Several methods are commonly used to decrease orthodontic pain, but versatile tools and standardized protocols are still lacking. In response to the need for alternatives to conventional analgesic methods, this study evaluates the analgesic effects of auriculotherapy (AT) during the first three months of fixed orthodontic treatment. 0) and again at two appliance adjustments (T1 and T2). At each of these treatment phases, VAS was applied in six different time moments (TM): immediately before, immediately after, after 4 hours, after 8 hours, after 24 hours, and after 72h hours. Descriptive statistical analysis, a Student’s t-test, and a Chi-square test were applied to the collected data .A sample of 36 subjects was selected, with patients randomly allocated into two homogeneous groups, Study Group (SG) and Control Group (CG), depending on the application/non-application of AT. Patients rated their pain scores monthly from 0 to 10, on visual analogue scales (VAS) at the time of bonding  for most TMs.SG patients reported lower pain levels than CG patients, both at TAT was effective in the pain treatment of patients with fixed orthodontic appliances. Further studies are needed with a sham control group to confirm the validity of these results.  Compared to other acupuncture methods involving the insertion of needles at the cutaneous level, auriculotherapy offers the additional advantage of being well-received by pediatric subjects. The study results demonstrate this technique to be an effective treatment for a variety of types of pain, both acute and chronic.,On the basis of this preliminary scientific evidence, it was decided to undertake an experimental study to evaluate the severity and evolution of pain in the early stages of fixed orthodontic therapy and to verify the efficacy of analgesic acupuncture in patients undergoing these kinds of therapies. The study was carried out by applying an acupuncture method not yet studied in the management of orthodontic pain: auriculotherapy (AT), which involves the application of This research aimed to analyze the efficacy of auriculotherapy in the control of pain associated with the use of fixed orthodontic appliances, and to propose a therapeutic protocol effective for reducing orthodontic pain.A consecutive series of eligible patients was selected from a university hospital ward, with no discrimination with regards to gender or age, between May 2018 and May 2019. All patients included in the study were undergoing a conventional fixed multibracket orthodontic therapy, applied to one or both dental arches. Patients with intellectual disabilities, chronic and/or metabolic diseases, as well as those undergoing analgesic drug therapy or who had already begun or previously undergone orthodontic treatment, were excluded. All patients were informed about the study, including its aims and the potential risks, and signed an informed consent form in advance. The study was approved by the Institutional Ethics Committee, Department of Oral and Maxillofacial Sciences, Sapienza University, Rome, Italy (#53/2018 - 0000711). Selected patients were randomly allocated into two groups, depending on the application/non-application of auriculotherapy during the first three months of orthodontic treatment:» Study Group (SG): auriculotherapy.» Control Group (CG): no auriculotherapy.pain assessment card was distributed to all participants, which was then returned to the medical staff, once fully completed.During the session for placement of the fixed orthodontic appliances, a All participants were asked to indicate their pain perception in the oral cavity and the maxillofacial region during the initial period of orthodontic treatment, at the following three time intervals:0): time at which the bonding of one or both dental arches occurred.» Start of therapy (T1): one month after T0. Time at which the orthodontic appliance was adjusted, by changing the archwire of one or both dental arches.» First adjustment (T2): one month after t1. Time at which the orthodontic appliance was adjusted, by changing the archwire of one or both dental arches.» Second adjustment  was used as a tool of pain self-assessment. The scale is represented as a straight line of 10 cm between two poles: “no pain” (0) and “maximum pain” (10). Study participants were instructed to indicate the value of pain experienced during all three times intervals by plotting a mark on the scale. Patients’ pain sensations were arbitrarily divided into five categories, based on the value given on the VAS scale: no pain (0), mild (1-3), medium (3-5), severe (5-7), very severe (> 7).0, T1 and T2), the VAS scale was used to quantify the sensation of pain immediately before, immediately after, after 4 hours, after 8 hours, after 24 hours, and after 72 hours. Each patient therefore completed six pain assessments at each of the above-mentioned time intervals  during the first three months of therapy. Both at the beginning of therapy and in the following two adjustments , malocclusion , and dental arch treated . A treatment protocol was developed according to the standardized auriculotherapy treatment methods used in traditional Chinese medicine (TCM), with the selection of application points based on TCM principles.0), the side for auriculotherapy application was selected. Side selection was based on the patient’s gender, with application on the right side for females and left side for males. The sides treated were then alternated at the following two adjustments (T1 and T2). The treatment was performed on a single auricle at each time interval. At the beginning of orthodontic therapy . This procedure was repeated for all the points to be treated. The auriculotherapy procedure started within 5 minutes of the end of the clinical bonding procedures (T0) and the following adjustments (T1 and T2). The Vaccaria seeds remained in place for three days after each application, and then were removed by the patient; the points where the seeds were placed were subjected to intermittent pressure for about one minute, 3 to 5 times a day, for the duration of the three days. This technique was taught to all participants, and it was confirmed that patients had correctly carried it out at each time interval. The alternate ear was treated in the same way after the subsequent adjustments. Treatment began after the ear surface was cleaned with a cotton wool pad soaked in ethyl alcohol and then dried. Three points for pain control were selected: the “Mouth” point and the points relating to the dental arch on which the fixed orthodontic appliance was applied. When both dental arches were bonded at the same time, all protocol points were selected. An auriculotherapy speculum was used to identify sensitive or reactive points, through palpation of the ear surface. Once a reactive or sensitive area was located, the speculum was pressed deeper so as to leave a mark on the skin corresponding to the point to be treated. A Since data regarding the application of auriculotherapy in orthodontic pain was not available from other clinical studies, patients were recruited using convenience sampling.All patients were randomly assigned to the control (CG) or study group (SG) at a rate of 1:1 allocation. The randomization was performed using a multiplicative congruential generator of pseudo-randomized numbers (Lehmer RNG). Patients were enrolled sequentially, based on the order produced by the generator. To increase the accuracy of the study, randomization continued until we reached the same number of patients in both groups; the final sample size was made up of 36 subjects (18 in each treatment group).Given the characteristics of the treatment, participants and investigators were not blinded to treatment allocation. The statistician was not involved in the randomization process and analyzed data without assess to information about allocation.0, T1 and T2) in both groups, for all the time moments analyzed. The secondary outcome was pain level distribution according to the epidemiological data . The primary outcome of interest was the pain level and its variation over the three time intervals .All obtained data were examined using SAS software. Descriptive statistical analysis involved calculation of the following quantitative characteristics: standard deviation, mean, median, minimum, and maximum. This analysis was carried out for both epidemiological characteristics: those related to the therapy and those concerning pain intensity and its trends over time. Performance of a Student’s The study sample was comprised of 36 Caucasian subjects, 14 male and 22 female, with a mean age of 19.5 years (range: 13-54 years) . Table 10, T1 and T2). 0, T1 and T2), with indication of whether or not patients underwent auriculotherapy treatment , T1 (first adjustment), and T2 (second adjustment). These results indicate that for both the SG and CG groups, pain appeared immediately after the bonding/adjustments, and tended to increase in the following hours, reaching the highest values after 24 hours. CG patients on average assigned pain values greater than those of the SG for all the time intervals considered , divided for each time moment analyzed: immediately before, immediately after, after 4h, after 8h, after 24h, and after 72h. t-test was significant in the comparative analysis of pain between the SG and CG for almost all time moments considered, at both the start of therapy and the following two adjustments  (The Student’s  and T2) .p> 0.05). The only exception was TM “after 24 h” in T0, where gender was found to be significant (p= 0.042). The Chi-square test did not show significant differences in pain perception for any of the following parameters: age, gender, malocclusion, or treated dental arch  should also have been applied in this study. However, this preliminary research aimed to evaluate the potential efficacy of auriculotherapy in the management of orthodontic pain, despite the lack of evidence of its previous use in this specific area; it was therefore considered appropriate to proceed without the sham group. Further studies should aim to improve upon this point by addressing such factors.Other factors were not evaluated in this study, and this can be considered a limitation of the research, since personal and psychological factors can affect the perception of pain. Ideally, sham auriculotherapy , which involves the application of , which are effective in reducing pain, but may limit the extent of dental movement during therapy.,,, although its use is poorly documented.,Juliao (ST3), Jiachengjiang (Extra), and the auricular point Ya (LO1). In this study, the pain scores of the TEAS group were lower than those in the two control groups. An animal study by the same authors showed satisfactory results regarding the therapeutic and preventive effects of TEAS on rabbits with orthodontic toothaches.Hegu (LI4), stimulated by needles or simple acupressure. Finally, Boleta et al.Hegu (LI 4) and Jiache (ST 6), and found a statistically significant reduction in pain level indexes, both for men and women, when acupuncture therapy was performed before the orthodontic adjustment. Considering the high number of patients reporting discomfort or pain during orthodontic therapies, several analgesic methods have been studied. Most existing studies propose the administration of non-steroidal anti-inflammatory drugs (NSAIDs)0) and in the two consecutive months of treatment (T1 and T2). The results show this difference in perceived pain for all the time moments considered , with a statistically significant difference between average values of perceived pain for most time moments considered (These studies highlight the effectiveness of acupuncture in the treatment of pain during fixed orthodontic therapy; the results obtained from the application of auriculotherapy in this study confirm such findings. From the moment of the application of orthodontic force, the study group undergoing auriculotherapy perceived lower pain values than the control group, both at the beginning of therapy (Tnsidered . The therapeutic auriculotherapy protocol proposed in this study is versatile, easy to apply, minimally invasive, and low-cost. Acupuncture procedures, including auriculotherapy, do not produce side effects and can be safely applied by qualified acupuncturists. This is an important feature, especially given the extreme heterogeneity of orthodontic patients, high percentage of pediatric subjects, and growing demand from patients to limit the use of medication. Auriculotherapy seems to be effective in pain management for patients undergoing fixed orthodontic treatment. Despite the limitations of this study, we can consider auriculotherapy a valid analgesic alternative in the treatment of orthodontic pain. Further studies must be conducted to confirm the results obtained.


This study was performed to investigate the mid-term results of Ti-Nb-Sn (TNS) alloy stem with a low Young’s modulus.This study was a multicenter prospective cohort study. A total of 40 primary total hip arthroplasties performed between April 2016 and September 2017 was enrolled in this study. With the unique functional gradient properties by heating treatment, the strength of the proximal portion was enhanced, while the distal portion maintained a low Young’s modulus. The surgeries were performed through the posterolateral approach using the TNS alloy stems. Radiographs were taken from immediately after surgeries until 3 years, and stress shielding and subsidence of the stems were evaluated. The incidences of the stem breakage were also assessed. Clinical assessments were performed using Japanese Orthopaedic Association (JOA) and Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) scores.Among the 40 enrolled patients, 36 patients were female and 4 were male. At 3 years after surgery, there were no radiologic signs of loosening, subsidence, or breakage of the stem. Stress shielding was observed in 26 hips (65%). Of 26 hips, 16 hips (40%) were grade 1 and 10 hips (25%) were grade 2. There was no advanced stress shielding. The JOA and JHEQ scores significantly improved compared with the preoperative scores.The current study using a new TNS alloy femoral stem showed good clinical outcomes at 3-year follow-up. Radiologically, there was no loosening or subsidence of the stem. The mild stress shielding was observed in 65% of patients.ISRCTN21241251.Current Controlled Trials The date of registration was October 26, 2021.Retrospectively registered. The good long-term results of total hip arthroplasty (THA) have been reported in patients with hip osteoarthritis. Previous long term follow-up studies demonstrated that the improvements of hip pain, functions and quality of life were achieved by THA , 2. FurtHowever, there are still several issues to be solved in THA with cementless stem. One of the major problems is the stress shielding due to inadequate load-stress distribution. Stress shielding refers to the bone atrophy and loss of bone density as results of load stress being removed from the bone by the femoral stem , 9. The To solve the mismatch of elasticity between the stem and the bone, the Robert Mathys (RM) isoelastic stem was developed as a low elastic stem to avoid stress shielding –16. HoweThe authors hypothesized that a TNS alloy stem with functional gradient properties of Young’s modulus and strength could prevent the stress-shielding problem and improve the postoperative outcome of cementless THA. The purpose of this study was to investigate the mid-term results of TNS alloy stem.2), severe diabetes mellitus, and infection around hip joint. The surgical cases with TNS femoral stems were selected based on the choices and consent of patients who met the inclusion criteria. In our institutes, total hip arthroplasties with antero-lateral supine hip approach using short-designed stems were mainly performed. There were few cases operated with posterolateral hip approach using conventional metaphyseal filling type stems of Ti-6Al-4V alloy in the study period. Therefore, the control cases were not able to be established in this study.The study was a multicenter, open-label, single-arm clinical trial. The approval of Clinical Research Ethics Committee of Tohoku University Hospital was obtained before the initiation of this study . From April 2016 to September 2017, a total of 425 total hip arthroplasties were performed at our institutions, and 40 primary total hip arthroplasties using the TNS alloy stem were performed. These 40 patients were enrolled in this study. The inclusion criteria for this study were patients over 20 years of age who had a preoperative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis, and consent to participate in the study. Patients who did not wish to participate in the clinical study did not undergo total hip arthroplasties with TNS alloy stems. The exclusion criteria were previous operation , bilateral hip disorder, rheumatoid arthritis of Charnley category C (multiple joint disease or other disease limiting mobility) [TNS alloy is a new material with a low Young’s modulus of 40 GPa . TNS allAll surgeries were performed at three institutions by 6 orthopaedic surgeons through the posterolateral hip approach. The femur was scraped with a hand-powered reamer and a broach. The TNS alloy stem was inserted with the press-fit technique. As acetabular component, ARC HA cup  was used in all patients. All the patients were allowed to begin full weight bearing with use of an assistive device on the first postoperative day.Anteroposterior radiographs of bilateral hips and lateral radiographs of affected hip with calibration measure were taken before the surgery, immediately after the surgery, at 3 weeks, 6 weeks, 3 months, 6 months, 1 year, and 3 years postoperatively. The incidences of stress shielding were assessed with radiographs at 3 years using the classification of Engh . Stem suThe Japanese Orthopaedic Association (JOA) hip scores were used to assess the clinical outcomes before the surgery, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The JOA hip score is a 100-point scale that comprises the subcategories of pain (Pain: 40 points), range of motion (ROM: 20 points), ability to walk (Gait: 20 points) and activities of daily living (ADL: 20 points) . To assep < 0.05 / k was considered statistically significant. Kappa coefficients for reproducibility of scores between examiners for grading of Engh’s classification were calculated using SPSS version 21  to assess the reliability of the measurements.All results were expressed as the mean ± standard deviation. For the evaluation of the differences between the preoperative and postoperative JOA hip scores and JHEQ scores, Bonferroni correction and Mann-Whitney U test were applied to evaluate statistical differences using a data analysis software . If number of the null hypothesis was k in the multiple comparisons, level of significance α was adjusted at α / k for each comparison by Bonferroni correction. A value of 2. In terms of diagnosis, 35 patients were osteoarthritis and the rest 5 patients were avascular necrosis. Patients with rheumatoid arthritis were not included . Of these 26 hips, 16 hips (40%) were grade 1 and 10 hips (25%) were grade 2 according to Engh’s classification. Severe stress shielding in grade 3 or 4 was not observed   , and the grade of stress-shielding was more advanced –30. In tThe clinical scores of TNS alloy stem at 3 years in this study was significantly improved compared with the clinical scores at baseline. Previous clinical studies using the conventional titanium alloy (Ti-6Al-4V) stem demonstrated excellent results in the improvements of clinical scores . We wereThe TNS alloy has a gradient functional property that allows us to change the modulus and strength by heat treatment, and this technology was applied for the stem used in this study. With the low thermal conductivity of TNS alloys, it is speculated that this functional gradient property could be applied to short designed stems used in anterior lateral supine hip approaches. In addition, the low Young’s modulus of TNS alloys may also be useful in other orthopaedic implants. Although locking plates with Ti-6Al-4V alloy for fracture treatment are widely used, the previous reports described that their excessive stiffness might inhibit an adequate micromotion for fracture healing and obstruct bone healing , 33. In To improve the biocompatibility of TNS alloy, the previous studies indicated the effect of anodic oxidation with acetic acid and sulfuric acid which demonstrated improved osseointegration with hydroxyapatite formation in experimental models –41. In cThe present study had several limitations. First, there was no control in this study. The comparison between control cases and cases with TNS alloy femoral stems was not performed in this study because there were few cases operated using Ti-6Al-4V alloy femoral stems with similar design in the study period. Ideally, a cementless femoral stem made of Ti-6Al-4V alloy with the same shape should be used as a control. Second, the number of participants was small, and there was no process for minimizing selection bias in the selection of cases with TNS alloy femoral stem. Third, the follow-up period was short. Future studies are needed to clarify the usefulness of femoral stem of the TNS alloy in a larger cohort study with a long-term follow-up.The current study using a new TNS alloy femoral stem showed good clinical outcomes at 3-year follow-up. Radiologically, there was no loosening or subsidence of the stem. The mild stress shielding was observed in 65% of patients. No safety issues occurred during the study period. TNS alloys may be useful as a material for femoral stem.


This randomized clinical trial examines the safety and efficacy of acupuncture as a supplemental preoperative treatment for pain in women who will undergo cesarean birth. Is adding preoperative acupuncture to standard pharmacological therapy effective for pain control in patients after cesarean delivery?In this randomized clinical trial with 180 female patients, acupuncture reduced pain on movement and accelerated patient mobilization after cesarean delivery compared with placebo acupuncture and standard pharmacological therapy alone.Findings from this trial suggest that use of preoperative acupuncture as an additional pain therapy is safe and effective in patients after elective cesarean birth. A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements.To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone.This single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019.In addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles.The primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain.d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group . On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group  and 35 patients (58%) in the standard care group . The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group  and 42 patients (70%) from the standard care group . Other parameters were comparable across the 3 study groups.A total of 180 female patients  were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen Results of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery.NCT02364167ClinicalTrials.gov Identifier:  Acupuncture is one such method.Better understanding of the pathophysiological and pharmacological components of nociception and the implementation of procedure-specific, multimodal analgesic pathways have led to improved quality of treatment for acute postoperative pain after various surgical procedures.14 For the treatment of post–cesarean delivery pain, acupuncture has been associated with decreased postoperative pain intensity and analgesics dose as well as increased patient satisfaction in several preliminary reports.17 Informed by the needling methods summarized by Sun et al,12 we developed and tested a combined body and ear acupuncture method for the treatment of postoperative pain in a series of patients who were scheduled for elective cesarean delivery.17 This method was well accepted, and the outcomes allowed the estimation of sample size for a subsequent RCT.17 The aim of the present investigation was to evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery compared with a placebo intervention and standard care alone.Acupuncture allows reduced use of postoperative opioid analgesics, intensity of postoperative pain, and incidence of opioid-related adverse effects.18 and was prospectively approved by the institutional ethics committee of the University Medicine of Greifswald. We followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. The trial protocol is available in This single-center, placebo-controlled, patient- and assessor-blinded RCT with an additional nonrandomized control (standard care) group was performed at the Department of Gynecology and Obstetrics at the University Medicine of Greifswald in Greifswald, Germany, between January 13, 2015, and June 27, 2018. All participants provided written informed consent. The study was carried out in accordance with the principles of the Declaration of HelsinkiWe included consecutive adult female patients with an American Society of Anesthesiologists physical status of II to III who were scheduled to undergo an elective Misgav Ladach method for cesarean delivery under spinal anesthesia. Patients who had a history of alcohol abuse, were using opioids or psychotropic medication, or were unable to understand the informed consent form and/or fill out the study questionnaire were excluded. Additional exclusion criteria after enrollment included failure of spinal anesthesia, cesarean delivery duration longer than 60 minutes, intraoperative complications, and neonatal complications.During the standard preoperative examination, eligible patients were invited to participate in the RCT wherein they would receive either acupuncture or placebo acupuncture in addition to standard postoperative pain treatment after cesarean delivery. Patients who agreed to participate and signed an informed consent form were randomized to either the acupuncture or placebo treatment  on the dOne of 3 physicians with experience in acupuncture  provided the acupuncture or the placebo intervention and performed the randomization using the sealed envelope method. The envelopes, each of which contained a piece of paper on which either “AKUPUNKTUR” or “PLACEBO” was typewritten, were opened by the physician to find out which procedure to perform. The physician attached a sticker with the patient’s name and date of birth to this piece of paper and then sealed the envelope again. The envelopes were reopened, and group allocation data were extracted and added to the main data table after the statistical analysis was finished. With this process, randomization was concealed from patients, assessors of the outcome, and practitioners who provided care during and after the cesarean delivery. Only the physicians who performed the study interventions were aware of the group allocation, although they had contact with the participants after the intervention was completed. The first patient who was randomized was included on January 13, 2015, and the last patient was included on June 7, 2017.Patients who met the eligibility criteria but were not included in the randomized investigation were invited to participate in a routine audit of quality management system in the treatment of acute postoperative pain. These patients constituted the third nonrandomized group, which received standard care without additional intervention (standard care group). The last patient for the standard care group was recruited on June 27, 2018.According to the trial protocol, all of the interventions were performed by at least 2 of 3 physicians  immediately after randomization in the patients’ ward and were completed within 20 minutes before the cesarean delivery. During the intervention, 1 of the physicians provided the patient with structured information on the (1) potential benefits of acupuncture, (2) potential mechanisms of acupuncture, (3) potential adverse effects, and (4) postoperative handling of semipermanent indwelling needles.17 Details and pictures of the equipment used for the interventions, the list of specific acupuncture points, and the rationale for their choice are published elsewhere.17While a physician was providing an overview of the intervention to the patient, the second physician was performing the bilateral needling of 4 auricular acupuncture points and 6 body acupuncture points, according to the trial protocol. For auricular acupuncture, indwelling fixed needles  were used, which were 1.5 mm in length and 0.2 mm in diameter. The indwelling fixed needles are tiny needles that are embedded in a small plastic hemispherical knob within a disc of flesh-colored self-adhesive tape. For body acupuncture, we used intradermal needles , which were 6 mm in length and 0.14 mm in diameter, that were covered and secured using placebo New Pyonex needles. Thus, these needles resembled auricular acupuncture needles but consisted of only the plastic knob and self-adhesive tape without needles, appearing identical to patients in the placebo group.The physicians instructed patients to stimulate the auricular needles and LI4 pressure points by massage for 3 to 5 minutes before asking for additional analgesic medication if they experienced pain. This pain had to have an intensity higher than 4 points on an 11-item verbal rating scale (VRS-11), where 0 points indicated no pain and 10 points indicated maximal pain.19 The SVESA neural pen has a thin tip that produces the feeling of needle insertion if certain pressure is applied to the skin. The physician informed the patient that the neural pen was being used to find the acupuncture point, but the pen was actually being used to produce a pressure with the tip.For patients in the placebo group, the second physician attached the placebo needles near the specific acupuncture points. To imitate the pricking sensation of real needles during the application of placebo needles, the physician examined the skin areas around acupuncture points with a SVESA neural pen , which is commonly used in acupuncture practice to identify skin areas with lower skin resistance.Both acupuncture needles and placebo needles were placed before spinal anesthesia was administered. The needles remained in situ for 3 days after cesarean delivery.5 Postoperative analgesia consisted of 1 g oral paracetamol 4 times a day and supplemented by 50 mg diclofenac potassium 3 times a day, if necessary. In case of insufficient analgesia, subcutaneous injections of 7.5 mg piritramide  were allowed up to 6 times a day.Immediately following the application of acupuncture or placebo needles, patients were transferred to the operating room where they received standardized spinal anesthesia consisting of 7.5 mg hyperbaric bupivacaine hydrochloride and 5 μg sufentanil citrate before cesarean delivery. The combination of bupivacaine and sufentanil provides sufficient analgesia for a maximum of 4 hours after the surgery. Standard postoperative pain treatment was provided according to local clinical guidelines.20 The primary end point was pain intensity on movement, which was measured on the first postoperative day using the VRS-11. Secondary end points were the intensity of maximal and minimal pain on the first postoperative day and the intensity of pain on movement on the day of discharge; incidence of analgesic adverse effects ; disturbance of movement, mood, sleep, and/or enjoyment of life by pain; total consumption of paracetamol, diclofenac, and piritramide during the postoperative period; and time to mobilization  and removal of the Foley catheter after cesarean delivery . On the day of discharge, patient satisfaction with treatment of pain after cesarean delivery was assessed using a 5-item VRS, where 1 point indicated excellent and 5 points indicated very bad. The quality of patient blinding (to randomization to either acupuncture or placebo group) was also tested. Moreover, the patients were asked whether, in the future, they would like to receive acupuncture for pain control after cesarean delivery. To assess the generalizability of the results, one of us  recorded self-reported race and ethnicity. All participants identified as being of non-Hispanic White race and ethnicity.5 (mean of 5.5 points on the VRS-11) and from the pilot investigation17 (mean of 4.1 points) were used for a sample size calculation in this RCT. Assuming the variability in pain intensity on movement on the first postoperative day of 2.0 SD, 55 patients per group were needed to demonstrate a difference between groups of 1.4 at a significance level (type I error rate) of .05 and power of 90%, taking into account a Bonferroni adjustment for multiple comparisons between the acupuncture, placebo, and standard care groups. To account for an expected dropout rate of 10%, the size of these groups was inflated to 60 patients each.Data on pain intensity on movement on the first postoperative day from the clinical auditt test. Skewed data were compared using the Mann-Whitney test. The Fischer exact test was used to analyze the dichotomous data. A 2-sided P < .05, which was Bonferroni-adjusted for multiple comparisons as appropriate, was considered to be statistically significant. The effect size for continuous variables was calculated using the standardized mean difference (Cohen d), and the effect size for dichotomous variables was calculated as relative risk .The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019. Normally distributed continuous data were compared using an unpaired, 2-tailed Statistical analysis was performed with the SPSS for Mac, version 22.0 (SPSS Inc) and QuickCalcs (GraphPad). Data are presented as mean (SD) and number (percentage) of patients, unless otherwise stated.Of 441 patients who were scheduled for elective cesarean delivery during the study period, 231 were invited to participate in the RCT, 73 declined to participate , and 8 wam, but this starting time was later  moved to 2 pm for all patients.Despite several cases with incomplete data, the records of 180 patients were included into the intention-to-treat analysis. The rate of missing data for the end points of this RCT did not exceed 8%  and the standard care group   pain intensity on movement as measured with the VRS-11 compared with patients in the placebo group  . Mean (S < .001) . Mean (S < .001) .The quantity of paracetamol as the standard pain killer and diclofenac as a supplement was comparable among the patients in all 3 groups. Twelve patients (20%) from the standard care group required rescue opioid analgesic piritramide vs 7 patients (12%) from the acupuncture group and 6 patients (10%) from the placebo group, but these differences were not statistically significant . PatientP = .003) and 12 patients (20%) from the standard care group  started their mobilization on the day of cesarean delivery (P = .01) and 35 patients (58%) from the standard care group  on the first postoperative day; there was a difference between the placebo group and the standard care group . By the first postoperative day, the Foley catheter was removed in 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group  and 42 patients (70%) from the standard care group  (Forty-one patients (68%) from the acupuncture group vs 19 patients (32%) from the placebo group  .Forty patients (67%) in either the acupuncture group or the standard care group and 38 patients (65%) in the placebo group complained of tiredness in the postoperative period. In the acupuncture group, 10 patients (17%) had nausea and 2 patients (3%) had vomiting; in the placebo group, 5 patients (9%) had nausea and 2 patients (3%) had vomiting; and in the standard care group, 16 patients (27%) had nausea and 4 patients (7%) had vomiting . The inc21 and the data for this patient were included in the intention-to-treat analysis. All other patients tolerated the acupuncture and placebo intervention well. The occurrence of bradycardia during cesarean delivery was comparable across the 3 groups: 21 patients from the acupuncture group, 13 patients from the placebo group, and 12 patients from the standard care group.Two patients from the acupuncture group complained about unpleasant sensations at the acupuncture sites: 1 patient removed the needles from LI4 points but wished to receive acupuncture for postoperative pain control in the future, whereas the other patient tolerated the needles but did not wish to receive acupuncture in the future. One patient developed bradycardia and hypotension during the placebo intervention after the parturient woman was informed about such adverse effects of acupuncture. The incident was immediately treated without consequences for mother and child,Twenty-five patients (43%) in the acupuncture group vs 11 patients (20%) in the placebo group believed that they received verum acupuncture, whereas 26 patients (45%) in the acupuncture group and 32 patients (58%) in the placebo group could not identify their group assignment . These dd, 0.73) and was large in comparison with standard care alone , the mean pain intensity on movement in patients from the acupuncture group was 4.7 points, thus exceeding the desired value of less than 4 points, which is considered on the VRS-11 as an adequate level for postoperative analgesia and patient satisfaction with postoperative pain treatment.23 Acupuncture may be recommended for routine use as supplemental pain therapy for patients after elective cesarean delivery, with consideration for required personnel and time expenditures.In this single-center RCT with randomized acupuncture and placebo groups and nonrandomized standard care group without intervention, we found that acupuncture with indwelling fixed needles for additional analgesia in patients after cesarean delivery was safe and effective in treating postoperative pain and accelerating mobilization compared with placebo and standard therapy alone. Although the clinical effect of acupuncture on postoperative pain intensity on movement was moderate in comparison with placebo (Cohen 13 and (2) the accelerated mobilization of patients who received acupuncture; a total of 70% of patients from the acupuncture group started their mobilization on the cesarean delivery day vs 32% of patients from the placebo group and a total of 19% of patients from the standard care group. Meanwhile, it is well known that the recovery priorities of new mothers after cesarean delivery are centered not on pain relief alone but also on mobilization and fast return to everyday activities, including caregiving and breastfeeding.25This unexpectedly high level (4.7 points) of pain intensity on movement in the acupuncture group can be explained by (1) the weak-to-moderate analgesic effect of acupuncture in case of acute pain7 on-label and off-label nonsteroidal anti-inflammatory drugs,9 and opioid analgesics.27 Such pain reduced quality of life and decreased patient satisfaction with postoperative pain treatment.23We speculated that the patients in this investigation used the analgesic effect of acupuncture stimulation to regain mobilization for the everyday activity of taking care of their children, while simultaneously taking into account higher  levels of pain. This finding may explain the reports from previous studies of high levels of pain in women after elective cesarean delivery, whereby the intensity of postoperative pain on movement was approximately 6 points (VRS-11) despite the use of various strategies, such as multimodal postoperative pain treatment,28 Recently, intrathecal morphine was recommended as the criterion standard that provides a minimum of 12 hours of sufficient analgesia in patients after cesarean delivery.29 Thus, we cannot be sure of the value of acupuncture when long-acting intrathecal opioids are used. Nevertheless, high levels of pain (>6 of 10 points on the VRS-11) have persisted longer than 24 hours after cesarean delivery,17 suggesting the necessity of further investigation of the combined acupuncture and intrathecal morphine for spinal anesthesia. Moreover, regarding the justified concerns of opioid overuse in the perioperative setting,30 adding acupuncture to nonopioid medications might be an alternative to using systemic opioid medication in patients who are scheduled for elective cesarean delivery.15We tested acupuncture in conjunction with short-acting opioid sufentanil, which is commonly used in Germany for intrathecal application for postoperative analgesia in patients.31 The mean pain intensity on movement of 4.7 points in patients who received acupuncture was comparable to that in patients from the pilot study5 and the RCT of Wu et al16; however, both of these previous studies did not record the mobilization parameters of patients. One RCT that involved 56 patients who were scheduled for cesarean delivery under spinal anesthesia and were randomized either to a single session of acupuncture or a sham procedure did not report any benefits of acupuncture over the sham intervention.32 However, a single session of 20-minute needling of 2 acupoints without stimulation suggests that the acupuncture dose was likely insufficient. The application of indwelling intradermal needles in this RCT may have provided an adequate ongoing acupuncture dose through the continuous stimulation of Aβ, Aδ, and/or C afferent fibers from skin and transmission via the spinal ventrolateral funiculus to the brain nuclei, which is considered a leading analgesic mechanism of acupuncture.33We believe the findings of this RCT support the results of previous prospective-controlled investigations on the treatment of acute pain in patients after cesarean delivery.34 This theory is in agreement with the experimental data of Komisaruk and Sansone,35 who demonstrated that the upper part of the vagina and the lower part of the uterus receive afferent vagal innervation and suggested the neurophysiological basis for a novel pain-blocking mechanism.36 This idea is supported to some degree by the findings of the present trial, in which hemodynamically relevant bradycardia occurred in patients from the acupuncture, placebo, and standard care groups during cesarean delivery. This adverse event required treatment using an antagonist of muscarinic acetylcholine receptors (atropine) to counteract the hypothetical stimulation of parasympathetic nerves from needling in the territory of the auricular branch of the vagus nerve. Beyond this clinically relevant finding, the use of indwelling acupuncture needles, which remained in situ for 3 days after cesarean delivery, was not associated with any adverse effects in this RCT. The safety of using indwelling intradermal needles has been thoroughly discussed in previous studies.17We believe that we could enhance the effect of peripheral stimulation of sensory afferents by the stimulation of cranial nerves, especially the auricular branch of the vagus nerve, which is currently considered the mechanism behind the analgesic effect of auricular acupuncture.38 was not possible for randomization in a perioperative setting and because all of the patients who were randomized but did not receive the intervention tended to refuse further participation and thus prolonged the RCT, we recruited patients for the nonrandomized standard care group. The use of a nonrandomized group may have introduced some bias and limited the validity of the data.39This study has several limitations. First, because the waiting list option for the control group with standard therapy alone, which is commonly used in clinical acupuncture research,41 This aspect might limit the generalizability of the findings; however, theoretically higher baseline levels of pain intensity (taken as the primary outcome measure) may have a greater chance of being influenced by analgesic interventions and may produce substantial change. Third, despite the successful blinding of patients and study personnel who were involved in the treatment of patients and the outcome evaluation, performance bias could have been introduced because of the inability to blind the practitioners (acupuncturists).Second, because of the single-center design of the trial, the recruitment was limited to patients with White race and ethnicity. White individuals are known to demonstrate the highest tolerance for experimental pain and lowest postoperative pain intensity.This RCT found that preoperative acupuncture for additional postoperative analgesia was safe, had a clinically relevant effect on pain, and accelerated the mobilization of patients after cesarean delivery without adverse effects within a particular perioperative setting. With additional consideration of personnel and time expenditure, acupuncture can be recommended for routine use as supplemental therapy for pain control in patients after elective cesarean delivery.


BackgroundPain is one of the common and devastating symptoms that affects millions of cancer patients globally. Despite published guidelines and education on the assessment and management of cancer-related pain, underestimated or undertreated pain continues to be a considerable worldwide public health concern among cancer patients. In this study, we aimed to assess physicians’ adherence to the World Health Organization (WHO) guidelines in the management and assessment of pain in oncology patients based on the available score of pain in the Princess Noorah Oncology Center (PNOC) at the King Abdulaziz Medical City in Jeddah.MethodologyThis cross-sectional, retrospective chart review study studied 451 patients (selected through computerized random sampling) who were admitted to the PNOC during the study period.ResultsThe pain was assessed using the Brief Pain Inventory in almost all patients . The pain was categorized as mild in 386 (85.6%) patients, moderate in 46 (10.2%) patients, and severe in 19 (4.2%) patients. Opioid prescriptions were significantly higher among patients with moderate (76.1%) and severe pain (89.5%) compared to those with mild pain .ConclusionsThe practice of pain documentation for cancer patients was adequate as indicated by reporting the pain scores of 99.8% of inpatients. Patients with moderate and severe pain were more likely to receive opioids and a combination of opioids plus non-opioid analgesics, whereas the prescription of analgesics was predicted by experiencing moderate cancer pain. Pain is one of the common and devastating symptoms that affects millions of cancer patients globally. On average, 30-50% of patients undergoing active cancer therapy and 75-90% with advanced disease suffer from chronic pain that necessitates pain management -3. Pain Inefficient treatment of cancer pain is a frequently reported issue despite the available effective therapies and pain management guidelines. Moreover, the application of pain management guidelines in clinical practice is still problematic . A revieOne of the most commonly used tools for pain assessment is the Brief Pain Inventory (BPI) which depends on several factors, including pain location, intensity, treatment, and effect on daily activities -11. The Despite published guidelines and education on the assessment and management of cancer-related pain, underestimated or undertreated pain continues to be a considerable worldwide public health concern in patients with solid and hematological malignancies; moreover, the adequate and usual self-reporting assessment of pain is the first step for effective and personalized treatment . ConsequThis cross-sectional, retrospective study investigated physicians’ adherence to WHO guidelines in the assessment and management of pain among oncology patients based on the available pain score in the PNOC at the KAMC-JD. KAMC-JD is a tertiary hospital with 558 functional beds located within the Makkah region (western region) of the Kingdom of Saudi Arabia. The PNOC in KAMC-JD is a tertiary cancer center with an 88-bed adult general oncology inpatient unit, a 22-bed bone marrow transplant unit, and a 32-bed pediatric hematology and oncology unit. The study design was approved by the King Abdullah International Medical Research Center ethics review board (SP21J/216/05), and the informed consent was waived because of the study design. The study was conducted from January 1, 2020, till December 31, 2020. We included all adult cancer patients who were admitted to the PNOC during the study period and excluded patients who did not fit the inclusion criteria or requested privacy. A total of 2,133 patients fit the inclusion criteria. We calculated the sample size using Raosoft software with a confidence level of 95% and an error margin of 5%, resulting in 326 patients. However, we included a total of 451 patients through computer-generated random sampling. Data were extracted from the BESTCare Health Information System (HIS) and our variables included pain, assessment scoring, and opioid prescribed (drug name and dosage per day). Demographic data including age, gender, area of residence, code status, co-morbidities, admitting diagnosis, the specialty the patient was admitted under, date and time of admission, the length of stay in each admission, and previous opioid usage (drug name and dosage per day) were collected.The opioid dose was expressed as morphine equivalent daily dose (MEDD) using the standardized factors, as reported previously ,14. BaseStatistical analysisDescriptive statistics were used to express categorical variables (frequencies and percentages) and numerical variables (means and standard deviation [SD] or median and interquartile range [IQR] as appropriate). Categories of pain intensity were defined as mild (0-3), moderate (4-6), and severe (7-10). For the univariate analysis, differences in the pain intensity based on drug prescription and the prescription of weak/strong opioids were tested using Pearson’s chi-square test for categorical variables, whereas the association between MEDD and pain intensity was assessed using Kruskal-Wallis one-way analysis of variance. In the multivariate analysis, the predictors of drug prescription were assessed using a logistic regression analysis (using the Enter method), where pain intensity was the independent variable. The analysis was adjusted for the following demographic and clinical characteristics: age, gender, marital status, body mass index (BMI), previous use of opioids, and the laboratory parameters assessed on admission. Results were reported as odds ratios (ORs) and their respective 95% confidence intervals (95%CIs). Statistical analysis was performed using SPSS version 26 . Statistical significance was considered at p < 0.05.Demographic, clinical, and admission-related characteristics2  patients. The majority of patients  were admitted with one type of cancer, one (0.2%) patient with two types of cancer , and another with three types of cancer (cancer of the breast and ovary and appendix adenocarcinoma). Breast cancer was the most common malignancy n = 111, 24.6%) followed by colon cancer (13.5%) and rectal cancer (6.4%) . The most common reason for hospitalization was undergoing chemotherapy (19.9%), workup (14.3%), and fever (8.6%) Figure .The majority of patients were admitted to the department of adult medical oncology (69.2%) and internal medicine 9.3%) . It was categorized as mild in 386 (85.6%) patients, moderate in 46 (10.2%) patients, and severe in 19 (4.2%) patients.Patterns of opioid use and opioid prescriptionIn general, 95 (21.1%) patients reported previous use of an opioid medication with a median (IQR) MEDD of 30 mg (20-45 mg). After the initial pain assessment, 218 opioid medications were prescribed for 203 (45.0%) patients. A total of 188 (41.7%) patients received one medication and 15 (3.3%) patients received two medications. In addition, 95 (21.1%) patients received weak opioids and 123 (27.3%) patients received potent opioids. Tramadol and morphine were the most commonly prescribed weak and strong opioids, respectively. The median (IQR) MEDD of the prescribed opioids was 40 mg (30-69 mg).Relationship between opioid prescription and pain intensity at initial assessmentIn the univariate analysis, opioid prescription was significantly higher among patients with moderate (76.1%) and severe pain (89.5%) compared to those with mild pain  Table . Based oPatterns of prescription of analgesicsPhysicians provided prescriptions for 280 non-opioid analgesics to 272 (60.3%) patients. Acetaminophen was the most commonly prescribed medication n = 254, 90.7%), and pregabalin was the most frequently prescribed adjuvant   received at least one analgesic medication more frequently compared to those with mild pain   and severe pain  regardless of their demographic and clinical characteristics. The independent association remained consistent for analgesic prescriptions for those with moderate pain only with the adjustment for opioid prescription . Furthermore, the prescription of NSAIDs or acetaminophen was independently associated with moderate pain intensity in the models adjusted for clinical and demographic characteristics  and opioid prescription  or zolpidem (BZD/zolpidem) were prescribed for 64 patients (representing 14.2% of the entire sample). Lorazepam (38.2%) and midazolam (30.9%) were the most frequently prescribed BZDs. Other characteristics of the prescribed BZD/zolpidem are listed in Table Regarding psychotropics and antidepressants, 14 medications were prescribed for 13 (2.9%) patients. Physicians used mirtazapine 28.6%) and olanzapine (21.4%) more frequently, and the majority of these medications were given orally (85.7%). Details about the patterns of psychotropic/antidepressant prescriptions are listed in Table % and olaPain management is an integral part of oncology care to optimize the quality of life and survival of patients . InadequThis study revealed that pain assessment was performed and recorded in the electronic records system for the vast majority of patients 99.8%). This is in compliance with the guidelines of cancer pain management %. This i. Pain doAdditionally, the fact that the pain score was documented for a proportion of patients who had a history of opioid use indicates that pain re-assessment is effectively performed in our setting. This also reflects the high-quality practice of assessment and re-assessment to monitor the performance of medications and to ensure that the prescribed treatments are appropriate and safe. However, data regarding pain reassessment shortly after opioid administration was not available because these were not collected from patient records. Pain reassessment rates were generally low in other studies in the literature (ranging from 44% to 61%) ,19. IndeThe present study showed that physicians had adhered to the published WHO guidelines . The patThe current study has also shown that opioids were prescribed according to the published guidelines, where the odds of opioids prescription were significantly high with increased pain intensity. Nevertheless, we could not find significant differences in the prescription of weak and strong opioids as well as the MEDD dose across different pain intensities. Presumably, the lack of significant differences may be due to the small sample size of patients who received opioids . Another possible explanation is that the practice of optimal opioid selection was not adequate among physicians. Accordingly, palliative care educational programs should be meticulously tailored based on the optimal use of different opioids along with their recommended dosages.In this study, acetaminophen (paracetamol) was the most commonly used non-opioid analgesic. Although current WHO guidelines and the classic analgesics ladder recommend the use of paracetamol in mild-to-moderate pain, patients with higher intensities of pain who are already being treated with a potent opioid may be less likely to gain any additional benefit ,20,22-23In this study, pain assessment was performed by one of the most commonly used tools BPI which concisely evaluates the location and intensity of pain, and it helps reveal the impact of pain on daily life activities . In factThe practice of pain documentation for patients with cancer was adequate at the KAMC-JD as indicated by reporting the pain scores of 99.8% of inpatients. Patients with moderate and severe pain were more likely to receive opioids and a combination of opioids plus non-opioid analgesics, whereas the prescription of analgesics was predicted by moderate cancer pain. Relevant educational programs in palliative care should be taught to physicians to guide opioid dosing and the prescription of weak or strong opioids. Future prospective studies should consider the patterns of drug prescription based on the type and stage of cancer and the economic and patient-related patterns of opioids use, as well as the temporal changes in analgesic dosing on admission and throughout the hospitalization period.


Low back pain represents a significant socioeconomic burden. Several nonsurgical medical treatments have been proposed for the treatment of this disabling condition. Epidural steroid injections (ESIs) are commonly used to treat lumbosacral radicular pain and to avoid surgery. Even though it is still not clear which type of conservative intervention is superior, several studies have proved that ESIs are able to increase patients’ quality of life, relieve lumbosacral radicular pain and finally, reduce or delay more invasive interventions, such as spinal surgery. The aim of this narrative review is to analyze the mechanism of action of ESIs in patients affected by low back pain and investigate their current application in treating this widespread pathology. Low back pain (LBP) and lumbosacral radicular pain are common causes of physical and mental morbidity and they are also a significant economic burden, causing an expenditure of more than USD 100 billion per year in the United States alone . In the Several nonsurgical medical treatments have been proposed for lumbosacral radicular pain, from lifestyle changes, exercise and physical therapy to analgesic local/oral drugs and epidural steroid injections (ESIs) ,8. The cAn ESI is a common and minimally invasive procedure, performed to successfully treat lumbosacral radicular pain, which has also proved its effectiveness in the treatment of back acute pain and leg symptoms. The injections are used to deliver steroids, and sometimes local anesthetics, to the epidural space, directly to the site that causes the pain using a caudal, interlaminar or transforaminal approach . The epiThe aim of this narrative review is to analyze the mechanism of action of ESIs in chronic lumbar pain patients and to understand their current use, application and success in treating this significant widespread pathology. A literature review using online databases was carried out regarding the use of epidural steroid injections for lumbar canal stenosis and disk herniation. Articles were extracted from PubMed, Google Scholar, MEDLINE, UpToDate, Embase and Web of Science, combining the terms “spinal disease,” “radicular pain,” “spinal stenosis,” “canal stenosis,” “disk herniation” and “epidural steroid injection” as keywords for the research. Only papers in the English language and regarding human studies were taken into consideration. Non-English language studies were excluded. Scientific publications up to September 2021were included. Only papers focusing on epidural steroid injections for lumbar canal stenosis or disk herniation were included. All reference lists of the relevant studies were then screened to identify any missing publications. The search and the study selection were performed by two investigators  working independently. At the first level, the titles and abstracts of identified studies were screened. At the second level, the full texts were retrieved and assessed. Ethical approval and patient informed consent were not required because this was a review of previously published studies and did not involve direct contact with patients or alterations to patient care. Any discrepancies were resolved by a third author (M.C.) through consensus. The following data were extracted from each eligible study: first author’s name; publication year; study design; intervention protocol type ; outcome parameters including Visual Analogic Scale (VAS), Numeric Rating Scale (NRS), Oswestry Disability Index (ODI) and successful events; and the summary of findings.Low back pain and radicular pain are caused by interrelated biomechanical and biochemical factors. With the advancement of age and the presence of chronic diseases such as diabetes, obesity, smoking and overload, a series of degenerative processes occur inside the intervertebral disk . The intGenerally, sciatica from lumbar disk herniation is a self-limiting condition that improves in weeks or months without medical intervention; in some cases, rest, analgesic drugs and a structured exercise program may be needed. Usually, the inflammatory state is more important than the mechanical compression in the pathogenesis and the chronicity of the disease, unless there are no neurological deficits . HoweverLumbar spinal canal stenosis is a process that could be part of the aging process and can be related to herniation of an intervertebral disk. Other common causes of stenosis are: congenital deformities; spondylolisthesis; osteophytes; arthritic degeneration; synovial cysts; hypertrophy of the facet joints; hypertrophy of the ligamentum flavum; epidural lipomatosis; spondylosis of the intervertebral disk margins; previous surgery; and neoplastic diseases. All these factors could cause lumbar nerve root compression with microvascular ischemia, axonal injury, intraneural fibrosis and an inflammatory state, leading to chronic back pain . Epidural injections are performed using a Tuohy needle with the tip placed inside the epidural space, which is located between the ligamentum flavum and the dura mater. Usually, the epidural space is localized thanks to the loss of resistance (LOR) technique, where the needle is advanced between the spinal processes of the vertebras with the help of a syringe full of air or saline solution, which is used to continuously test the pressure on the piston of the syringe. The needle passes through the ligamentum flavum and, when the epidural space is reached, a loss of resistance is felt by the operator on the syringe piston. Moreover, epidural injections can also be performed rapidly under CT and navigation guidance . These tCorticosteroids are widely used in regional anesthesia and chronic pain procedures, such as epidural injections, intraarticular injections and nerve blocks. Corticosteroids have a similar structure and activity to the endogenous produced hormone cortisol, which has an anti-inflammatory, immunosuppressive, vasoconstrictive and antiproliferative effect. They work by preventing the enzyme PLA2 from liberating arachidonic acid from the cells. This inhibits the cyclo-oxygenase and lipoxygenase production, which is responsible for the level of prostaglandins, thromboxanes and leukotrienes, before finally decreasing the inflammatory state . They alThe epidural administration of corticosteroids is one of the most common mini-invasive medical treatments for chronic spinal pain caused by disk herniation ,30. In fIn clinical practice, both corticosteroids and local anesthetics are used ,36; the The difference in the use of a local anesthetic alone or local anesthetic with a corticosteroid in the epidural administration to treat disk herniation pain has been indagated in numerous papers without a clear result ,38, althHowever, a good number of studies have described significant pain relief and improvement of functional status after an ESI, especially in short–medium terms ,43,44,45On the other hand, the Spine Patient Outcomes Research Trial (SPORT) , a prospFinally, Kreiner et al. , in theiThe administration of steroids via epidural injection as a nonsurgical treatment for lumbar spinal stenosis (LSS) has been analyzed in various studies but, again, there is not a clear consensus regarding their efficacy in relieving the symptoms, especially in the long-term follow-ups. It is important to notice that a consistent number of studies have reported some degree of benefit, especially regarding short-term improvements ,57,58,59A randomized, double-blind controlled trial with a 2-year follow-up was conducted by Manchikanti et al., which compared the epidural injection of local anesthetic alone to local anesthetic plus steroids, and the authors found a significant relief of the symptoms in a convincing percentage of the patients treated, but without significant difference between the two groups . AccordiMoreover, some other studies did not find any significant improvement in symptoms or quality of life after an ESI for the treatment of LSS ,68,69,70Finally, Liu et al., in their systematic review and metanalysis, also concluded that there is minimal evidence to show that epidural steroids are better than local anesthetic alone in the treatment of LSS patients .Special consideration should be given to image-guided techniques that may help the clinician in performing epidural injections, although no significant difference has been shown regarding outcomes. The use of ultrasound in performing an interlaminar approach could help to estimate the distance from the skin to the epidural space and the optimal needle direction ,74. HoweChronic lumbar pain is a widespread problem, which affects a large part of population at some point of their life. Disk herniation and canal stenosis are the most common causes and they need to be treated due to the high impact of the symptoms on patients’ quality of life, especially because they could affect walking and ability to work . Surgical intervention has been proven to be effective but is not usually considered as the first option . On the In this narrative review, we tried to analyze the existing literature regarding the use ESIs for these kinds of patients, considering randomized controlled studies as well as reviews, meta-analyses and guidelines. Overall, ESIs seem to be safe and quite effective in relieving the main symptoms, especially in short-term follow-ups, and in delaying surgery, according to a consistent number of studies and to the guideline written by Kreiner and colleagues . MoreoveAs mentioned before, literature consensus is still missing and numerous studies did not find significative improvements, especially in long-term follow-ups. In addition, it seems to be difficult to find significative differences between using local anesthetics alone or local anesthetics plus steroids in the injection. Due to the anti-inflammatory action of steroids, patients with high local inflammatory status could probably benefit more from using steroids . HoweverIn this context, the identity of the patients who could benefit the most from this procedure has not been completely established yet and could be a crucial future goal. This narrative review has some limitations. Firstly, the studies taken into consideration did have different epidural injection approaches. Secondly, the heterogeneity of the enrolled patients, analyzed parameters and data collection in the studies taken into consideration could be an important bias. Lastly, the heterogeneity of the purposes of the studies, such as the comparison of steroid injections versus nothing or local anesthetic injections versus local anesthetic plus steroids, could make global analysis difficult.Surely, more randomized studies with larger numbers of patients are needed to fully understand the efficacy of ESIs and define which patients could benefit more from the procedure, especially in order to delay or prevent surgery.According to the literature analyzed in this narrative review, there is no consensus on the use of ESIs for patients with chronic lumbar pain. ESIs seem to be effective in relieving symptoms in the short term and delaying surgery, while evidence of any long-terms benefits is still lacking. More studies are needed to better understand which patients could benefit more from epidural steroid injections.


Partner’s responses to pain behaviours play a pivotal role in the patient’s adjustment. This study aims to further our knowledge regarding patients’ and partners’ interpretation of partners’ responses to pain behaviours, and the possible discrepancies between patients’ and partners’ perceptions. Further, this study examines patients’ preferred responses to pain behaviours and possible discrepancies between received and preferred responses to pain behaviours.A qualitative research design based on a semi‐structured in‐depth interview.n = 54) were recruited through purposive sampling and interviewed. Data were analysed based on an inductive analytic approach.Patients with chronic low back pain and their partners  more positively than responses that showed less active involvement of the partner.Patients and partners are likely to make various interpretations of a certain partner response to pain behaviours. Our findings underscore that patients’ interpretation about a certain behaviour might determine whether that behaviour is rated as desirable or aversive. What is already known on this subject?Partner’s responses to pain behaviours play an important role in the patient’s adjustment.Previous research has mostly focused on patients’ perceptions of partner responses to pain behaviours.Solicitous responses to pain behaviours are not always perceived positively by patients.What does this study adds?This study is among the first qualitative studies investigating patients’ and partners’ interpretations of partners’ responses to pain behaviours.The same partner response to a patient’s pain behaviour can be interpreted in various ways by both patients and partners.Patients’ perceived helpfulness of partner responses is not solely related to support content, but also on patients’ interpretations of support.This study highlights the importance of considering interpretations in the couple’s interactions.The operant conditioning model of chronic pain posits that partners’ responses to patients’ pain behaviours play a key role in disability due to pain. According to this model, partners’ solicitous responses to pain behaviours  serve as positive reinforcement and therefore contribute to the persistence of pain behaviours and disability Fordyce, . HoweverA growing number of studies examined cognitive factors in interactions between patients and their partners. For example, evidence suggests that the frequency of partner’s solicitous responses reported by patients is a better predictor of patients’ pain behaviour than the frequency of solicitous responses reported by partners  more positively than solicitous behaviours  while a greater variety of responses might be demonstrated by partners in a couple’s interaction, including encouraging task persistence, problem‐solving, and observing only  and their partners were recruited through purposive sampling at two pain clinics located in Tehran, Iran. All couples were heterosexual. Patient inclusion criteria were having low back pain for more than 3 months. Partners reporting CLBP were excluded. Both members of the couples were 18 years or older, and they had to speak Persian and have been living together for at least 1 year. Exclusion criteria for both patients with CLBP and partners comprised of having a serious mental illness, or current drug and alcohol abuse based on participants’ report. A further exclusion criterion for patients was having pain caused by malignant conditions .The Ethics Committee of [Name] University, [City], [Country], provided ethical approval for this interview study. Participating clinics identified patients meeting inclusion criteria. Eligible patients were contacted by the interviewer (FA) by phone and were provided with a short description of the study. Recruitment for the study ran from January to July 2018. In total, 40 couples were contacted, of whom 27 (68%) agreed to take part in the study. Main reasons for refusal to participate were no interest of the partner for taking part in the study, personal problems, or lack of time. After giving their informed consent, participants filled out a number of questionnaires, including demographic characteristics and the Dyadic Adjustment Scale Spanier, . Next, pPatients and partners were given a series of eight vignettes describing an interaction between a chronic low back patient and his or her partner. In the vignette, the patient showed pain behaviour of some kind, and the partner responded in a certain way to this behaviour. The responses were developed based on a qualitative study that found twelve possible categories of partner responses to patients’ pain behaviours  immediately following each interview. All interviews were imported into Atlas.ti v. 8.3.20, a qualitative analysis programme that assists with the coding of textual data Friese, . Data ann = 15). Both patients and their partners reported a mean age of 49 and mean marriage duration of 24.2 years. The mean duration of patients’ CLBP was 10 years. The mean score of marital satisfaction for patients and partners was 101.2 (SD = 18.15) and 103.4 (SD = 22.65), which is slightly higher than the cut‐off score of 98 used for differentiating between marital satisfaction and marital discordance  rather than emotional support. Patients associated three response categories with partners’ intent for relieving pain, namely providing help, encouraging pain talk, and hostile‐solicitous responses. For example, they indicated that the partner takes over the activity in order to prevent negative outcomes. ‘He helps to prevent her pain from getting worse.’ . With regard to encouraging pain talk, some patients explained that the partner’s aim for encouraging pain talk is problem‐solving or distracting the patient’s attention away from pain. ‘[Encourage pain talk] She intends to find a solution for the pain problem. She aims to relieve pain and solve the problem.’ . Patients who associated a hostile‐solicitous response with relieving pain believed that this response is a reflection of the partner’s care and concern about the patient and the hostility that accompanied this behaviour does not signify a negative intent. ‘This response [Hostile‐solicitousness] shows that he cares about her. The intention is showing compassion. It is much better than showing no reaction.’ .Compared with patients, partners also perceived responses such as providing help, encouraging pain talk, problem‐solving, encouraging task persistence, and hostile‐solicitousness as an indication of partners’ attempts for relieving pain. ‘[problem‐solving] He responds this way to prevent the pain from getting worse, so she does not experience worse consequences after the party.’ . In comparison with patients, partners were more likely to perceive a hostile‐solicitous response positively. They explained that the partner shows irritation while providing support because the patient does not follow their recommendations with regard to the pain problem. ‘He gets angry because she does not care about herself. He aims to make her care more about herself and convey that her health is more important than household activities.’ .Some partner responses were interpreted as partners’ attempts for conveying acceptance and understanding of the pain experience, for example, by showing care or empathy. Providing help and encouraging pain talk were perceived as validation by a large number of patients. ‘When she is providing help, it means that she has really understood that he cannot do the task. Helping means understanding.’ . ‘This response [Encouraging pain talk] is meant for showing empathy. It assures the patient that there is someone there to hear him.’ .Similar to patients, partners also considered providing help and encouraging pain talk as validation. ‘This response [Providing help] reflects care, empathy, and understanding the pain condition. He cannot heal her pain, but he can show understanding by providing help.’ .Some partner responses were considered as partners’ efforts for instilling courage, perseverance, and hope in the patient, for example, by encouraging them to remain active. Many patients described problem‐solving as the partner’s attempts for encouraging the patient to remain active in order to prevent feeling disappointed. ‘[problem‐solving] He intends to help her not to feel useless and raise her spirit by fulfilling the task.’ . Encouraging task persistence and observing only were also perceived as encouraging though by fewer patients. Patients believed that the partner thinks that physical activity improves pain or they aim to encourage the patient’s independence. ‘[Observe only] He intends to encourage her to manage the pain by herself and stay on her own feet.’ .In comparison with patients, partners mentioned encouragement more frequently and linked it to a larger variety of responses . They explained that the partner might observe only or ignore to encourage the patient to stay independent. ‘[Ignore] He does not provide help. He thinks that this response helps his partner to manage to do the activity on her own. Remaining active helps her to feel better very soon.’ . With regard to problem‐solving and encouraging task persistence, partners provided the same explanations as patients did. They explained that these responses reflect the partner’s attempts to encourage hope in the patient by getting them involved in the activities or fostering their independence.Some partner responses were attributed to the partner's feelings of frustration or being tired of the prolonged process of caregiving. Only a few patients indicated that the partner might encourage task persistence because of their exhaustion. They explained that the partner might also be pressured by a heavy load of work.In contrast to patients, partners associated the partner’s responses with caregiving exhaustion more frequently, especially negative responses. They believed that the partner might observe only, ignore, and express frustration because they are fed up with providing care for a long time. ‘She might respond this way [observe only] because of being tired of the patient's persistent pain and the long process of caregiving.’ .Some partner responses were linked with problems in the marital relationship. Some patients believed that the partner observes only or ignores the pain behaviour because of feeling resentful towards the patient or experiencing marital conflicts. ‘That she is not offering help is because of their previous conflicts. She intends to take revenge on the patient.’ .Similar to patients, partners also indicated that the partner is observing only and ignoring the patient’s pain because of marital problems. Alternatively, the partner may disregard the patient’s pain behaviour because the patient has previously rejected help. In comparison with patients, partners attributed this response  to marital problems more often than patients did. ‘[Ignoring] maybe he doesn’t like his wife. They do not have a happy marriage. There is a problem in their relationship.’ .The responses to the patients’ question, ‘How does it make you feel if your partner responds the same way as described in the vignettes?’ were categorized into positive and negative feelings. Providing help, encouraging pain talk, and problem‐solving were the most positively rated responses. Patients reported positive emotional reactions to these responses, such as feeling understood, hopeful, and being cared for. In contrast, expressing frustration, ignoring, observing only, and encouraging task persistence were usually rated negatively. The negative emotional reactions to these responses commonly reported were feeling upset, annoyed, and disappointed. The hostile‐solicitous category was rated negatively by some of the patients while some others perceived it positively because they reported feeling ‘cared for’ in response to this behaviour. Figure Some patients indicated a positive interpretation for the provided response in the vignette but reported negative feelings about the same response in their personal situation. For instance, they indicated that the partner described in the vignette provides help to show empathy. However, if their partners provide help, they do not feel good about it. They described that their partners provide help but in an irritated manner, or they indicated that they are afraid of burdening their partners. ‘She cares about her partner. She intends to show empathy. However, if my partner responds this way, I don’t feel good about it.’ . One patient indicated that although providing help reflects his partner’s empathy, he did not feel good about this response because as a man, he preferred to fulfil the activities by himself. ‘She means to show empathy by helping him. But I do not like this to occur to me because as a man, I like to fulfil my duties’. . With regard to observing only, none of the patients reported a positive feeling, even those who provided a positive interpretation for this behaviour. They preferred to receive support regardless of the meaning of the partner’s response. Furthermore, some patients did not consider encouraging pain talk as favourable despite interpreting this response positively. Instead, they preferred to receive instrumental support or being distracted from the pain. Among patients who perceived problem‐solving positively, some of them preferred to receive the same response while others favoured this response accompanied by a partner’s active involvement in the activity. The majority of patients did not consider hostile‐solicitous responses as favourable even those providing a positive interpretation for this behaviour.When patients were asked about the responses they receive in similar situations as described in vignettes, the majority of patients pointed out that their partners usually provide help or take over the activity in similar situations. ‘When I am in the same situation, my partner gives me a massage/medication.’  As the second most common response category, patients mentioned invalidating responses , ‘He observes only in the same situation or teases me. He thinks that I am to blame because of doing house chores or not doing my exercise.’ , while patients rated encouraging  and validating responses  as less frequent responses. However, patients preferred providing help and validating responses from their partners, and rated encouragement of activity as less favourable.Partners rated themselves as more likely to provide help compared with other responses. Nevertheless, they rated themselves as less likely to provide validating, invalidating, and encouraging responses. In particular, providing help was the most common form of response that partners provided. While validating, invalidating, and encouraging responses were equally reported as the least occurring responses. Reasons for providing invalidating responses included partners’ exhaustion, marital conflict, and doubting the effectiveness of validating responses in relieving pain. With regard to encouraging pain talk, some partners were not willing to encourage their partners to talk about the pain despite providing a positive explanation for this response. They thought that talking about pain is not helpful for their partner’s pain. ‘Maybe he thinks that talking about pain alleviates her pain. He is trying to help her feel better. I do not encourage my partner to talk about pain because I want her not to think about pain.’ .The participants, both patients and partners, interpreted the different partner responses to pain behaviours as displayed in the vignettes in various ways. These interpretations were categorized into invalidation, attempts to relieve pain, validation, encouragement, caregiving exhaustion, and expressing resentment. Different partner responses were sometimes interpreted in the same way by both patients and partners. For example, many responses were viewed as invalidating by at least some of the patients and partners. Also, patients and partners provided different interpretations for the same response. For example, problem‐solving was interpreted as validating by some, but invalidating by others. However, the partner response encouraging pain talk was mostly interpreted as validation of the pain experience, while ignoring and observing only were interpreted as showing resentment. The main difference between patients and partners was that partners attributed ignoring, observing only and expressing frustration also to caregiving exhaustion. Overall, in comparison with partners, patients were more likely to interpret partners’ responses negatively. Furthermore, among partner responses, providing help, encouraging pain talk, and problem‐solving were perceived as the most desirable responses, while expressing frustration, ignoring, and encouraging task persistence were usually perceived negatively by patients.One of the main results concerns the unexpected finding that some of the responses were perceived as invalidation despite having a positive content. Although research has shown that encouraging physical activity is associated with less disability and pain interference in daily activities  can enhance intimacy and healthy emotion regulation . On the other hand, partners’ positive interpretation of unsupportive responses might be due to their attempt to represent their own behaviours in a positive manner. Furthermore, ignoring was the only response category, which was always interpreted negatively by patients. This response category was perceived as either invalidation or expression of resentment towards patients. Given that invalidation can amplify patients’ pain and exert a negative impact on patients’ relationships  and validation  as their most preferable responses, they commonly reported receiving instrumental and invalidating  responses from their partners. Our finding that patients did not receive validating responses despite their desire for receiving such support is in line with previous research suggesting that patients engage in pain behaviours to seek validation but partners fail to acknowledge their needs for validation  influence the interpretations of partners’ responses as research suggests partners tend to make more benign attributions of each other’s behaviour if they have a more positive overall evaluation of one another  as patients’ interpretations might determine the role of responses in their pain experience. These and previous findings regarding patients and partners interpretations of each other’s behaviours  Somayyeh Mohammadi  Mohsen Dehghani  Robbert Sanderman  Mariёt Hagedoorn .Appendix S1. Vignettes used as prompts in the interviews.Appendix S2. Patients’ and partners’ Interpretations of partners’ responses to pain behaviours as displayed in the vignette.Appendix S3. Patients’ and Partners’ illustrative quotes of each category.Click here for additional data file.