Children and adolescents with juvenile idiopathic arthritis (JIA) may suffer from temporomandibular disorder (TMD). Due to this, imaging diagnosis is crucial in JIA with non-symptomatic TM joint (TMJ) involvement. The aim of the study was to examine the association between clinical TMD signs/symptoms and cone-beam computed tomography (CBCT) findings of TMJ structural deformities in children and adolescents with JIA.This cross-sectional study is part of a longitudinal prospective multi-centre study performed from 2015–2020, including 228 children and adolescents aged 4–16 years diagnosed with JIA, according to the International League of Associations for Rheumatology (ILAR). For this sub-study, we included the Bergen cohort of 72 patients . Clinical TMD signs/symptoms were registered as pain on palpation, pain on jaw movement, and combined pain of those two. The severity of TMJ deformity was classified as sound (no deformity), mild, or moderate/severe according to the radiographic findings of CBCT.Of 72 patients, 21 (29.2%) had pain on palpation at and around the lateral pole, while 41 (56.9%) had TMJ pain upon jaw movement and 26 (36.1%) had pain from both. Of 141 TMJs, 18.4% had mild and 14.2% had moderate/severe structural deformities visible on CBCT. CBCT findings were not significantly associated with either the pain on palpation or the pain on jaw movement. A significant difference was found between structural deformities in CBCT and the combined pain outcome  for both TMJs for the persistent oligoarticular subtype (p = 0.031).There was no association between painful TMD and CBCT imaging features of the TMJ in patients with JIA, but the oligoarticular subtype of JIA, there was a significant difference associated with TMJ pain and structural CBCT deformities.The online version contains supplementary material available at 10.1186/s12903-021-01870-z. Juvenile idiopathic Arthritis (JIA) is a heterogeneous condition that includes all forms of chronic arthritis of unknown origin with a duration of more than six weeks and an onset before 16 years of age . The repTherefore, the aim of this study is to examine the association between clinical signs/symptoms of TMD and structural TMJ deformities found from CBCT in this patient group.We followed the strengthening the reporting of observational studies in epidemiology (STROBE) reporting guideline. This cross-sectional study is part of a longitudinal prospective multi-centre study performed from 2015–2020, including 228 children and adolescents aged 4–16 years, diagnosed with JIA according to the International League of Associations for Rheumatology (ILAR) [Clinical TMD examinations were performed by using a shortened version of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I  and the During clinical examination, we determined whether there was pain on direct palpation at and around the lateral pole. Moreover, we asked the patient whether he/she currently experienced TMJ and masticatory muscle symptoms on vertical, lateral, and or protrusive jaw movements, and we also registered combined pain . The CBCT examination was performed using a 3D Accuitomo 170 (Morita) with a field of view of 4 × 4 cm and a voxel size of 80 µm. The exposure parameters were adjusted for each individual patient. All images were exported into iDixel One Volume Viewer (Version 2.6.0 Morita), and analysed by an experienced paediatric radiologist  with additional information in the image masked. The overall impression of TMJ deformity was categorized into one of three groups based on the radiographic appearance in the condyle and temporal parts: sound = normal anatomical variation, mild = slight flattening of the fossa/eminence or condyle, or minor joint surfaces irregularities, moderate/severe = apparent deformation of fossa/eminence or condyle, apparent reduction of condyle volume or more severe joint surface irregularities. Examples of typical cases are shown in Fig. Descriptive statistics were reported as mean with SDs, percentages, or median (ranges). For analyses, we dichotomized the TMJ deformity variable to absent or present due to low number of cases in the mild and moderate/severe groups. Associations between localized pain (TMD) and structural deformities visible in CBCT were examined using Fisher’s exact/chi-square test and an independent/two-sample t-test as appropriate. Statistical analyses were performed using SPSS version 25 . All tests were two-sided and statistical significance was set at 5% (p ≤ 0.05).Ethical approval for this study was obtained from the Regional Committee For Medical And Health Ethics (REC west), Universitetet i Bergen, Det medisinske fakultet, Postboks 7804, 5020 Bergen, reference number: 2012/542/REC west. Written informed consent was obtained from the parents or legal representatives of the children and adolescents. The study was registered in ClinicalTrials.gov (No: NCT03904459).A total of 72 children and adolescents (44% girls) and a median age of 13.1 years (range 5.9–16.5 years) were included  participants without pain on palpation at and around the lateral pole, while mild or moderate/severe TMJ deformity was found in 8 of the 21 (11.1%) patients with pain (p = 0.711). TMJ deformity was seen in 10 of the 31 (13.4%) participants without pain on jaw movement but 17 of 41 patients (23.6%) had pain (p = 0.333). No association was seen for either palpatory pain or for pain upon jaw movement between boys and girls  and between right and left or both TMJ . CBCT findings grouped according to pain on palpation and painful jaw movement for right and left side (separately) are presented in detail in Figs. Twenty-one of the 72 participants 29%, 12 girls) experienced pain on palpation at and around the lateral pole, while 41 (56.9%) reported TMJ pain on jaw movement , or between pain on jaw movement and CBCT findings (p = 0.45 right side and p = 0.84 left side). No association between TMJ deformity and combined pain outcome  was seen, with p-values of 0.603 and 0.067 for the right and left TMJ, respectively. Statistical significance was found between CBCT findings and a combined pain outcome  in both TMJs for the persistent oligoarticular subtype (p = 0.031).We have shown that nearly one-third of patients with JIA had pain on palpation at and around the lateral TMJ-pole, and that nearly 60% experienced painful jaw movements. Moreover, assessment by CBCT showed that one-third of the TMJs in these patients was associated with structural deformities, more often in girls than in boys. No associations were seen between pain on palpation of TMJs or painful jaw movements and structural deformities visible with CBCT. The persistent oligoarticular subtype of JIA revealed an association between structural deformities visible with CBCT and clinical signs and symptoms.The lack of association between clinical signs/symptoms and structural deformity on CBCT in patients with JIA is in line with previous studies that used panoramic radiography as a diagnostic modality –27. In aIn this study, we were able to define TMJ deformity in CBCT as either mild or moderate/severe because bony deformities on the condylar surfaces of young individuals are readily detectable using CBCT scans , 35. OthIn their retrospective CBCT study of 19 JIA and 19 patients with idiopathic condylar resorption (both groups with a mean age of 15.3 years old), Alimanovic and colleagues  reportedOur study had some limitations. First, the number of patients with CBCT findings of structural deformities was relatively low. Second, we used a relatively crude CBCT score. The strengths are the meticulous calibration and standardization work performed for both TMD and CBCT assessments. Nonetheless, for this group of patients, longitudinal, prospective studies should be performed to evaluate deformities in pathologies of the TMJ over time.There was no association between painful TMD and CBCT imaging features of the TMJ in patients with JIA, but in the subtype of JIA, persistent oligoarticular type, it was found statistical significance between symptoms and signs of TMJ pain and structural CBCT deformities.Additional file 1. Painful and painless TMJs upon jaw movement and palpation according to ILAR categories.


Both shockwave therapy (p = 0.001) and ultrasound therapy (p = 0.003) were effective in reducing pain. In terms of disability, both treatments had similar effects (p = 0.439). Conclusion: Radial shockwave was significantly more effective than ultrasound in reducing pain and increasing the quality of life, bringing additional vitality and emotional comfort to the patient with idiopathic scoliosis. In terms of disability, both treatments had similar effects when associated with kinesitherapy.Background: This study aimed to compare the effectiveness of radial extracorporeal shockwave and ultrasound therapies in adult patients with idiopathic scoliosis in terms of pain, disability, and quality of life. Methods: Forty-eight patients with idiopathic scoliosis were randomly divided into three groups of 16: shockwave, ultrasound, and control. The patients were evaluated at admission (day one) and at discharge (day 14) for pain, by using the visual analogue scale; for disability, by using the Oswestry disability index; and for the quality of life, with short form-36. Results: Radial extracorporeal shockwave therapy was more effective than ultrasound in reducing pain ( Idiopathic scoliosis is a three-dimensional spinal deviation of the spinal axis with a curvature exceeding 10° on a plain anteroposterior X-ray image, with no other underlying disease identified to provoke it . A propo5–1 × 106 Hz [2), application time (minutes), and pulse application form (continuous/burst) [Oscillatory electro-mechanic therapy is the application of oscillation waves with high frequency and pressure, which relies on a mechanical means of propagation. In theory, this category includes ultrasonic waves and ballistic shock waves. Ultrasound is a mechanical oscillation produced by physiotherapy devices based on the inverted piezoelectric effect, which spreads within tissues with high frequencies in the range of 8 × 10× 106 Hz ,10,11. Ts/burst) ,10,11.Shockwaves are a complex of “high-pressure” oscillation waves that yield around 150 mega Pascals (MPa), causing real mechanical shocks in the targeted tissues. Alternate names such as “high-pressure waves”, “ballistic waves”, or “shockwaves” were assigned for this very reason, as they cause micro-trauma ,13. TherBoth US and SWs produce a mechanical impact on the target tissue, causing similar physical and chemical effects, such as heat generation, cavitation, and diffusion. The two types of waves also have common clinical effects, mainly, pain relief and muscle relaxation ,15. HoweThe effectiveness of US and SWs has been compared in pathologies such as fibromyalgia/myofascial pain syndrome , plantarThe study comprises 48 patients diagnosed with idiopathic dorsal-lumbar scoliosis, either admitted to the hospital or benefiting from ambulatory care, between February 2019 and February 2020.Patients over 30 years old;Low back dorsal-lumbar nonspecific musculoskeletal pain;Diagnosed with dorsal-lumbar idiopathic scoliosis of any type  and any degree of curvature from 10 to 60 degrees.Idiopathic scoliosis that required surgery intervention;Any vertebral or spinal bone marrow pathology other than idiopathic scoliosis: disc herniation, spinal cord injury, benign or malignant tumors, and so on;Fever, regardless of the cause;Acute or decompensated diseases, regardless of their nature: infectious, inflammatory, cardiovascular, respiratory, neurological, rheumatological, metabolic, and so on;Uncontrolled hypertension with systolic blood pressure higher than 150 mmHg;Any mental disorder;Any neoplasm;Osteosynthesis materials or other metals in the area of application;Patients carrying a cardiac pacemaker;Pregnant women, women during menstruation, women with intrauterine devices (IUD);Patients with altered general condition or cachexia;Patients with any pathology that could generate a disability other than idiopathic scoliosis;Patients with any type of idiopathic scoliosis other than dorsal-lumbar;Patients with any pain other than low-back dorsal-lumbar pain.Our study employed the classical contraindications for any electrotherapy procedure :IdiopathIn our study, we used block randomization to obtain three balanced groups. We set block randomization for gender , scoliosis type , curves in degree categories , and age groups  . We balan = 16) received US treatment (UST), applied bilaterally in the paravertebral dorsal-lumbar region. The regimen was 0.5 W/cm2, for 5 min, using continuous emission, dynamic application in a slow rhythm, and daily application rhythm over a total of 10 sessions. Group B (n = 16) received RSW treatment (RSWT) to the paravertebral dorsal-lumbar area using a pressure of 0.2 MPa (2 Barr) in addition to a series of 2000 shocks in pulse emission (BURST mode) with a frequency of 10 Hz and an average energy transfer of 0.4 m J/mm2 for a duration of 4.48 min. The application rate was every two days with a total of five sessions. Radial extracorporeal shockwave therapy was delivered every two days in order to avoid microtrauma cumulating effects. Group C (n = 16) was the control group and did not receive physiotherapy. The total treatment time was 14 days.Group A , which highlights 10 degrees of pain from 0 (no pain) to 10 points (the most severe pain) . The VASDisability: using the Oswestry disability index (ODI). The ODI scale was performed on days 1 and 14 for all patients .Quality of life (QoL): using short form-36 (SF-36), which consists of 8 subscales with 36 items that evaluate the physical, social, and usual activity limitations due to physical or emotional problems, bodily pain, mental health, vitality, and general health perceptions . The QoLFor all groups, the total time for evaluation was 14 days. The following parameters were assessed:t-test for equality of means, the Mann–Whitney test, and the Wilcoxon test were used for comparison of parameters. The Tamhane post hoc evaluation was employed after multiple comparisons were performed by ANOVA when equal variances were not assumed. Pearson’s chi-squared test was used for comparing categorical data. The statistical significance of p-value was considered p < 0.05. For the Kolmogorov–Smirnov test, p-value was considered p > 0.2.SPSS Statistics for Windows version 15.0  was used for statistical analysis. The distribution of patient demographic features was analyzed using descriptive statistical methods. Population normality was assessed using the Kolmogorov–Smirnov test. Levene’s test for equality of variances, The demographic analysis of the study groups showed that the patients were similar in terms of age  and gender  distribution .p < 0.001 and p = 0.004, respectively (Mann–Whitney). The difference in the VAS score was also significantly lower in the UST patients compared with the control patients . The evaluation of pain on the VAS scale shows that the average differences in the final VAS  were significantly lower in the RSWT lot (−6.38 ± 1.02) compared with the UST lot (−5.38 ± 0.71) and the control group (−4.50 ± 0.62), with a statistical significance of patients .p = 0.361 Mann–Whitney, p = 0.439, ANOVA, post hoc Tamhane 0.955).The analysis of the initial ODI in all lots shows a comparable value . Regarding the evaluation of disability using ODI (highlights), the average of the differences between the final and the initial ODI in the RSWT group (−28.06 ± 4.32) did not differ significantly from that of the UST group (−29.56 ± 6.29) or the control group (−27.31 ± 4.743) (p = 0.003) and emotional component  in the RSWT group versus UST; no other statistically significant differences were noted (Regarding the QoL, the SF-36 subscales showed significantly better values for the following parameters: vitality (means 21.22 versus 11.78; re noted .No significant immediate or delayed adverse reactions were observed following the physiotherapy procedures.In this study, we used five large block randomizations to increase the comparability between groups by keeping the ratio of the number of subjects between them almost the same. Consequently, the risk of selection bias was increased as the treatment of the subject in the block was known. Because we analyzed a new physiotherapy treatment, we chose this type of randomization in order to recognize its therapeutic benefits, starting from similar lots, to the best of our ability . AlthougAnalyzing the results, we observed that RSWT produces a statistically significant decrease in pain generated by idiopathic scoliosis versus UST. It should be noted, however, that both treatments determined an average decrease in the VAS score for pain: UST by 5.38 points, and RSWT by 6.38 points, respectively; however, RSWT proved to be statistically more effective and was further followed by a significantly higher state of emotional comfort and vitality according to the analysis of the patients’ QoL. Regarding the rest of the parameters analyzed in SF-36, we did not detect any other statistically significant differences. The mental health component of QoL SF-36 was not analyzed because the presence of mental illness was considered an exclusion criterion in our study; moreover, according to literature data, mental health factors do not influence QoL SF-36 in patients with scoliosis . Radial Regarding the disability induced by idiopathic scoliosis in adults , which wBoth types of physiotherapy were very well-tolerated by patients, who showed no side effects; therefore, we recommend both methods in terms of safety and tolerability profile.After a short-term evaluation, radial extracorporeal shockwave therapy and ultrasound therapy were both effective in reducing pain due to muscle contraction in adult patients with idiopathic scoliosis; however, RSWT had statistically superior effects in reducing pain and increasing the quality of life, as well as bringing additional vitality and emotional comfort to the patients. In terms of disability, both treatments have similar effects when associated with kinesitherapy. Both types of physiotherapy are safe and well-tolerated by patients with idiopathic scoliosis. Further studies involving larger study groups and follow-up examinations are needed in order to extend and confirm our reported findings, as well as to develop appropriate standardized protocols for these types of patients.


Dynamic slip (DS), dynamic segmental angle (DA), dynamic lumbar lordosis, and slip percentage (SP) were significantly increased after pain reduction . According to the diagnostic criteria for segmental instability , there were 4%, 4%, and 0.7% of total motion segments fulfilling the criteria which markedly increased to 42%, 32%, and 16.7% after analgesia was administered. The incidence of instability also increased from 6% to 38% after analgesia. Conclusions: The diagnosis rate of intervertebral instability is commonly underestimated in the presence of low back pain. This short-term pain relief facilitates reliable functional imaging adding to the diagnosis of intervertebral instability.Background: Diagnosing intervertebral instability is crucial for the treatment of degenerative lumbar spondylolisthesis (DLS). Disabling back pain will reduce spinal mobility which leads to an underestimate of the incidence of intervertebral instability. We hypothesized that adequate analgesia could alter the flexion/extension exam performance, and thus increase the diagnostic accuracy of segmental instability. Materials and methods: One hundred patients with low-grade DLS were prospectively enrolled in the before–after cohort study. Standing lateral flexion/extension radiographs of lumbar spines were examined and analyzed before and after intramuscular injections of 30 mg ketorolac. Results: Pain score decreased significantly after analgesic injections ( Low back pain (LBP) is the most common musculoskeletal disorder and the leading cause of disability endured for years . About 2The decision to perform spinal fusion requires evidence of intervertebral instability, but it is difficult to define the segmental instability. Several methods including the detection of facet joint effusion in T2-weighted magnetic resonance imaging ; the meaPain is an important factor affecting spinal activity, but the reported results of pain reduction on motion improvement are controversial. It was reported that the spine motion arc and curvature in patients with chronic LBP could be restored after pain control . On the This before–after cohort study was approved by our institutional review board (KMUH-IRB-F(I)-20170129). Informed consent was obtained from each patient before examinations. From February 2018 through December 2019, patients with the presenting chief complaint of mechanical LBP defined as worsening symptoms with standing and sitting for periods or upon standing from the seated position, or bending forward, with/without radicular symptoms were recruited. The inclusion criteria were as follows: patients with LBP lasting 6 months or more and diagnosed with low grades (Meyerding grade I and II) [Intramuscular (IM) injection with ketorolac 30 mg (30 mg/L Amp)  was adopted for the treatment of back pain. Ketorolac is a NSAID that is commonly used for the short-term treatment of moderate to severe pain after a medical procedure or after surgery. The basic vital signs including blood pressure, heart rate, temperature, and respiration rate were recorded within the 30–40 min after injection, and patients with abnormal vital signs were excluded from the study. Side effects after injection were recorded, such as nausea/vomiting, headache, or dizziness. Standing lateral lumbar flexion/extension radiographs were taken before and after 30-40 min of ketorolac injection depending on the condition of preparation. The time interval between ketorolac injection to radiography was determined according to the pharmacokinetics  and the The visual analog scale (VAS) scoring system was used to evaluate back pain level in patients before and 30 min after analgesia. We recorded baseline and final VAS scores with reference to radiographic performance. The difference in VAS scores between pre- and post-analgesia was recorded.The digital images were evaluated on a Picture Archiving and Communication System (PACS). Sagittal translation and segmental angulation on lateral flexion/extension radiographs were used to assess segmental instability and the results were measured by two observers who were completely blinded to all information, including the age, name of patients, and time of image. The mean measurement values between the two observers were adopted for analysis. Target motion segment (TS) comprised two vertebrae; forward or backward displacement of one vertebra over a lower vertebra detected by previous standard lumbar X-rays was named according to the position of the two vertebrae. Radiographic measurement parameters were as follows: (1) Vertebral body width (mm); (2) Segmental translation (mm); (3) Segmental angulation (°); (4) Lumbar lordosis angle (LA) (°); (5) Dynamic slip (DS) (mm); (6) Dynamic segmental angle (DA) (°); (7) Dynamic lumbar lordosis (DL) (°); and 8) Slip percentage (SP) (%), defined in  Slip pert test was used to assess the difference between pre- and post-injection. Pre–post changes within different groups were estimated via the standardized response mean, with mean differences between pre- and post-analgesia divided by the standard deviation of the difference parameters. Adjusted mean differences (AMDs) were calculated to quantify the between-group effects. General linear models were used to assess the difference between the two sample groups. Linear regression analysis was used to evaluate the relationship between radiograph measurement and pain scores. p < 0.05 was considered significant.All analyses were performed with SPSS version 19.0 . Continuous variables were presented as mean ± standard deviation. The intraclass correlation coefficient (ICC) two-way random model of absolute agreement was used to analyze measurement reliability. A paired-Demographic data and radiographic measurements of the 100 patients enrolled in the study are shown in p < 0.001, p < 0.0001 in both). The mean DL of post-analgesia (42.61 ± 12.94) was 109.17% compared with 39.03 ± 13.61 pre-analgesia. The mean DL was markedly increased by 9.17% after analgesia, and the SP significantly increased after injection . The measurement reliability of radiographic variables was high; the ICC ranged from 0.958 to 0.997, and SEM ranged from 0.012479 to 0.099168. The measured results in lateral flexion/extension radiographs before and after analgesic injection are presented in Generally, ketorolac IM injections provided significant analgesia for LBP. After injection, the VAS score was significantly dropped down  total TSs showed instability after analgesia compared with those without analgesia . On the other hand, 48 of 150 total TSs (32%) exhibited instability after analgesia compared with those without treatment  while using the segmental angulation criteria to determine instability. In considering the SP instability as criteria, the patients after analgesia also exhibited more instability  compared with those before analgesia . After injection, the number of patients diagnosed with unstable spondylolisthesis  was increased from 6  to 38  .p = 0.046). In regard to the radiographs taken after the injection, the severe pain group had a significantly greater increase in DA than the moderate pain group (p = 0.03). Although there was no significant extension and flexion angle increase between the two groups, the increase in extension angle after the intervention was approaching significance (p = 0.07). Reevaluation tests demonstrated that the results were similar and the multiple testing problem was not significant.The patients were divided into moderate pain  and severe pain groups  based on the median baseline VAS scores (70 mm) . We obse2 = 0.335, p < 0.001), where y is the DS and x is the VAS score. Similarity, DA and pain scores also showed an inverse relationship   showed an inverse relationship. The regression equation was y = 5.73−0.52x (R< 0.001) .The present study examined the effect of alleviating LBP on the variables measured from flexion/extension radiographs of the lumbar spine. We found that 30 mg of IM administered ketorolac was effective for alleviating LBP and caused an increased motion of spondylolisthesis segments in aspects of 2.4 (±1.36) mm in DS, 4.85 (±4.59) degrees in DA, and 6.23 (±3.46)% in SP. About 32% more patients with segmental instability were detected in lateral flexion/extension radiography after pain relief. Severe pain (VAS > 70 mm) could prevent patients from performing adequate flexion/extension exercises, resulting in an underestimation of the segmental instability.The reoperation rate of DLS has been reported to be high both in either decompression alone or decompression plus fusion surgery ,22,23,24Pain prohibits normal spinal mobility  and muscAnalgesic methods and outcomes of spinal mobility examinations from previous studies were inconsistent ,17,18 T. MoreoveThere were several limitations to this study. First, we did not investigate whether pain reduction could decrease back muscle splinting. Further studies are necessary to shed more light on measuring flexion relaxation by using the electromyography method. Second, the leg tension sign was not classified and the effects of analgesia on the tension sign were not evaluated. Third, this study cohort lacked patients with mild pain and lacked a comparative group with placebo injections, and whether these patients would demonstrate similar results is uncertain. Finally, there is a substantial risk that an order effect of participant performance in repeated flexion and extension radiographs may have influenced results. Future studies should include the placebo injection and investigate whether repeated measurements might demonstrate increases in ROM even without analgesia, or whether the motion arc returns to pre-analgesia levels once the analgesia has worn off.The diagnosis rate of intervertebral instability is underestimated in moderate to severe LBP. The intervertebral sagittal translation, segmental angulation, SP, and instability diagnosis rate increased after adequate analgesia was administered. A single dose of ketorolac 30 mg IM injection is a safe and convenient regimen to provide effective analgesia for dynamic radiologic examinations. This short-term pain relief facilitates the reliable functional imaging of the spine and is a feasible option for the diagnosis of intervertebral instability.


Stroke is one of the most frequent causes of death and disability worldwide. It is accompanied by the impaired motor function of the upper extremities in over 69% of patients up to hemiplegia in the following 5 years in 56% of cases. This condition often is characterized by chronic poststroke pain, difficult to manage, further worsening quality of life. Poststroke pain occurs within 3–6 months. Robot-assisted neurorehabilitation using the Automatic Recovery Arm Motility Integrated System (ARAMIS) has proven efficacy in motor function recovery exploiting the movements and the strength of the unaffected arm. The rationale of the ROBOCOP (ROBOtic Care of Poststroke pain) randomized trial is the assessment of the impact of robot-assisted functional and motor recovery on the prevention of poststroke pain.t1, half of the rehabilitation); 2 months after stroke ; and 3 months (t3) and 6 months (t4) after stroke, critical for poststroke pain development.A total of 118 patients with hemiplegic arms due to stroke will be enrolled and randomly allocated with a 1:1 ratio to ARAMIS or conventional neurorehabilitation group. After a baseline screening at hospital discharge, ARAMIS or conventional rehabilitation will be performed for 8 weeks. The primary endpoint is the prevention of the development of poststroke pain and the secondary endpoints are prevention of spasticity and efficacy in clinical motor rehabilitation. The primary outcome measures consist in the visual analog scale and the doleur neuropatique 4 and the secondary outcome measures include: the Modified Ashworth Scale, the Resistance to Passive movement Scale; the Upper Extremity Subscale of the Fugl–Meyer Motor Assessment; the Action Research Arm Test; the Barthel Index for activities of daily living; and the magnetic resonance imaging (MRI) recovery-related parameters. After baseline, both primary and secondary outcome measures will be performed in the following time points: 1 month after stroke (This is the first clinical trial investigating the efficacy of robot-assisted neurorehabilitation using ARAMIS on poststroke pain prevention. This study could remarkably improve the quality of life of stroke survivors. Stroke represents one of the most serious causes of death and disability-adjusted life-years lost  destinedIn agreement with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as the core outcome for pain  this ranThis randomized single-center trial will recruit subacute hemiplegic patients of any age with hemiparesis of the arm after stroke. The trial is designed as a prospective, exploratory, and interventional study without drugs. The study does not request the use of drugs. This study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist .ClinicalTrials.gov ID has been requested. According to the D.lgs 196/2003, the Helsinki agreements and subsequent amendments, the Good Clinical Practice and current legislation, the Guidelines for the treatment of personal data in clinical trials of 24 July 2008, and in accordance with European data protection legislation, each participant or his/her legal representative will be required to sign a consent form as acceptance of all aspects of the study contained in the patient information sheet and as a consequent expression of his willingness to participate in the study. The information sheet will be duly illustrated to the subjects or legal representatives by the study staff and the same staff will ensure that the consent form is properly signed and dated by all the parties involved before any procedure foreseen by the protocol is carried out.This trial has been approved by the Calabria Region Ethics Committee (protocol N.244 of 09/21/2021) and the The study will be carried out at the Sant' Anna Institute of Crotone , which is specialized in motor and cognitive treatment and rehabilitation of neurological diseases.Consecutive patients, admitted to Sant' Anna Institute with the diagnosis of stroke after hospital discharge will be enrolled, accordingly with the following inclusion criteria:- First-ever stroke within 24–72 h from diagnosis confirmed through functional MRI scan, regardless of the side, location, and extension of the lesion;-Stroke-related hemiplegic patients of any age at hospital discharge within 48–72 h after stroke with fMRI scan of the area affected;-Severe upper limb impairment, according to the Upper Extremity Subscale of the Fugl–Meyer Motor Assessment [FMA-UE (0-35) ];-Absence of hemiplegic upper limb-related baseline pain based on the visual analog scale (VAS), the bedside active examination with a numerical rating and, also, the douleur neuropathique en 4 questions (DN4) for the evaluation of neuropathic prestroke pain.Exclusion criteria will be:-Bilateral impairment;-Presence of aphasia;-Presence of cognitive impairment, as assessed using the cognitive assessment scale for patients with stroke , to avoi-Stroke diagnosis without the occurrence of hemiparesis of the upper limb;-Previous rehabilitation.Due to the lack of specific observational tools for poststroke pain in noncommunicative patients, this pilot study will not include patients affected by aphasia and cognitive impairment. The informed consent will be obtained by healthcare operators and patients will be informed about the study and they will be provided with a consent form. No additional consent provisions for biological specimens will be needed since the latter will not be collected.ARAMIS is composed of two computer-controlled, symmetric, and interacting exoskeletons able to compensate for the inadequate strength and accuracy of residual motor function of the paretic arm movements  Figure . ThroughIn case of discontinuation of the treatment, the patient will be excluded from the study. The treatment will be performed by healthcare operators preventing lack of adherence.The effect of robot-assisted rehabilitation using ARAMIS on the prevention of the development of poststroke pain is the primary endpoint of the ROBOCOP study. The primary outcome measures consist in the assessment of pain through the VAS, including a bedside active examination and probing of somatosensory functions to test touch, temperature, and pain sensations . The devt0); 1 month after stroke (t1), i.e., at half of the rehabilitation period; 2 months after stroke (t2), i.e., after the completion of neurorehabilitation with ARAMIS in the intervention group and of conventional rehabilitation in the nonintervention group; 3 months (t3) and 6 months (t4) after stroke, since the latter are critical for rehabilitation and pain development. Routine clinical and neurophysiological assessments will be performed before and at the end of the treatment. Loss of tolerance to the procedure up to discontinuation will be recorded on a specific form. The schedule of enrollment, interventions, and assessments is reported in Patients will be randomly allocated to the intervention or control group in a 1:1 allocation ratio. The enrollment will last up to the achievement of the sample size. The most important time points for the assessment of pain development are 3 and 6 months poststroke, with the addition of measurement time points in the subacute phase , 34. In *Power 3.1.9.7 , where d = 10%  to reach the target sample size. Patients will be randomly allocated to in a 1:1 allocation ratio to ARAMIS or conventional neurorehabilitation group. Different researchers/operators will independently recruit patients, generate the allocation sequence, and assign participants to interventions and no member of the trial will have access to the codes up to the end. Both males and females will be enrolled due to differences in baseline pain perception  and to st3 and t4 vs. t0, will be expressed as mean and standard error and assessed for statistically significant differences using independent t-test for data normally distributed or Mann–Whitney U test for skewed data. Based on the CONSORT NPT item 12b, the evaluation of the outcome measures over time will be carried out through a linear mixed model. The correlation between pain (VAS measure) and recovery (FMA-UE), assessed at t0, t1, t2, t3, and t4, will be performed through the Pearson product-moment correlation coefficient (r). In agreement with the CONSORT NPT item 12a, the clustering of data will be performed by blinded care providers of the center. Statistical analysis will be performed using SPSS statistics software . Values of p < 0.05 will be considered statistically significant.The statistical analysis plan follows the Consolidated Standards of Reporting Trials (CONSORT) evidence-based reporting guideline to ensure research transparency, specifically to trials of nonpharmacologic treatments (NPTs), as rehabilitation . The priCerebrovascular accidents are often accompanied by motor disability and chronic pain. Poststroke pain consists of complex syndromes including both nociceptive musculoskeletal and neuropathic features . Due to All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.DS is a researcher in the frame of the project supported by the Italian Ministry of Health: NET-2016-02361805 (WP 5).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Background: To reduce pain and anxiety associated with interventional pain procedures, sedation is often used, with benzodiazepines, opioids, and propofol the most commonly used classes of drugs for sedation. However, patient coherence and ability to communicate procedural pain and abnormal sensations help prevent adverse outcomes. Therefore, discovering alternative therapies to mitigate the anxiety and pain associated with these procedures and to minimize risk is important. The aim of our study was to investigate whether lavender has an effect on pain and anxiety associated with lumbar epidural steroid injections and lumbar medial branch blocks.Methods: In this randomized controlled study, 54 subjects were randomly assigned to 1 of 3 intervention groups, and 46 patients were included in the final analysis: experimental lavender group (n=17), control almond oil group (n=15), and placebo sterile water group (n=14). Patients wore a mask infused with either lavender, almond oil, or water for 5 minutes prior to and during their procedure. Patients rated their anxiety using the State-Trait Anxiety Inventory prior to and after the procedure based on how they felt during the procedure. Patients rated their pain according to the numerical rating scale. Outcome measures were a comparison of pain among the 3 groups and a comparison of the change in anxiety before and after the procedure among the 3 groups.Results: The lavender group demonstrated the highest mean change in anxiety scores (9.9) compared to almond oil (5.3) and water (3.6) preprocedurally vs postprocedurally. The lavender group also reported the lowest mean pain level (3.8) compared to almond oil (5.6) and water (5.6). However, none of the differences between groups showed statistical significance at the P<0.05 level.Conclusion: Lavender may have a clinically beneficial effect on anxiety levels and pain reduction. Based on evidence-based clinical practice guidelines for interventional techniques,5 the evidence for diagnostic lumbar facet joint nerve blocks is good, with 75% to 100% pain relief as the criterion standard. The same guidelines found good evidence for lumbar epidurals in managing disc herniation or radiculitis; fair evidence for managing axial or discogenic pain without disc herniation, radiculitis, or facet joint pain; and fair evidence for treating postsurgery syndrome with caudal epidural injections.Back pain is one of the most common forms of musculoskeletal pain causing patients to seek medical care6 Studies have shown a correlation between pain and anxiety.9 To reduce pain and anxiety associated with interventional pain procedures, sedation is often used. Based on a 2017 survey that involved 337 pain physicians, sedation is used in approximately 50% of epidural injections and medial branch blocks.10 The survey also found that the most commonly used classes of drugs for sedation were benzodiazepines (97% of respondents), opioids (77% of respondents), and propofol (36% of respondents). Today's medical culture places an emphasis on patient satisfaction, which may be a reason that sedation is frequently used. However, studies have shown a lack of significant improvement in patient satisfaction with the use of sedation.11 The use of anxiolytics and analgesics carries a significant amount of risk involving erroneous nerve ablation and local anesthetic systemic toxicity; therefore, patient alertness during procedures involving spinal nerves is imperative. Patient coherence and ability to communicate procedural pain and abnormal sensations help prevent adverse outcomes.12 The American Society of Regional Anesthesia and Pain Medicine convened a group of experts to develop the Practice Advisory on Neurologic Complications in Regional Anesthesia and Pain Medicine, and per the guidelines, general anesthesia or heavy sedation removes the opportunity for the patient and/or physician to recognize, report, and respond to an atypical symptom during the interventional spine procedure, and the guidelines therefore recommend against this practice.13 In addition to impairing patient alertness during procedures, short-acting anxiolytic agents such as benzodiazepines and pain-relieving opiates are associated with side effects such as respiratory depression15 and may skew medial branch block outcomes. Benzodiazepines produce skeletal muscle relaxation and amnesia that may result in a false-positive response by alleviating baseline back pain16 or in a false-negative response by reducing pain tolerance.17 Therefore, discovering alternative therapies to mitigate the anxiety and pain associated with these procedures and to minimize risk and false outcomes is important.Interventional spine procedures such as lumbar epidural steroid injections and nerve blocks can be particularly painful or anxiety-provoking for patients. Introduction of needles can cause patient discomfort because of the presence of nociceptors in skin and underlying tissue.18 Aromatherapy is defined as the therapeutic use of essential oils derived from plants and involves transmission of signals from the olfactory system to the brain, which regulates anxiety, depression, and mood disorders by secreting neurotransmitters such as serotonin and dopamine.19 While more than 40 plant derivatives have been identified for therapeutic use, lavender, eucalyptus, rosemary, chamomile, and peppermint are the most frequently used extracts.20Patients often use aromatherapy for pain relief, psychological comfort, and disease prevention, although evidence for the therapeutic efficacy of aromatherapy remains limited.21 Lavender essential oil is primarily sold as an over-the-counter herbal medicine and has been granted the status of “Generally Recognized as Safe” by the US Food and Drug Administration, an indication of its safety when used as a dietary supplement.22Lavender extracts are widely used in aromatherapy. Lavender aromatherapy has been reported to possess several therapeutic effects including antianxiety, mood stabilization, and analgesia.23 and has been shown to decrease anxiety associated with dental procedures.24 Lavender has also been shown to decrease pain during procedures, particularly when inhaled prior to a generally painful procedure such as catheter or needle insertion and chest tube removal.27 While the effects of lavender on various medical procedures have been investigated, no studies to the authors’ knowledge have examined the effects of lavender on fluoroscopic spine procedures. This study investigated whether inhalation of lavender essential oil reduced the pain and anxiety associated with interventional spine procedures, particularly lumbar epidural injections and medial branch blocks.Clinically, lavender has been shown to decrease anxiety in patients scheduled to undergo colorectal surgeryThis study was approved by the MetroHealth Institutional Review Board. In addition, this study was registered at clinicaltrials.gov (NCT04257019). Clinical consent for the procedure was first obtained and then the subjects were consented for the study. After informed written consent was obtained, 56 patients ≥21 years who presented for lumbar epidural or lumbar medial branch block were included in the study. Exclusion criteria included an allergy or sensitivity to lavender or almond oil, a preexisting problem with the sense of smell, the inability to follow basic instructions relating to the design of the experiment, or the inability to answer questions regarding their pain or anxiety. Subjects were assigned to each group by a computer-generated randomizer.Lavandula x intermedia [PipingRock Health Products]), sweet almond oil , or sterile water into a standard surgical mask. Five drops were applied to different areas on the interior of the mask prior to asking the subject to don the mask on the day of the scheduled procedure.The method of inhalation involved instillation of either lavender  questionnaire regarding their current anxiety. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 20 questions with total scores ranging from 20 to 80; higher scores indicate higher anxiety.Patients were then taken to a quiet area away from the triage room, asked to put on a standard surgical mask, and instructed to breathe slowly and deeply for 5 minutes. Patients were then taken to the fluoroscopy suite for their scheduled procedure. Patients were told that they could remove their mask and terminate participation in the study at any point without any effect on the procedure. Immediately after completion of the procedure, patients were asked to remove the mask, taken back to the triage area, and asked to complete the STAI questionnaire again based on how they felt during the procedure. In addition, subjects were asked to rate their pain on the numerical rating scale (NRS) based on the pain they experienced during the procedure. The scale ranges from 0 to 10, with 0 being least severe and 10 being most severe.The authors intended to recruit 75 subjects to have sufficient power, but the study had to be stopped because of critical mask shortages during the coronavirus disease 2019 (COVID-19) pandemic.As stated earlier, 56 subjects were initially recruited, but 2 withdrew from the study. One subject in the lavender group reported that when filling out the STAI questionnaire, she became upset as it made her reflect on personal life events, and she requested to be withdrawn from the study. Another subject reported that she felt claustrophobic with the surgical mask on and also requested to be withdrawn from the study.For the statistical analysis, only patients who answered all the questions were included, which was 46 of the 54 patients. Of those 46 patients, 6 took an anxiolytic  on the day of the procedure; none reported taking an analgesic. Patients were told that benzodiazepines, opioids, or nonsteroidal anti-inflammatory drugs were included in these categories. We did not ask patients to report scheduled daily medications such as selective serotonin reuptake inhibitors and anticonvulsants.The 46 patients were randomized into the following treatment groups: 17 in the lavender group, 15 in the almond oil group, and 14 in the water group.Outcome measures were comparison of pain among the 3 groups during the procedure and comparison of change in anxiety among the 3 groups before and after the procedure using analysis of variance. Statistical analysis was performed using SPSS software, version 26 (IBM Corp).P<0.05 level.None of the differences between groups showed statistical significance at the We performed a separate analysis to check for confounding variables. Whether subjects took anxiolytics or analgesics on the day of the scheduled procedure or had the same procedure during the preceding 2 years had no effect on results.No adverse reactions to lavender or almond oil were reported, but 3 subjects reported that the smell was potent in the lavender group.P<0.001).28 Inhalation of lavender also resulted in lower pain levels experienced during the scheduled procedure when compared to almond oil and placebo at a clinically relevant although not statistically significant level. Based on studies evaluating clinical meaningfulness for reduction in pain among patients with low back pain, a score of 1.8 to 1.9 on the NRS that was used in our study correlates with a minimum clinically important change.29This study focused on the anxiolytic and analgesic effects of lavender using 2 questionnaires, the NRS for pain and the STAI for anxiety, in patients scheduled for lumbar epidural injections and lumbar medial branch blocks. Inhalation of lavender resulted in a greater change in anxiety scores after wearing a mask infused with lavender when compared to the almond oil and placebo groups, but this change was not statistically significant. Based on a 2019 systematic review, 54 of 65 randomized controlled trials reported a significant result in favor of lavender use for anxiety when measured by the STAI: a mean change of –5.99  through a reduction of its expression and binding ability, the way that a selective serotonin receptor inhibitor medication works.32 In animal models, linalyl acetate anxiolytic effects were not observed in anosmic mice, indicating that the effects were triggered by olfactory input. In addition, flumazenil, a benzodiazepine antagonist that competitively inhibits by interacting with benzodiazepine receptor sites on the GABA/benzodiazepine receptor complex, was found to antagonize odor-induced anxiolytic effects, indicating that gamma-aminobutyric acid transmission plays an important role in anxiolytic effects.33Different mechanisms have been proposed for the effects of lavender therapy. First is the influence of aroma on the brain through the limbic system via olfaction, and the other is through the direct pharmacologic effects of the essential oil. Lavender contains 2 compounds, linalool and linalyl acetate, both of which have been shown to stimulate the parasympathetic nervous system.34 A meta-analysis conducted in 2016 summarized 12 studies that examined the effects of aromatherapy on pain, and a significant positive effect was found in the reduction of pain. Types of aromatherapy included in the studies were lavender, eucalyptus, lemon grass, and rose oil.35Other studies have investigated inhalation of essential oils during interventional spine procedures. Eucalyptus, specifically its constituent 1,8-cineole, was found to decrease anxiety before selective nerve root blocks.36 In addition, satisfaction with pain management often has little correlation to pain reduction and is more often associated with communication, staff behavior, and empathy.37 A pleasant scent added to a potentially anxiety-provoking experience, such as a fluoroscopically guided medical procedure, may play a role in patient satisfaction.The potential for anxiety to alter the course of pain is well known. Evidence shows that the emotional and behavioral responses to pain are strongly guided by 2 related psychosocial factors, fear and anxiety. Individuals who have lower anxiety do not interpret pain as negatively as those with higher anxiety levels, which aids in recovery.This study has several limitations. The study administrator was not blinded to which patients received which treatment, and although patients were told they were assigned to 1 of 3 groups and not told which treatment they were receiving, complete blinding, because of the smell of the lavender and almond oil, was not possible. These results are based on a preliminary analysis because of the COVID-19 pandemic that resulted in a temporary pause in all clinical research due to public health guidelines and a shortage of masks that limited the sample size and the duration of the study. Future directions include conducting a larger-scaled study and expanding the procedure pool to include other fluoroscopically guided procedures such as cervical epidurals and cervical medial branch blocks as well as genicular nerve blocks and radiofrequency ablation. As some subjects reported that the smell of lavender was potent, researchers for future studies may consider using a dilution or instilling <5 drops of lavender into a mask. Last, whether instructing patients to breathe slowly and deeply had an effect on outcomes, because all patients were asked to breathe this way, is unknown.Because of patient tolerance of the intervention, lack of adverse effects, low cost, and clinical effect on pain and anxiety levels, a feasible clinical practice may be to include a lavender scent in the waiting area or preprocedural area.Lavender may have a clinically meaningful effect on decreasing pain during lumbar epidural injections and medial branch blocks but was not found to have a significant effect on reducing anxiety related to lumbar epidural injections and medial branch blocks.


Purpose: To evaluate medium-term clinical outcomes of transcatheter embolization and stenting in women with several pelvic venous disorders responsible for chronic pelvic pain and varicose veins of the lower limbs.Materials and Methods: The study population included 327 consecutively recruited patients referred to the interventional radiology unit from January 2014 to December 2019 due to chronic pelvic congestion , lower limb varices , or a combination of both the symptoms . Preprocedural pelvic, transvaginal Doppler ultrasound (US), and MRI were conducted in all the patients and revealed anatomical varicosities and incompetent pelvic veins in 312 patients. In all the patients, selective catheterization demonstrated uterine venous engorgement, ovarian plexus congestion, or pelvic vein filling. Retrograde flow was detected on catheter venography in the left ovarian vein , the right ovarian vein , the left internal iliac vein , and the right internal iliac vein . Patients were followed-up at 1, 6, and 12 months, and years thereafter systematically by the referring angiologist and the interventional radiologist of center. They were contacted by telephone in November and December 2020 to assess pain perception and quality of life by using the visual analog scales from 0 to 10 with assessments made at the baseline and last follow-up. Of the 327 patients , 312 patients were suffering from pelvic congestion syndrome and 236 patients was suffering from lower limb varices. All underwent embolization by using ethylene vinyl alcohol copolymer (Onyx®). Eighty-five right ovarian veins, 249 left ovarian veins, 510 tributaries of the right internal iliac vein, and 624 tributaries of the left internal iliac vein were embolized. A cohort of patients also underwent nutcracker syndrome angioplasty (6.7%) and May–Thurner syndrome angioplasty (14%) with a stent placement.Results: The initial technical success rate was 80.9% for embolization of pathological veins and 100% for stenting of stenoses. Overall, 307 patients attended 12-month follow-up visits and 288 (82%) patients completed the telephone survey at mean 39 (±18)-month postintervention. Main pelvic pain significantly improved from 6.9 (±2.4) pre- to 2.0 (±2.4) postembolization (p < 0.001), as did specific symptoms in each category. Improvement or disappearance of pain was achieved in 266/288 (92.36%) patients with improved quality of life in 276/288 (95.8%) patients. There were 16 minor and 4 major adverse events reported on the follow-up.Conclusion: Pelvic vein embolization (Onyx®) is an effective and safe procedure with high clinical success and quality of life improvement rates. Chronic pelvic pain (CPP) is a common health problem among women of childbearing age, which is responsible for about 10% of gynecological consultations . While sSeveral therapeutic options have proven efficacious in alleviating pain and distress of patients including medical therapies such as medroxyprogesterone acetate, goserelin, and surgical interventions. As a curative-intent option, transcatheter embolization therapy has become a reference treatment in the PeVD setting . Followi®), unlike sclerotherapy, allows for easy fluoroscopic monitoring and control with less risk than coils and glue of additional migration or recanalization. Consequently, this study sought to evaluate the clinical medium-term outcome regarding symptom relief and quality of life (QoL) based on the visual analog scale (VAS) scoring conducted before and after embolization by using ethylene vinyl alcohol copolymer in patients with PeVD.Nevertheless, published studies focused on interventional radiology in patients with PeVD are still scarce, while mostly including only small-sized samples with the short follow-ups. Ethylene vinyl alcohol copolymer (OnyxThis retrospective study involved consecutively-recruited patients with PeVD suspected PCS or lower leg varicose (LLV) treated by using embolization from January 2014 to December 2019 at the interventional radiology unit. Patients were referred from gynecologists for PCS suspicion or from vascular surgeons and angiologists for concomitant or isolated varicosities of pelvic and lower extremity veins.Inclusion criteria were CPP or LLV for more than 6 months with an imaging diagnosis of CPVI on Doppler ultrasound (US) and MRI. While the main concern for people with PeVD is CPP, varicose veins of the lower limbs of pelvic origin must be treated specifically.Exclusion criteria involved other pelvic pathologies  and pregnancy. It must be noted that endometriosis was not deemed an exclusion criterion provided that CPP had persisted for more than 6 months after appropriate medical endometriosis treatment with visualization of pelvic varices on imaging studies.From January 2014 to December 2019, 384 patients were referred to the department for pelvic vein embolization in a CPVI setting. A total of 15 patients (3.9%) were referred for pelvic venous disorders at the origin of lower limb varices. All the other patients suffered from chronic non-cyclical pelvic pain that persisted for more than 6 months and all completed a pain assessment questionnaire. A total of 12 patients were excluded from analysis because of other pelvic pathologies, while another 45 patients did not undergo any embolization therapy for various reasons. Overall, 327 patients were considered for the analysis  and theiAll the patients benefited from a pretreatment consultation with clinical and radiological evaluation. During this visit, data on age, parity, prior LLV, past pelvic surgery, medical history, and associated pelvic pathologies were collected. All the patients were asked to subjectively assess the level of CPP, postcoital pain, lower limb pain, and QoL by using the VAS . The VASOther clinical symptoms that were assessed included pain on standing, pain on lying down, menstrual pain, and increased urinary frequency. At physical examination, lower limb, vaginal, and vulvar varicosities were assessed. The VAS assessments were made before embolization and during the follow-up.All the patients benefited from pelvic, transvaginal, and lower limb Doppler US and pelvic MRI. In 127 cases, a CT angiogram of abdomen and pelvis was performed to identify anatomical variants and compression of the left renal veins and common iliac veins. Pelvic and transvaginal US were routinely conducted, with the patient in a supine or semi-upright position, by using transabdominal and transvaginal techniques with color flow and Doppler examinations in order to ascertain PeVD diagnosis according to the US criteria described by Park et al. . Reflux T2-weighted images, the axial T1-weighted images, and the contrast-enhanced T1-weighted images. Pelvic MR angiography was performed in coronal three-dimensional (3D) Dixon-Volumetric Interpolated Breathold Examination (VIBE) gadolinium sequences, so as to assess pelvic varicocele, diameter of dilated ovarian veins, pelvic differential diagnoses, and secondary congestion. The MRI criteria applied were the presence of at least four ipsilateral parauterine veins of varying caliber with at least one measuring more than 5 mm in diameter or an ovarian vein diameter exceeding 8 mm  was narrowing of the lumen of the vessel by >50%, presence of prestenotic venous dilation in CT scan, reflux of contrast agent into the internal iliac vein, and contrasting of collateral pelvic veins. Symptomatic obstruction of the left renal vein (LRV) was defined by hematuria, flank pain, CT parameters, such as a beak sign, LRV diameter ratio, and pressure gradient between the LRV and inferior vena cava ≥3 mm Hg after left ovarian vein embolization.Following the intervention, patients were followed-up by the referring angiologist and the interventional radiologist of center at 1, 6, and 12 months and yearly thereafter including clinical evaluation, pain and symptom assessment, QoL scoring, and Doppler US. In the event of persistent pain in the 6 months after the procedure, an indexed procedure with another venogram was carried out to reveal any pelvic vein reflux or other vein abnormalities.Intravascular embolization was intended to occlude ovarian or pelvic veins that presented spontaneous or induced reflux or other vascular abnormalities; always starting with the most pathological vein .Because of the veins of the uterus, ovaries, bladder, distal colon, and the parietal structures of the pelvis communicated, to each other and through the pelvic floor, with veins from the anterior thigh, perineum, buttock, and posterior thigh, we realized distal supraselective embolization of them when a retrograde flow was demonstrated. The specific pelvic veins embolized were based on the assessment of reflux and leakage from the pelvis to the lower limbs. All the embolization procedures were performed by two radiologists both presenting over 10 years of experience in interventional radiology. In all the cases, diagnostic venography was conducted by using a transfemoral or brachial approach under local anesthesia in semi-upright position. The brachial approach was used when the right ovarian vein had to be embolized. A 5-Fr introducer sheath  was placed in the femoral vein  and a 4-Fr Cobra II customized guiding catheter  was advanced up in order to investigate the gonadal veins and afferent vessels. For brachial access, a 4-Fr vertebral  guiding catheter was used. A selective hand injection in each internal iliac vein was conducted, under a Valsalva maneuver, in order to detect venous incontinence and pelvic opacification. Thereafter, the catheter was advanced into each renal vein and pointing to the origin of the left ovarian vein within the left renal vein. Reflux into the left ovarian vein was investigated by injecting iodinated contrast medium into the left renal vein with reflux into right ovarian vein similarly investigated by selective iodinated contrast medium injection. An automated pump injector was used for contrast injections into the common femoral vein and the left renal vein (10–15 ml at 5 ml/s). After ovarian vein insufficiency was confirmed, the catheter was further advanced to the pelvic level with a selective pelvic-centered, hand-injection performed. These maneuvers were aimed at detecting pelvic varicose veins or reflux in the lower limb or groin under Valsalva maneuver. Embolization was indicated for all the ovarian and pelvic veins demonstrating reflux, whether spontaneously or following a Valsalva maneuver .®, Medtronic, or Progreat®, Terumo, Tokyo, Japan) was employed to selectively catheterize the most distal pathological vein. Onyx® is an elastic ethylene vinyl alcohol copolymer that is dissolved in dimethyl sulfoxide (DMSO) with micronized tantalum powder, thereby providing contrast for fluoroscopic visualization  anterior angioplasty, May–Thurner syndrome (MTS) angioplasty, and NCS posterior angioplasty. Iliac or left renal angioplasty was indicated when increased venous pressures, resulting from proximal obstruction with reflux, induced symptoms related either to varicose veins or to increased venous pressure. The aim of the therapeutic interventions was directed toward decreasing the upstream venous pressure. The procedure was performed at the same time as the embolization if the stenosis was explored on CT and confirmed with angiography. If not, the patient was informed and a CT scan was scheduled. Then, a new intervention was organized if specific symptoms persisted and was classified in indexed intervention. In all the cases, venous self-expanding stents with diameter of 14–16 mm in diameter by 40–60 mm in length for left renal vein and 14–18 mm in diameter by 60–90 mm for common iliac vein after sizing on CT scan. In case of residual stenosis, balloon angioplasty was performed. After stenting, all the patients received antiplatelet drugs (clopidogrel 75 mg) for 3 months after intervention.Patients with multiple venous refluxes with significant pelvic varicose veins and multiple communications to the pelvic floor and extrapelvic veins of the thigh were rescheduled directly after the procedure if embolization was incomplete. Repeat embolization excluded intentional staging of embolization for complex lesions.Moreover, intravascular or surgical treatment of symptomatic varicose limb veins was carried out in additional, separate sessions. Patients were hospitalized 6–24 h postembolization in order to monitor pain and venous access. They were then discharged with a 5-day sick leave protocol for home pain management under nursing control. For the management of postoperative pain, opioids were administered if necessary.via telephone calls that were made in November and December 2020 to all the patients having undergone intravascular embolization between January 2014 and December 2019 in the institution. During this telephonic conversation, patients were interrogated about pain, dyspareunia, dysmenorrhea, mictional urgency, and associated symptoms. All the patients were asked to subjectively assess pain, symptoms, and QoL  level using the VAS  and QoL from baseline to the last follow-up.Clinical success was defined as improvement or disappearance of pain. For better analysis of the results, the VAS pain scores were classified into four categories: no pain heaviness (0–1), mild pain (2–4), moderate pain (5–7), and severe pain (8–10). Clinical success was considered complete when the VAS score decreased to 0–1; the latter was considered partial when the VAS score dropped to a lower category such as from severe to moderate. No change was recorded when VAS score stayed in the same category. Worsening was noted when the score escalated to a higher category. Recurrence was defined as the return of pain after 6 months of clinical improvement to the same basic before treatment.Secondary endpoints were perioperative safety issues and postoperative complications. Complete technical success was defined as the occlusion of ovarian and iliac pelvic veins that previously displayed reflux or other vascular abnormalities on fluoroscopy and endovaginal Doppler US.Complications were assessed according to the Society of Interventional Radiology grade reporting standards .p-values inferior to 0.05 indicating statistical significance. The results of the satisfaction surveys were compared by using the Student's t-test. Analysis was performed by using the Microsoft®  Office Excel or the Medistica®  PValue.io software.Qualitative variables were expressed as frequencies and quantitative variables were expressed as mean ± SD. Comparisons of quantitative variables were performed by using the Kruskal–Wallis testing with the Fisher's exact test applied for comparing qualitative variables. The outcomes of the hypothesis tests were two-tailed, with Before initiation of study, the Ethics Committee for Research in Imaging (CERIM) provided approval of the study protocol. Written informed consent was obtained from each patient prior to conducting any interventional procedure.The primary indication for embolization was PCS in 312 (95%) and LVV in 15 (5%) patients .The clinical examination, pelvic and transvaginal Doppler US, and pelvic MRI were instrumental in confirming PCS diagnosis in 315 (96.3%) patients . Mean PCThe venograms performed demonstrated pelvic vein dilatation and retrograde venous flow under Valsalva maneuver in all 327 (100%) patients, while a retrograde venous flow without Valsalva maneuver was recorded in 267 (82%) patients. Concerning with the internal iliac veins, a right retrograde flow was noticed in 185 (57%) patients and a left retrograde flow was noticed in 222 (68%) patients. The mean PCS was retrospectively assessed by using the PCS scoring system suggested by Champaneria et al.  as folloOverall, 614 embolization procedures were performed in 327 patients on overall 1,468 veins, meaning that 1.9 (±0.9) procedures on 4.5 veins were performed per patient on average, including 249 (76%) left ovarian vein and 85 (26%) right ovarian vein, 510 tributaries of the right internal iliac vein , and 624 tributaries of the left internal iliac vein embolizations. Further therapeutic details have been provided in A total of 14 patients (4.6%) required repeated treatment in an already embolized vein because of symptom recurrence. A technical embolization failure occurred in one patient involving an ovarian vein with an abundant collateral system. It must be noted that LVV was generally treated in subsequent, separate sessions.® migration, and one infectious syndrome at day 15 postembolization. There were 16 minor complications recorded as follows: a panic attack, seven delayed allergies, a severe vagal reaction requiring 1-day hospitalization, four phlebitis at perfusion site cases, and four dyspnea cases at home, yet without any abnormality detected upon checkup in the emergency room. One patient suffering from salpingitis was operated at 1-month postintervention. During the overall follow-up, no long-term complications were reported.There were 20 complications recorded postoperatively including four major complications as follows: an allergic bronchospasm requiring 72-h hospitalization, a false common femoral artery aneurysm treated by direct embolization, one asymptomatic Onyxp < 0.001). Dysmenorrhea, dyspareunia, and postcoital pain that had been present in 260 (±79%), 164 (±50%), 226 (±69%) patients prior to embolization were only still present in 58 (±19%), 57 (±19%), and 34 (±11%) patients at 1 year with markedly decreased intensity levels (p < 0.001).The data retrieved at the 1-year consultation regarding symptom relief are given in p < 0.001) were recorded on all the US parameters.The US data retrieved at 1-year consultation in comparison with the preembolization results are given in p < 0.001). Improvement or disappearance of pain was achieved in 266/288 (92.3%) patients. Complete clinical success was recorded in 155 (53.8%) cases and partial success was recorded in 101 (35%) cases. No clinical change was observed in 29 (10.1%) cases. Worsening was noted in three patients (1.0%). One patient reported a deterioration in her QoL due to vulvar pain during sexual intercourse and sports and two others suffering from enhanced inguinal pain. Significant improvement (p < 0.001) in each specific symptom category was similarly reported with postcoital pain improving from 4.7 (±3.5) to 0.8 (±2.0), right inferior limb pain from 4.1 (±3.1) to 1.8 (±2.4), and left inferior limb pain from 4.4 (±3.0) to 1.8 (±2.4). Almost all the patients  reported an improvement in QoL by a mean of 6.7 (±2.4) with only seven patients (2.5%) declaring no amelioration.Of the treated patients, 288 patients completed the telephone survey at a mean 39 (±18.5) months follow-up with outcome data compared to pre-embolization ones, as listed in Overall, 14 (5%) patients experienced a recurrence of symptoms after clinical improvement. Statistical analysis found no significant difference in the follow-up according to treatment variables .A total of 17 (6%) patients carried a pregnancy to term. Overall, 259 patients (93%) had no change in menstrual periods, 8 (3%) patients experienced irregular cycles, and 21 (7%) patients had an improvement in menstrual cycle regularity after treatment.Analysis of this large cohort of PCS women that underwent endovascular treatment revealed significant improvements in overall pain perception levels and each of the specific symptom categories and in QoL.In this study, the imaging workup by using different techniques proved to be instrumentally useful. The transcatheter venography guided by MRI and Doppler US enabled to opacify major venous channels with their extensive venous tributary network including ovarian, uterine, vaginal, myometrial, and lower leg anastomoses. The CT scan has also allowed to better evaluate venous compressions and to detect the numerous anatomical variants that are sources of therapeutic errors. This combinative approach was actually effective for tackling impaired venous reflux. The disappearance of Doppler venous reflux following embolization testified to the success of intervention. In addition to investigation of abdominal US, an additional endovaginal investigation was carried out. This was effectively useful, as it enabled to further objectify pelvic reflux and measure the diameters of pathological veins as well. Likewise, these complementary imaging techniques permitted to better control the outcome of the intravascular intervention. Embolization was deemed complete when Doppler examination revealed no clinically relevant venous pelvic leaks into lower limb veins with a complete occlusion of pelvic varices and dilated veins. Notably, we would like to remind the reader that a proper control of the interventional outcome including transvaginal Doppler US is paramount.®.In this study, pain improvement was 92.3% with a median follow-up period of 39 months, which is similar to the results of other studies. While the use of coils, with or without sclerotherapy, glue, and plugs has been most commonly reported for pelvic embolization, no study has reported significant differences in clinical outcomes between one specific embolization agent and another or in a combination of them. In 1993, Edward et al. reported the first case of uterine ovarian varices embolization . Since t® as an embolizing agent was based on several reasons that we carefully evaluated. Yet, in our view, several shortcomings such as clinical failures, coil migration, and recurrences were reported following coil embolization. We suggest that it is necessary to treat all the pathological veins, as necessary, with subsequent control imaging. Moreover, ovarian and iliac coils embolization lead to a risk of difficulty in treating a clinical recurrence. With all this taken together, we eventually selected another embolic agent: ethylene vinyl alcohol copolymer  and more dyspareunia  compared to all the patients without a nutcracker. Similarly, there was no significant statistical difference between the population that underwent unilateral or bilateral embolization of the ovarian veins after treatment. However, there was more pain after intercourse , dysmenorrhea , greater intensity of pain in the right lower limb , and pelvic pain  before treatment in the population that underwent bilateral embolization.Based on this experience and owing to an improved understanding of the underlying pathology, we recommend investigating and treating the entire pathological vein network. If the treatment of venous compressions included in the series can lead to confusion on the interpretation of the results, it seemed important to us to report the results in accordance with the international recommendations , 21. VenIndeed, significantly different results depending on treatment completeness. In this study, the VAS-recorded symptom improvement was the best in patients that underwent complete therapy amounting to 7.0 ± 2.3. In contrast, for patients with persistent pelvic varices, it was only 5.0 ± 2.0. For complete treatment, several treatment sessions may be required some weeks apart with a full diagnostic workup to be performed prior to each new intervention.Dysmenorrhea, dyspareunia, and inferior limb varices that had been present in 260, 164, and 226 patients, respectively, prior to embolotherapy were still present in only 84, 54 and 176 patients, yet with markedly decreased intensity levels.According to the study by Kim et al. , ovarianThe small statistically significant increase in pain at the end of this study compared to the level of pain at the 1-year consultation, which was not reported from other studies, can be explained by the strategy of stopping analgesics after stabilization for all the patients and continuous hormonal treatments in agreement with the referring gynecologist to the patient.It was important to note that no statistical difference was found in the evaluation of pain and also QoL scores according to the presence or absence of endometriosis.Several limitations of this study must be highlighted. The major limitation of study is its retrospective, non-randomized study design, with the lack of a control group. Secondly, US evaluation criteria were not predefined prior to the study initiation, which may have contributed to some inconsistency in US assessments. We used the VAS scale to evaluate QoL, an applicable questionnaire of QoL assessments would have been more relevant. Lastly, of the 327 patients, only 288 patients attended the last follow-up telephonic interview. This may have somewhat biased the outcome data. Prospective randomized studies are needed to confirm these encouraging results.® technique and stent placement has been shown to be an effective and safe technique, resulting in relevant clinical success, with an overall improvement of pain and other symptoms and QoL.In conclusion, embolization of pelvic veins by using the OnyxThe original contributions presented in the study are included in the article/The studies involving human participants were reviewed and approved by the Ethics Committee for Research in Imaging (CERIM). The patients/participants provided their written informed consent to participate in this study.QS, PE, and MBr contributed to conception and design of the study. QS and MF performed the statistical analysis. MBo and LJ reviewed the MRI. FL and JF reviewed the CT Scan. EP wrote sections of the manuscript. All authors contributed to manuscript revision, read, and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Background and Objectives: The success rates of surgical dental implant insertions are high. However, knowledge of patients’ recovery is still lacking. “Health-related quality of life” (HRQOL) questionnaires are gaining popularity in all fields of medicine. The present survey assessed the perception of recovery after the surgical placement of dental implants. Materials and Methods: Forty individuals  filled a questionnaire evaluating patients’ perception of recovery for 7 consecutive days post-surgery. Confounding factors included age, gender, oral habits, smoking, bruxism, bone quality  and quantity, implant location, number of implants, implant type, length and diameter, one-stage vs. two-stage, and the need for bone grafting. Results: The most serious difficulties were found in swelling, which became minimal after 5 days, followed by eating everyday food, ability to enjoy everyday food, maximal pain and average pain (3 days); analgesics consumption (2.5 days); limitations in daily routine, mouth opening, and speech (2 days); swallowing and sleep (1.5 days); and, within 1 day, all other measures attained minimal levels. Gender, and implant location (anterior vs. posterior) were significant predictor variables exerting their different characteristic delayed recoveries. Conclusions: (1) Patients should expect, in general, recovery within 4 days after dental implant placement; (2) women will experience a delayed recovery, (3) implants placed in the intercanine area will result in postoperative eating difficulties for nearly one week, and (4) the number of implants placed during the same appointment has no effect on post treatment recovery. Endosseous dental implants have become an important method of treatment of complete or partial edentulism ,2,3. ComThe advantages of the Brånemark protocol for achieving osseointegration have been demonstrated over many years of successful application . NeverthThe relatively long healing time, during which the patient is subjected to significant inconvenience and difficulty in eating, as well as the requirement for two surgical procedures with associated expense, pain, and further inconvenience, are significant disadvantages and are often powerful disincentives to a treatment that would have great benefits to the patient’s health and quality of life ,11,12,13Our knowledge of patients’ recovery is scarce . “HealthThe study was approved by the ethics committee of the Rabin Medical Center, Campus Beilinson, Israel (0674-19rmc). The HRQOL instrument  was prevAfter surgery, the HRQOL questionnaire was given to the patients. A daily telephone confirmed patient compliance. Individuals not responding to the questionnaire were excluded.p < 0.05 taken as the minimum criterion of significance.A visual analog scale (VAS) was used for pain assessment. A 5-point scale was used for other parameters ,23. RecoThis study included 40 patients . Ninety-eight implants were inserted in the 40 individuals, resulting in an average of 2.45 ± 1.43 (range: 1–6) implants per patient. Implant length averaged 12.27 ± 1.22 mm (range: 10–13 mm) and implant diameter averaged 4 ± 0.54 mm (range 3.3–5 mm). All the implants were from Zimmer Dental.Bone quality  was typeThe two-stage traditional protocol was used in 32 (80%) cases, while in 8 (20%) cases a one-stage protocol was used. Disregarding the used protocol, the questionnaire was given only for the first surgery.Minimal bone augmentation was required in 7 (17.5%) cases.In 19 (48%) cases, the implants were placed in the mandible, while in 21 (52%) cases the implants were placed in the maxilla.Thirty-three (33.7%) implants were inserted in the intercanine area and in the premolar area, respectively, and 32 (32.6%) were inserted in the molar area.Eight (20%) patients were smokers and 5 (12.5%) patients were reported as bruxers.On postoperative day (POD) 1, 52.5% of the patients reported severe pain (score 8–10/10) at some point in the day , decreasConsumption of analgesics also declined gradually over the first three postoperative days .On POD 1, difficulty in eating  was the Improvement in most oral functions  was evidLimitation in daily routine declined to 12.5%  by POD 2, resembling absence from work, which reached 12.5%. Sleep was minimally affected during the entire postsurgical period.Swelling, the major distressing postoperative symptom , resolveThe median recovery time , as reflected in swelling, required 4–5 days to reach minimal levels; the ability to eat, enjoy, and taste food along with pain and analgesics consumption required 3 days; mouth opening, speech, and everyday activity required 2 days; and within 1 day, all other measures attained minimal levels. None of the patients returned with aggravation of symptoms, for postoperative visits.The influence of predictor variables on “recovery time” was assessed. The statistically significant predictor variables were gender and implant location. The presence of healing abutment in one-stage cases, inserting one versus several implants at the same surgical appointment, smoking, and bruxism resulted in a similar recovery period and did not can contribute to the results.p < 0.05), the ability to enjoy food , everyday activity , and pain  and analgesics consumption  compared to men.Regarding gender, women showed slower recovery regarding eating difficulties .Implants placed in the anterior area of the jaw (intercanine area) showed slower recovery regarding eating difficulties compared to the posterior area . The results show that swelling resolved by POD 4 while the majority of the oral functions recovered within 3 days. Pain and analgesics consumption also required 3 days while all other measurements attained minimal levels within 1–2 days.One of the limitations of the current study is the use of a single implant brand  only. Consequently, the influence of different implant designs on recovery was not assessed as in previous studies . CorrespAnother limitation of the study is the lack of randomization. To overcome these limitations, consecutive patients were included.The same HRQOL questionnaire was used for studying post treatment recovery ,23. A coGender (women) was the main predictor variable significantly affecting recovery. It affected eating difficulties, the ability to enjoy food, everyday activity, pain, and analgesics consumption. Assessment of post-surgery pain response and impairment of life activities in 42 periodontal patients between the ages 26 and 67 demonstrated that dental anxiety, fatigue, and depression were positively associated with measures of post-surgery sequelae . The preIt is perhaps surprising to see that inserting one versus several implants at the same surgical appointment resulted in a similar recovery period. Thus, the concern expressed by many patients that if several implants are performed simultaneously, the patient will suffer more, is largely unsupported.More studies with larger sample sizes should be carried out to compare implant surgery to other oral surgical procedures. Confounding factors affecting pain perception should be considered. Tooth extraction, for example, is usually accompanied by inflammation. Post extraction pain can increase 3-fold for symptomatic teeth due to inflammatory mediators increasing nociceptors activity. Consequently, it is expected that implant placement will have less postsurgical pain and discomfort. Moreover, implant surgery is elective, and is hence more controllable than symptomatic non-elective surgical procedures. Future studies should validate such findings ,36,37,38The present findings may be used as a means to provide information for the patient to evaluate, together with the more direct factors surrounding the treatment options. This study demonstrates that recovery is rapid and the practitioner should allay patient concerns surrounding the implantation procedure. This should be done with the aim of eliminating it as a factor, in favor of the objective reasons itself for or against implant placement in any given prosthetic treatment plan.Patients should expect, in general, recovery within 4 days after dental implant placement.Women will experience a delayed recovery.Implants placed in the intercanine area will result in postoperative eating difficulties for nearly one week.The number of implants placed during the same appointment has no effect on post treatment recovery.Within the limits of the present sample, the following may be concluded: