age. There were no differences in procedure duration (46 (±29) vs. 56 (±32) min, p = 0.18) or in hypnotic/antalgic consumption (midazolam 1.95 (±1.44) vs. 2.00 (±1.22) mg, p = 0.83; sufentanyl 3.78 (±2.87) vs. 3.58 (±2.48) μg, p = 0.9) between the control and VRH groups. In a multivariate analysis, the use of VRH was independently associated with lower comfort during the procedure assessed by postoperative visual analogue scale . There was no influence of VRH use on pain or drug consumption. Conclusions: In our experience, compared with VRH, human care is preferable during procedures in electrophysiology lab to improve the comfort of the patient. VRH has no influence on pain or drug consumption.Aims: Virtual reality hypnosis (VRH) has been used successfully in various clinical settings to decrease anxiety and the sensation of pain. We aimed to investigate the feasibility and safety of VRH in patients undergoing electrophysiology and pacing procedures under conscious sedation. Methods: During a two-month period, VRH support was proposed and accepted by 25 patients undergoing electrophysiological procedures. Data were compared with a control group ( Virtual reality (VR) is a technology that allows a user to become immersed and to interact with an engrossing computer-generated environment. It was developed in the medical field in the early 2000s , mostly The technique can be clinically used to draw the patient’s attention into the virtual world, distracting him/her and therefore leaving less attention available to process the nociceptive signals or pain . As a noIn the field of interventional cardiology, potential interest has been demonstrated in VRH during transcatheter aortic valve replacement (TAVR) procedures . ElectroWe aimed to describe the feasibility of this technique in the setting of interventional electrophysiology and to examine the potential gains in comfort and pain reduction for the patient compared with conventional human care. In fact during all medical procedures, including electrophysiological ones, a direct relationship is created between the doctor, the nursing staff and the patient. Words and physical contact are often able to reassure the patient.The main objective here was to assess the impact of the use of VRH on perioperative pain compared with usual human care in patients undergoing electrophysiology and cardiac stimulation under conscious sedation. Secondary objectives were to appraise the impact of VRH use on postoperative comfort and to analyse the factors influencing the analgesics and hypnotic doses received by the patients during the procedure.Ethical approval for this study was obtained from the ethics committee of our institution (IRB 198711). All subjects were required to give written informed consent prior to participating in the study. The study was conducted at the EP lab of the cardiology department at Arnaud de Villeneuve Teaching Hospital in Montpellier, France. A retrospective, monocentric and comparative study was performed using a before–after design.VR headsets were offered to all patients who were admitted to the EP lab during a two-month period (May–July 2020) and assessed for eligibility. https://www.youtube.com/watch?v=bZFbvs5KCWU (accessed on 1 February 2020)). The virtual reality system produced the three-dimensional simulation of a natural environment; the surroundings could be traversed, creating a sense of immersion. This allowed the patient to have a complete and captivating sensory experience. During the procedure, doctors and nurses were advised to minimize vocal inferences and avoid contact with the patient to allow for greater concentration. Patients admitted to the EP lab were asked to use a VR headset  with a dedicated VRH program  associated with an audio headset: this allows the patient to view short video and hear audio sequences with a hypnotic and relaxing impact . n = 61) were enrolled during the following three-month period to allow for a 2:1 case-control comparison  were enrolled for a comparative analysis. The control group patients  and hypnotic (midazolam) drugs were administered before the beginning of the procedure, and doses were increased according to the patient’s need during the procedure.Immediately after the procedure (postoperative) and at hospital discharge, each patient was subjected to a visual analogue scale (VAS) on which the patients identified their levels of pain and comfort. The VAS is a numerical rating scale consisting of 10 gradations  with an additional 10 sub-gradations for each point.The quantitative variables were presented as means (±standard deviation). The qualitative variables presented as total numbers and percentage.The postoperative pain and comfort VAS scores did not follow a Gaussian distribution. Therefore, they were categorized in five quintiles, and we performed an ordinal logistic regression to assess the impacts of the use or not of VR, age, sex, type of procedure, duration of the procedure, dose of hypnotics, and dose of analgesics. No variables were selected to avoid the effect of overfitting on our estimates. The factors associated with the doses of hypnotics and analgesics during the procedure were assessed using multivariate linear regression with the stepwise selection of variables and an alpha threshold of 0.2.n = 17, 32%) are listed in n = 10) refused because of difficulties in understanding the VR setting. Throughout the procedure, patients were free to withdraw the headset for any reasons.A total of 53 patients were screened to be enrolled in the VRH program, and 36 accepted wearing the VR headset. The reasons for refusal  withdrew it during the procedure. The reasons for headset withdrawal are listed in Finally, 25 patients in the VRH group and 61 patients in the control group were enrolled for comparative analysis. The characteristics of the population are shown in In the VRH group, 14 EP procedures and 11 cardiac pacing procedures (CP) were performed. In the control group, 34 EP procedures and 27 CP procedures were performed. The specific type of procedure per group is summarized in In patients undergoing VRH, the mean pain values measured with the VAS immediately after the procedure and at discharge were 3.7 (±2.2) and 2.1 (±2.9), respectively; the mean comfort values were 7.8 (1.8) and 7.9 (2.1), respectively. In the control group, the mean VAS pain values were 3.1 (±2.9) and 2.6 (±2.9) immediately after the procedure and at discharge, respectively; the mean comfort values were 9.5 (1.1) and 9.7 (0.7), respectively.p = 0.51). Only the type of procedure and procedure duration were independently associated with the reduction of pain in the multivariate model   .p = 0.46) but was associated with a lower comfort VAS score   see .The use of VRH did not influence midazolam or sufentanyl consumption during the procedure A,B. VRH is widely used as an adjunctive therapy in various medical settings, and numerous reports have documented the potential analgesic benefits of immersive VR in medical settings ranging from cancer therapy to urological procedures and venous puncture in both children and adults ,10,11,12VRH as an adjunctive tool in the alleviation of the patient’s pain and anxiety in a catheterization lab setting is seldomly used . Our worRoxburgh et al. recently published a similar study in a population undergoing the AF cryoablation , but ourp = 0.07). This highlights a tendency not to propose the VRH headset to older patients, generally deemed to be less receptive to such novel technologies. This probably is not a real limitation, as this approach has been reported as promising in patients admitted for TAVR [Our study population represents the daily practice population in an EP lab. Consecutive and unselected patients were asked to participate in the study. However, patients without VRH tend to be older, even if non-significantly  were ultimately not included. This could be explained by the 68% feasibility as well as by physical limitations of the patients, although 6 (35.3%) refused without any physical reason (mainly due to fear or lack of explanation).The VRH headset was removed by 11 (30.5%) patients during the procedure, for a percentage of acceptability of 69.5%. The main reason for removal was discomfort. We did not encounter typical “cybersickness” syndrome  described in previous VR experiences [In their work on VR in TAVR, Romano Bruno et al.  reportedRegarding the procedure duration, the study and control groups did not differ significantly. A 10 min difference was observed, which may reflect the time required to install and explain the VRH headset.The use of VRH had no influence on either postoperative VAS score, or use of antalgic or hypnotic drugs. Because hypnosis is intended to help reduce pain perception, as demonstrated in various studies and conditions, this result might seem unexpected. In fact, in interventional and cardiac surgery, data on VRH effects are scarce. In a recent review of the literature, Rousseaux et al.  identifiIn our results, there is no evidence that VRH has beneficial effects on medication use and pain reduction during EP procedures. However, the level of pain reported was low in both groups, as were the doses of medications. The VAS pain perception scores are in contradiction with those of Roxburgh et al., who found a significant difference between groups : indeed,p < 0.01) are opposite those of Roxburgh et al. obtained 45 min after the end of the procedure . Even if we cannot fully exclude the impacts of different VR programs or study populations, these results advocate for the standardization of VRH and support the need for randomized studies in this field. Our main finding is that patients who accept VRH throughout the procedure report less comfort than the controls, and the results are confirmed by a second VAS measurement performed at discharge. With the same VAS scores in the VRH group compared with the control group, the results obtained immediately after the end of the procedure  contact, all by a professional nurse during the procedure. On the contrary, during the VRH program, the team present in the EP lab was required to avoid conversation and contact with the patient. Our results suggest that standard human care is more effective than the VRH program.Future randomized studies with devices capable of allowing greater patient involvement are needed to definitively establish the role of VRH during electrophysiology procedures.This was a retrospective, monocentric, non-randomized trial. Substantial biases cannot be ruled out, and the refusal and withdrawal rates were approximately one third each. Furthermore, we cannot exclude that our study was underpowered to reach significant results.Sufentanyl together with short-half-life benzodiazepines are routinely used to section patients in our electrophysiology laboratory, as well as in numerous interventional cardiology laboratories in France and Europe . VRH hasIn the setting of EP procedures in the EP lab under conscious sedation, we found that conventional human care is better than adjunctive VRH because it increases patient comfort with procedures. VRH has no influence on pain or drug consumption; procedure duration is non-significantly longer by a mean of ten minutes. One third of the patients refused the VRH, and one third had to remove the headset during the procedure. It is still unclear whether VRH can improve patient care. Future randomized trials will be needed to definitively prove the possible benefit of VRH.


Increasing use of emergency departments (EDs) by patients with low urgency, combined with limited availability of medical staff, results in extended waiting times and delayed care. Technological approaches could possibly increase efficiency by providing urgency advice and symptom assessments.The purpose of this study is to evaluate the safety of urgency advice provided by a symptom assessment app, Ada, in an ED.The study was conducted at the interdisciplinary ED of Marburg University Hospital, with data collection performed between August 2019 and March 2020. This study had a single-center cross-sectional prospective observational design and included 378 patients. The app’s urgency recommendation was compared with an established triage concept (Manchester Triage System [MTS]), including patients from the lower 3 MTS categories only. For all patients who were undertriaged, an expert physician panel assessed the case to detect potential avoidable hazardous situations (AHSs).Of 378 participants, 344 (91%) were triaged the same or more conservatively and 34 (8.9%) were undertriaged by the app. Of the 378 patients, 14 (3.7%) had received safe advice determined by the expert panel and 20 (5.3%) were considered to be potential AHS. Therefore, the assessment could be considered safe in 94.7% (358/378) of the patients when compared with the MTS assessment. From the 3 lowest MTS categories, 43.4% (164/378) of patients were not considered as emergency cases by the app, but could have been safely treated by a general practitioner or would not have required a physician consultation at all.self-triage that has a high rate of safety, a rate of undertriage, and a rate of triage with potential to be an AHS, equivalent to telephone triage by health care professionals while still being more conservative than direct ED triage. A large proportion of patients in the ED were not considered as emergency cases, which could possibly relieve ED burden if used at home. Further research should be conducted in the at-home setting to evaluate this hypothesis.The app provided urgency advice after patient German Clinical Trial Registration DRKS00024909; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00024909 The need for acute medical care in emergency departments (EDs) and primary care clinics has become increasingly important from medical and health policy perspectives -3. Partipretriage or urgency advice, which patients can use before visiting an ED, although a number of solutions have been proposed including telephone triage and video-assisted triage through health care apps ). An expert physician panel evaluated all the cases of the app’s undertriaged advice. We investigated the hypothesis that the urgency advice provided by the app to patients in the ED waiting room would be similar to triage by HCPs in terms of safety of advice.The study was conducted at the interdisciplinary ED of Marburg University Hospital, which is attended by approximately 48,000 patients per year, with data collection performed between August 2019 and March 2020. The completed Strengthening the Reporting of Observational Studies in Epidemiology checklist is included in . The study assistant did not offer any content-related assistance, for example, explanations of terms, but only helped with the technical operation. The assessment report was accessible to study staff only.The patients entered factors such as sex, age, and specific risk factors , followed by their most troubling symptoms, which were the reasons for their ED visit. The app then proceeded through an adaptive question flow, asking the essential next questions to lead to the optimal condition suggestions and urgency advice .This study had a single-center cross-sectional prospective observational design to evaluate the safety of urgency advice given by the app. To assess safety and identify all cases where a less conservative advice level could have the potential to harm the patient’s health, we used the approach reported by Meer et al  via a phThe MTS score given by the triage nurse in the ED was compared with the advice level given by the SAA. This comparison was conducted using a predefined mapping . The panel members were asked to record a brief justification for each of their decisions .Then, each panel physician saw the MTS score and the app’s advice level to adjudicate whether the app’s advice would have been health-damaging if the patient had used the app at home and followed the provided advice .κ coefficient [κ coefficient [κ to assess the interrater agreement.To determine the correspondence of the urgency assessment of the app and the triage nurse, Cohen fficient ,30, inclfficient , was calIn addition, the chi-square test was performed to determine whether the distribution of the assessments of urgency differs between the ED medical departments . Missingκ with a 2-sided 95% CI and a width of 0.1 units . Owing to the COVID-19 pandemic, the study had to be terminated prematurely before reaching the calculated 554 patients. Early in the pandemic, additional staff, including clinical study personnel, were not permitted to work in the ED to prevent further endangerment of patients and clinical staff.In this single-center cross-sectional prospective observational study, patients were enrolled between August 2019 and March 2020. A total of 544 patients were estimated to be enrolled using Cohen During the study period, 1640 patients who met the eligibility criteria used the facility. Owing to staff availability, only 24.21% (397/1640) of them could be approached, and all of them agreed to participate. Of the 397 patients, 4 (1%) were excluded because informed consent was not complete and 8 (2%) were excluded because of technical problems (report was not sent from the app to the study email address). Therefore, 96.9% (385/397) of the patients were included in the study, of whom 98.2% (378/385) provided enough information to analyze the primary endpoint. For the 1.8% (7/385) excluded patients, either the MTS or the app’s triage level was missing. See The mean age of participants was 46  years. In all, 43.4% (164/378) of the patients were aged ≥50 years and 57% (215/377) of the patients were men. The most common presenting symptom was extremity pain  followed by gastrointestinal symptoms such as abdominal pain, nausea, or change of bowel movement . Of the 378 participants, 44 (11.6%) participants presented at the ED with headache or vertigo. Of all participants, 43.4% (164/378) were allocated to the orthopedics and trauma department, 26.9% (102/378) to internal medicine department, and 19% (72/378) to neurology department. Totally, 10.6% (40/378) of included patients were examined at and treated by other departments. When comparing the data from this study with data from a study focusing on patient characteristics in an ED of a German university hospital over the period of a year in 2019, we could see that the mean age of their patient population was 47  years, which was similar to that reported in this study  . This sturgent , 75.9% (287/378) of the patients as standard , and 4.2% (16/378) of patients as nonurgent . To determine the safety of the app’s urgency assessment, the 2 systems were compared in d=4.97; P=.05). Cohen κ calculated based on the merged comparison table showed low agreement between MTS and the app’s advice level  of cases to seek emergency treatment, as seen in Of 8.9% (34/378) of the undertriaged cases, 15% (5/34) were considered to be accurately triaged by all 3 panel physicians. The panel judged that for 26% (9/34) of the participants, the app’s urgency assessment could have posed a particular risk to the patient’s health when only considering the information the patient presented with, but when considering the whole case retrospectively, there was no risk. Of the 9 patients, 4 (44%) were considered to have received accurate advice by at least one physician.. Fleiss κ, interpanel physician reliability of agreement when evaluating the likelihood of health risk, was Fleiss κ=0.0533 (95% CI –0.2267 to 0.3333), indicating slight agreement, following the interpretive guidelines reported by Fleiss et al [In 5.3% (20/378) of the cases, at least one physician considered the app’s advice as potentially health-damaging if followed by the patient after considering all the case information. Of the 20 patients, 5 (25%) patients were admitted as inpatients, 10 (50%) patients were treated in the ED and subsequently discharged for further outpatient treatment, and 5 (25%) patients were discharged without treatment. The most common reason for attending the ED for these patients were wounds that needed to be stitched , followed by fractures , and infections . The list of potential AHS characteristics is presented in Table S5 in Multimedia Appendix 1ss et al .total undertriage of 8.9% (34/378) of the participants, of which 59% (20/34) were potential AHSs. The app provided safe advice for 94.7% (358/378) of the patients when compared with the stand-alone MTS assessment, which served as the gold standard in this study. This includes identical or more conservative advice  and cases defined as safe by the physician panel . Of the 378 participants, 164 (43.4%) were not considered as emergency cases by the app.Compared with usual hospital triage, 91% (344/378) of the participants were triaged identically or more conservatively by the app, and there was a undertriage and rate of leading to a potential AHS are similar to those reported for telephone triage by HCPs. Placing this in context with the literature on triage, Meer et al [potential AHS triage (95% CI 1.85%-9.20%), Morreel et al [clinically relevant undertriage. The urgency advice safety of the app is similar to or better than that reported in vignette studies of HCPs in a GP clinic setting, with 19.6% (69/352 vignette assessments) [The app’s rate of er et al  reportedel et al  reportedel et al  reportedel et al  reportedssments)  and 17.1ssments) . In a ressments) . This waOf the few studies reporting app-based self-assessment triage, a study reported 11.1% (14/126) undertriage  and anotExamination of all collected information in this study enabled the identification of the reason for undertriage. Most commonly, the relevant condition was not modeled by the app; for example, 25% (5/20) of potential AHSs were related to non–life-threatening skin wounds, which must be examined and treated. Adapting the app to provide these scenarios would be a simple improvement. Potential AHSs also resulted from limitations in gathering information on previous injuries, a common reason for ED visits, as mild pain symptoms reported for the pre-existing injury site were not accompanied with descriptions of the injury itself, and therefore, received lower triage than appropriate after an accident. This can be resolved through an initial question about accidents. Multimorbidity also led to triage inaccuracy, as patients intermixed old and new symptoms and conditions.total overtriage compared with nurse MTS triage was 57.1% (216/378), which compares with 42.1% (101/240) for intuitive triage of patients in ED by GPs [total overtriage includes even the most minor overtriage. The patient populations in the studies listed above partly differ from that in this study owing to a pretriage setting, making a direct comparison moderately difficult.The number of the apps D by GPs , 19.3%  should be developed.A recognized challenge in comparison with triage methodologies is defining a reference standard . CompariIn addition, the MTS, which was the system used as a gold standard in this study, has been shown in previous studies to have deficiencies affecting its overall safety and performance ,47. SpecIn the interpretation of these results, it should be considered that some of the authors of this paper were also affiliated with the company that developed the app.total overtriage is relatively high owing to a limitation in the study methodology. This could be resolved by having the appropriateness of all the app advices assessed by a panel instead of assessing only the patients who were undertriaged. Every patient in the ED, irrespective of whether he or she required ED treatment, received an MTS level requiring ED consultation. Studies have shown that the condition of 32%-37% of patients in the ED waiting room cannot be considered as urgent [In addition, the reported s urgent . TherefoIt has been proposed that self-assessment triage apps could reduce unnecessary ED visits . Of thosThe relatively high number of overtriaged cases in this study was, to a large degree, a result of the limitations of the study matching design, in which patients already waiting to seeing a GP in the next 4 hours were counted as overtriage. However, overtriage error of the app was detected in the context of this study. Pretriage has high potential to reduce the burden on EDs and to support the patient’s decision-making regarding where and when to best seek medical care before they visit the ED. It is important that developers of SAAs address the degree of overtriage by systems, while still ensuring that their system provides safe advice.Further research in this area is needed to measure not only appropriate and safe advice in the at-home setting but also the willingness of patients to follow this. Studies should also address in more detail the appropriateness of advice of SAAs for users who require emergency treatment. We have identified several usability optimizations and recommendations for additions and optimizations of some ED-relevant presentations. These were incorporated into Ada’s product development process after reporting the study; for example, revising the advice level for ED cases that showed a high rate of overtriage.self-triage that can be considered safe in 94.7% (358/378) of assessments when compared with the stand-alone MTS assessment, has a rate of undertriage and a rate of triage with potential to be an AHS equivalent to those of telephone triage by HCPs, and still, is a more conservative approach than direct ED triage by HCPs. In all, 43.4% (164/378) of patients who considered themselves as emergency cases were not considered so, indicating a possible relieve on EDs if the app was used at home. Continuous app optimization, followed by future research, should be conducted specifically in the at-home setting to investigate this hypothesis.This observational study addressed an underresearched SAA triage topic in the ED . We show