The baseline Cobb degree negatively correlated (p = 0.0459) with the preoperative SST-LI. The plasma SST-LI significantly increased in fraction 3 compared to the baseline (p < 0.05), and significantly decreased thereafter (p < 0.001). In contrast, in herniated disc operations no SST-LI changes were observed in either group. The VAS decreased after surgery both in the traditional  and microdiscectomy groups . More extensive and destructive scoliosis surgery might cause greater tissue damage with greater pain (inflammation), which results in a significant SST release into the plasma from the sensory nerves. SST is suggested to be involved in an endogenous postoperative analgesic (anti-inflammatory) mechanism.Somatostatin (SST) released from capsaicin-sensitive sensory nerves in response to stimulation exerts systemic anti-inflammatory, analgesic actions. Its elevation correlates with the extent of tissue injury. We measured plasma SST alterations during spine operations (scoliosis and herniated disc) to determine whether its release might be a general protective mechanism during painful conditions. Sampling timepoints were baseline (1), after: soft tissue retraction (2), osteotomy (3), skin closure (4), the following morning (5). Plasma SST-like immunoreactivity (SST-LI) determined by radioimmunoassay was correlated with pain intensity and the correction angle (Cobb angle). In scoliosis surgery, postoperative pain intensity (VAS 2.) 1 day after surgery significantly increased (from 1.44 SEM ± 0.68 to 6.77 SEM ± 0.82,  Sensory neuropeptides released from the capsaicin-sensitive peptidergic sensory nerves play crucial roles in regulating various physiological functions, including tissue homeostasis, immune responses, endocrine signalling, and neural processes associated with pain and inflammation. These sensory fibres do not only transmit sensory input and pain signals to the central nervous system (afferent functions), but they also have important local and systemic efferent actions ,3,4,5,6.1–sst5) [1 and sst4 have been identified as key targets in mediating the anti-inflammatory and analgesic effects of SST [Proinflammatory neuropeptides, such as tachykinins  and calcitonin gene-related peptide (CGRP) mediate vasodilation, plasma protein extravasation, and immune cell activation in the innervated area collectively called neurogenic inflammation ,3. Moreo1–sst5) ,9,10. Ams of SST . These rWe have shown earlier both in animal models and humans that SST is released from the capsaicin-sensitive afferents in response to inflammatory processes  and tissue damage  ,13. DataIn light of the dense innervation of the spinal column and intervertebral joints by peptidergic nociceptive fibres, our study aimed to assess changes in plasma SST-like immunoreactivity (SST-LI) during scoliosis orthopaedic surgery and disc hernia neurosurgical interventions, both conducted under general anaesthesia. During these operations, we monitored the levels of SST-LI in the bloodstream to understand the dynamics of SST release in response to the surgical procedure and pain. The objectives were to establish the correlation between the plasma SST levels and the intensity of pain, as well as the extent of the tissue damage incurred during the procedures and to investigate whether the release of SST could potentially serve as a general protective mechanism during painful conditions and surgical procedures.Altogether 30 spine surgery patients undergoing orthopaedic and neurosurgical interventions were enrolled in our study, which lasted for 8 weeks. Patient numbers in the different groups and their mean ages are summarized in Orthopaedic surgery offers a treatment approach for scoliosis through the utilization of segmental fixation of the spine with Cotrel–Dubousset instrumentation. This technique provides patients with the ability to swiftly return to their normal lives and activities following the procedure. To assess the severity of spinal deformities in scoliosis, the Cobb angle is commonly employed. This measurement involves determining the sum of the tilt angles of the upper and lower end vertebrae, providing a quantitative evaluation of the magnitude of the deformity.In neurosurgery, disc hernia operations aim to alleviate nerve compression by removing small fragments of the intervertebral disc, bone, and ligaments. The primary goal of these procedures is to free the affected nerve root by eliminating any disc fragments and degenerated disc material that may be causing compression. Traditional discectomy techniques typically involve larger incisions and significant muscle retraction. However, the advent of microdiscectomy has revolutionized the treatment of herniated discs, offering a minimally invasive alternative. This procedure requires only a small incision and employs surgical glasses or a microscope to magnify the operative site, facilitating the meticulous manipulation of the nerve root. By utilizing microsurgical tools, the surgeon can operate within the confined space of the spine. This approach allows for the precise removal of the disc material causing the compression while minimizing trauma to the surrounding tissues.We assessed pain intensity using a standardized visual analogue scale (VAS). VAS is a commonly used tool for clinicians to assess the pain intensity of patients after surgery. VAS is a simple method to use, it is a straight line with two endpoints: it starts from a low intensity value  and ends with an extreme level of pain (unbearable pain sensation: 10). There is a numerical scale between the two endpoints, and the patient has to assess a value according to the pain sensation. A higher measurable value illustrates higher pain intensity, while a lower value points out less pain sensation.v/v; Abbott Laboratories, Wiesbaden, Germany). During the surgical procedure, the major opioid analgesic fentanyl was administered intravenously at doses ranging from 25 to 50 μg according to the patient’s physiological parameters.Prior to the surgical procedure, premedication was administered to the patients, involving the use of midazolam torrex  and atropine . The induction of general anaesthesia was initiated through the intravenous administration of 1% propofol  and fentanyl . Following intubation, the patients were placed on mechanical ventilation to maintain adequate oxygenation. A balanced inhalation anaesthesia approach was employed, utilizing a mixture of oxygen and medical air in a 1:2 volume ratio, along with sevoflurane at a concentration of 1.6–2%  during induction, and a maintenance dose of 10 mg every 20 min was administered intravenously. Towards the end of the operation, the effect of the muscle relaxant was reversed by administering a combination of neostigmine and atropine intravenously .For effective postoperative pain management, intravenous morphine  was administered as needed. Furthermore, intravenous doses of Tramadol , Diclofenac , and Paracetamol  were given according to pharmaceutical instructions to address pain as required after the operation.The procedures were conducted under the administration of general anaesthesia, which was augmented with the use of parenteral opioids for pain management. Prior to the surgical procedures, patients adhered to our hospital’s established surgical protocols, which involved fasting in accordance with the “nil by mouth” guideline starting from midnight on the day preceding the scheduled surgery. In both groups of orthopaedic and neurosurgical patients, blood samples were collected on five separate occasions to measure the levels of SST-like immunoreactivity (SST-LI) in the plasma. The first sample was obtained at the outset, before any surgical intervention took place (sample 1). Subsequently, additional samples were taken after the retraction of muscles, ligaments, and soft tissues (sample 2), following osteotomy or herniotomy (sample 3), at the time of closing the skin (sample 4), and the next morning at 8 o’clock (sample 5). To prevent clotting, two separate 5 mL blood samples were immediately collected in Vacutainers containing EDTA (18 mg REF 367525 and 143 I.U. REF 367674) that were maintained at a low, ice-cold temperature. Furthermore, to inhibit enzymatic degradation, 200 µL of the peptidase inhibitor aprotinin  was promptly added to the sample intended for somatostatin measurement. Following centrifugation at 1000 rpm for 5 min and subsequently at 4000 rpm for 10 min, the plasma was frozen and stored at −70 °C until further analysis. All samples were analysed under standardized conditions at the end of the study.It should be noted that previous investigations have indicated that a precise determination of SST-LI using the radioimmunoassay (RIA) requires 10 mL of blood and the subsequent acquisition of 6 mL of plasma. In cases where smaller volumes are used, the radioactivity measurements may not reliably align with the standard curve of the assay.The RIA method has been broadly used as a laboratory technique in clinical practice and research to precisely measure the concentration of different peptides and proteins. Its specificity and sensitivity allow this method to determine low concentrations of substances in biological samples . A highly specific antibody binds to the molecule, a radioactive tracer (labelled radioactive isotope) helps to measure the formed antigen-antibody complexes. After a certain incubation time, the antibodies compete with the radioactive antigen for the binding sites. Unbound antigens have to be removed from the complexes and the radioactivity of the separated complexes is measured. The higher the concentration of the substances, the lower the quantity of the radioactive labelled antigen that will be bound to the specific antibodies. After a calibration method the actual concentration of the substance can be measured. Plasma SST-LI was determined with a specific and sensitive RIA technique developed and validated by us as described earlier in detail ,13,26. Wt-test. Correlations between the plasma SST levels and other laboratory parameters were assessed by linear regression and Pearson correlation. Plasma SST-LI data were tested for outlier values using the ROUT method in all groups in an identical manner. For all statistical analyses p < 0.05 was accepted as significant.Statistical analysis was performed using the GraphPad Prism 6.0  software. Results are expressed as means ± standard errors of the mean (SEM). Comparisons between the SST levels measured at different time points within the same group were performed by repeated measures one-way ANOVA, followed by Tukey’s multiple comparison test. The VAS changes within groups were analysed by paired samples We made an assessment individually for each patient regarding the initial pain intensity (VAS 1.) and the level of pain after scoliosis surgery on day 1 (VAS 2.) using the VAS method. VAS 2. significantly increased in patients after scoliosis surgery A on day As we measured the level of plasma SST-LI activity during the operation on five different occasions, the plasma SST-LI activity significantly increased in fraction 3 compared to fraction 1. Plasma SST-LI activity peaked in fraction 4, followed by a significant drop in fraction 5, A. PlasmaIn disc hernia operations, initial pain intensity (VAS 1.) was high in both the traditional and microdiscectomy surgical groups, which is basically attributed to the nature of the original disease in these patients. Pain after the operation (VAS 2.) significantly and similarly decreased after both types of interventions A,B.Plasma SST-LI did not alter in disc herniated patients regardless of the type of the operation A,B. No sThe present pilot clinical study provides the first findings for the significant increase in plasma SST-LI during the orthopaedic scoliosis operation. However, a remarkable change in the plasma SST-LI was not detected after either a traditional or microdiscectomy type of disc hernia neurosurgical intervention performed under general anaesthesia. It is well-established that SST released from the peptidergic nociceptive fibers exhibits analgesic and anti-inflammatory effects ,7,27,28.We suggest that SST is released from the activated peptidergic capsaicin-sensitive fibres in response to tissue injury and/or inflammatory mediators and enters into the bloodstream, inducing systemic analgesic/anti-inflammatory effects. Although we have no direct evidence for this theory by our descriptive results, a broad range of earlier animal experimental data in inflammation and pain models might provide a sufficient explanation ,7,11,29.During scoliosis surgery, plasma SST-LI significantly increased, presumably in response to tissue damage throughout the whole operative procedure, but no increase was observed in disc hernia operations. Scoliosis surgery caused more extensive tissue damage and remarkable pain, as shown by the significantly increased VAS 2. values during the first postoperative day. The greater the correction degree of the spinal column (Cobb angle), the higher the pain intensity, which is explained by the more extensive and stressful surgical procedure resulting in greater damage on skeletal muscles, joints, and tendons. This triggers inflammatory processes with consequent sensory nerve activation and SST release into the circulation. The neurosurgical interventions to remove the ruptured and herniated intervertebral discs represent remarkably smaller tissue damage and sensory nerve stimulation . FurtherThe plasma SST-LI level negatively correlates with the initial Cobb angle (Cobb 1): the greater the deformity of the spinal column, the lower the plasma SST-LI level of the patients. SST might be depleted from the sensory nerves in patients with a greater deformity of the spinal column in response to continuous activation and ongoing chronic pain. Moreover, scoliosis is likely to be due to genetic defects and environmental factors , which mSST inhibits activity-dependent nociceptors, and reduces pain sensation and perception following intrathecal and epidural administration , therefoThe role of SST in pain and inflammation is complex, involving multiple signalling molecules and pathways in neuronal and immune cells. Identifying the specific role and effects of SST within the intricate network can be very challenging. When tissue damage or an inflammatory stimulus occurs, immune cells, such as macrophages and lymphocytes, are activated and release various signalling molecules including cytokines and chemokines, as well as further neuropeptides. These molecules modulate pain and inflammation by acting on immune cells at the site of injury/surgical site. Moreover, SST reduces the release of inflammatory mediators such as cytokines and histamine from immune cells ,37, and A limitation of the present research is the relatively small sample size involved in the study, which might not be well representative and conclusive for a larger population. Another limitation is that it did not thoroughly address the specific types of pain medication, including various analgesic drugs that patients had been using prior to the surgery. Therefore, it leaves a gap in the understanding and analysing the potential influence or interactions between pre-existing medication regimens and postoperative pain management strategies. Nevertheless, in the future, we aim to increase the number of patients and carry out further investigations including pharmacotherapy-based subgroup analysis.In our study we could establish a link between SST levels and the intensity of patients’ pain, as well as the extent of tissue damage resulting from medical procedures. Further data could help to understand the multifaceted role of SST in inflammation and pave the way for its potential clinical implementation as a valuable intervention in the field of postoperative pain management.SST release into the systemic circulation presumably from the sensory nerves is likely to be a general protective mechanism during spinal surgical procedures: scoliosis orthopedic surgery and disc hernia neurosurgical interventions with extensive tissue injury, pain, and inflammation. Tissue damage and pain sensation might increase plasma SST levels in patients during surgery.The results of this study have the potential to enhance our understanding of the neurophysiological mechanisms underlying pain and tissue response during spinal operations. By elucidating the role of SST, we can potentially explore novel therapeutic approaches that target the modulation of neuropeptide signaling to optimize pain management and improve patient outcomes in the context of surgical interventions.


Are there racial or ethnic disparities in how emergency management services professionals record and treat pain with opioid or ketamine analgesia for traumatic injuries?In this cohort study of over 4.7 million patient encounters across the US during a 3-year period (2019-2021), among patients with acute traumatic injuries, patients from minoritized racial and ethnic groups were less likely to have a pain score recorded. Among patients with a high pain score, Black patients were significantly less likely to receive analgesia when compared with White patients.These results suggest that patients from racial and ethnic minority groups with acute traumatic injuries do not have their pain treated equitably in the prehospital setting. This cohort study assesses whether racial and ethnic disparities exist in rates of emergency medical services practitioners recording a pain score and treating pain with opioid or ketamine analgesia among patients with acute traumatic injury. Racial and ethnic disparities in pain management have been characterized in many hospital-based settings. Painful traumatic injuries are a common reason for 911 activations of the EMS  system.To evaluate whether, among patients treated by EMS with traumatic injuries, race and ethnicity are associated with either disparate recording of pain scores or disparate administration of analgesia when a high pain score is recorded.This cohort study included interactions from 2019 to 2021 for US patients ages 14 to 99 years who had experienced painful acute traumatic injuries and were treated and transported by an advanced life support unit following the activation of the 911 EMS system. The data were analyzed in January 2023.Acute painful traumatic injuries including burns.Outcomes were the recording of a pain score and the administration of a nonoral opioid or ketamine.The study cohort included 4 781 396 EMS activations for acute traumatic injury, with a median (IQR) patient age of 59 (35-78) years . The analysis showed that race and ethnicity was associated with the likelihood of having a pain score recorded. Compared with White patients, American Indian and Alaskan Native patients had the lowest adjusted odds ratio (AOR) of having a pain score recorded . Among patients for whom a high pain score was recorded (between 7 and 10 out of 10), Black patients were about half as likely to receive opioid or ketamine analgesia as White patients  despite having a pain score recorded almost as frequently as White patients.In this nationwide study of patients treated by EMS for acute traumatic injuries, patients from racial or ethnic minority groups were less likely to have a pain score recorded, with Native American and Alaskan Natives the least likely to have a pain score recorded. Among patients with a high pain score, patients from racial and ethnic minority groups were also significantly less likely to receive opioid or ketamine analgesia treatment, with Black patients having the lowest adjusted odds of receiving these treatments. To gain a snapshot of the entire US and how its agencies administer medications, we used the newly available pain score field and the robust size of the data set to expand on prior research previously limited to smaller cohorts or individual agencies. Focusing on patients with traumatic injuries, our first aim was to assess whether patients’ race and ethnicity were associated with the recording of a pain score by an EMS care practitioner. Our second aim focused on the subset of traumatic injury patients who reported a high pain score, to measure the association between a patient’s race and ethnicity and the care practitioner’s administration of opioid or ketamine analgesia.STROBE) reporting guidelines. The analysis was conducted with SAS Enterprise Guide version 8.1, update 2 (SAS Institute Inc). The prespecified statistical analysis plan was registered at Open Science Foundation.32 The protocol for the study and waiver of informed consent was approved by the Stanford University institutional review board (Human Subjects Review Board).This study followed the Strengthening the Reporting of Observational Studies in Epidemiology , which administers the database. The first was demographic data from the American Communities Survey (ACS) 5-year estimates, which the TAC linked to the NEMSIS data through zip code, which was masked to the research team. The second was agency identifier, coded by TAC to maintain anonymity.International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes S00-S99, T0-T14, T20-T32, and G89.11. We excluded activations lasting 5 minutes or less because the paramedic would not likely have had time to conduct an assessment with vital signs, which are required before administering opioids or ketamine. We excluded the few activations lasting over 4 hours as extreme outliers. Patients could have more than 1 activation if, for example, 2 units respond to a scene, and each reported 1 activation to NEMSIS. In these cases, we included only the transporting agency.We selected individual activations from the years 2019 to 2021 involving patients aged 14 to 99 years located in the 50 US states and territories. We included 911 scene responses by advanced life support (ALS) paramedics who treated and transported the patient by ground, and excluded those who had been cared for by other health care practitioners, such as interfacility transfers. We restricted our cohort to acute traumatic injuries such as bone fractures or burns, as defined by Last, we removed all activations from agencies that did not record a single pain score or administer a single dose of opioid or ketamine analgesia to any trauma patients during our study years. These agencies likely had nonclinical barriers such as written policies precluding them from giving opioids or ketamine, or agency-wide technical difficulties with reporting data to NEMSIS.31 In this analysis, race and ethnicity were combined into 1 variable, which is referred to as race and ethnicity, even as we recognize that this approach may misclassify some patients. Race and ethnicity are required variables in the patient care reports of many states, but the method of collection is similar to other acute care health care settings in that it is comprised of a combination of self-report, observer report, or choosing unknown. Results are reported using the same categories of race and ethnicity as NEMSIS, with the exception of multiple race, which is composed of records where more than 1 race was recorded.Pain scores were measured on a scale from 0 to 10, with 0 being no pain and 10 being the strongest pain. If multiple pain scores were recorded, the highest pain score was selected without regard to time of pain medication administration. Within the EMS scope of practice, ketamine has multiple indications including pain, induction for airway management, and altered mental status. Doses for pain are smaller than for other indications, so we only counted ketamine as analgesia if the dose was 100 mg or less. NEMSIS uses the race and ethnicity classifications set forth by the Office of Management and Budget.We describe the analytic cohort with counts and percentage distributions for all variables. To address the aims, we built multivariable logistic regression models estimating each binary outcome from patient characteristics , encounter characteristics (time spent with paramedic), agency characteristics , regional characteristics , and year. We accounted for agency-level intraclass correlations by fitting a random effect for agency. The large number of agencies in the data set precluded a fixed effect model. The dependent variable for aim 1 was whether a pain score was recorded, and for aim 2 whether either an opioid or ketamine analgesia was administered. For aim 2, the population was restricted to patients with a high pain score (7 or higher), and the specific integer pain score was included as an additional control in the model. Results are reported as adjusted odds ratios (AORs) with 95% CIs.P values and interpret the results on race and ethnicity only. We consider the other variables as controls, so we present their AOR estimates in P values or interpret their results.The analyzed population includes greater than 1 million records for both aims, and the models contain only 8 or 9 variables. As a result of this overpower, we a priori expected that all associations would be highly significant, and the risk of false discovery would be high. Our variable of interest was the patient’s race and ethnicity; to avoid multiple testing we present ICD-10 codes.The race and ethnicity variable in NEMSIS has high missingness, which may not be at random, threatening the validity of our primary risk factor. To check our complete-case models, we ran multiple sensitivity analyses. First, noting that missingness of race and ethnicity was strongly related to census division, we grouped the divisions based on level of missingness: high (40% or more missing), medium (10% to 40% missing), and low (below 10% missing). We ran both complete-case models in each of these 3 groups and compared their AORs on the race and ethnicity variable. Second, we imputed missing race and ethnicity values using the zip code–level ACS variables: percentage male, percentage of each of 7 specific race and ethnic categories, percentage of each of 3 specific levels of educational attainment, percentage of households below the poverty line, and percentage of households who speak a language other than English. We then compared the AORs for the race and ethnicity variable for both aims on the complete case vs imputed data sets. Multiple sensitivity analyses were conducted for both aims including all patients irrespective of pain score recording or level, limiting the analysis to those agencies with less than 3% missingness, and controlling for grouped A total of 4 781 396 EMS activations  met criteria for acute traumatic injury during the study period . The smaIn this sample of acute traumatic injury primary impressions, a pain score was recorded in 3 276 692 EMS transports (68.5%) . AdjustiAmong patients with a pain score recorded, 1 304 783 (39.8%) reported high pain of 7 or greater, and among those with high pain, 479 694 (36.8%) received opioid or ketamine analgesia . In the The sensitivity analysis results are presented and discussed in depth in the eMethods in Models for each aim were run based on the level of missingness. For aim 1, the 95% CIs arising from the low-, moderate-, and high-missingness regions of the country all overlapped, suggesting that the missingness on race and ethnicity may not have been systematically related to census division. The exception was the American Indian and Alaskan Native group, which had one of the smallest samples, especially in the high missingness regions (Northeast). The AOR estimates using imputed race and ethnicity were similar to the complete case estimates for all race and ethnicity groups. For American Indian and Alaska Native patients, this suggests that the differences noted in the first sensitivity analysis were due to small sample size and not differential missingness .35Building on an improved NEMSIS database that contains pain scores, we were able to better control for variables that might contribute to treatment disparities by race and ethnicity. In order to reduce the bias that is introduced in the clinical care of subjectively painful conditions, we limited our study to acute traumatic injury primary impressions. This may bias our results toward the null, as racial and ethnic disparities seem to be less apparent in the ED setting when fracturesIn aim 1, we found that pain scores were not recorded for 31.5% of patients who had an acute traumatic injury primary impression. Any patient who experiences a traumatic injury should have a pain score obtained and recorded as part of general patient care per the National Association of EMS Physicians (NAEMSP) evidence-based guidelines. We further found that pain scores were less likely to be recorded for all race and ethnicity groups compared with White patients, and that these disparities were largest for Asian patients and American Indian or Alaskan Native patients. For patients reporting multiple races, the evidence for a difference from White patients was marginal.In aim 2, we found that 63.2% of patients reporting high pain were not administered opioids or ketamine analgesia , which iComparing results across the 2 aims, we note that American Indian or Alaskan Native patients appear to be most disadvantaged relative to White patients, both in recording pain scores and in receiving pain medication. This may be due to a multitude of factors, including racial bias, but also statistical bias in that they comprise a small percentage of the US population and may be clustered in areas that have low rates of recording race in traumatic injury encounters.Black patients are nearly as likely as White patients to have a pain score recorded , yet when they report high pain, they are much less likely to receive pain medication . Of all racial and ethnic groups, this is the largest difference between the 2 models. This large difference indicates that among certain patient populations with severe pain, evaluating and recording pain level is not enough to ensure administration of analgesia.36 Another dynamic is the norms and policies of the various states and transporting agencies regarding data collection, data quality, and reporting to NEMSIS. We do note differential recording of patient race and ethnicity by census region, which may drive or distort some of the observed associations. Finally, implicit or explicit bias among EMS practitioners toward various racial and ethnic groups can promote disparities.37 Research has shown that the level of implicit racial bias among health care professionals roughly mirrors that of the wider population.38The causes of the disparities we observed in pain score recording and analgesia administration unfortunately cannot be fully understood from the NEMSIS data. In speculating about potential causes, we recognize that racial and ethnic categories are constructs without biological meaning, and that the stubborn disparities by race and ethnicity reflect complex social dynamics. One possible dynamic is the opioid epidemic, which can cause people both to decline opioids out of fear of potential drug addiction and, conversely, to inflate their pain score to increase the chances of receiving opioids. This may be at work in different ways across the country and by racial and ethnic groups.This study had limitations. The biggest threat to validity, in our view, is that 15.6% of cases in our analytic sample were missing race and ethnicity, which is the central variable of interest. The sensitivity analyses evaluating this did find some evidence of missingness not at random for some race and ethnicity groups in certain analyses. Our results must be interpreted accordingly.Second, some patient encounters could result in more than 1 activation in the NEMSIS data; for example, if both an ALS-equipped fire apparatus and a transporting agency arrived to a single patient. In that case, the transporting agency record was selected, but there is no way of knowing if pain medications were given by the other unit excluded from the analysis. We mitigated this issue in aim 2 by selecting only patients with a high pain score, meaning that any initial pain medication given elsewhere had not been effective and would likely require redosing.21 Fourth, the NEMSIS data faces all the complexities of categorizing race and ethnicity as does all social science research on US populations. We recognize certain distortions, such as the inclusion of Hispanic and Latino patients, who could also self-report other races, as solely Hispanic and Latino in the data set. The NEMSIS data cannot ascertain whether the race and ethnicity of patients was self-identified or simply perceived by EMS practitioners. Lastly, as in all observational research, we can only detect associations, not causal relationships.Third, certain variables in NEMSIS are not required for entry and their missingness can vary drastically. For this reason, we were not able to control for certain confounders such as insurance status, which have been shown elsewhere to be related to prehospital pain care.This study found disparities by the patient’s race and ethnicity in prehospital care for pain due to acute traumatic injury, including in how emergency care practitioners document pain and how they administer pain medication when high pain is reported. Compared with White patients, all other race and ethnicity groups had lower adjusted odds on both outcomes, with the largest discrepancies observed among American Indian or Alaskan Native patients. Black patients were nearly as likely as White patients to have a pain score recorded, but when they reported high pain, they were much less likely to receive pain medication. The causes for these racial and ethnic disparities require further research. Subsequent efforts to measure and improve prehospital patient-centered outcomes would benefit from national and state efforts to include race and ethnicity data collection in all future patient care reports.


The experimental group used 60 mg KTP every 6 hours, and the control group received 400 mg ibuprofen tablets every 6 hours for 1 day. The severity of pain experienced by patients was quantified before and at 2, 4, 8, 12, 24, and 48 hours after endodontic treatment, using the numerical rating scale (NRS). Data were analyzed by using the t-test, Mann–Whitney test, and generalized estimating equation (GEE) .  In this randomized clinical trial, 64 patients who had mandibular first and second molars with irreversible pulpitis were randomly divided into two groups (P > 0.05). The reduction in the pain score was significant in both groups from 2 to 10 hours and 10 to 48 hours, postoperatively (P < 0.001). The interaction effect of time and group was not significant on the postoperative pain score in the abovementioned time intervals, and the pattern of pain reduction was the same over time in both groups (P > 0.05).  The pain score was not significantly different between the two groups at the baseline or any other postoperative time point ( Both KTP and ibuprofen effectively decreased postendodontic pain. Considering the comparable pattern of pain reduction, KTP can be used as an alternative to ibuprofen tablets for effective pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. Pain is an unpleasant sensory experience, which is often associated with possible or actual tissue injury . PreventPostoperative administration of analgesics is often imperative to decrease postendodontic pain especially in teeth with irreversible pulpitis . PatientA high level of postoperative pain is a common concern for both patients and dental clinicians, and it can underline patients' trust in treatment. Thus, analgesics, particularly nonsteroidal anti-inflammatory drugs (NSAIDs), are commonly prescribed before and after endodontic treatment , 10. NSAIbuprofen is among the most commonly prescribed NSAIDs for arthritis, menstrual pain, postoperative pain, edema, and fever. Approximately 80% of ibuprofen is absorbed through the gastrointestinal system when taken orally, and the analgesia onset occurs 30 minutes after use. It is metabolized in the liver and has a half-life of 1.8 to 2 hours. Also, it is mainly excreted in urine and slightly through the bile .Ketoprofen is another NSAID that has a similar structure to ibuprofen since it has a P-phenylpropionic group . Like IbAnalgesics can be used through oral, injection, inhalation, and transdermal routes. Oral medication intake is associated with possible hepatic primary metabolism, resulting in subsequent elimination of a large part of medication prior to its systemic absorption . MoreoveTransdermal patch is a relatively novel form of medication delivery. The patch adheres to the skin and releases a certain dose of drug that passes through the skin and underlying tissues to reach the blood vessels . The advConsidering the limited number of studies on the efficacy of analgesic transdermal patches for postendodontic pain control, this study aimed to compare the efficacy of ketoprofen transdermal patch (KTP) and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis.This study was conducted at the Shahid Beheshti University of Medical Sciences between February 2019 and April 2021. The study was approved by the Ethics Committee of this university (IR.SBMU.DRC.REC.1398.226) and registered in the Iranian Registry of Clinical Trials (IRCT20190716044230N1).An intention-to-treat randomized clinical trial was designed in which the experimental group received KTP, while the control group received ibuprofen tablets to control postendodontic pain. The results were reported according to the guidelines of the Consolidate standards of Reporting Trials .The inclusion criteria were age between 18 and 65 years, ASA class I physical health status , having The exclusion criteria were emergency cases, presence of radiolucency on the radiograph, presence of edema and fistula, use of more than 2 anesthetic cartridges for inferior alveolar nerve block or supplemental injections during the endodontic procedure, noticing pulpal necrosis in general or in one canal after initiation of treatment, not being able to complete endodontic treatment of the respective tooth within a 2-hour single session, iatrogenic errors during treatment , postoperative edema and the need for postoperative antibiotic therapy, and noncompliant patients not precisely reporting the postoperative pain scores.The sample consisted of 64 eligible patients with mandibular first or second molars with irreversible pulpitis and moderate to severe pain presenting to the Endodontics Department of School of Dentistry, Shahid Beheshti University of Medical Sciences.Eligible patients were enrolled after signing informed consent forms. They were briefed about the study protocol and objectives and the advantages and possible side effects of medications.Demographic information of patients was recorded, and their preoperative level of pain and anxiety was quantified using an NRS. Accordingly, they were requested to select a number from 0 to 10 that best described their pain level . A graded NRS with information below each number was used in this study for easy understanding and high accuracy . Mandibu#2 and #3 Gates-Glidden drills, and then SP1 rotary system  was used by the crown-down technique to accomplish root canal preparation. The mesial canals were prepared to #30 with 4% taper, and the distal canals were prepared to #35 with 4% taper. The root canals were then dried with paper points  and filled with gutta-percha and AH26 sealer  by the lateral compaction technique. All patients underwent endodontic treatment by two calibrated postgraduate students of endodontics under the supervision of an experienced endodontist. The teeth were then temporarily restored with temporary restorative material . Immediately after the treatment, the patients were instructed to record their level of pain at 2, 4, 8, 12, 24, and 48 hours after treatment using the NRS. The patients then randomly received an envelope containing pain medication and instructions for use. To ensure that the patients had fully understood the instructions for use of medications after opening the envelopes, the instructions for use were once again explained to patients and the patients used their first dose right after completion of their treatment [All procedures were entirely performed under rubber dam isolation. Patients received 1 cartridge of 2% lidocaine with 80,000 epinephrine  for inferior alveolar nerve block. If the patients had pain during access cavity preparation or root canal therapy, they received a PDL supplemental injection of lidocaine. An apex locator  was used for determination of the working length. The working length was determined 1 mm shorter than the radiographic apex and confirmed by a periapical radiograph. In addition, 1 mL of 2.5% sodium hypochlorite was used for root canal irrigation after using each file to the working length. First, the coronal part of the canals was flared with reatment  as a resSide effects and complications reported by patients were also recorded.The main objective of this study was to compare the efficacy of KTP and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. The effects of sensitivity to percussion preoperatively, type of tooth, and gender of patients on postoperative pain were also assessed as the secondary outcome measures.The sample size was calculated to be 28 in each group  according to a previous study by Murthykumar and Varghese  assumingNo interim analyses were performed, and no stopping guidelines were established.n = 16) were considered for randomization: (I) males with a mandibular first molar with irreversible pulpitis, (II) males with a mandibular second molar with irreversible pulpitis, (III) females with a mandibular first molar with irreversible pulpitis, and (IV) females with a mandibular second molar with irreversible pulpitis. In each of the four groups, each patient randomly received KTP or ibuprofen tablets. Thus, first, four sequences of 16 of the two drugs were randomly created by filliping a coin. Next, 64 envelopes with aluminum covers (to mask the contents) were created and coded. The medications were placed in the envelopes and sealed. A copy of the list of blocks was created by an assistant (who had no involvement in the next phases of the study).The patients were randomly divided into two groups by stratified permuted block randomization with block size = 4 using sequentially numbered, sealed, opaque envelopes . Since 6A dental assistant randomly assigned the medication envelopes to patients. The dental clinician, researcher, and statistician who analyzed the data were all blinded to the group allocation of patients. Only the dental assistant who randomly assigned the coded envelopes to patients was aware of the contents of the envelopes. To ensure allocation concealment, sequentially numbered sealed opaque envelopes were used .t-test. Pain data had non-normal distribution at 24 and 48 hours. Thus, comparisons at these time points were carried out by the Mann–Whitney test. The independent t-test was used to compare the level of pain of patients in the two groups before treatment. Spearman's correlation coefficient was applied to analyze the correlation of pain and anxiety before treatment with pain after treatment.Normal distribution of pain data was evaluated by the Kolmogorov–Smirnov test. The results showed that distribution of pain data was normal at 2, 4, 8, and 12 hours. Thus, comparisons at these time points were performed by the Considering the differences in distribution of data at different time points, the quantitative trend of pain over time was analyzed by generalized estimating equation (GEE). Since the trend of pain reduction over time was not linear, the Spline technique was used to analyze the trend of pain score change over time such that one line was considered from 2 to 10 hours and a second line was considered from 10 to 48 hours post-treatment. The overall form of the linear regression formula was as follows:Mean pain score:Finally, Fisher's exact test was used to compare the two groups regarding complete analgesia (NRS score 0) at different time points. All statistical analyses were carried out using SPSS version 20 at the 0.05 level of significance.P > 0.05). The sample consisted of 64 patients including 32 males and 32 females, in two groups with equal gender distribution . The mean age of patients was 34.87 ± 11.16 years in the experimental group and 35.81 ± 11.19 years in the control group. The two groups had no significant difference regarding the mean age . At 24 and 48 hours, the groups were compared by the Mann–Whitney test, which revealed no significant difference (P > 0.05). Also, the Mann–Whitney test showed no significant difference in the pain score between the first and second molars (P > 0.05).P=0.002) and postoperative pain at 2 , 4 , 8 , 12 , and 24  hours but not at 48 hours . Spearman's test also showed that irrespective of the group, the preoperative pain score of patients was significantly correlated with their postoperative pain score at 2 , 4 , 8 , 12 , and 24  hours but not at 48 hours .Spearman's correlation test showed a significant positive correlation between the anxiety score of patients before treatment with their preoperative . However, in the ibuprofen tablet group, the preoperative pain score had a significant positive correlation only with the pain score at 4 hours (P=0.027).P > 0.05).Comparison of patients with pain score 0 between the two groups at each time point by Fisher's exact test revealed no significant difference . At other time points, pain was higher in the group not sensitive to percussion but not significantly (P > 0.05).Regarding sensitivity to percussion before treatment, 21 patients were evaluated (since the results of the percussion test had been recorded for only 21 patients); out of which, 5 were sensitive and 16 were not sensitive to percussion. The Two out of 32 patients in the ibuprofen tablet group reported gastrointestinal problems in the form of mild pain. Also, one patient in the KTP group experienced slight redness and itchiness when used the first KTP. Since he wanted to continue using the patch, he applied the next patch on another area with no problem.Assessment of the pain score over time showed a nonlinear trend of reduction in pain over time in both groups . Thus, bP=0.141). In both groups, the reduction in the pain score in both the first (2–10 hours) and second (10–48 hours) intervals was significant (P < 0.001 for both).Although the mean preoperative pain score was higher in the KTP group, the difference between the two groups was not significant (P=0.432 for KTP and P=0.571 for tablet group), which means that the pattern of pain reduction over time was the same in both the groups.The interaction effect of time and medication was not significant at any interval in any group (P=0.298).GEE was applied to assess the effect of type of tooth on postoperative pain and showed that although patients with a second molar with irreversible pulpitis had higher postoperative pain than those with a first molar with irreversible pulpitis , this diP=0.472).GEE was also used to analyze the effect of gender, and it indicated that although females in both groups had a higher pain score than males , this diThis study compared the efficacy of KTP and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. The severity of preoperative pain and pulpal diagnosis are among the factors that can affect postoperative pain . Thus, tIn the present study, the NRS was used for quantification of pain due to its slightly superior efficacy to the visual analog scale . Also, tEvidence shows that preoperative pain and periapical allodynia (sensitivity to percussion) can significantly affect postendodontic pain . In addiAssessment of the effect of gender on the postoperative pain score by GEE in the present study showed that although females in both groups had a higher pain score than males, this difference did not reach statistical significance, which was in line with a previous study . HoweverGEE also assessed the effect of type of tooth on postoperative pain, and it showed that although patients with a second molar with irreversible pulpitis had higher postoperative pain than those with a first molar with irreversible pulpitis, this difference was not significant. No previous study is available on this topic to compare our results with.In the present study, 2 patients in the ibuprofen tablet group had mild gastrointestinal pain, which was reported in 12 out of 16 patients in a study by Mangal et al. . DiffereIn the current study, although the mean preoperative pain score was higher in the KTP group, the difference between the two groups was not significant. In both groups, the reduction in the pain score in both the first (2–10 hours) and second (10–48 hours) intervals was significant. The interaction effect of time and medication was not significant at any interval in any group, which means that the pattern of pain reduction over time was the same in both the groups.As mentioned earlier, several studies have evaluated the effects of NSAIDs in the form of transdermal patch on pain after tooth extraction , 20, 41,Moreover, controversy exists in the literature regarding the efficacy of transdermal patches. Three studies on pain control by oral intake of diclofenac sodium and its transdermal patch following periodontal flap surgery showed that its transdermal patch could have a higher , comparaTo the best of the authors' knowledge, this study is the first to assess the efficacy of KTP for postendodontic pain control, which is a major strength of this study. Assessment of the effect of gender on postoperative pain was another strength of this study.This study had some limitations as well. Absence of a placebo group was a limitation of this study. However, it was not ethically possible to have a placebo group. Also, subjective nature of pain is another limitation, which cannot be controlled for. Moreover, the age range of the study population was high, which can affect the pain threshold.Future studies on a larger sample size are required to increase the generalizability of the results.Both KTP and ibuprofen effectively decreased postendodontic pain. Nonetheless, considering the optimal analgesic efficacy of KTP comparable to that of ibuprofen tablets and lower side effects of KTP, it may be used as an alternative to oral ibuprofen tablets for pain control following endodontic treatment of mandibular first and second molars with irreversible pulpitis.


People of Hispanic or Latino ethnicity (Latinx people) experience pain diagnosis, treatment, and care disparities relative to non-Latinx Whites. Those whose preferred language is Spanish may experience additional disparities when receiving care in a language-discordant environment. In order to better understand medically underserved Spanish-speaking Latinx patients’ pain care experience in primary care, we conducted semi-structured qualitative interviews with federally qualified health center staff members (n = 9) and Spanish-speaking adult Latinx patients with chronic pain (n = 12) to capture data on their perspectives. Interview data were mapped to the individual (microsystem), interpersonal (mesosystem), organizational (exosystem), and environmental (macrosystem) levels of Bronfenbrenner’s Ecological Systems Theory and analyzed using thematic content analysis informed by the Framework Method. Findings suggest that Spanish-speaking patients and English-speaking care team members may interpret information about pain state and severity differently, may have misaligned expectations about care, treatment methodologies, and treatment goals, and may experience difficulty forming a mutual understanding during health care encounters due to cross-linguistic and cross-cultural miscommunication. Patients preferred to describe their pain in words rather than with numbers or standardized scales, and both patients and frontline care team members expressed frustration with medical interpretation services, which added time and complexity to visits. Patients and health center staff emphasized the diversity of experiences among Spanish-speaking Latinx people, and the need to account for both linguistic and cultural differences during care encounters. Both groups supported hiring more Spanish-speaking, Latinx healthcare personnel who better resemble the patient population, which has the potential to improve linguistic and cultural concordance and competence, with the aim of improving care outcomes and patient satisfaction. Further study is warranted to examine how linguistic and cultural communication barriers impact pain assessment and treatment in primary care, the extent to which patients feel understood by their care teams, and their confidence in their ability to understand and interpret treatment recommendations. Chronic pain is defined as pain lasting beyond the duration of normal healing time, and is often understood to persist for at least three to six months . ApproxiThe United States Census Bureau classifies individuals of any race who were born in or who have ancestry or nationality in Cuba, Mexico, Puerto Rico, South or Central America, or other Spanish cultures as Hispanic/Latino/Latina . Here, wPain endurance and sensitivity can vary based on cultural expectations and norms for pain management –30. WhenThough language-concordant care has been shown to increase patient satisfaction and improve pain care outcomes , 43, heaFederally Qualified Health Centers (FQHCs)  are non-Community Health Center, Inc. (CHCI) is a large, statewide FQHC in Connecticut that serves as the primary care medical home for 145,000 patients. Two-thirds of CHCI patients are Medicaid-insured, the majority are racial and ethnic minorities, and 90% of patients have income at or below 200% federal poverty level. Approximately 48% of CHCI’s adult primary care patients are Latinx, and 26% have Spanish documented as their preferred language.We conducted semi-structured interviews with 9 FQHC staff , and 12 Spanish-speaking adult primary care medical patients with chronic pain. FQHC staff were recruited to represent diversity in location, job role, demographics, and Spanish proficiency, and patients were purposively sampled to reflect a variety of care delivery locations, pain complaints, and demographic characteristics. Patients were eligible for inclusion if they were age 18+, had Spanish listed as their preferred language in the electronic health record, had screened positive for chronic pain during a primary care visit conducted between 3/1/20 and 9/30/20 by reporting pain “most days” or “every day” within the past 3 months , 51, andWe used a constructivist analysis paradigm , 54, to We conducted thirty-minute videoconference interviews with FQHC staff between November 2020 and January 2021, in English, using a semi-structured interview guide, which included a demographic questionnaire . Teams oWe followed the Standards for Reporting Qualitative Research (SRQR) reporting guidelines for qualitative studies . The ComInformed by the Framework Method of thematic analysis , 59, we FQHC staff participants (n = 9) routinely worked at 10 care delivery sites, and had worked at the health center for an average of 5.4 years. They averaged 36.5 years old, were mostly female-identifying (n = 8) and the majority (n = 8) had an advanced degree, with 6 participants holding terminal academic or medical degrees . About half of the participants were non-White (n = 5), and two reported more than one race or ethnicity. Four participants self-identified as Latinx, most of whom (75%) reported Puerto Rican ethnicity. On average, participants self-rated their Spanish proficiency as 3.6/5.0 on a 0–5 Likert scale, indicating that they spoke and understood enough Spanish to express themselves in professional settings. Three participants spoke Spanish as their first language, and two participants reported understanding only basic Spanish. We placed phone calls to 32 patients aged 18+ with Spanish listed as their preferred language in the electronic health record who had screened positive for chronic pain and completed the PEG pain interference measure between 3/1/2020 and 9/1/2020. Fifteen patients (46.9%) consented to be interviewed and confirmed that they experienced chronic pain. We excluded three interviews from our analysis where the participant endorsed acute pain at the time of the call as their only pain complaint (n = 1), and where the participant endorsed chronic pain but was unwilling or unable to discuss their history of chronic pain with the interviewers (n = 2).Interviewed patients (n = 12) received care at eight different primary care sites, and half (n = 6) were Medicaid-insured. All had screened positive for chronic pain at their most recent visit (self-reported pain “Most Days” or “Every Day”), with nearly all reporting pain “Every Day” (n = 11). The mean score on the PEG pain interference measure was 6.9/10.0 (n = 12), though the majority of patients (n = 9) recorded a severe average score (≥7.0/10.0). All participants self-identified as Latinx (n = 12), a slight majority were male (n = 7), and the average age was 52.5 years. Demographic information for interviewed patients is summarized in “Estoy sufriendo con la rodilla, mi cadera, y mi espalda. Me estoy poniendo vieja. No hay nada que puedo hacer. Entonces yo qué hago, algunas veces no aguanto el dolor, me quedo en la cama y lloro. Es lo que puedo hacer.”  .Patients expressed frustration that their chronic pain had not been completely alleviated by treatment. Many expressed sadness, futility, or anger, and several endorsed the use of home remedies concurrent with prescribed treatment, or reliance on “God” to help manage or alleviate pain. A patient stated “Ya tú sabes que yo soy Puertorriqueña y cojo el [name-brand topical pain relief product] pero sufro del dolor. Me pongo el [topical pain relief product], me tomo mucho té y a lot of ‘rubbing ointments’, [rubbing] alcohol, [name-brand mentholated topical ointment] y hielo, pero no puedo hacer más nada.”  [P12].Patients who reported using home remedies in addition to what their doctor had recommended also reported limited success alleviating their pain. A patient who had a history of multi-site joint pain and orthopedic surgery stated: molestia’… And it’s hard sometimes for them to put into words. It’s [translated as] ‘something’s bothering me’ or ‘it’s this annoying bothersome thing’ but no [descriptors like] ’dull ache’, that sort of thing" [S6]. A second bilingual clinician commented, “[Spanish-speaking patients] are more descriptive in terms of using metaphors, like ‘El dolor que me quiere arrancar la vida’ (‘Pain that wants to rip the life out of me’) or they describe [pain] using a comparison with an animal, for example: ‘Hoy tengo el mono atrapado’ (’Today I have a trapped monkey’”) [S9].Clinical staff’s description of their Spanish-speaking patients with chronic pain aligned with patients’ description of their own experiences. Several clinicians noted that their Spanish-speaking patients with chronic pain regularly report multiple pain complaints, diffuse or widespread pain, and high pain scores, and it can be difficult to make appropriate care recommendations. A bilingual clinician stated, “[Patients say] ’I have a “Yo nunca padecí de depresión ni ansiedad ni nada de eso y ahora estoy tomando como cinco pastillas para ansiedad y depresión… Los doctores te dicen ‘tienes esto’ pero cómo es que ellos no se meten en el cuerpo de uno y pensar que saben que le ha afectado a uno?” (“I never suffered from depression or anxiety or anything like that and now I’m taking about five pills for anxiety and depression. The doctors tell you ’you have this’ but how is it that they don’t get into one’s body and they think that they know what has affected you?”) [P2]. Later in the interview, when asked what aspects of her treatment were helpful, the patient acknowledged that behavioral health treatment had helped her pain: “Yo venía de muchos doctores. Pero en realidad… la que ha venido un poquito a ayudarme es la terapista y la psicóloga, ok?”  [P2].Patients’ use of non-quantifiable terms, metaphors, and comparisons was challenging for primary care teams, who often use patient-provided descriptors and scores to better understand overall health status and guide treatment recommendations. Though pain assessment and care at the FQHC emphasizes the biopsychosocial nature of pain, most patients seemed to view their physical pain as separate from other biopsychosocial factors, and few acknowledged behavioral health comorbidities that contributed to or co-occurred with their pain. One patient felt that her provider had incorrectly assumed she needed treatment for depression and anxiety in conjunction with pain: Care team members espoused the importance of assessing how a patient’s mental health impacted their pain, but several expressed concern that Spanish-preferred patients might omit information or avoid discussing their mental health status and any contributing events. A clinician commented that in her experience, not all patients feel secure enough to disclose information about psychosocial distress with their care team: "Depending on where someone is from in the Spanish-speaking world, in a scenario where maybe it wasn’t safe to talk about depression or anxiety or something like that, sometimes what will come out is more of a physical complaint. So I think teasing that out sometimes can be difficult" [S5].“Como te digo, yo entiendo que los doctores te dan cualquier pastilla p’al dolor pero en realidad, pues, ellos no le importan lo que uno está sufriendo…. No le dan importancia a los síntomas de la gente …”  [P6]. A second patient corroborated this frustration when discussing how clinicians did not seem receptive to the information he provided when asked about his pain: “Mira, para ser franco es que no quieren entenderme verdad porque yo sé que yo tengo y a veces ellos malentienden. Ellos no saben lo que yo siento. Yo le expreso a mi doctor, pero no sé. No me [han] ayudado.”  [P9].Patients recommended that frontline care teams express greater empathy towards their patients with pain. A patient stated: ‘tonto’ [‘silly’] saying a number because they feel that a number doesn’t sufficiently describe the pain they feel” [S9].Care team members’ perceived lack of empathy may be partially explained by misalignment between patient and provider regarding how to discuss pain during a clinical encounter. Communication between patients and their care teams about pain often starts with the patient being asked to rate their pain level. A bilingual clinician commented that in her experience, Spanish-speaking patients prefer not to use a 0–10 pain scale to describe their pain, stating, “Many have said that they feel A non-clinical staff member who is a native Spanish speaker posited that giving a high pain score helps patients signal the importance of their complaint to their care team, stating: “I am bothered or frustrated when [my] doctor says ‘on a scale of 0 to 10…’ How? Just please treat me! … If I say 8, they’re gonna prioritize something else… do I always have to say 10? … In Spanish I can say ‘it’s a 6, but this is what’s happening’. But in English, I might say it’s a 6 and then not really be able to describe what it really is” [S3].“Me siento cómodo porque mi proveedor… es muy comprehensiva y me entiende. Me da tiempo, toma tiempo de escuchar lo que me pasa.”  [P1].Despite some misalignment between how patients and their care teams characterized, described, and understood pain, most patients interviewed were pleased with the relationships they had developed with their primary care provider and care team. A patient attributed her positive relationship with her (Spanish-speaking) primary care provider to feeling understood: Staff members and patients expressed that the language translation resources available to them made communication possible, but that translation services are not sufficient to foster personal connections with patients. A clinical staff member observed: "You can’t get any less personal than [the telephone translation service used at the FQHC]. There’s no human connection there, literally… In order for you to have any true impact on a patient’s life, in my experience, you have to build that relationship" [S2]. A second clinical team member reflected that when given a choice, some patients decline translation services, stating, “Most of my patients would rather [I use] my broken Spanish than use a translator. My conversations… [are] more nuanced and can be more about forming a connection with my patient that’s kind of casual—casual conversations with the translator can be tough" [S7].“Cuando yo siento que necesito hablarle [al proveedor] algo que me este preocupando estoy preocupado que [estoy pidiendo algo]”extra” si pido traductor para poder explicarlo con el doctor.”  [P2].A patient expressed that she hesitated to ask for a translator unless absolutely necessary due to uncertainty about making an “extra” request of her care team: FQHC staff also felt conflicted about how using translation resources impacted their visits with Spanish-preferred patients, but were concerned about whether they were able to do enough to make patients feel comfortable and meet their needs. A clinician remarked on the challenge of having the same amount of time with each patient regardless of whether translation is needed: “My clinic could run like an hour behind… I don’t want to short-change [patients] just because I’m using an interpreter—I want to connect in the same way that I connect with my English-speaking patients” [S1]. A second clinician remarked that some patients were already frustrated at not having more visit time with their clinical team, and felt that using a translation service made the visit time seem even shorter: “[Patients will say] ’I don’t even know why I come here! I only see you for 5 minutes and then you charge my insurance!’ [Patients will] tell the provider just like that” [S2].“Sería buena que las clínicas tuvieran más personas bilingües porque unas personas tienen problema hablando en ingles y nada mas hablan español”  [P1]. FQHC staff recommended modifying hiring practices with respect to both language and culture. An administrative leader stated: “There’s something to be said of recruiting people who are representative of the community that we serve… [and] intentional recruitment in the communities or neighborhoods where [FQHC] is located” [S8]. Staff recommended salary incentives as potential motivation for care team members to build their Spanish competence. An administrative leader posited, “Maybe [FQHC] should open some specific Spanish-speaking positions where [we] will only take a bilingual person and then actually pay them additional because of that, because it’s such a valuable asset…” [S5].When asked what the FQHC might do to better meet patient needs, patients expressed that they would appreciate more bilingual care team members: Clinicians noted that some Spanish-preferred patients who had previously received care for their pain outside of the mainland U.S. had developed treatment expectations that differ from current standards in place at the FQHC, often leading to difficult conversations. A behavioral health provider remarked on such patients’ expectations about seeking care for pain: “If we are defining Spanish-speaking patients as a whole culture, like being Hispanic or Latino, the tolerance of pain could be lower than other cultures, [with] more focus on relieving physical pain [and] discomfort right away… They are thinking that I’m going to prescribe a medication to relieve their pain so I have to clarify… explaining again the connection between chronic pain and mental health" [S9]. A primary care provider observed that patients may also expect medications, dosages, and treatment plans that are not aligned with the FQHC’s prescribing policies or with guideline-informed pain care: "Prescribing practices around opioids are really different [outside the mainland U.S.]… patients come over on, like, long-term [opioid analgesics]… Per current guidelines, that’s not really indicated for chronic pain that’s non-cancer-related… It’s really hard to navigate that conversation, because what do you do when someone’s been on this medication for 10 years?" [S5].When discussing recommendations for health center policy changes to improve pain care for Spanish-speaking patients, staff recognized that the FQHC’s Latinx patients come from diverse cultural backgrounds, and that it is not appropriate to assume that linguistic competence corresponds to cultural understanding. A non-clinical staff member and native Spanish speaker advocated for placing equal emphasis on linguistic proficiency and cultural competence, reflecting that, “You still want to provide bilingual bicultural services… we need to understand that the culture is different, and it’s not that one is less than the other… We need to make sure that we appreciate as much as we can, empathize with them, and then at the same time make sure that we are also able to contribute rather than impose" [S3]. A bilingual clinician who had worked in primary care outside the mainland U.S. suggested offering more treatment alternatives designed to appeal to patients’ cultural experiences and preferences: “A lot of people who are native Spanish speakers come from more collectivist cultures. And often, group care, like group visits, can work well …And I think in some settings, yes, that it’d be cool if we had more Spanish-language chronic pain support groups for patients" [S4].Staff members discussed the connection between pain, stress, trauma, and the contributory factors beyond the control of the healthcare system that might impact pain care experience and ability to follow care recommendations. A clinician observed: “ minority patients certainly have a higher percentage of economic hardships, social hardships, and just other social stressors in their life—food insecurity, transportation insecurity … Even decreased access to basic things like medical care” [S4]. A non-clinical staff member identified unequal information access as an additional source of disparity, stating, “The Spanish-speaking community might be segregated or secluded–not only geographically, but also in terms of knowledge about community resources” [S3]. A second staff member commented on the downstream impact of information and access disparities on pain severity: “By the time they come to a healthcare professional’s attention [the pain] may already [be] severe, right? Like a pain that they’ve been struggling with for years. So it goes back to those social root causes” [S8].“Básicamente ellos no te ponen atención… yo tuve que pedirle favores al doctor que me diera de baja en el trabajo porque yo tenía de 5 días de trabajo me lo pasé para 4 [días] a 32 horas y de 32 horas baje a 3 días. Y de los 3 días de trabajo que tenía casi siempre estaba ‘calling out’… Llevo 25 años viviendo en los Estados Unidos y mi plan era, pues como todo hispano, venir aquí a trabajar y salir adelante.”  [P2].Both patients and staff recognized lack of financial resources and loss of income as major barriers to adhering to pain care recommendations. A primary care provider recalled a patient with severe pain who worked physically demanding day labor jobs and repeatedly declined additional testing, since he feared that both the testing and the result might cause him to miss work and lose income: "He kept telling me, ’I’m fine’, because he wanted to keep working. And I insisted he get an x-ray, but it was a big to-do to convince him, because of financial and occupational stressors” [S5]. When asked how it felt to speak with a primary care provider and care team about pain, a patient shifted the conversation to discuss how their care team had been unable to help her keep working despite her pain: Pain is among the most common reasons for seeking primary care treatment , is subjIn our sample, clinical staff members noted nuances in idioms, terminology, and ways that Spanish-speaking patients commonly discussed their pain. Staff members acknowledged the need to navigate cultural and linguistic barriers, and the persistent challenge of relieving chronic pain. Patients expressed both desire for more pain relief and passivity and fatalism with regard to their pain. They commented on the difficulty of being understood during care encounters, and the importance of connection with their care teams. Several who were satisfied cited feeling understood by their provider and care team as a reason they were happy with their care.The United States Department of Health and Human Services’ Health Communication objectives for Healthy People 2030 include increasing the number of adults with limited English proficiency (LEP) whose healthcare providers offer explanations that are easy for patients to understand . The U.SDiffering approaches to pain treatment add to the friction between patients and clinicians during pain-related encounters. From clinicians’ perspectives, the general goal of pain treatment is more likely to be measurable improvement than complete pain relief . NumericStaff interview participants recognized that sociodemographic factors and unequal information and access might impact Spanish-preferred patients’ pain care experience and ability to follow care recommendations. Latinx people in the U.S. are less likely than non-Latinx people to utilize and access health services or to have a usual source of care, and are over twice as likely to be uninsured as non-Latinx Whites . CompareFQHCs should also strive to recruit, hire, and retain personnel who share culture and language with the diverse patient populations they serve. Patient-physician racial concordance is associated with higher levels of patient satisfaction about clinical communication . Some puOur investigation was intended to help improve our organization’s understanding of patients’ and care team members’ experience during language-discordant pain care encounters. Further study is warranted to examine how linguistic and cultural communication barriers impact pain assessment and treatment in primary care, the extent to which patients feel understood by their care teams, and their confidence in their ability to understand and interpret treatment recommendations. Findings from this study will be used by clinical and administrative leaders to help update policies and procedures for asking patients about pain and function during primary care visits. As an organization that strives to deliver healthcare in the most equitable way, we recognize that the patient perspective is valuable in creating and co-creating knowledge that improves clinical care. More broadly, these findings are intended to shed light on patients’ lived experience and to draw frontline care providers’ attention to the many aspects of patients’ social identities–including language and culture–that can impact their pain care experience.We did not explicitly ask patients about their immigration status, which may have limited our understanding of the context of their responses. Our study was set in an FQHC that cares for patients regardless of their documentation status, and does not collect immigration status or documentation status information at intake, which may have helped mitigate patients’ concerns about disclosing their status if it was relevant to their experience. Due to small sample size and unavailability of data on patients’ country of origin, we were not able to compare patients’ responses based on country or region of origin.Due to restrictions imposed by the COVID-19 pandemic, we were unable to conduct in-person interviews with patients and staff, which may have impacted rapport between interviewers and interviewees. Further research examining the needs of Spanish-speaking patients with pain should utilize in-person interview methods to mitigate potential communication barriers imposed by use of telephone or videoconference, and should consider expanding the interviews . Though The scope of our study did not permit direct comparison between monolingual or LEP Spanish-speaking patients with chronic pain and patients with stronger comprehension of English, who may feel more comfortable using at least some English during a care encounter. Future work will aim to better understand differences between how monolingual and LEP Spanish-speaking patients and patients who are comfortable using at least some English during medical visits interpret questions about “pain” from their care teams, interpret questions about how pain impacts their lives, communicate their needs to their provider and care team, feel that those needs are understood and met, and understand and interpret treatment recommendations.Current literature has demonstrated disparities between English-speaking and Spanish-speaking Latinx patients in reporting pain, seeking pain care, and receiving treatment. This study adds to the body of knowledge on how to develop and refine patient-centered pain care practices to meet the needs of medically vulnerable Spanish-language-preferred primary care patients. We advocate for including the voices of patients and care teams to guide formulation of chronic pain screening and follow-up policies.S1 Appendix(DOCX)Click here for additional data file.S2 Appendix(DOCX)Click here for additional data file.


Symptoms of temporomandibular disorders (TMD) could be present as otologic symptoms like earache and dizziness in some patients. In most cases, these symptoms are not recognized because otolaryngologists fail to diagnose TMD as a source of the problem. This investigation was conducted to evaluate the effect of TMD treatments on the otologic symptoms which after taking history and clinical examinations seemed to be related to TMD. In the present study, the patients who were complaining of otalgia, ear fullness, tinnitus, hearing loss, and dizziness were evaluated by an ear fellow. Forty patients who had no known otologic or other primary causes to explain their symptoms, were referred to the orofacial pain clinic with the possible diagnosis of TMD. If the diagnosis was confirmed by an orofacial pain specialist, a combination of TMD treatments was administered to each case and the patients were followed up. The results showed that following implementation of treatment protocols for TMD, more than 50% of the patients reported complete or partial recovery in the second follow-up (p < 0.05). The most common otologic symptom of the referred cases was earache, and the most common associated complaint was neck pain. All the patients had one or more parafunctional habits. This study showed that TMD treatments were significantly efficient in improving otologic symptoms partially or completely and the authors concluded that for the patients with otolaryngologic unexplained symptoms, an overhaul examination is needed to assess TMD as a possible cause of the patient complaint. It is recommended that in cases with unexplained otologic symptoms, otolaryngologists care more about the neck trigger points (TP) and ask about the patient’s parafunctional habits. Otolaryngologists and dentists need to be aware of the risk of developing otologic symptoms caused by these habits or cervical TPs. Temporomandibular disorders (TMD) refers to a wide range of clinical problems that affect the masticatory muscles, temporomandibular joint, and the surrounding soft tissues  , 2. TMD TMDs affect either or both articulation and masticatory muscles. The most common signs and symptoms of TMD include temporomandibular joint (TMJ) pain, mouth opening limitation, asymmetric movements of the mandible, pre-auricular and/or masticatory muscle soreness, and joint noises(clicks or crepitus) , 11. TMDIn addition, some patients with TMD show ear-related signs and symptoms. Otologic signs and symptoms are less common but have been reported as common TMD signs and symptoms over the last few decades . These sSome studies have shown that patients with otologic symptoms such as otalgia, dizziness, tinnitus, and ear fullness experience significant or complete improvement after treatment of TMD (17–19). On the other hand, other studies have shown that treatment of TMD is not always effective, and its effect in alleviating otologic symptoms has not been proven , 29. In Patients with complaints of earache, tinnitus, hearing loss, and dizziness were referred from an ear fellow to the Department of Orofacial Pain with the possible diagnosis of TMD from January 2021 to January 2022. The Kerman University of Medical Sciences ethics board approved the study, and informed consent was obtained from all the participants. Physical examinations included otolaryngology examinations, cranial nerve examination, stomatognathic examination, and audiometry, MRI and ECG were done in some patients. Patients who had associated systemic diseases with vertigo (like anemia and thyroid issues), as well as patients with earache due to referred pain from the neck and laryngeal masses, were excluded from the study.If the otolaryngologist did not identify any cause of the otologic symptoms except TMD, the patient was introduced to the Department of Orofacial Pain. Patients who had not received any treatment for TMD by the interview were included in this study. Exclusion criteria were patients who were not compliant with TMD treatment protocol or who did not complete the course of treatment and patients with neurological or cognitive disorders.Before the interviews and clinical examinations, the patients were asked to complete the following questionnaires:Brief Pain Inventory (BPI-P) .Patient Health Questionaire-9 (PHQ-9) .Anxiety Generalized Disorder-7 (GAD-7) .After completing the questionnaires and gathering the demographic information, including age, marital status, levels of education, medical and medication history, the characteristics of the otologic symptoms, the severity of earache according to the Visual Analog Scale (VAS) , and hisThe history of pain included time of onset of pain, previous history of pain, duration and number of pain episodes, pain quality, pain-aggravating and relieving factors, location of pain, spreading patterns of pain, and previous treatments. Based on the Oral Behaviors Checklist (OBC) , a histoTenderness on palpation of the head and neck muscles, including temporalis, masseter , medial pterygoid, splenius capitis, sternocleidomastoid, and trapezius as well as the temporomandibular joint, were assessed. The compression technique of the latent trigger points in the muscles was performed by pressing index finger using a constant, calibrated pressure of 0.5-1 kg/cm2 on the trigger points for at least 2 s. The temporalis muscle was examined at 3 points .Pain severity and spreading pattern of pain were recorded. Patients were also evaluated for oral health, dental caries, periodontal disease, tooth wear, abfraction, tooth chipping, cheek ridging, and tongue scalloping. Diagnosis of TMD was based on RDC / TMD (research diagnostic criteria for TMD) Fig.  36]..36].All patients received standard treatment protocol instructions, including a soft diet, stretching exercises, moist heat and ice pack, correcting neck posture, and eliminating parafunctional habits.Full coverage stabilizing mandibular night guard was fabricated for patients with parafunctional habits and delivered after two weeks. We ask the patients to abandon unhealthy habits like chewing gum and keep stretching exercises during their follow-up period.Sleep hygiene tips and proper medication were considered in patients with sleep deprivation or insomnia. Patients were also instructed to do breathing exercises to relieve the stress and tension.Two weeks after treatment initiation (including physiotherapy and medication), the patients were asked about the changes in their otologic, and other symptoms attributed to TMD using VAS.They were also asked to determine the cure rate of the ear symptoms according to the following options: (1) Complete cure, (2) Significant improvement, (3) Relative improvement, (4) No improvement. The patients were also asked to determine the rate of improvement for each otologic symptom. VAS was also used for earache symptoms.SPSS 26 program was used for data analysis. First, a descriptive statistic on demographic variables, type of otologic symptoms, and type of treatment of TMD was obtained. Then, Paired T-test was used to determine the rate of improvement over time. A significant value was considered < 0.05.In this study, 42 patients were referred from the Department of Otorhinolaryngology to the Department of Oral Medicine and Orofacial Pain. After performing a comprehensive examination to evaluate the temporomandibular joint disorders, 2 patients with the diagnosis of trigeminal neuralgia were excluded based on the exclusion criteria. Finally, 40 patients diagnosed with TMD associated with otologic symptoms were treated. Thirty-five (87.5%) women and five (12.5%) men participated in this study. The mean age of the subjects was 37.16 (SD = 67 13.67).The prevalence of otologic symptoms is shown in Table Signs and symptoms of TMD during patient examinations included capsulitis, jaw click, reduced mouth opening, jaw deviation, myofascial pain, and myalgia in the masticatory muscles Table .On examinations of the masticatory muscles, neck muscles, and TMJ, the most imitated otologic symptom in TMD examinations was earache, which was imitated when touching the TMJ, masticatory muscles  and neck muscles (sternocleidomastoid and splenius capitis). Tinnitus was also imitated when touching the TMJ, the splenius capitis muscle, the superficial masseter, and sternocleidomastoid muscles.Patients described the rate of improvement of each of the otologic symptoms at 2 weeks and 2 months’ follow-up. We have reported the results as follows: In the form of complete recovery, significant improvement, low recovery, and no improvement, as shown in Fig. According to the BPI questionnaire in the first session, the mean pain intensity was 3.98 out of 10 (SD = 48 2.48), and the mean pain interference with the function was 3.78 out of 10 (SD = 50 2.50). According to the VAS index, the mean pain intensity of patients was initially 45 mm (SD = 0.06 33.06). In the follow-up session, the mean pain intensity was 24.5 mm (SD = 0.01 28.01), which indicated a significant reduction after 2 weeks (p = 0.0001). Also, based on the VAS index the mean of the most severe and lowest pain in the last 5 days and the interference of pain with jaw movements reduced significantly (p = 0.0001).The GAD and PHQ questionnaires were completed only in the first session. The mean and standard deviation of the GAD and PHO questionnaire were 9.07 (SD = 94 5.94) and 7.94 (SD = 0.2 7.28) showing that most patients had mild anxiety and depression. The results of the mental status assessment based on the VAS index showed improvement in mental status in the follow-up session (P = 0.0001). Twenty-seven (69.2%) patients were sleep-deprived, making it difficult to fall asleep, stay asleep, or both. An assessment of the patient’s sleep quality after 2 weeks based on the VAS index shows an improvement in sleep quality (p = 0.0001).The present prospective clinical study was conducted to examine TMD treatment’s effect on improving otologic signs and symptoms in patients with TMD. In this study, out of 42 patients who were referred from the ENT department to the Department of Oral Medicine and Orofacial Pain, 17 patients (42.5%) only complained of otologic symptoms.Numerous studies have been conducted to investigate the association between the prevalence of otologic symptoms and TMD, some of which have found a strong association between the severity of TMD and earache. Patients with moderate to severe TMD often report earache –39. AccoStudies have reported a strong association between TMD and parafunctional habits, including teeth grinding and clenching during sleep with ear symptoms , 47. ParSome studies have shown the relationship between TMD and neck problems due to the relationship between the structure of the mouth and face and the movement of the neck vertebrae and the presence of more trigger points in the neck and shoulders of people with TMD than the general population , 50. StuWe found that in 16 patients (40%), palpation of splenius capitis and sternocleidomastoid muscles mimicked the otologic symptoms. It is interesting to note that head and body posture play a significant role in developing TMD problems. This is because long-term changes in cranio-cervical position lead to changes in the mandible through mechanical, biomechanical, and neuromuscular mechanisms , 51. ConIn this study, 27 patients (67.5%) had inappropriate head and neck positions due to wrong working habits, incorrect positions while studying and using mobile phones, carrying mobile phones in bed, and similar habits. Patients were instructed to correct these habits. In addition, in patients who complained of neck pain or whose neck muscles were painful on palpation and mimicked the patient’s ear symptoms, stretching exercises were performed to deactivate the trigger points of these muscles. Although neck pain was not the main complaint in several patients, palpation of the neck muscles mimicked their otologic symptoms.Numerous studies in different populations have shown that some types of headaches, including migraines and tension headaches, are more common in TMD patients –55. SomeAlthough in the present study, headache was the main complaint in only 8 patients (20%), historically, other patients also had experienced headaches such as migraines, headaches attributed to, and Medication overuse headaches (MOH). Patients’ headaches have been replicated by palpation of the muscles such as temporalis and sometimes SCM. Some researchers have suggested a link between the onset of a headache and the stimulation of trigger points in the neck on the same side of the headache , 61. In Chronic pain is strongly associated with sleep disorders, both qualitatively and quantitatively. Sleep disorders inactivate analgesic chemical systems and mediators  and neutralize inflammatory chemical mediators such as Nitric oxide (NO) and adenosine signaling . In thisPatients with ear symptoms for whom an otolaryngologist cannot determine the specific cause of the symptoms, require a thorough and standard examination to assess the likelihood of TMD as a cause of their symptoms. Anatomical proximity between the TMJ and ear structure, Eustachian tube dysfunction, common embryonic origin, and neuromuscular and neurovascular communication may explain this association. Referral neck pain can also have otologic manifestations even in patients whose neck pain is not one of their main complaints. Therefore, paying attention to myofascial neck pain in patients with unexplained otologic symptoms is important as well. TMD treatments and muscle stretch exercises are effective in completely or partially improvement of unknown otologic signs and symptoms. In addition, due to the limited number of studies on the effect of TMD treatment on otologic symptoms, further studies in this area with appropriate methodology are needed.Many TMD patients with otologic symptoms usually consult with an otolaryngologist but unfortunately mostly receive inappropriate treatment. TMD has multiple etiologies, including muscular, joint, psychological, neurological, and traumatic problems. Accordingly, the treatment also requires a team of specialists such as orofacial pain specialists, psychiatrists, and physiotherapists. As a result, proper conservative treatment of TMD patients with otologic symptoms and timely referral to orofacial pain specialists will prevent confusion, long-term irritation, and chronic problems.During this study, we had to alter our planned data collection and follow-up period because of the COVID-19 pandemic. The number of patients studied in this investigation was limited, and a larger sample size is needed to better assess the effects of TMD treatment on otologic symptoms and draw more accurate conclusions. On the other hand, longer patient follow-up is recommended to assess the stability of alleviation of ear symptoms in TMD patients.