Background and Objectives: Early postoperative mobilization is central for postoperative outcomes after lower extremity joint replacement surgery. By providing adequate pain control, regional anaesthesia plays an important role for postoperative mobilization. It was the objective of this study to investigate the use of the nociception level index (NOL) to determine the effect of regional anaesthesia in hip or knee arthroplasty patients undergoing general anaesthesia with additional peripheral nerve block. Materials and Methods: Patients received general anaesthesia, and continuous NOL monitoring was established before anaesthesia induction. Depending on the type of surgery, regional anaesthesia was performed with a Fascia Iliaca Block or an Adductor Canal Block. Results: For the final analysis, 35 patients remained, 18 with hip and 17 with knee arthroplasty. We found no significant difference in postoperative pain between hip or knee arthroplasty groups. NOL increase at the time of skin incision was the only parameter associated with postoperative pain measured using a numerical rating scale (NRS > 3) after 24 h in movement . There was no association with intraoperative NOL values and postoperative opioid consumption, nor was there an association between secondary parameters  and postoperative pain levels. Conclusions: Intraoperative NOL changes may indicate regional anaesthesia effectiveness and could be associated with postoperative pain levels. This remains to be confirmed in a larger study. Orthopaedic joint arthroplasties can be stressful procedures for patients due to high pain levels, especially in the context of postoperative mobilization . TherefoUnlike processed electroencephalography (EEG) for the assessment depth of anaesthesia, the objective measurement of intraoperative pain and stress has not yet become part of the anaesthesiological standard, although corresponding devices have been available on the market for years . Thus, aSince both over- and underdosing of analgesia can lead to undesirable side effects for the patient, individualized administration of pain medication is desirable . So far,With the use of supplemental regional anaesthesia, it is of importance to have early feedback on block effectiveness to be able to provide adequate analgesia. Regional anaesthesia is also an integral part of multimodal pain management within the framework of ERAS (Enhanced Recovery After Surgery) protocols. Here, however, the dosage of analgesics is commonly based on a fixed standard and is not individually tailored to patient requirements .The application of a monitor for the objectifiable recording of pain and stress under anaesthesia could be advantageous to the administration of analgesics at the end of anaesthesia at an optimal dosage. With this study, we aimed to investigate whether intraoperative nociception is associated with postoperative pain or analgesic consumption using the nociception level index (NOL) and postoperative and pain scores with the numeric rating scale (NRS). We hypothesized that intraoperative nociception measurement can determine the effectiveness of peripheral nerve blocks in terms of postoperative pain and opioid consumption in patients undergoing lower extremity joint arthroplasty. We hypothesized a relationship between NOL changes at skin incision and during surgery and postoperative pain as well as opioid consumption.Additionally, in a sub-analysis, it was evaluated how changes in heart rate and bispectral index (BIS) as standard references behave after a stimulus and in relationship to postoperative pain.In a prospective, monocentric observational study, 45 patients who underwent knee or hip joint replacement in the Department of Orthopaedics and Trauma Surgery at the University Hospital Bonn, and for whom a regional anaesthesia procedure was established preoperatively, were included during the period 01-05/2019.The study was approved by the University of Bonn ethics committee . After informed consent, patients were enrolled in the study. For anaesthesia induction, patients received standard monitoring with electrocardiography (ECG), peripheral oxygen saturation, and non-invasive blood pressure monitoring. Additionally, bispectral index (BIS) monitoring was established, and the finger clip of the PMD-200 NOL monitor  was attached to the patient for continuous monitoring. Anaesthesia was induced with 0.2–0.3 mg of Fentanyl and 2 mg/kg bodyweight Propofol. Neuromuscular block was achieved with 30–50 mg Rocuronium. Patients were endotracheally intubated and mechanically ventilated. Depending on the surgical procedure, a fascia iliaca block or an adductor canal block as a single-shot procedure was applied. Patients with hip arthroplasty received a fascia iliaca block: using a linear ultrasound transducer placed on the inguinal crease, the femoral artery was located. The iliacus muscle was identified laterally to the artery and medially in relation to the sartorius muscle. Thus, 30–40 mL of Ropivacain 0.375% was injected underneath the iliacus fascia in an in-plane technique. Patients undergoing knee arthroplasty received an adductor canal block. The sartorius muscle was located at mid-thigh level using ultrasound from an antero-medial direction, with the artery, vein, and nerve on the dorso-lateral side. We followed the artery distally with ultrasound to the point where it moved away dorsally into the adductor canal. A volume of 20 mL of Ropivacaine 0.375% was injected via an in-plane technique into the fascial structure on the lateral side of the artery.During surgery, anaesthesia was continued with a balanced anaesthesia regime consisting of Isoflurane and Remifentanil. For postoperative analgesia, pain pumps were used starting in the post-anaesthesia care unit (PACU), with a mixture of Metamizole and Tramadol in knee replacements and Piritramide in hip replacements, respectively.All perioperative vital signs and administered medications were recorded and evaluated in the electronic patient management data system (PDMS). In addition to the standard monitoring, which included ECG, blood pressure measurement, oxygen saturation, and BIS monitoring, the intraoperative nociception level (NOL) was recorded with a monitor from Medasense (PMD 200), which was blinded for the anaesthesiologist.Pain levels were assessed in PACU, 24 and 48 h after surgery using the numerical rating scale (NRS). Pain was assessed based on an interview of the patients’ current pain experience at rest and in movement. Assessment and documentation were performed by trained and specialized nursing staff. The opioid consumption documented from the pain pumps was evaluated and converted into morphine equivalents. The NOL display was covered during the procedure to avoid influencing the anaesthesiologist’s decision in the use of analgesic medication.-Relationship between NOL values at skin incision as well as during surgery and postoperative opioid consumption at 24 and 48 h after surgery.-Relationship between change in secondary parameters  at skin incision and postoperative pain at 24 and 48 h after surgery.Primary outcome parameters were the association between NOL values at skin incision as well as during surgery and postoperative pain at 24 and 48 h after surgery. Secondary outcome parameters were:Baseline characteristics of the study population are presented as means with standard deviations (SDs) or median with interquartile range (IQR) for continuous variables and counts with percentages for categorical variables.The intraoperative NOL, BIS, and heart rate (HR) values were summarized into the following variables: median during surgery, median value during 60 s before intubation or skin incision, median value during 60 s after intubation or skin incision, and knife-to-skin reaction: percentage change of NOL, BIS, or HR values after skin incision (pre vs. post (%)). Additionally, time-weighted averages (TWA) of NOL values lower than 10 or higher than 25, 30, 35, 40, and 45 were calculated in accordance with the manufacturer’s recommended intraoperative range of 10–25.Concerning postoperative pain, patients were split into two groups according to numerical rating scale (NRS) values: low pain (NRS ≤ 3) and high pain (NRS > 3). NOL, BIS, and HR variables were tested for differences regarding these two groups using the Wilcoxon Mann–Whitney tests. The association between NOL values and morphine equivalents was investigated using linear regression models.p-values < 0.05 (two sided) were considered statistically significant.Assuming equal group size of patients with low and high postoperative pain (NRS ≤ 3 vs. NRS > 3), mean NOL values of 20 and 30 were assumed for the groups, respectively, with a standard deviation of 10. Using the Wilcoxon Mann–Whitney test, a power of 80%, and a level of significance of 5% (two-sided), the resulting sample size is 18 participants per group. Assuming a drop-out rate of 20% due to technical issues, we aimed for a final sample size of 23 patients per group.Initially, 45 patients were included; after checking for dropout criteria, 35 patients remained for final analysis . See Of the remaining patients, 18 had received hip arthroplasty and 17 knee arthroplasty. Demographic and surgery related data can be seen in p = 0.005). Although a tendency could be observed, this effect was not significant on the second postoperative day (p = 0.072). See p = 0.055). NOL- and NRS-related data for 24 h after surgery in movement are shown in We found a relationship between the NOL reaction to skin incision and postoperative NRS > 3 in movement within 24 h after surgery (Knee and hip replacements are among the most common joint operations in the field of orthopaedics ,6,7. ThiEarly mobilization of patients plays a decisive role, as it has been shown to reduce the length of hospital stay and, thus, save costs ,12. HoweCurrently, there is no established means of evaluating regional anaesthesia effectiveness during surgery. Therefore, intraoperative nociception measurement may be beneficial in predicting the effectiveness of peripheral nerve blocks and, thus, optimize patient’s postoperative analgesia, also with regard to early mobilization. However, in our patients, elevated nociception levels during anaesthesia do not appear to be associated with postoperative opioid consumption. It has been suggested previously that nociception, as experienced under anaesthesia, is by no means comparable to pain experienced in an awake state . In contNOL changes after skin incision and their association with postoperative pain may suggest that NOL may be used to evaluate block effectiveness during general anaesthesia. Bollag et al. also reported a difference in NOL response to skin incision in patients undergoing thoracoscopy with and without epidural anaesthesia  and concNaturally, there are some limitations inherent in this study. First, this is an observational study with relatively few cases, and the results should be interpreted in this context. Furthermore, we included both hip and knee arthroplasty surgery, and there may be differences in the NOL response to regional anaesthesia, which has to be considered when interpreting our results. Since not only patients with primary arthroplasty were included, the results may not be generally applicable in the setting of orthopaedic surgery. Finally, while our results propose the utility of NOL in the setting of joint arthroplasty, this may not apply to other surgical fields, although previous works suggest otherwise.In our cohort of patients undergoing hip or knee arthroplasty, our data suggest that intraoperative nociception measurement can be used for the evaluation of peripheral nerve block effectiveness. We found a difference in NOL change after skin incision between groups reporting postoperative NRS > 3 vs. NRS ≤ 3 during movement on the first postoperative day, but not on the second, although a tendency could be observed.In summary, it can be concluded that intraoperatively, nociception may be used to evaluate peripheral nerve blocks and could possibly have its value as an additional method for optimizing anaesthesia. These results remain to be confirmed in a larger cohort.


Degenerative disc disease and low back pain are common challenges that persist even after a discectomy. However, characterizations and quantifications of these illnesses from the patients' perspective are insufficient. We aimed to perform a systematic review of the literature and meta-analysis to determine the frequency of chronic pain after spinal surgery. We searched MEDLINE (PubMed), Google Scholar, and the Saudi Digital Library to retrieve research articles describing the frequency of persistent back pain, reoccurring disc herniation, and undergoing another operation following primary lumbar discectomy. We excluded articles that did not disclose the proportion of patients who experienced ongoing back or leg pain for over six months after the operation. We included 16 studies evaluating 85,643 patients. The pooled prevalence of persistent pain was 14.97% . With all advancements in technology and operation techniques, many patients (14.97%) still have failed back surgery syndrome. Appropriate preoperative communication and multidisciplinary and coordinated treatment strategies yielded the best results. Low back pain (LBP) is a frequent symptom globally; an estimated 60-80% of people will have LBP at some point in their life . LBP symSearch strategyWe identified search terms and combined them with appropriate Boolean operators. We searched MEDLINE (PubMed), Google Scholar, and the Saudi digital library for research articles published in English. The search sequence submitted was as follows: “Failed back surgery syndrome,” OR “Pain recurrence after discectomy,” OR “Post-surgical spine syndrome,” OR “Repeat spinal surgery,” OR “Disc herniation requiring reoperation,” OR “Persistent spinal pain syndrome,” OR “Post-laminectomy reherniation relapse pain,” OR “Chronic pain after spinal surgery,” OR “Chronic pain after back surgery,” OR “Post spinal surgery syndrome,” OR “Post-laminectomy syndrome.” The search was conducted in April 2023 and was limited to publications between 2010 and 2022. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) of observational studies ,22. We sInclusion and exclusion criteriaWe included research articles written in English that (1) were published in peer-reviewed journals; (2) investigated the prevalence of pain that persisted for more than six months after spinal surgery; (3) had a reported cross-sectional, cohort, or longitudinal design; (4) had a defined sample; and (5) evaluated at least one of the primary clinically significant outcome variables  with a valid instrument; (6) their patients were individuals with sciatica due to a herniated disc; and (7) scored at least 5 out of 9 on the Joanna Briggs (JBI) checklist . We exclData collection processTwo reviewers (HS and AS) independently assessed the electronic search titles and abstracts and obtained complete papers. If no consensus could be achieved, a third reviewer (SA) was consulted to determine whether the article should be included or excluded. The entire texts of all articles preserved from the first stage were reviewed for inclusion and exclusion criteria in the second stage.Quality assessmentSince the "prevalence" estimate is the most important one, the JBI Critical Appraisal Checklist was chosen to assess validity compared with other critical appraisal tools for systematic reviews of epidemiologic studies ,25. It aData synthesisWe compiled tables of the retrieved studies and their key results. The extracted data consisted of authors, publication year, research, population, design (prospective versus retrospective), follow-up period, sample size , age, type of surgery, the measure of interest prevalence and tools to identify it, satisfaction, risk factors, the prevalence of persistent back or leg pain, and quality assessment score. If the prevalence was analyzed by subgroups such as sex, we included this column in the table. The project protocol was registered in PROSPERO (CRD42023418143).Statistical analysisWe conducted a meta-analysis using MedCalc for Windows version 15.0  to estimate the combined (pooled) prevalence of persistent pain after spinal surgery. Forest plots were used to graphically show the pooled prevalence (using fixed- and random-effect models) of the studies included in the meta-analysis. Heterogeneity in the pooled data was assessed using Cochran’s Q and I2, indicating the total variation percentage across the studies. A cut-off value of I2 > 50% was used to rule out higher levels of unexplained variability in the effect sizes. The significance of publication bias was assessed using Egger’s test. The precision of estimates was reported using 95% confidence intervals.ResultsThe initial search yielded 115 published studies. We excluded 86 duplicate articles. The remaining 29 publications had their titles and abstracts reviewed; eight were disqualified after the screening. Twenty-one reports were retrieved; however, two articles were not retrieved. Three of the 19 studies assessed for eligibility were excluded for various reasons. Articles were also disqualified if they failed to provide the proportion of patients who experienced ongoing back or leg pain after spinal surgery were also excluded. Finally, 16 studies were included -40. The Table The 16 articles included spanned approximately a decade from 2010 to 2022. The study population consisted of 70,581  patients from various countries. The studies covered experiences of centers in the USA -28, UnitDiscussionThis systematic review examined clinically relevant back and leg pains following spinal surgery. Most studies have shown that standard discectomy has long-term benefits despite residual LBP and recurrent herniation. Nevertheless, FBSS accounts for 5-27.6% of spine surgery despite advances in surgical technique . Ikeda eDespite technological and surgical advancements, FBSS affects many patients, accounting for 5-27.6% and a pooled prevalence of 14.97%. FBSS is a complex illness with multiple known and unknown etiologies. It is associated with increased age, female sex, depressive symptoms, multilevel procedures, and posterior fusion. Respondents with FBSS experienced a lower QOL, lower satisfaction, and higher psychological distress or depression. PPP significantly increased healthcare and pain medication costs. No differences were observed in body pain or physical function during the long-term postoperative period, regardless of the surgical center. Appropriate preoperative communication, as well as multidisciplinary and coordinated treatment strategies, yielded the best results. FBSS impairment necessitates proper patient selection. In addition, surgeons must consider poor prognostic indicators, including psychological factors. Residual symptoms can influence surgical satisfaction, QOL, and mental health. Preoperative communication between patients and doctors may help reduce the incidence of postoperative FBSS. MED was associated with LDH recurrence and reoperation rates equal to those of conventional discectomy. Prospective longitudinal studies examining the incidence of recurring degenerative back pain, disability, and QOL using standardized methodologies and validating outcome instruments are required.


Background: There are various therapeutic options for the conservative management of lower back pain (LBP). A combination of two or more treatment options may be more effective in the clinical management of non-specific LBP. In this study, we compared the effects of simultaneous heat massage with conventional physical therapy in patients with subacute LBP. Methods: A single-center randomized controlled trial in which 40 participants with LBP were allocated to one of two groups: a heat massage group (HMG) and physical therapy group (PTG). The HMG received simultaneous heat massage therapy using a mechanical device . The PTG received conventional physical therapy. Both groups received 40 min of therapy once daily, five times a week, for a total of four weeks. Changes in serum cortisol, epinephrine (EP), and norepinephrine (NE) were assessed. The outcomes were measured using the pain numeric rating scale (PNRS), the Oswestry disability index (ODI), the Roland–Morris disability questionnaire (RMDQ), the short-form McGill pain questionnaire (SF-MPQ), the multidimensional fatigue inventory (MFI-20), the Beck depression inventory (BDI), surface EMG (sEMG), and sympathetic skin response (SSR) at baseline (PRE), at 2 (2 W) and 4 weeks (4 W) following the intervention. Results: The serum EP and NE levels in the HMG decreased after treatment. The PNRS, ODI, RMDQ, and SF-MPQ scores improved without significance in both groups. The BDI score showed improvement in the HMG before the PTG. The MFI-20 score improved in both groups, but the results were better in the HMG than in the PTG at 4 W. All the activities of sEMG were significantly decreased in both groups. However, the improvement of the %MVIC in the HMG was better than that in the PTG at 4 W. The SSR latency on sEMG decreased while the amplitude increased in the HMG at 2 W and 4 W, respectively. Conclusions: Following 4 weeks of combined therapies, heat massage was not superior to conventional physical therapy alone. Both treatments were shown to be effective in improving LBP and pain-related disability. However, heat massage was shown to have a better effect on the control of autonomic nerve function and underlying moods. Lower back pain (LBP) is a widespread problem in clinical practice . ResearcThe clinical management of LBP broadly ranges from conservative to intensive approaches and includes surgical interventions in some cases . A non-sThe most common conservative treatment approach to the management of non-specific pain is the application of heat and low-frequency TENS. The clinical effects of thermal therapy produce temporary pain relief from enhanced blood flow and metabolism and improve the elasticity of the connective tissues . A heat On the opposite end of the spectrum, in terms of pain management, massage therapy is considered to be one of the oldest and most widely used non-pharmacologic approaches to LBP management. It promotes circulation and increases lymphatic drainage, improves the elastic and inelastic properties of connective tissues and muscles, reduces muscle pain, relaxes rigid muscles, and systemically relaxes the body . In a prThe clinical effects of combined heat and massage application include increased blood flow to the affected areas, reduced muscle spasms, and increased flexibility . If heatn = 40) through convenience sampling and exceeded the minimum recommended number of participants for pilot studies [This pilot study is a single-blinded, prospective, randomized, controlled trial. The study was approved by the Institutional Review Board of the Presbyterian Medical Center (IRBN. 2019-03-006) and was registered with the Clinical Research Information Service . All ethical considerations were addressed and incorporated in the explanation of the research study to participants, and their written consent was obtained thereafter. We enrolled 20 participants in one of two groups  or heat massage treatment (HMG) groups based on the random allocation sequence. The two groups were managed in separate buildings of the medical center to ensure blinding. The clinical characteristics of the participants, including age, body weight, height, BMI, and history, were recorded before group allocation.Patients were eligible for enrollment if they were aged 18 years and over, experienced LBP for more than 6 weeks, had a Roland–Morris disability questionnaire (RMDQ) score of 4–6 points, and an Oswestry disability index (ODI) score of 40% or lower. Patients were excluded from the study if they had a history of recent illness, malignancy, pregnancy, muscle disease, surgical history of the lumbar or thoracic back region, or inflammatory spine disease. They were excluded if they were taking medications, including non-steroidal anti-inflammatory drugs (NSAIDs); if they had cognitive dysfunction, compression of the dorsal root, or discogenic pain. Patients who scored 7 points or higher on the pain numeric rating scale (PNRS) with accompanying pain radiating to the lower limbs were also excluded, as were those experiencing muscular weakness and abnormal sensations in the lower limbs. Finally, patients with positive RA, ANA, HLA-B29, and CRP through laboratory testing were also excluded before the start of the clinical trial.The heat massage device  was run in the eighth mode  in the HMG study . Once th2. Both treatments were applied to specific areas of the lower back where patients complained of pain. This is the representative non-surgical approach to the conservative therapeutic regimen commonly used for LBP patients in the Republic of Korea [In the PTG, the participants received physical therapy treatment (from 4 physiotherapists) for up to 5 days per week for 4 weeks in total. Treatment consisted of a typical physiotherapy program without exercises, with the application of 5 min of therapeutic ultrasound (US), 10 min of transcutaneous electrical nerve stimulation (TENS), and 15 min of hot pack application. TENS was applied with a frequency of 75~125 Hz and an intensity of 40 mA. Ultrasound was applied for 5 min with a frequency of 1MHz and an intensity of 1.5 W/cmParticipants who received physical therapy or heat massage for at least one session were reported to the researcher if they experienced any adverse events.The pain numeric rating scale (PNRS), the Oswestry disability index (ODI), and the Roland–Morris disability questionnaire (RMDQ) were used as tools to assess the back pain intensity and its impact on pain and function . The PNRThe short-form McGill pain questionnaire (SF-MPQ) is an abbreviated version of the widely used MPQ and is a combination of a descriptive scale, VAS, and present pain intensity (PPI) scale. The descriptive scale and pain rating index are based on 15 selected words, including a sensory subscale with 11 words and an affective subscale with 4 words .The Beck depression inventory (BDI) and the multidimensional fatigue inventory (MFI-20) were used as parameters to assess pain-related depression and fatigue.Surface electromyography (sEMG) and the sympathetic skin response (SSR) were measured to analyze the voltage level of the spinal muscles and the changes in sympathetic activities.Using the FREEEMG device , a sampling rate of 1000 Hz and a band-pass filtered from 20 to 500 Hz, the sEMG signals of the spinal extensor muscles were obtained. This examination was performed at rest and in the most flexed position. The pairs of electrodes were placed on the right and left sides of the muscles. Upon finding the L3 level through palpation, each of the two recording electrodes was attached at the L3 vertebral level, 2–3 cm away from the center of the spine. The reference electrode was attached 10 cm above the L3 recording electrode .In order to assess activities during the motion of trunk flexion extension, sEMG was measured in the lumbar paraspinal muscles. The participant was in an upright standing position with arms crossed over their chest, then flexed about the waist fully forward, and held this position for 6 s before returning to a straight standing position. The data obtained for 6 s in a completely flexed posture showed an average RMS value of 4 s, excluding 1 s before and after. Participants were placed in the prone position for the isometric contraction test with the lower limbs fixed to the bed with straps, and the MVIC (maximum voluntary isometric contraction) was measured for 6 s while the lumbar extensors were maintained in the prone position. The acquired data, treated as the RMS with the average value for 4 s, excluding the first and last second, was recorded as the MVIC ,21. All The sympathetic skin response (SSR) was monitored using a Viking IV  instrument to measure changes in the sympathetic nervous system reflecting pain-induced stress. The filter settings were adjusted (0.2~20 Hz), and the participant was laid in the supine position in a quiet, dimly lit room with an ambient temperature between 22 and 24 °C. A round surface electrode with a diameter of 1 cm was attached 2 cm from the medial border of the left palm, while a reference electrode was attached to the dorsal surface of the right hand. Nerve stimulation was applied 3 times on the proximal part of the volar wrist on the right medial nerve distribution surface, and the intensity was set at 15~20 mA.All parameters, except for blood sampling, were evaluated before the start of the clinical trial (PRE), after 2 weeks (2 W), and at 4 weeks (4 W). The laboratory tests included evaluation of the epinephrine (EP), norepinephrine (NE), and cortisol levels before the clinical trial (PRE), with the changes in these levels compared at 4 weeks (4 W). Coffee, tea, chocolate, and allergy medications were prohibited a day before blood sample collection.p-value of <0.05 was considered statistically significant. A Shapiro–Wilk test was performed to assess the normality of the distribution. The independent sample t-test, Mann–Whitney U-test, and Chi-squared test were conducted to determine the general characteristics and homogeneity of the pre-measured values in both groups. In order to verify the effectiveness of the thermal massage device, the independent sample t-test and Mann–Whitney U-test were used to compare the outcomes between the two groups. Repeated measures of ANOVA and Friedman test with a Bonferroni correction assessed the between-group differences regarding changes in the PNRS, SF-MPQ, RMDQ, and ODI.All statistical tests and analyses were conducted using SPSS for Windows . A p > 0.05) between the two groups on homogeneity testing was deemed suitable for conducting the trial . This is summarized in Cortisol levels were not different before and after treatment, and these values were not significantly different between the two groups, as shown in p < 0.05)  .p < 0.05) , 2 W (54.44 ± 4.06), and 4 W (47.50 ± 5.38) with treatment. Similarly, in the PTG, the MFI-20 was improved to PRE (58.17 ± 2.18), 2 W (54.28 ± 3.80), and 4 W (51.22 ± 3.75). The MFI-20 of both groups were improved at 2 W, but there was no significant difference. However, at 4 W, The MFI-20 of the HMG showed a significant improvement compared to that of the PTG ( < 0.05) .p < 0.05) , 2 W (9.44 ± 3.52), and 4 W (7.61 ± 1.9). In the PTG, the BDI was improved to PRE (11.11 ± 3.18), 2 W (10.11 ± 3.32), and 4 W (9.39 ± 4.10). The BDI of the PTG was improved at 4 W compared to PRE and 2 W, whereas that of the HMG was improved at 2 W ( < 0.05) .p < 0.05)  were changed at PRE (60.17 ± 20.67), at 2 W (59.35 ± 16.97), and at 4 W (42.94 ± 11.22) among the HMG based on treatment progress; changes were also observed at PRE (59.58 ± 19.92), at 2 W (56.02 ± 18.80), and at 4 W (54.15 ± 21.17) in the PTG. The %MVIC was significantly decreased at 4 W in both groups. However, there was a decrease in the HMG compared to the PTG at 4 W ( < 0.05) .p < 0.05)  .There were no adverse events observed in either group during each visit.The study aimed to verify changes in the level of disability and symptoms related to LBP by undergoing physical therapy or heat massage treatment options among patients who have had underlying back pain for more than 6 weeks.The literature shows that the levels of epinephrine (EP) and norepinephrine (NE) are higher in patients with frequent episodes of back pain; labor-related stress factors were associated with inducing musculoskeletal pain and NE concentration ,25. In oODI and RMDQ evaluated the functional level of daily life, and the SF-MPQ was used to assess the degree of pain and related emotional states among those with LBP. These are specific measurement tools related to LBP rather than an indication of the patient’s performance, disability, and overall health. Although both groups showed improvement in LBP after the intervention, there were no differences between the two groups regarding pain and pain-related indicators, such as the VAS, ODI, and RMDQ. The results suggest that both clinic-based PT with simultaneous heat massage application can effectively control LBP and function.In this study, the BDI and MFI-20 were assessed to observe the changes in the quality of life based on pain improvement by comparing both types of management, and these were shown to be effective using these measurements. Fatigue and accompanying various morbidities, including LBP, can also profoundly impact the quality of life. Participants with LBP and fatigue had greater pain intensity, more depressive symptoms, and increased levels of disability compared to those without substantial fatigue. Further, chronic LBP patients were found to be more fatigued [The fatigued ,27.Pain alone can be a single cause of fatigue. Fatigue and pain have a synergic effect in reducing the functional capacity in LBP patients. The loss of function may be increased due to the simultaneous occurrence of fatigue and LBP . TherefoPrevious studies have shown higher scores for depression among patients with acute or subacute non-specific LBP than among asymptomatic participants without underlying pain , and depEMG amplitudes between individual muscle fascicles or between subjects because the RMS value of sEMG is affected by the age, sex, and body fat of the individual. For example, the amplitudes of sEMG will be decreased in those with higher fat and less water content in the body [In the meta-analytic review for sEMG, as an objective marker of LBP, sEMG is a simple and noninvasive measure of muscle activity . The northe body . In thisthe body . The mosthe body . The flexion-relaxation phenomenon (FRP) is defined as the reduced EMG activity of the lumbar erector spinal muscle during full trunk flexion, and it is achieved in healthy individuals but not in most LBP patients. The FRP is the most studied sEMG response among the various physiologic indicators of LBP ,36. The SSR, usually with increased amplitude and decreased latency [Musculoskeletal pain triggers constant stress, which activates the SNS, resulting in increased blood pressure, tachycardia, dizziness, anxiety, and muscle tension. Persistent pain is accompanied by physiologic changes within the autonomic nervous system (ANS) . The exc latency . SSR, the latency increased while the amplitude decreased in both groups. However, in the HMG, the latency and amplitude of the SSR after treatment were different compared to those of the PTG. A previous study concurrently showed that the application of simultaneous thermal massage reduced sympathetic activity, and similar results have also been observed in the SSR [In our measurement of the  the SSR . These oA Cochrane review for LBP concluded that massage might be beneficial for subacute and chronic nonspecific LBP, especially when combined with exercise and patient education .Massage therapy benefits the human body through muscular relaxation, improved blood and lymph circulation, and neurohormonal immunologic effects. Moreover, when heat is combined with massage and is applied to a painful area, the resultant benefits are further heightened. It promotes increased blood flow with vasodilatation, an increased metabolic rate, relaxation of muscle spasms, pain relief via the gate-control mechanism with reduced ischemia, and increased connective tissue elasticity. Circulatory vessels also widen to enhance blood flow to transport excess lactic acid and other toxins away from fatigued muscles. It also relaxes muscle tone by reducing muscle spindle and gamma-efferent firing rates . A CochrTherefore, when applying both heat and massage simultaneously, it was expected that a synergistic effect of the two applications would have a better impact than conventional physical therapy. Ironically, the results from this study did not confirm this expectation. On the contrary, in a previous study on the effects of massage on LBP, the results showed that massage was significantly better than general physical therapy in improving pain or disability .Other studies have also shown that hand massage is therapeutically better than physical therapy modalities for the management and decrease of (1) pain intensity, (2) disability, and (3) missed work days ,46.There is the likelihood of potential confounding bias in terms of the therapist–patient relationship, as well as the techniques and experiences in the application of therapeutic hand massage. These confounding variables should be controlled in order to obtain a true effect size as much as possible. To control for this and standardize the delivery of intervention in our study, the massage device was used. In this study, the comparative analysis between heat massage and physical therapy and the resultant effects on pain and pain-related dysfunction were similar. Nevertheless, heat massage was shown to have a better effect on autonomic nerve function and the underlying mood.The limitations of this study included the small sample size, short study period, and exclusive focus on subacute LBP. For the purposes of generalizability, a comparative study is warranted in the future, which includes an adequately powered sample size and a longer duration of treatment application with other therapeutic modalities.The resultant effects on pain and pain-related dysfunction were shown to be similar in this study that compared heat massage with conventional physical therapy. Both treatments were shown to be effective in improving pain and pain-related disability. Combination heat massage management is not superior to conventional physical therapy. Nevertheless, heat massage was shown to have a better effect on the control of autonomic nerve function and underlying mood.


Reversal of direct oral anticoagulants (DOACs) is currently recommended prior to emergent surgery, such as surgical intervention for traumatic geriatric hip fractures. However, reversal methods are expensive and timely, often delaying surgical intervention, which is a predictor of outcomes. The study objective was to examine the effect of DOAC reversal on blood loss and transfusions among geriatric patients with hip fractures.This retrospective propensity-matched study across six level I trauma centers included geriatric patients on DOACs with isolated fragility hip fractures requiring surgical intervention (2014–2017). Outcomes included: intraoperative blood loss, intraoperative pRBCs, and hospital length of stay (HLOS).p < 0.01). Most patients (92%) had blood loss ; the median volume of blood loss was 100 mL for both those groups, p = 0.97. Thirteen percent had pRBCs transfused (13% passively reversed and 13% not reversed); the median volume of pRBCs transfused was 525 mL for those passively reversed and 314 mL for those not reversed, p = 0.52. The mean HLOS was significantly longer for those passively reversed .After matching there were 62 patients , 29 patients were not matched. The only reversal method utilized was passive reversal (waiting ≥ 24 hours for elimination). Passively reversed patients had a longer time to surgery (mean, 43 vs. 18 hours, Passive DOAC reversal for geriatric patients with isolated hip fracture requiring surgery may be contributing to delayed surgery and an increased HLOS without having a significant effect on blood loss or transfusions. These data suggest that passive DOAC reversal may not be necessary prior to surgical repair of isolated hip fracture. The use of direct oral anticoagulants (DOACs) is increasing due to the quick onset and offset of DOACs, lower rates of major hemorrhage, lack of the need for coagulation monitoring, and the reduction in the risk of fatal bleeding and intracranial hemorrhage when compared to vitamin K antagonists –6. DespiThere are two drugs approved by the Food and Drug Administration for DOAC reversal: idarucizumab for the reversal of dabigatran and andexanet alfa for the reversal of apixaban and rivaroxaban , 8. OtheThere has been an anecdotal increase of physicians not reversing DOACs prior to traumatic hip fracture surgery who instead are sending patients straight to surgery because of purported benefits of timely surgery on outcomes. There are a lack of studies examining the effects of surgical intervention without DOAC reversal on blood loss and the need for transfusions among geriatric hip fractures. The purpose of this study was to compare outcomes among geriatric patients with traumatic hip fractures who had their DOAC reversed prior to surgery to those who did not.This retrospective propensity-matched study across six US level I trauma centers included geriatric patients, aged ≥ 65 years, admitted from 1/1/2014 to 12/31/2017 with an isolated fragility hip fracture  requiring surgical intervention recorded in these six centers trauma registries. Patients’ medical records were examined for pre-injury medications, and patients who were not taking pre-injury DOACs were excluded, as were patients who were taking pre-injury antiplatelets or pre-injury therapeutic heparin. All centers institutional review boards reviewed and approved of this study.Patients who were reversed were matched 1:1 to patients who were not reversed prior to surgery using propensity scores. A 1:1 ratio was used as there were not enough matching patients to use a larger ratio, i.e., 1:2 or 1:3. Propensity scores were created using a stepwise logistic regression model, having a caliper distance of 0.001, an entry criterion of 0.20 and an exit criterion of 0.05. Variables available to the model were significantly different in the univariate analysis before matching which can be seen in Table Methods considered as DOAC reversal were: idarucizumab, FFP, cryoprecipitate, PCC, factor VIIa, or passive reversal utilizing the “wait and watch” method. Patients who went to surgery more than 24 hours after the last dose of DOAC medication were considered passively reversed using the wait and watch method. The 24 hour cut-off was used based on the DOAC medications half-lives when the bioavailability would be reduced to less than 10%. The decision to reverse was at the discretion of the treating physicians, thus the six participating centers were not following one uniform protocol for DOAC reversal.Variables that were abstracted from the patients’ medical records or the trauma registry included the following: age, sex, race, prior hip fracture, indication for DOAC medication, comorbidities , pre-injury medications , DOAC type, admission laboratory results , time from arrival to surgery, time from the last dose of DOAC to surgery, type of fracture, type of procedure, reversal methods, early blood loss , early packed red blood cell (pRBC) transfusion , and early FFP transfusion , intraoperative blood loss, intraoperative pRBC transfusion, and intraoperative FFP transfusion.The primary outcome was the total volume of intraoperative blood loss which included blood collected by drain or estimated blood loss from soaked sponges. All intraoperative blood loss recorded in the medical record was included in the analysis. Secondary outcomes included any intraoperative blood loss (% with volume > 0 mL), total volume of intraoperative pRBC transfusion, receipt of intraoperative pRBC transfusion (% with volume > 0 mL), pre-operative hemoglobin, intensive care unit (ICU) length of stay (LOS), hospital length of stay , complications , discharge disposition, and in-hospital mortality. Volumes are reported in milliliters (mL).Statistical analysis was performed with SAS V9.4  and alpha < 0.05. Continuous variables were summarized as mean (standard deviation) and median (interquartile range) when appropriate based on the distribution of the data. Dichotomous and categorical data are summarized as proportion (count). Paired Student’s t-tests, Wilcoxon paired rank sum test and McNemar’s tests were used when appropriate.p < 0.01), were more likely to have congestive heart failure (p = 0.02), dementia (p = 0.03), COPD (p = 0.02), had a higher comorbidity count (p < 0.01), and were more likely to be taking beta-blockers (p = 0.03) (Table There were 91 patients identified who were taking pre-injury DOACs (rivaroxaban (55%), apixaban (36%), dabigatran (8%), and edoxaban (1%). Of those, 51 were reversed and 40 were not. Across all 91 patients, the mean age was 81, 40% were male and 99% were white. Prior to matching, patients who were reversed were significantly older (p > 0.99), received intraoperative pRBCs (p > 0.99), or had intraoperative blood loss (p > 0.99). Nor were there differences in ICU LOS (p = 0.68), the volume of intraoperative blood loss (p = 0.14) or volume of intraoperative pRBCs (p = 0.65). Time from hospital arrival to surgery (p = 0.003), time from the last dose to surgery (p < 0.001) and HLOS (p = 0.02) were significantly longer among patients reversed. Of the unmatched patients who were reversed, 90% were passively reversed, 5% were reversed with FFP, and 5% were reversed with FFP and the wait and watch method.Among patients who were not matched , there were no differences in the proportion of patients who died in-hospital , followed by DVT or PE (n = 8) and CAD (n = 6). There were no patients in either group who needed early FFP or pRBC transfusions (within the first six hours of admission); two patients who were not reversed experienced early blood loss, in volumes of 100 mL and 250 mL, while no other patients had early blood loss (within the first six hours of admission).Twenty-nine of the 91 patients were excluded after matching. There were 62 patients included in the matched analysis, 31 reversed matched to 31 not reversed, Fig p < 0.01) as well as a longer median time from the last dose of DOACs to surgery . The most common hip fracture type was a fracture of the femoral neck (58%), there were no differences in fracture type. The surgical procedure was also similar between groups. Intramedullary fixation was the most common procedure (45%), followed by hemiarthroplasty (29%). The median pre-operative hemoglobin was also similar between groups, 13.5 vs. 11.5, p = 0.78.Compared to those not reversed, the passively reversed patients had a longer mean time to surgery . The median volume of pRBCs transfused intraoperatively was 525 mL for those passively reversed and 314 mL for those not reversed, p = 0.52. The median HLOS was significantly longer for those passively reversed compared to those not reversed . The ICU LOS was not statistically different, p = 0.56. In-hospital complications were rare. Among those passively reversed, 6% (n = 2) developed pneumonia, 3% (n = 1) had an MI, 3% (n = 1) had an DVT. Among those not reversed, 3% (n = 1) patient had an unplanned return to the ICU and 3% (n = 1) had an MI. There were no patients with unplanned intubation, cardiac arrest requiring CPR, pulmonary embolism, stroke or CVA. There was a lower proportion of patients who were not reversed and were discharged to rehabilitation . There were no patients who died in-hospital.Most patients 92%) had intraoperative blood loss (90% passively reversed and 94% not reversed) (Table % had intp = 0.50); nor was there a difference in the median (IQR) volume of intraoperative blood loss . In a stratified analysis of patients on pre-injury beta-blockers, there was no difference in the proportion of patients with blood loss by reversal status ; nor was there a difference in the median (IQR) volume of blood loss . Among only patients who were not taking pre-injury beta-blockers, the proportion of patients with blood loss was still similar , as was the median (IQR) volume of blood loss .There was no difference in the proportion of patients with blood loss when compared by pre-injury beta-blocker use  of the patients who were reversed. The wait and watch method may have been preferred to pharmacological reversal  due to cost or convenience. There were no methods of pharmacological reversal utilized in this study, only the wait and watch method which may not have been intentional. We defined “wait and watch” based on the time each DOAC mediation is dissipated to less than 10% using the half-life for each medication in a geriatric population. Larger prospective studies are needed to confirm the results. Further research identifying geriatric patients with hip fractures on pre-injury DOACs who did benefit from reversal may be useful.This was a retrospective study with a relatively small sample size and blood transfusions were rare. It was a multicenter study conducted across six level 1 trauma centers over 4 years so may be more generalizable than other previous single center studies. The participating sites were not following standardized reversal protocols or blood transfusion protocols which was conducted at physician’s discretion. The reason why the physician chose to reverse to use was not recorded for 13% (Passive DOAC reversal for geriatric patients with isolated hip fractures may be contributing to delayed surgery, an increased HLOS, and an increase in patients discharged to rehabilitation rather than home without having a significant effect on intraoperative blood loss or transfusions. This information may be useful to physicians who are wondering which is more important, timely surgery or delaying surgery for DOAC reversal, when treating geriatric patients with traumatic hip fractures on DOACs.


Cannabinoids are considered a therapeutic option to patients suffering from treatment refractory chronic pain (TRCP) insufficiently relieved by conventional analgesics or experiencing intolerable adverse events (AEs) from those. This study aimed to explore safety and effectiveness of oral cannabinoids among patients with TRCP.A retrospective study was conducted among Danish patients with TRCP being prescribed oral cannabinoids. Data on AEs and changes in pain intensity by numeric rating scale (NRS) before and after initiation of oral cannabinoid therapy were analysed.intention‐to‐treat analysis whereas the figures were 32% and 45% respectively, in per‐protocol analysis.Among 826 eligible patients ≥18 years old, 529 (64%) were included for data analysis at first follow‐up (F/U1) (median 56 days from baseline) and 214 (26%) for second follow‐up (F/U2) (median 126 days from F/U1). Mean age was 60 ± 15.9 years and 70% were females. AEs were in general reported mild to moderate by 42% of patients at F/U1 and 34% at F/U2. AEs were mainly related to gastrointestinal (F/U1: 17% and F/U2: 13%) and nervous system disorders (F/U1: 14% and F/U2: 11%). Reduction in NRS was significantly different at both follow‐up consultations compared with baseline (<0.0001). Clinically relevant pain reduction (NRS ≥30%) was reported by 17% at F/U1 and 10% of patients at F/U2 in Oral cannabinoid therapy seems to be safe and mildly effective in patients with TRCP. Randomized controlled trials with focus on comparable pain characteristics in diagnostical homogenous patient subgroups are needed for further improvement of evidence level for relief of chronic pain using oral cannabinoids.The findings in this retrospective study conducted in a real‐world clinical setting suggest a favourable safety profile of cannabinoids. Moreover, one‐sixth (intention‐to‐treat) and one‐third (per‐protocol) of patients with chronic pain refractory to conventional analgesics, or experiencing intolerable adverse effects, benefited significantly from therapy with oral cannabinoid regimens. Combination of THC and CBD seems overall more effective than cannabinoid monotherapy. Conduction of randomized controlled trials investigating safety and efficacy of cannabinoid therapy to diagnosis specific patient subgroups with comparable clinical and pathophysiological chronic pain characteristics is warranted, hence contributing further to the process of clinical evidence clarification currently in progress. Even though the pilot program primarily aimed to assess medicinal cannabis products, the availability of these products in general failed during the programme due to technical complications with authorization of the submitted products by the Danish Medicines Agency. Consequently, majority of prescriptions in the pilot programme have so far been related to therapy with cannabinoids, either as biologically active constituents of cannabis, or synthetic compounds. The aim of this study was therefore to elucidate tolerability and effectiveness of oral cannabinoid therapy among patients with treatment refractory chronic pain (TRCP) during the initial period of the Danish pilot program.2This retrospective real‐world study was conducted between August 2018 and February 2021 at the North Denmark Regional Hospital in collaboration with a Danish pain clinic.The indication for oral cannabinoid therapy was TRCP for the patients included as study population. The definition of TRCP is pain lasting more than 3 months with insufficient pain‐relieving effectiveness or intolerable adverse events (AEs) of conventional analgesic regimens. Patients with incurable cancer and chronic cancer‐related pain were also included in the study although this group did not necessarily fulfil the definition of TRCP in relation to history of pain and conventional pain‐ relieving treatment. Common clinical guidelines for conventional analgesic regimens for treatment of chronic pain in Denmark include opioids as primary analgesic, and secondary analgesic including tricyclic antidepressants, antiepileptic drugs and serotonin and noradrenaline reuptake inhibitors. Two treatment scenarios were applied in the pain clinic in conjunction with initiation of oral cannabinoid therapy, either prescribed to a patient with a history of TRCP either as add‐on therapy to a current conventional pain‐relieving regimen upon the baseline consultation or as monotherapy if the patient was not receiving any conventional analgesics. Moreover, for the first group of patients, no changes were made to the current conventional regimen at the baseline consultation unless a patient reported intolerable adverse events to a conventional analgesic. Then, this analgesic was either decreased in dosage or discontinued.Patients were included in this study if the following inclusion criteria were fulfilled Figure : being iData from medical records were registered on diagnosis, pain intensity, quality of sleep, QoL, treatment‐related AEs, and cannabinoid therapy specifications. Diagnoses were presented in accordance to International Classification of Diseases version 2010 (ICD‐10)  purified THC 0.83 mg/drop or 2.5 mg/capsule as monotherapy (THC), (ii) CBD 1.67 mg/drop, 2.86 mg/drop or 10 mg/capsule as monotherapy (CBD) or (iii) a capsule combination product with purified THC 2.5 mg and purified CBD 5 mg as combination therapy (THC/CBD). Some patients were prescribed an oral regimen containing a purified THC product together with a purified CBD product, which was then also registered as THC/CBD. The prescribed oral cannabinoid products are manufactured and controlled at Glostrup Pharmacy  according to the European Union Good manufacturing practices (EU GMP). The purified THC and CBD ingredients in the prescribed oral cannabinoid products are manufactured, controlled, and supplied to Glostrup Pharmacy by EU GMP‐approved suppliers in Europe. The treatment outcomes for the three regimens  are presented regardless of route of administration and dosage.2.2Figure 2.3The patients were at the follow‐up consultations in the pain clinic asked if any AEs had occurred during course of treatment, and if so, status of potential causality to oral cannabinoid therapy was assessed on discretion of the attending physician. If a plausible relation was suspected or could not be ruled out, the treatment‐related AEs was registered in the patient medical record. After data collection AEs were divided in groups based upon Common Terminology Criteria for Adverse Events (CTCAE) 5.0  ranging from 0 to 10  was used. Patients were asked at baseline and follow‐up to state the perceived level of pain intensity within the last 3 days.Secondary effectiveness outcomes were measured as semi‐structured differences in quality of sleep and QoL between baseline and follow‐up consultations using a simple non‐validated approach. Patients were asked by the physician how they were feeling lately without precise time limitation. The outcomes were assessed as patient‐reported outcome (PRO) items at each consultation using the three following response categories: (1) improved, (2) no changes, or (3) worsened.2.5One and the same person (KLH) entered data in REDCap as a measure against risk of inter‐observer errors. A quality control of data was completed in 54 of the 1081 screened patients (5%), who were randomly selected to assess intra‐observer reliability. KLH inspected if the entered data in REDCap was consistent with data in patient medical records. Entry errors were divided into mild, moderate, and severe, respectively. Mild errors were of no importance for results, moderate errors were of some importance for results, but they were corrected for all patients during data management and severe errors were of great importance for results. Severe errors were detected in 3% of the patients included in the quality control analysis. It was concluded that the entered data were of high reliability and no further quality control was needed.2.6This study did not require ethical approval from the Danish National Committee on Health Research Ethics. Disclosure of data from patients' medical records from the Danish pain clinic to the North Denmark Regional Hospital was approved by the Danish Patient Safety Authority (3–3013‐2588/1), wherefore signed informed consent from the patients was not required. The study was approved by the Danish Data Protection Agency (2018–102).2.72. Normal distributed data regarding age, body mass index (BMI) and difference in NRS between the oral cannabinoid regimens were analysed by one‐way ANOVA. Nonparametric data regarding number of days from baseline to follow‐up were analysed by Kruskal‐Wallis method. Moreover, Tukey Studentized Range Test was applied for additional post hoc testing. Comparison of changes in NRS at baseline and follow‐up within the three individual oral cannabinoid regimens was analysed by paired t‐test as data was normal distributed. A p‐value<0.05 was defined as statistically significant. Missing data was handled by pairwise deletion. Per‐protocol data analyses were supplemented with intention‐to‐treat data analyses. Data were analysed using SAS Enterprise Guide 7.1 and 8.3.Data were examined by descriptive analysis and are presented as percentage, and some parametric data are presented as mean ± standard deviation (SD) and median interquartile range (IQR) if non‐normal distributed. Each analysis was performed for each of the three regimens  and a total group. Primary effectiveness outcome and secondary PRO were both analysed by comparing data at baseline and follow‐up. A reduction in pain intensity ≥30% between baseline and follow‐up was considered clinical relevant  (Table p = 0.0098)  were included in the final analysis of F/U1 data and among those 214 patients (40%) were included for analysis of F/U2 data  Table . No sign7) Table . Also, n8) Table .3.1p = 0.003). The mean age of the Overall population was 60 ± 15.9 years, and mean BMI was 25.9 ± 5.7 . More females were prescribed an oral cannabinoid regimen , CBD  and THC/CBD  (Table p < 0.0001). A total of 146 patients (28%) treated with oral cannabinoid products had been registered with more than one diagnosis associated with perception of chronic pain and by which oral cannabinoid therapy was considered an option (Table p = 0.0013), injury, poisoning and certain other consequences of external causes  and malignant neoplasm .The distribution of the three oral cannabinoid regimens were as follows: THC (%) Table . The medon Table . The mos3.2p < 0.0001), while no significant difference was observed at F/U2. Complaints related to the gastrointestinal system (F/U1:17% and F/U2: 13%), the nervous system (F/U1: 14% and F/U2: 11%) and general disorders and administration site conditions (F/U1: 14% and F/U2: 9%) were the most predominant categories of AEs. A detailed overview of AEs is presented in Table p = 0.0011 and p = 0.0245, respectively). AEs in the nervous system were more frequently observed in patients treated with THC monotherapy (p < 0.0001). No difference between oral cannabinoid regimens and reported AE categories were observed at F/U2. One patient (<1%) developed hallucinations and was hospitalized due to intake of a higher THC dosage than instructed by the attending physician in the pain clinic. Treatment with THC was then discontinued.A total of 42% patients reported one or more AEs during oral cannabinoid therapy at F/U1 Table  and 34% 3.3p < 0.0001). The THC group had a mean reduction in pain intensity of 1.5 at F/U1 and 1.8 at F/U2 in comparison to 1.2 at F/U1 and 1.8 at F/U2 in the CBD group, and 1.9 at F/U1 and 2.4 at F/U2 in the THC/CBD group. The reduction of mean NRS at F/U1 and F/U2 was significant  for all three oral cannabinoid regimens.Comparison of mean pain intensity on NRS at baseline versus at F/U1 and F/U2 is presented in Table n = 73, 17%) experienced no changes in pain intensity in comparison to 21 patients (12%) at F/U2. A total of 285 patients (66%) experienced a reduction in NRS at F/U1 and 129 patients (73%) at F/U2. Per‐protocol analysis revealed that one in three patients (32%) experienced a clinically relevant reduction in pain intensity of at least 30% in NRS at F/U1, while almost half  had a reduction in NRS of at least 30% at F/U2. By per‐protocol analysis, a pain reduction of ≥30% was also observed in 30% (F/U1) and 41% (F/U2) of patients who were prescribed THC. The figures were 31% (F/U1) and 43% (F/U2) for patients treated with CBD as opposed to 50% (F/U1) and 72% (F/U2) treated with THC + CBD. Patients prescribed THC/CBD were significantly more like to obtain a ≥ 30% pain reduction than THC and CBD as monotherapy (F/U1: p = 0.0446 and F/U2: p = 0.05). The number of eligible patients intended for oral cannabinoid therapy was 826 and taken this figure into consideration. Hence, intention‐to‐treat analysis revealed that 17% at F/U1 and 10% at F/U2 of the baseline population reported a clinically relevant reduction of ≥30% in pain intensity.Table p = 0.0003)  Table . Figuresp = 0.05 and p = 0.006, respectively), while patients with non‐cancer‐related pain were more likely to be treated with CBD monotherapy (p = 0.0003). Differences in PRO, including changes in quality of sleep and QoL after initiation of oral cannabinoid therapy are presented in Table p = 0.0175) at F/U1. This tendency was also observed at F/U2 regarding quality of sleep (p = 0.05). For intention‐to‐treat, 30% of eligible patients at F/U1 and 11% at F/U2 reported uniformly improvement in both sleep and QoL.Also, a higher number of patients with chronic cancer‐related pain were prescribed THC, either as monotherapy or in combination with CBD , CBD , and THC/CBD . In this group, 26 patients (13%) died before follow‐up, 24 with a cancer diagnosis. After F/U1, 45 patients (9%) were registered as lost to follow‐up, and an additional 122 patients (23%) discontinued oral cannabinoid therapy . As known reasons were registered no perceived effect , AEs , death , insufficient funds  and other reasons 279 .As presented earlier, F/U1 data were not available in 297 (36%) of the 826 patients having attended a baseline consultation . However, the findings are related per‐protocol analysis, whereas the intention‐to‐ treat analysis could not demonstrate any difference of importance . Moreover, the former group was also more frequently treated with THC containing regimens, which may have a potential confounding effect. Of notice, pain is not the only complaint typically reported by this group of patients addressed. The patients may also have other complaints, including sleep disturbances, anxiety, loss of appetite, nausea, muscle spasms and so forth and for which THC may provide additional benefits, which may then have a positive impact on pain perception.The lack of follow‐up for major proportion of patients in this study could be caused by insufficient pain‐relieving effect of oral cannabinoid therapy, occurrence of AEs or both. In the intention‐to‐treat data analyses, NRS pain reduction of ≥30% was confirmed in 17% at F/U1 and 10% at F/U2 of the 826 study eligible patients attending the baseline consultation, equal to one out of six and one out of 10 patients, respectively. When interpreting this effectiveness outcome, one should take into consideration that the group of patients in this study were characterized as potential difficult‐to‐treat patients with chronic pain. In that perspective oral cannabinoid therapy could be perceived as a justified approach for management of chronic pain in particular for a subgroup of patients failing conventional treatment or experiencing intolerable AEs.Of interest, 17% (F/U1) and 15% (F/U2) of the patient cohort reported an increase in pain intensity by NRS at follow‐up. The findings indicate that some patients have not achieved a desirable effect of oral cannabinoid therapy, or simply that some patients' medical condition deteriorates from baseline to follow‐up. The German Pain e‐Registry group investigating effectiveness and tolerability of THC/CBD found that patients with nociceptive pain in general reported a deterioration of pain using a visual analogue scale (VAS) after 12 weeks of treatment. In comparison, patients with neuropathic pain or a mix of neuropathic and nociceptive pain experienced an improvement in pain by VAS , but tend to diminish within a few weeks  it is likely that the potential placebo effect is of less importance in interpretation of the effectiveness results. Second, extraction and subsequent structuring of real‐world data for analytic purpose is often challenged when using medical records as main source of data in retrospective studies. Patient data may not always be registered systematically and in a uniform way by the health care professionals in the daily clinical practice. As a result, a proportion of data are categorized as missing, which was also the case in this study in a range of 10% to 20% of patients with incomplete datasets. Thirdly, the pain clinic did not use validated questionnaires to collect PRO, which may yield less valid data and conclusion should be made with caution. Fourthly, in overall, NRS is a subjective instrument and rather sensitive for day to day, and even hour to hour variation. In future consultations, validated questionnaires will be incorporated routinely in the clinic, where the study took place. As a final limitation, patients were not anonymous when reporting outcomes at consultation with the physician which might influence their responses.A strength of this study was that patients were treated using the same portfolio of oral cannabinoid products consistently from the same pharmacy manufacturer. Moreover, the clinical guidelines for oral cannabinoid regimens, including administration and dosing, were also applied uniformly in the pain clinic. Both elements, oral cannabinoid products and clinical guidelines, should be considered as important prerequisites in the overall process of data analysis and interpretation. Of notice, the study was conducted in a single site as opposed to multiple sites and therefore the study results should be interpreted and translated into a general practice context with some caution.In conclusion, oral cannabinoid therapy in general appears to be safe and effective for relief of chronic pain in some patients, including a subset of patients with cancer‐related pain (9%), not responding adequately to conventional treatment regimens or experiencing intolerable AEs. Moreover, beneficial effects on sleep and QoL were reported by the patients receiving oral cannabinoid therapy, although the assessment was not performed in a validated manner. Hence, our study confirms previously reported findings related to patients with chronic pain receiving oral cannabinoid therapy and in that way the study contributes further to the evidence pyramid at the level of observational studies. The findings encourage more initiatives to be taken towards conduction of RCTs aiming at a higher level of evidence clarification. Emphasis should be made on addressing diagnosis‐specific patient groups with different pain types representing distinct pathophysiological characteristics, and possible in need of different analgesic therapy strategies.TH, KH and PL designed and conceptualized the study. TH performed the measurements and handled the subjects. KH performed data entry, statistical analysis and wrote the manuscript. All authors have contributed to the final version of the manuscript.The study was partially funded by Bionorica SE, and Oda and Hans Svenningsens Research Grant. The sponsors had no role in the design or reporting of this study.KH and PL declare no conflicts of interest. TH has provided medical care to the patients in the study.Table S1.Table S2.Table S3.Table S4.Table S5.Click here for additional data file.


Acute radiating low back pain is a frequently occurring clinical condition among the population, and it represents a significant portion of urgent care in public health services. Consider the clinical characteristics, demographics, as well as the intensity of the pain, discomfort, and dysfunction of patients who show a clinical diagnosis that is compatible with acute radicular pain, new or reoccurring after an asymptomatic period. Patients that display a clinical diagnosis that is compatible with acute sciatic nerve pain, with the beginning of it starting within three months, without previous history of a similar occurrence, were seen in an orthopedic health clinic from July 2020 to January 2021. A total of 42 patients were seen with a compatible diagnosis, which represents 1.4% of all medical visits. To the best of our knowledge, no studies have considered the clinical and demographic characteristics of patients with acute radicular pain in the Brazilian population. This study has found a mean value on the disfunction index that is greater than what is suggested by the current literature.Level of Evidence IV, Cross-Sectional Study. About 30% of individuals showed functional involvement that was considered crippling, which presented a stronger association with individuals with the presence of motor deficits, intensity of radiating pain, and professional inactivity.  Acute radiating low back pain, also known as sciatic pain or sciatica, is a very common clinical condition in the population and accounts for a significant portion of emergency care visits in public healthcare services.The incidence and prevalence of sciatica is still controversial, with wide variation among studies available in the literature. An epidemiological review from 2008The natural history of acute radicular pain (onset within the last three months) is mostly benign, with approximately 70% of patients experiencing significant improvement within four weeks, and 60% of these individuals returning to work within that periodWe have not found any studies investigating the epidemiology of acute radicular pain in the Brazilian social context. This study aims to assess the clinical and demographic features, as well as pain intensity and dysfunction in patients with clinical profiles consistent with acute radicular pain, whether it is a first-time experience or a recurrence after a symptom-free period. The study was conducted at an orthopedic emergency unit that is reference in the Brazilian public health system.This cross-sectional observational study was conducted in the orthopedic emergency unit of a quaternary care hospital that serves as a reference facility within the Brazilian Unified Health System, namely the Sao Paulo Hospital of the Universidade Federal de Sao Paulo.This research is an extension of another umbrella project being conducted by the same group of researchers, which has received approval from the Research Ethics Committee of the institution under reference number 4.232.193 (CAAE: 32486420.7.0000.5505).Patients exhibiting clinical symptoms consistent with acute sciatic pain-radiating low back pain to lower limbs accompanied by positive results in femoral stretch tests-within the past three months, without any history of a similar episode, and presenting to an orthopedic emergency department from July 2020 to January 2021 were included for the evaluation by spine group. Eligible participants received information about the study procedures and signed an informed consent form.Patients with symptoms present for over three months prior to the study, exhibiting consistent clinical history and ongoing symptoms, as well as those with a history of spinal surgeries, infections, or trauma/fractures, were excluded from the study. Additionally, the presence of comorbidities or personal history that contradicts the use of oral corticosteroids, which is investigated by this umbrella project, was also considered as a criterion for exclusion.During the initial interview, the research team physicians collected demographic/social and clinical data. They also applied the translated and adapted Brazilian Portuguese version of the Oswestry Disability Index (ODI) and the Visual Analog Scale (VAS) for pain in the lumbar region that extends to the lower limbs.The survey collected demographic information such as age, gender, weight, height (expressed as body mass index or BMI), employment status, regular physical activity, smoking history, and comorbidities. The clinical factors considered were time of onset of symptoms, side affected, and presence of motor or sensory deficits.The RedCAP system was used for storage and confidentiality of the acquired data, with exclusive access granted to the research team following verification and approval by the São Paulo Hospital Research Ethics Committee (CoEP).Statistical analysis was conducted using SPSS Statistics software program, based on the variables exported from the RedCAP database.Categorical and continuous variables were analyzed by calculating the frequency and the mean standard deviations, respectively. The chi-squared test and Fisher’s exact test were applied for statistical evaluation in the contingency table and the Student’s t-test for independent samples.To determine the correlation between demographic and clinical factors and dysfunction observed during the initial consultation , participants were split into two groups: mild to severe dysfunction (ODI < 60), which does not interfere with daily activities, and incapacitating dysfunction (ODI ≥ 60), which requires assistance to perform these activities. Sociodemographic data between individuals in both groups were compared. Statistical significance was determined at p < 0.05 .Correlation tests such as Pearson’s Coefficient and Spearman’s Coefficient were performed to analyze the strength of the association for statistically significant differences.From July to December 2020, 42 patients received treatment for a clinical condition consistent with acute sciatica, representing roughly 1.4% of all orthopedic consultations provided by this service during that period. From these patients, 19 (45.2%) were male and 23 (54.8%) were female. The mean age of the participants was 44.2 years, with a standard deviation of 16.35 years. We found no significant difference between sexes. Regarding ethnicity and skin color, 15 patients identified as Mixed-race (37.5%), 13 (32.5%) as White, 11 (27.5%) as Black, and three participants were unable to define.The mean body mass index (BMI) was 28, with a standard deviation of 5.49. When stratified by sex, the mean for male patients was 27.03 with a standard deviation of 4.71, whereas for female patients it was 29.73 with a standard deviation of 5.66. However, we found no statistically significant difference between the two (p = 0.11). Regarding habits, 10 (23.8%) patients reported regularly using tobacco, and 36 (85.7%) participants reported not engaging in regular physical activity (at least three times a week). Of the participants who did exercise regularly, four reported running or walking and two engaged in gym activities.Concerning employment status, 34 patients (81.91%) held formal jobs with contracts, four (9.5%) were unemployed , and four (9.5%) were already retired. Of those who retired, two (50.0%) were due to length of service and two (50.0%) due to previous pathologies/incidents.Considering the clinical history of the current pathology, 9 (21.4%) patients reported that the symptoms started less than 7 days ago, whereas 22 (52.4%) patients reported that the onset occurred 7 to 30 days ago, and 11 (26.2%) patients sought medical attention from 30 days to 3 months after the onset of the current condition. For 19 patients (45.2%), acute sciatic pain was a new occurrence, whereas 23 participants (54.2%) had reported a similar event for more than one year but were asymptomatic.The physical examination identified the presence of motor deficits  in seven patients (35.3%). Among these, four patients had more than one affected root, of which six (85.2%) had a deficit in the L5 lumbar root, three (42.9%) in the L4 root, and two (28.6%) had a clinically evident reduction in motor strength in the S1 root. Sensory deficits were noted in 16 participants (38.1%). Hypoesthesia was identified in the L4 dermatome of nine participants (56.3%), the L5 dermatome of eight (50%), and S1 in six (37.5%).Regarding the assessment of function using the Oswestry scale, it was found that the sample followed a normal pattern after applying the Shapiro-Wilk test. The mean value was 49 points, with a SD of 17.48 . AccordiThe intensity of pain at the initial consultation was assessed using the VAS, and the mean value found for low back pain was 7.11, with a SD of 2.49, whereas for radiating low back pain it was 6.71, with a SD of 2.28. Furthermore, we investigated the relationship between sociodemographic variables and degree of dysfunction. A cut-off point of 60 was used since it is considered a determining factor for functional incapacity. To compare the prevalence of variables, contingency tables  and 4 weUsing the same cut-off value for dysfunction, a contingency table was constructed to compare both groups regarding clinical data. A statistically significant difference was observed between them in terms of the presence of motor deficits (p = 0.021) and the intensity of pain symptoms radiating low back pain measured by the VAS (p = 0.043).Finally, measures of association were applied, such as Pearson’s Coefficient of Contingency and Spearman’s correlation. The values indicated a moderate association between professional activity (R = 0.33) and intensity of radiating low back pain (R = 0.77), along with the presence of disabling dysfunction secondary to acute sciatica and motor deficit (R = 0.778).When acute low back pain radiates to the lower limbs, it is referred to as radicular or radiculopathy pain, which is a primary cause of dysfunction in individuals aged 20 to 60 years.To the best of our knowledge, no studies in the literature have evaluated the clinical and demographic characteristics of patients with acute radicular pain in the Brazilian population. A study by Gotfryd et al.The sample of 41 patients evaluated in this study showed a normal distribution concerning sociodemographic characteristics . The patIn another meta-analysis published by the same author,Regarding the clinical characteristics of this group of patients, the mean ODI value was 48.6 ± 17.47, with a median of 49.0, which is considered severe dysfunction according to the scale. This value is substantially higher than that found in most comparable literature that, despite evaluating different outcomes, involved a sample of patients with radicular pain. Meyer et al.,One of the main causes associated with this higher rate of dysfunction in initial care can undoubtedly be attributed to the prevailing social context at the time of this research. Patients were recruited for this study during the COVID-19 pandemic, which began in Brazil at the end of February and continued until the publication date of this study. In the absence of an effective treatment to slow down or prevent the spread of Sars-CoV-2, the main prevention policies were the use of masks and social distancing. Furthermore, public authorities have recommended that the general public avoid hospital environments due to the higher risk of contagion in these locations, except in the most serious cases.As a result, it is possible that most people who had milder acute radicular pain did not seek medical attention due to public health guidelines aimed at reducing COVID-19 transmission. Therefore, it is possible that “indirect selection” of patients occurred, that is, those with greater dysfunction were the ones who opted to be evaluated in a more complex hospital, which is also a regional reference in COVID-19 treatment, thus increasing the baseline value of the dysfunction index evaluated by the ODI.To compare clinical and demographic variables among individuals with incapacitating dysfunction (ODI ≥ 60 points) and those with mild to severe dysfunction (ODI < 60 points), we designed a contingency table that compares both groups . We founWhen assessing variations in professional activity, a higher prevalence of inactive patients, either due to unemployment or retirement, was found in the group with greater dysfunction compared with those with an ODI < 60 points, who were mostly formally employed. Among the possible explanations, employee payment and benefits are highlighted. In 2000, Atlas et al.Another possible explanation, which has become even more important during the context of economic instability due to the COVID-19 pandemic, is related to the deterioration of mental health with the appearance of symptoms of anxiety, fear, and distress related to financial difficulties, which are more prevalent in professionally inactive individuals. The association between the perception of acute sciatic pain, both in terms of intensity and dysfunction, and mental health is well established, as is the prognosis and evolution of the clinical picture.Finally, a statistically significant higher prevalence of objective motor deficits  was identified among those with a degree of dysfunction considered crippling. The correlation coefficient analysis identified a strong association between the severity of the dysfunction and the presence of reduced motor strength. The mean ODI for patients with motor deficits  was 64.5 ± 12.6, whereas the mean ODI for patients without deficits  was 45.4 ± 16.6, with a statistically significant difference (p = 0.007) between the groups. These findings agree with the case series described by Falavigna et al.Our opinion is that the sample in this study displays distinct characteristics from the 2014 article since it only included patients who sought emergency care due to recent onset of symptoms. In contrast, the previous article focused on patients whose conservative treatment had failed, receiving surgical indication. Thus, it is possible that patients who have had the deficit for a longer period have already adapted their usual and professional routines to the limitation in motor strength, and, therefore, the functional impact has diminished over time. This opinion is strengthened by an article published by Stienen et al.This study contains some limitations. The main reason for this is the exceptional social context caused by the COVID-19 pandemic, which, combined with the recommendations for social isolation by health authorities, has affected the treatment provided by healthcare services for several diseases. Thus, the demographic and social portrait of patients with acute sciatic pain reproduced by this study may not represent the pattern observed in periods of normality. Research conducted in the post-pandemic period could more accurately reflect the manifestation of this pathology in the Brazilian population and also allow assessment of the impact of the pandemic on the outcome of these patients.Furthermore, since this is a cross-sectional observational study with a single-center sample, the analysis of causal factors associated with dysfunction in this group of patients is limited. Longitudinal studies are needed to assess whether the variables that showed statistically significant differences in relation to the proportions have a causal relationship with the severity measured by the ODI. Since this is a sub-project of another protocol developed by the same group of researchers, whose primary outcome is the clinical and functional response after treatment with oral corticosteroids, patients with comorbidities or contraindications to the use of this class of medication, especially those with type 2 diabetes mellitus, were not included.This study aimed to analyze the profile of Brazilian patients who seek emergency medical attention due to acute radicular pain, with onset of up to three months. We found that these patients suffer from more significant functional impairment compared with samples from similar series conducted in other countries. Around 30% of the individuals had functional impairment considered to be crippling, and the presence of motor deficits, intensity of radiating pain, and professional inactivity was statistically higher in this group than in the others, suggesting that these variables may influence the perception of symptoms.However, we highlight that the evaluation was conducted during the COVID-19 pandemic, and the social isolation measures recommended during that period may have resulted in only patients with more severe clinical conditions seeking medical care, given the risks associated with SARS-CoV-2 infection. Future longitudinal studies should be conducted to assess the impact of the pandemic on the management of this group of patients.


The mean number of devices per case was 4 ± 1.1 for the VP group and 2 ± 0.31 for the VPPF group (p < 0.001). No major complications were recorded in either group. The VPPF group had a significantly longer fluoroscopy time (42.8 min ± 14.2 vs. 25.4 min ± 7) and longer radiation dose ). Conclusions: Embolization for PCS resulted in pain relief in 90% of patients; the use of polidocanol did not demonstrate changes in the clinical outcome. The use of a VP alone was associated with decreased fluoroscopy time and radiation dose.Level of Evidence: Level 2. Purpose: To compare the safety and efficacy of vascular plug (VP) and vascular plug and polidocanol foam (VPPF) treatments for embolization in pelvic congestion syndrome (PCS). Materials and methods: A comparative, prospective, two-center study enrolled 50 women with PCS from January 2019 to January 2020. The patients were divided into two groups, and embolization was performed with VP (n = 25) and VPPF (n = 25) treatments. The mean age of the patients was 45.6 years ± 6.9. Three clinical parameters were assessed: abdominal pain, dyspareunia, and lower limb pain. The primary outcome , number of devices, procedure and fluoroscopy times, radiation doses, costs, and complications were compared. The participants were followed-up at 1, 3, 6, and 12 months. Results: At the 1-year follow-up, clinical success did not significantly differ between the two groups (VP vs. VPPF) regarding the improvement of the symptoms analyzed (pelvic pain, dyspareunia, lower extremity pain, and other symptoms ( Pelvic congestion syndrome (PCS), included in a pathology called pelvic venous disorders (PeVDs) in women , is a coPelvic venous congestion may be due to hormonal changes, venous valve insufficiency, or secondary to venous stenosis or obstruction ,6.The treatment of pelvic congestion syndrome (PCS) includes hormonal drug therapy and, in some cases, surgical ligation, including hysterectomy. However, endovascular embolization has been shown to be as effective as traditional surgery, while less invasive and better tolerated by patients ,8.Various embolizing agents have been used to embolize the gonadal or iliac veins involved in PSC. The purpose of this study is to compare a solid agent  (VP) with a solid agent (vascular plug) and a sclerosing agent (polidocanol 2% foam) (VPPF).This prospective comparative study was approved by the institutional review board  and was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants for both the procedure and the study. Eligible patients were assigned to two groups without randomization. The patients were consecutively assigned to one of the two groups without considering any differential factor to receive VP or VPPF treatment. All patients were recruited from January 2019 to January 2020. The primary outcome was clinical success subjectively assessed by patients. The secondary outcomes were complications with a need for re-embolization secondary to lack of improvement, recurrence of initial symptoms, or DVTUS revealing venous reflux or venous diameter > 6 mm.This study was conducted at two centers. The patients were referred by various specialists. All women underwent a Transvaginal Doppler Ultrasound (TVDUS) to diagnose pelvic varices and met the eligibility criteria . The diaThe sample size was determined using computer software  using prospective data from patients seen in 2019–2020 [A solid medium, such as the Amplatzer Vascular Plug (AVP) , and a liquid medium, a sclerosing agent, were used as embolizing agents. AVP II (Amplatzer) with diameters from 8 to 22 mm and lengths from 6 to 18 mm were used. Depending on its sheath, it requires a 5–8 F caliber catheter .2. The contents were mixed until a blend of homogeneous foam was achieved [Polidocanol  is a sclerosing and irritating liquid substance formed by the ethoxylation of dodecanol. Injected to treat varicose veins, it causes fibrosis within the varicose veins, occluding the lumen of the vessel and reducing the appearance of varicose veins. A mixture of 2% polidocanol with air and 1 cc of iodinated contrast Iopamiro 300  was used. The 2% polidocanol foam was prepared by connecting two 10 mL Luer lock syringes using a three-way stopcock containing 2% polidocanol  and 8 mL of COachieved .Two experienced interventional radiologists, both with >30 years of experience, performed all embolization procedures in both hospitals.The technique has been described by the authors in previous publications and has not changed substantially for plug embolization (Group VP). In all cases, the four venous axes were closed ,10.In the VPPF group, the existence of direct venous connections to the systemic venous circulation was ruled out. When these were found, the connection and flow were reduced by releasing a VP of the appropriate caliber. On a few occasions, it was required to close the connection with an occlusion balloon. Coaxially to the MPA 5F catheter, a 2.7 F 130 cm Progreat microcatheter  was introduced, and a foam of 2 mL of 2% polidocanol was mixed with 8 mL of air and 1 mL of iodinated contrast. This mixture was injected slowly until the vessel was obstructed, verifying that there was no migration of the foam towards the systemic venous circulation. Occlusion  was confirmed through venography performed after embolization . During Clinical success was defined as the relief of symptoms experienced before the procedure, including abdominal pain, dyspareunia, lower limb pain, dysmenorrhea, and urinary urgency . The subjective abdominal pain, dyspareunia, and lower limb pain was assessed with a VAS scored from 0 (no pain or symptoms) to 10 (worst pain or symptoms possible). Two categories were created: relief of symptoms (VAS score decreased by 4 points) and no improvement or worsening  [The patients in both groups had clinical follow-up at 1, 3, 6, and 12 months after the embolization procedure. The related symptoms were recorded, and subjective pain was assessed by the patients at each follow-up visit. When no improvement was observed, initial symptoms recurred, or DVT showed venous reflux or persistent venous diameter > 6 mm, re-embolization was scheduled.To assess quality of life, a telephone survey was conducted (at 12 months). The patients were asked about abdominal pain, sexual intercourse, and pain in the lower limbs. Each question was scored from 0 to 10 according to the following distribution: almost always = 0, often = 1–3, sometimes = 4–6, occasionally 7–9, and never = 10. At the end of this study, a survey was conducted, including regarding the quality of the telephone service, with patients scoring their satisfaction with the procedure: the treatment received and the possibility of recommending it to other patients from 0 to 10.p < 0.05 was regarded as significant in all two-sided tests of significance. Using IBM SPSS Version 21.0 , data were processed and examined.By applying the Kolmogorov–Smirnoff test, normality was evaluated. The mean, standard deviation, and range were used to express quantitative variables. Total events and percentages were used to convey qualitative data. The parametric Student t test and the nonparametric Mann–Whitney U test were used to assess continuous data. For categorical variables, the Thec2 test and Fisher exact test were employed. A scatterplot was used to represent time data, and a line chart was used to show how the VAS score changed over time . Fifty patients were randomly assigned to the two groups. Except for those excluded in the first month, no patients were lost at 3, 6, or 12 months of follow-up, and all 50 patients were analyzed. See p < 0.0001). The total procedure time, total fluoroscopy time, and radiation dose were significantly lower in the VP group compared to the VPPF group . Tin toto achieve total occlusion of the four veins in the VP group, a mean of 4.2 plugs was used. The sclerosing substance was never used in this group. In the VPPF group, a mean of 2.2 plugs were used, and all four venous axes were sclerosed in 21 (84%) patients. Sclerosis in the hypogastric veins was ruled out in four patients because they had a very wide communication with the external iliac system  presented pelvic pain with a mean intensity VAS of 6.4 ± 3.1 (range 0–10) with a duration of 40 min ±27 h (range 0–72 h) that required treatment with Metamizole and/or Tramadol. Higher VAS values and longer duration of pain were observed in the VPPF group A,B.Clinical success was achieved at 1-year follow-up in all 50 patients. At 1-year follow-up, clinical success did not differ significantly between the two groups (VP vs. VPPF) in terms of improvement in the symptoms analyzed .In both groups, the relief of symptoms was found in the VAS for abdominal pain and dyspareunia, pain in the lower limbs, and other symptoms (there was a decrease of >4 points with respect to the pre-treatment score) in 88%, 96%, and 48% of patients, respectively. The VAS for lower limb pain and other symptoms showed no worsening but no change in 52% of patients.Two patients’ symptoms in each group did not improve (score <3 points) in a corresponding way when the four values  were analyzed compared to when only abdominal pain was analyzed. Of the patients whose symptoms did not improve, two of them, one in each group, underwent a second embolization at 5 and 10 months, respectively; despite this, the symptoms did not improve substantially.The satisfaction score, personal treatment, and recommendation interest at the end of this study, according to the quality questionnaire carried out by telephone, can be seen in It has been described that embolization produces total or partial improvement in symptoms in between 60 and 100% of patients diagnosed with pelvic venous disorders (PeVDs) . Despitep > 0001) and therefore a higher air kerma and DAP . Another limitation is that clinical success, referring to abdominal pain and pain and discomfort in the lower limbs, is difficult to measure objectively. A subjective scale, such as the VAS, can be influenced by other concomitant disorders and environmental or psychological conditions .While complications arising from venous embolization are infrequent, certain complications can bear clinical significance. Both minor and severe complications are plausible and may manifest during the surgical procedure, shortly thereafter, or during the postoperative follow-up period. This can include vein thrombosis, entry-point hemorrhage, changes in heart rate due to right heart passage, inadvertent release of embolizing agents into unintended veins, material migration, venous rupture, and iodinated contrast adverse reactions.Of the studies encompassed within the systematic review by Daniels et al. , six stuIn a survey conducted by Leal Monedero  in 2006,Given the paucity of research pertaining to its investigation, the precise impact of vein embolization on fertility remains unknown, although instances of pregnancies after embolization are well documented ,28,29.The main long-term complications include migration to the lung, thrombosis of the access vein, foreign body reactions, and compression-induced neuralgia. Conversely, immediate complications primarily entail pain, abdominal discomfort, and the unintended migration of embolizing agents.Henceforth, whether employing venous plugging (VP) or venous plugging plus polidocanol foam (VPPF), the practice of venous embolization as a therapeutic intervention for pelvic congestion syndrome (PCS) demonstrates equivalent levels of safety and efficacy. Both modalities yield a substantial alleviation of pelvic symptoms associated with PCS. Clinically, the outcomes of both procedures reveal a comparable attainment of varicose vein occlusion.In a direct comparison of the VPPF and VP techniques, it is evident that the VPPF procedure requires a longer duration and exposure to radiation. Furthermore, the occurrence of postprocedural abdominal discomfort is notably more frequent in cases of VPPF as opposed to VP, consequently requiring analgesic intervention as a usual measure.