Patients with metastatic spinal disease are affected by disabling pain. The treatment of spinal metastases is focused on pain reduction and improvement in quality of life. Until recently, many patients with metastatic spinal disease did not qualify as surgical candidates due to the risks of surgery and length of recovery period. However, recent advances in minimally invasive surgery such as kyphoplasty and vertebroplasty allow patients to safely undergo surgery for pain relief with a short recovery period.The studies reviewed here suggest that vertebral augmentation is successful in reducing pain and disability scores in patients with painful metastases and multiple myeloma and are a safe modality to provide lasting pain relief. As the use of kyphoplasty and vertebroplasty for treatment of vertebral metastases is becoming more common, new combinations of cement augmentation with other techniques such as percutaneous pedicle screws and radiofrequency ablation are being explored. The implementation of kyphoplasty and vertebroplasty, in conjunction with other minimally invasive surgical techniques as well as nonsurgical modalities, may lead to the best palliative management of cancer patients with spinal metastases and help them ultimately achieve a better quality of life. Pain from the invasion of cancer into the spinal column is a key detriment to the quality of life of cancer patients. Treatment is focused on pain reduction and quality of life rather than curing the disease process. Multimodal and multidisciplinary treatment is necessary in these patients and includes radiation, medical management, and a variety of operative measures.While medical treatment may be effective in managing pain for some patients, mechanical pain due to pathological fractures may require surgical intervention. Traditionally, neurological symptoms have been treated by decompression of the spinal cord with a laminectomy. However, many patients with spinal tumors are at a higher risk of complications with open surgery . Recent Here we provide a brief review of the pathophysiology and clinical symptoms of vertebral tumors along with diagnostic and nonsurgical treatment strategies. We then review percutaneous surgical treatment with an emphasis on the efficacy and safety of vertebroplasty and kyphoplasty.The metastatic neoplasms that most commonly present with spinal cord compression are breast (in 22% of patients with breast cancer), lung (15% of patients with lung cancer), and prostate (10% of patients with prostate cancer) .Several theories exist regarding the pathogenesis of vertebral metastases. The 1940 Batson study on cadavers suggested cancer cells are pushed into a valveless venous plexus from the chest and pelvis during periods of increased intra-abdominal pressure. The low-pressure venous system and repeated reversal of flow likely allow for cancer cells to be lodged in the vertebral bodies . Tumors While metastases are the most common form of cancer in the spine, multiple myeloma is the most common primary tumor to invade the vertebrae. While multiple myeloma is a “primary” neoplasm in the sense that it begins in the bone marrow, it is derived from plasma cells rather than osteocytes like many of the other bony primary cancers.Multiple myeloma patients are especially at risk for pathological fractures due to the combination of local invasion of malignant myeloid cells and the cytokine-mediated activation of osteoclasts that causes an increase in bone resorption . In thesThe most common symptom at the time of diagnosis is severe pain, which usually precedes the onset of neurologic dysfunction by a median time of seven weeks -12. The Local pain occurs at the site of the metastasis, is severe and progressive in quality , and is Mechanical or axial pain typically appears later than local pain and can occur secondary to vertebral instability and compression of the spinal cord. This pain is described as sharp and stabbing , is exacAfter pain, the second most common symptom of metastatic spinal disease is neurologic dysfunction secondary to spinal cord compression. Sixty percent to 85% of patients have corticospinal dysfunction, presenting with upper motor neuron disease. Loss of sensation occurs along with (or soon after) the onset of weakness . PatientSimilarly, multiple myeloma patients experience pain secondary to invasion of the periosteum which causes local pain and weakening of the vertebral body. The multiplicity of pain sites due to the diffuse involvement of numerous vertebrae is the rule with multiple myeloma.X-ray is typically the first imaging modality used for patients with vertebral metastases. Plain anteroposterior and lateral radiographs may reveal asymmetry with areas of radiolucency or opacity, depending on the type of lesion present. The classic “winking owl sign” can be seen on anteroposterior plain films due to a missing pedicle, but requires significant bone destruction to be visible. When an abnormality is present on an x-ray, computed tomography (CT) is recommended to visualize the bone abnormalities at higher resolutions .While x-ray and CT are important in assessing bone involvement, magnetic resonance imaging (MRI) with gadolinium enhancement is the gold standard imaging modality for suspected spinal metastases. MRI has a high sensitivity for tumors using sagittal T1 or short T1 inversion recovery. T2 sagittal and axial T1 or T2 are useful in detecting soft tissue involvement and determining the degree of spinal cord compression . MoreoveThere are several nonsurgical methods for managing spinal pain in cancer patients. The 1997 World Health Organization (WHO) pain ladder remains the standard for the medical management of pain. Patients are categorized as having mild to moderate or moderate to severe pain and are treated with the corresponding medications. Mild pain is managed with nonopioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, while moderate pain is managed with weak opioids such as dihydrocodone or tramadol. NSAIDs may be added at any level on the analgesic ladder. Oral morphine is the drug of choice for treating the severe pain experienced by patients with metastatic spinal lesions -17. PatiTreatment of pain following the WHO guidelines is successful in reducing pain by 70% to 80% . Local nCorticosteroids can also reduce pain in patients with spinal metastases by inhibiting prostaglandin synthesis and decreasing vascular permeability. Pain is abated by reducing edema in the surrounding tissue, which prevents the compression of pain-producing structures . DexametRadiotherapy can also be used to decrease pain from spinal metastases, especially in conjunction with surgery. Radiotherapy has become the standard of treatment of patients with multiple metastatic lesions who are not surgical candidates due to poor prognosis and severe comorbidities. However, recent advances in percutaneous surgery indicate the benefits of these procedures may outweigh the risks .In a prospective study of metastatic cancer pain treated with radiation therapy, 49% of patients experienced complete pain relief while 51% had a >50% reduction in pain . While hManagement of axial pain is similar for multiple myeloma in that the WHO guidelines are used to manage pain medically. The most commonly used treatment of multiple myeloma is chemotherapy, while the definitive treatment requires autologous hematopoietic stem cell transplant .Medical treatments may help significantly with local pain; however, they do not address mechanical spinal pain caused by vertebral collapse and deformity . SurgicaKyphoplasty and vertebroplasty are both effective in relieving axial pain, but no consensus has been made on when to implement one over the other . While tVertebroplasty and kyphoplasty have traditionally been performed in the lumbar and lower thoracic spine, using a transpedicular approach as shown in Figure The upper thoracic spine also proves to be difficult for kyphoplasty due to the small pedicles. An extra-pedicular approach has been developed for upper thoracic spinal metastases, which involves inserting the needle into a plane between the proximal rib and transverse process at the lateral wall of the pedicle, and then traversing the needle through the transverse process, costotransverse joint, and rib to access the vertebral body. This requires extensive expertise and skill to implement successfully and may have a higher risk of complications. A recent study of kyphoplasty using an extra-pedicular approach in 14 patients with metastatic disease of the upper thoracic spine showed significant improvements in mean visual analogue scale (VAS) scores from 79 preoperatively to 30 postoperatively (p < .001), and mean Oswestry disability index (ODI) scores from 83 preoperatively to 33 postoperatively .Fourney, et al.  studied The Cancer Patient Fracture Evaluation (CAFÉ) trial by Berenson, et al.  was the Assessment after one month showed statistically significant improvements in physical function, back pain, and quality of life in the kyphoplasty group; the effects were not statistically significant for the nonsurgical treatment group. The mean Roland Morris disability questionnaire (RDQ) treatment effect for kyphoplasty was statistically significant Table . Mean KaThis trial was the first randomized controlled trial to assess the efficacy of kyphoplasty in patients with painful spinal metastases. Although randomization was only sustained for follow-up at one month, results suggest that kyphoplasty is an effective palliative care strategy for patients with painful spinal metastases, improving quality of life, functional status, and back pain.Markmiller  recentlyRecently, studies on percutaneous vertebral augmentation for multiple myeloma have emerged. While both metastatic tumors and multiple myeloma invade the vertebral bodies, the pathophysiology of multiple myeloma is drastically different, as previously described. It is important to investigate whether patients with multiple myeloma can benefit from kyphoplasty and vertebroplasty with as much success. McDonald, et al.  measuredIn a study comparing unilateral versus bilateral kyphoplasty in multiple myeloma patients, patients who received either form of kyphoplasty experienced improvement in pain scores. VAS scores improved from baseline by 30% . There was, however, no significant difference in reduction of mean VAS scores between unilateral and bilateral vertebroplasty. The results of this uniform cancer population refute previous notions that bilateral kyphoplasty is more effective in pain resolution than a unilateral approach. The authors recommend the use of unilateral kyphoplasty whenever feasible to reduce operation time and risks of surgery, especially because patients with multiple myeloma often require cement augmentation on multiple levels .There is no consensus in the literature on the maximum number of adjacent levels that can be treated in one session. A study compared the biomechanics of multilevel polymethylmethacrylate (PMMA) vertebral augmentation in cadavers . Zero, oThe main concern with kyphoplasty and vertebroplasty is the potential for PMMA cement leakage. Possible but seldom seen complications secondary to cement leakage include spinal cord compression, radiculopathy, and pulmonary embolism. One-third of patients in Markmiller, et al. experienced cement leakage; however, only three 2.6%) were symptomatic with resolution after three months . In Four.6% were Although symptomatic cement extrusion is uncommon, there are several strategies to prevent leakage. Fourney, et al. suggest that their low leak rate may be due to dedicated time for sufficient thickening of the cement before injecting into the vertebral body. Another strategy is to use smaller amounts of PMMA cement .In McDonald, et al. , 13 of 6In patients with involvement of the pedicle and posterior elements, cement augmentation may not be adequate treatment. Moreover, open resection, decompression, and fusion can be morbid secondary to steep recovery in late-stage cancer patients. In patients who require additional stabilization but cannot tolerate open surgery, percutaneous pedicle screw fixation may be considered. In a study by Chi, et al. in 2013 , 16 patiZairi, et al.  studied One concern of pedicle fixation is the risk of screw pullout due to the poor bone quality and lack of strong purchase of the pedicle screws in the bone. Moussazadeh, et al.  combinedGu, et al.  demonstrExperimental use of PMMA cement mixed with chemotherapeutic agents is currently being studied. Rosa, et al.  showed tRecently, the application of radiofrequency ablation (RFA) has been used in tumors that are unresectable and not responsive to radiation therapy. The affected vertebral body is percutaneously accessed, and a high-frequency alternating current is sent to cause thermally-induced necrosis of the tumor. The pathophysiology of pain relief caused by RFA is unclear. One explanation is that it reduces pain by destroying nociceptors as well as reducing the tumor burden . GevargeRFA treatment of tumors within the vertebral body may cause instability if done alone. In a cadaveric study comparing RFA and vertebroplasty with RFA alone, RFA was shown to decrease mechanical stability and increase the risk of subsequent burst fractures . CombiniSeparation surgery, as described by Bilsky and Smith , is a teTatsui, et al.  recentlyIn another study, Tatsui, et al.  reportedThe study demonstrates that SLITT can be performed safely to relieve epidural spinal cord compression with low morbidity in select patients, namely those with radioresistant tumors, and allows for the prompt resumption of adjunct therapy. Like other minimally invasive techniques, this offers a viable alternative for patients who are not candidates for open surgery.In addition, SLITT can be combined with percutaneous instrumentation in patients who require immediate stabilization . A pilotPatients with painful vertebral metastases and multiple myeloma of the spine must be treated with multiple modalities in a multidisciplinary fashion including but not limited to radiation and medical management. Percutaneous surgical techniques are minimally invasive with high efficacy and a low rate of complications. The studies reviewed here suggest that kyphoplasty and vertebroplasty are successful in reducing pain and disability scores in patients with painful metastases and multiple myeloma. The main concern of these techniques is the extrusion of cement, which has rarely caused lasting neurological symptoms. While kyphoplasty has been implemented traditionally in the lower thoracic and lumbar spine where a trans-pedicular approach can be made, modified techniques to access the vertebral bodies in the upper thoracic spine and cervical spine may allow more patients to benefit from kyphoplasty and vertebroplasty.Implementation of kyphoplasty and vertebroplasty in conjunction with other minimally invasive techniques as well as nonsurgical modalities may lead to the best palliative management of cancer patients with spinal metastases and help them ultimately achieve a better quality of life.


A cohort of pediatric patients with AML treated at hospitals contributing to the Pediatric Health Information System was used to evaluate differences in opioid utilization by sex, age, race, and insurance.Billing data were used to compute the prevalence of opioid exposure and to quantify rates of utilization among those exposed to opioids as days of use per 1000 inpatient days. Multivariable regressions were used to compare opioid prevalence, and rates of utilization among those exposed.On average across courses, 95.2% of patients were exposed to analgesics, 84.7% were exposed to non-opioid analgesics and 77.7% were exposed to opioids. The proportion of opioid-exposed patients increased with age, but did not differ by gender, race, or insurance status. Analyses limited to patients exposed to opioids revealed modest differences in days of opioid use among female patients (adjusted rate ratio (aRR) = 1.19, 95% CI: 1.11, 1.28), patients <1 year  or ≥10 years of age , whereas Asian patients received fewer days of opioids compared with white patients . There was moderate hospital-level variability in both the prevalence of opioid utilization overall and preference for specific opioid medications. There was greater inconsistency in practice concerning choices for supplemental and alternative opioids than in first-line opioid utilization.Additional work is needed to discern whether observed differences in opioid utilization by age and race reflect a difference in treatment or a difference in the experience of pain. Future studies should also explore the factors which guide decisions on opioid selections in an attempt to explain the variability across institutions. Pain is the most common symptom experienced by pediatric patients with cancer , 2. PainOpioids are recognized by WHO as essential for treatment of moderate-to-severe pain in children and are the mainstay of oncology pain management . While 7Differences in opioid prescribing by patient race and socioeconomic status have been reported for a variety of diagnoses among adult and pediatric patients in emergency department and ambulatory care settings with a majority of studies finding non-white patients and uninsured patients less likely to receive opioids –25. StudObjectives of the current study were to describe overall trends in opioid utilization among a homogeneous population of pediatric patients undergoing standard chemotherapy treatment for newly diagnosed acute myeloid leukemia and to evaluate whether differences in opioid utilization exist with respect to sex, age, race, or insurance status. Hospital-level variation in opioid utilization was also assessed.The Pediatric Health Information System (PHIS) is an administrative database that contains inpatient, emergency department, ambulatory surgery, and observation unit information from over 40 not-for-profit, tertiary care pediatric hospitals representing 17 large metropolitan areas in the United States . Data inThe current study population was derived from a cohort of children receiving chemotherapy for new onset AML assembled from PHIS data using a previously described and validated process . BrieflyCourse-specific follow-up began on the first inpatient day of systemic chemotherapy and continued until the earliest of death, start of the next chemotherapy course, or 30 days (Inductions I and II), 35 days (Intensifications I and II) or 40 days (Intensification III) after commencement of that chemotherapy course. Course-specific follow-up periods were based on experience regarding expected time to absolute neutrophil count recovery.The primary outcome of interest was opioid exposure. Opioids included morphine, fentanyl, oxycodone, hydromorphone, meperidine, methadone, codeine, alfentanil, remifentanil, nalbuphine, butorphanol, sufentanil, levorphanol, oxymorphone, and pentazocine. We first evaluated the occurrence of opioid exposure , overall  and for specific agents, during the course-specific follow-up periods. Then, we assessed the rates of utilization among the subset of patients receiving opioids. To compute the rates of utilization among those exposed, binary indicator variables were created for each agent to designate exposure on each inpatient day which were summed to obtain the total number of days exposed. Opioid utilization rates were reported as the number of days of use per 1000 inpatient days. Information on the utilization of non-opioid analgesics  was also similarly summarized. Given that the chemotherapy regimens utilized in frontline treatment for AML in pediatric patients in the United States are not associated with neuropathy, adjuvant pain medications are generally not utilized and are therefore not included in this analysis. Of note, PHIS data do not include information on medication dosage or frequency and does not include non-pharmacological treatments for pain.Patient characteristics including gender, race as recorded by the treating institution , age , insurance status at the start of each course as recorded by the treating institution , and diagnosis year were ascertained from PHIS.ICU-level care was captured at each course as a marker for patients with a more severe clinical status and potentially higher pain intensity. ICU-level care was defined by the occurrence of specific ICD-9-CM procedure codes or clinical resources considered a priori as a marker of ICU care, rather than by physical location . The preDistributions of patient demographic and clinical characteristics were tabulated by course and compared across courses using chi-square tests. Opioid exposure prevalence, overall and for specific agents, was computed for each course. Trends in opioid exposure prevalence over time were evaluated using chi-square tests. Daily prevalence estimates for specific opioids were plotted to illustrate trends in utilization over each chemotherapy course. Multivariable log-binomial regression models were used to estimate adjusted prevalence ratios (aPR) and corresponding 95% confidence intervals (CI) comparing the prevalence of analgesic use overall, and separately for opioid use and non-opioid use, by covariates defined above. Among those exposed to the class, multivariable Poisson regression models with inpatient days as offset were used to estimate adjusted rate ratios (aRR) and 95% CI comparing opioid utilization rates. Robust variance estimates were obtained using generalized estimating equation methods with an exchangeable correlation matrix to account for intra-individual correlation between course-specific observations. Fully adjusted models included all demographic and clinical factors examined. Patients with missing covariate information were excluded from analyses.R) were used to identify associations between the two hospital-level opioid utilization variables and their association with the total number of AML cases contributed per year.Plots of hospital-specific opioid prevalence and rates of use among those exposed as well as a plot of the proportion of hospitals reporting each specific opioid were generated to assess variability in practice. Pearson correlations .This study was deemed by the Institutional Review Board of the Children’s Hospital of Philadelphia to not constitute human subjects research.The initial PHIS cohort included 1,695 patients with newly diagnosed AML treated at 42 institutions across the United States. Of these, approximately 94%  met inclusion criteria for at least one course and in total contributed 4,902 chemotherapy courses .Distributions of patient characteristics by chemotherapy course are presented in Overall, 95.2% of courses were exposed to analgesics, 84.7% were exposed to non-opioid analgesics (mainly acetaminophen) and 77.7% were exposed to opioids. Intravenous (68.8%) opioid administration was more common than oral administration (44.5%) . The patOverall there was a temporal trend toward reduced opioid utilization with 88.9% of courses exposed in 2000–2001 and 73.9% of courses exposed in 2012–2014 (p = 0.041) and corresponding increase in non-opioid utilization . The decline in opioids was primarily driven by significant declines in codeine  and meperidine utilization .Comparisons of the rates of opioid use among those exposed  revealedRates of non-opioid utilization among those exposed increased with age (p<0.001). Otherwise, trend in the rates of utilization paralleled those observed for the overall prevalence of non-opioid use.R = 0.661, p<0.001). Additionally, higher total number of AML diagnoses per year was moderately correlated with both higher hospital-level opioid prevalence  and higher average rate of utilization among those exposed . There was no significant correlation between hospital-level opioid and non-opioid utilization with respect to prevalence (p = 0.174) or averages number of inpatient days of use (0.077).Across hospitals, there was moderate variability in the proportion of courses exposed to opioids  as well as the average rate of utilization among opioid-exposed patients  , Panel aThere was also variability across hospitals in the use of specific opioids , Panel bOur study found that the likelihood of opioid exposure among pediatric patients with newly diagnosed AML varied by treatment course and consistently differed by age. Among those exposed to opioids, there were only modest differences in the total number of days of use by gender and race. In addition, we observed moderate hospital-level variability in both opioid utilization overall and preference for specific opioid medications. There was greater inconsistency in practice concerning choices for supplemental and alternative opioids than in first-line opioid utilization. Together these findings provide some reassurance that large disparities in pain control in pediatric AML patients are unlikely.Opioid utilization was highest in Induction I and Intensification II which likely reflects higher patient acuity at diagnosis, additional invasive diagnostic evaluations, and greater treatment-related complications in those courses, an explanation supported by the parallel increase in ICU-level care and TPN utilization. Patterns of daily inpatient utilization of specific opioids observed in the current study are consistent with expectations based on guidelines for use in practice, thus highlighting the overall validity of the data resource. In particular, the bimodal distribution of morphine and the single peak of fentanyl at the start of a chemotherapy course reflect their predominant uses as first-line pain management and procedural pain control, respectively. Patterns of use observed for other specific opioids accurately correspond to their use as supplemental pain management or as alternative treatment in patients who experience morphine-related adverse effects.Observed differences in opioid utilization by age and Asian race are comparable to prior reports. One previous study using a general population of pediatric inpatients reported that opioid exposure was lowest among infants and increased with age but once exposed infants experience a longer duration of use . Others Our finding that opioid-exposed female patients experienced more days of opioids compared to males, though small, is also consistent with others who reported higher sensitivity to both clinically and experimentally induced pain, higher pain scores, and greater temporal summation of pain in females , 33–36. In contrast to other studies on opioid prescribing for a variety of diagnoses in emergency department and ambulatory care settings –25particWe found that higher hospital volume of AML diagnoses correlated with both higher hospital-level opioid prevalence and longer average duration of use among exposed patients. A higher volume of AML diagnoses may be a proxy for greater experience in its treatment, thus differences clinical experience may be a contributing factor to the observed institutional variation in opioid utilization.Our analyses were performed using a large nationally representative cohort of pediatric AML patients, which enhances the generalizability of our results. Also, unlike most previous evaluations of opioid use in hospitalized pediatric populations which include a combination of diagnoses, our study population was restricted to a homogeneous cohort of newly diagnosed AML patients receiving the same standard chemotherapy treatment. In the absence of this restriction, any heterogeneity in the associations between patient factors and opioid use across diagnoses would be obscured with results reflecting the associations for the most common diagnoses.Our results should be considered in light of potential limitations. First, PHIS does not include medication dosage or frequency data thus precluding the evaluation of these factors. As such, it is possible that the observed center-level variability may reflect differences in institutional prescribing trends. For example, an institution that administers opioids daily could be administering less total opioid than a center which uses continuous dosing but on fewer days. PHIS does not capture results of pain assessments thus we have no information on the levels of either pain or pain relief. We also lack data on the exact indication prompting utilization of pharmacologic agents and non-pharmacologic strategies employed to relieve pain. Therefore, we cannot differentiate whether observed differences in opioid utilization between patients reflect differences in pain assessment, pain management, or the severity of pain experienced. Likewise, the lack of an observable difference in opioid use between some compared groups may not reflect equivalent adequacy of pain management particularly if there are differences in acuity which we did not have the ability to directly measure. We attempted to adjust for differences in severity of pain using ICU-level care and TPN requirements as a crude proxy to identify patients with more severe pain. However, observed differences in opioid use were not explained by differences in TPN or ICU utilization. Lastly, these results only reflect trends in inpatient opioid utilization and may not extend to trends in outpatient analgesia.In summary, these data suggest that patient-level and hospital-level variability exists in the utilization of opioids during the treatment of pediatric AML. The limitations of our data resource prevent definitive conclusions regarding the reason for such differences, but suggest areas for further research. Namely, additional work is needed to identify the specific mechanisms leading to these differences and to address ways to overcome treatment barriers and mitigate disparities in pain management, if such inequities exist. Future studies should focus on identifying the factors which guide decisions on opioid selections in an attempt to explain the wide variability across institutions. Research efforts aimed at refining pain prevention and developing best practices and clinical guidelines for optimal pain assessments and treatment are necessary to maximize standardization in pain management in pediatric AML.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.S3 Table(DOCX)Click here for additional data file.S1 FigAbbreviations: PHIS = Pediatric Health Information System database; AML = acute myeloid leukemia, pt = patients.(DOCX)Click here for additional data file.S2 FigPatterns of daily inpatient utilization of specific opioids over (a) Induction II, (b) Intensification I, (c) Intensification II, (d) Intensification III.(DOCX)Click here for additional data file.


Musculoskeletal pain is a common reason for emergency department (ED) visits. Following discharge from the ED, patients, particularly older patients, often have difficulty controlling their pain and managing analgesic side effects. We conducted a pilot study of an educational video about pain management with and without follow-up telephone support for older adults presenting to the ED with musculoskeletal pain.ED patients aged 50 years and older with musculoskeletal pain were randomized to: (1) usual care, (2) a brief educational video only, or (3) a brief educational video plus a protocol-guided follow-up telephone call from a physician 48–72 hours after discharge (telecare). The primary outcome was the change from the average pain severity before the ED visit to the average pain severity during the past week assessed one month after the ED visit. Pain was assessed using a 0–10 numerical rating scale.Of 75 patients randomized (mean age 64 years), 57 (76%) completed follow up at one month. Of the 18 patients lost to follow up, 12 (67%) had non-working phone numbers. Among patients randomized to the video (arms 2 and 3), 46/50 viewed the entire video; among the 25 patients randomized to the video plus telecare (arm 3), 23 were reached for telecare. Baseline pain scores for the usual care, video, and video plus telecare groups were 7.3, 7.1, and 7.5. At one month, pain scores were 5.8, 4.9, and 4.5, corresponding to average decreases in pain of -1.5, -2.2, and -3.0, respectively. In the pairwise comparison between intervention groups, the video plus telecare group had a 1.7-point  greater decrease in pain compared to usual care, and the video group had a 1.1-point  greater decrease in pain compared to usual care after adjustment for baseline pain, age, and gender. At one month, clinically important differences were also observed between the video plus telecare and usual care groups for analgesic side effects, ongoing opioid use, and physical function.Results of this pilot trial suggest the potential value of an educational video plus telecare to improve outcomes for older adults presenting to the ED with musculoskeletal pain. Changes to the protocol are identified to increase retention for assessment of outcomes.NCT02438384. Registered on 5 May 2015.ClinicalTrials.gov, The online version of this article (doi:10.1186/s13063-017-2403-8) contains supplementary material, which is available to authorized users. Acute musculoskeletal pain is one of the most common reasons for emergency department (ED) visits by older adults –3. AcuteRecognizing these concerns, emergency providers have the opportunity to improve outcomes for older adults with musculoskeletal pain by optimizing early outpatient treatment. Because most of these patients will make decisions regarding use, dosing, and discontinuation of medications without immediate access to a medical provider, patient self-management education is critical to achieving this goal. Given the risks of analgesics in older adults, behaviors that promote recovery, such as physical activity, sleep, and relaxation, are also likely to be valuable. In patients with chronic pain conditions such as arthritis, pain self-management education reduces pain and disability , 11. SucThe purpose of this pilot study was twofold: (1) assess the feasibility of a clinical trial to test an educational video and pain management telecare intervention for older ED patients with acute musculoskeletal pain and (2) obtain preliminary estimates of the effect of the video plus telecare vs. usual care and of the video alone vs. usual care on pain symptoms and other outcomes over the first month.We conducted a pilot randomized controlled trial of patients aged 50 years and older presenting to an academic ED in Southeastern USA with a chief complaint of musculoskeletal pain. The trial was registered at ClinicalTrials.gov (NCT02438384), and abides by Consolidated Standards of Reporting Trials guidelines. The study was approved by the site’s institutional review board. Recruitment took place during a period of 11 months between August 2015 and March 2017. Recruitment was interrupted for a total of 7 months during the winters of 2015 and 2016 and the summer of 2016 due to limited availability of research assistants (RAs). Screening and signed informed consent were completed by trained RAs. Patients, stratified by age (50–64 or ≥65 years), were randomized into one of three groups (described subsequently) using computer-generated, sequentially numbered opaque envelopes; randomization occurred following completion of baseline data collection. Patients were followed for 30 days.RAs approached all English-speaking patients aged 50 years and older presenting to the ED with musculoskeletal pain. RAs monitored the ED track board for chief complaints suggesting musculoskeletal pain . We excluded patients complaining of head, chest, or abdominal pain and patients with pain suspected to be due to infection, ischemia, or another non-musculoskeletal problem, such as a kidney stone. If RAs were unsure if the patient’s pain was musculoskeletal in nature, input was requested from the attending physician before approaching the patient. Patients were also excluded if they were a prisoner or on a psychiatric hold, were critically ill (Emergency Severity Index score of 1), or had moderate or severe cognitive impairment (Six-Item Screener score of 3 or less) .During baseline interviews, RAs obtained information on patient demographics, contact information, health and physical function, and pain characteristics. Health was assessed using a self-reported general health measure , number Follow-up assessments occurred at 1 month after the ED visit, or for patients who were admitted, 1 month after discharge from the hospital. Pain was reassessed by asking patients to rate their average pain over the past week using the same 0–10 scale. Capacity for physical function was reassessed at 1 month. Participants were also asked if they had received any prescriptions or medication recommendations upon discharge from the ED, the names of the medications, how long they took them, and if they experienced any side effects from the medications. Patients were also asked if they had “taken any other pain medications other than those prescribed or recommended to you in the ER one month ago?” Side effects were assessed by asking patients to affirm their experience of any of the following side effects commonly experienced by older adults discharged after an ED visit for musculoskeletal pain: fatigue, drowsiness, trouble sleeping, trouble thinking, dizziness, unsteadiness, nausea, vomiting, constipation, abdominal pain, black or bloody stool, trouble urinating, loss of appetite, itching, or shortness of breath . AdditioThe primary outcome was the change in average pain from the average pain prior to the ED visit to the average pain during the week prior to the one-month assessment. Negative values reflect decreased pain severity. We also report the percentage of patients with at least a 1-point decrease in pain during this time period; a 1-point decrease has been described as the minimal clinically important difference in chronic musculoskeletal pain .Participants were randomized to one of three intervention groups: (1) usual care, (2) viewing a brief interactive educational video in the ED, or (3) viewing the video and receiving a follow-up phone call from one of two study physicians who were not involved in the patient’s ED care. Patients in all three arms received prescriptions, recommendations for over-the-counter medications, and behaviors at the discretion of the ED provider without any restrictions imposed by the study.The development of the interventions was grounded in shared decision-making, a process in which both patients and providers contribute to the medical decisions. The outpatient treatment of musculoskeletal pain in older adults is an appropriate context for shared decision-making because (1) there are multiple possible treatment options; (2) there is uncertainty about the best approach; and (3) the optimal approach often depends on specific characteristics and values of the patient . Patient engagement in the decision process in the ED also makes sense because most patients are discharged, and many make decisions about which medications to take, when to take them, and what behaviors to pursue without input from a medical provider. The feasibility and value of shared decision-making in the ED is well-established , 23. FurWe developed a 13-minute educational video that presented information on the pharmacologic and non-pharmacologic management of musculoskeletal pain . The phaTelecare consisted of a phone call from an emergency physician 48–72 hours following discharge from the ED. For patients who were admitted to the hospital, this phone call occurred 48–72 hours after they were discharged from the hospital. During the phone call, the physician followed a standardized protocol that first determined whether the patient was likely to benefit from a conversation about pain management. Patients who reported experiencing a current pain rating of 4 or higher (indicating moderate or severe pain ), pain aSociodemographic and health characteristics are presented for patients in each of the three study arms. Intention-to-treat  and per-protocol analyses (participants who viewed the video to completion and received telecare follow up if randomized to receive those interventions) were performed. Change in average pain scores for each group was calculated. Changes in pain were then estimated with adjustment for age, gender, and baseline pain scores using the STATA command predxcat, which estimates values for each group using mean total sample values for variables used for adjustment. Pairwise differences in change in average pain between each of the three possible comparison pairs  were estimated along with 95% confidence intervals, adjusted for baseline pain, age, and gender. For the purpose of adjustment, baseline pain and age were treated as continuous variables. Process outcomes including analgesics prescribed or recommended by the emergency provider and opioid prescription by another provider after the ED visit are described. All analyses were performed using STATA 14.1 .n = 9), “in too much pain” (n = 4), and “too stressed/overwhelmed” (n = 3). Of the 77 consenting participants, two patients were discharged prior to randomization, leaving a final randomized sample of 75 patients and an enrollment rate of 7 patients per month.Of 138 patients screened for eligibility, 100 (72%) were eligible and 77 (77%) gave consent  and discharged from the ED following treatment for musculoskeletal pain (79%). Most patients (89%) reported moderate to severe pain (pain score ≥4) in the ED, and 60% received pain medication prior to the ED interview. The most common locations of pain were the leg (24 patients), back (19 patients), hip (15 patients), neck (6 patients), and arm (6 patients). Patient characteristics by study arm are presented in Table Of the 75 study participants, 57 (76%) were reached by phone 1 month following the ED visit to complete a follow-up assessment. Follow-up rates for the usual care, video only, and video plus telecare groups were 68%, 76%, and 84%, respectively. Of the 18 patients lost to follow up, 12 (67%) were due to phone numbers that were either disconnected or for which the phone rang but there was no response and no option for leaving a message. Excluding these patients, following the methods suggested by Sun et al. to call the number in the ED, would have produced a follow-up rate of 90% (57 patients out of 63), with rates for usual care, video only, and video plus telecare being 85%, 90%, and 95%, respectively.n = 12), pain affecting normal activities (n = 10), and pain affecting sleep (n = 9).Of the 50 patients that were randomized to receive the video, 46 (92%) completed the video. Of the 25 patients randomized to the video plus telecare group, 23 out of 25 patients were reached for the 48–72 hour follow-up call and 20 met criteria for a physician conversation. The most common criteria identifying patients at need for a physician conversation were a pain score of 4 or more , an ideal trial would only include discharged patients. However, the optimal time during the ED visit to enroll patients in a study and show them a video is while they are waiting for the results of tests and a decision on their disposition, not after they have been discharged. In a subsequent trial, additional criteria might be used to minimize the number of admitted patients who go through randomization.We included a video-only arm in the trial because educational videos require fewer human resources than telecare and are likely to be easier to implement widely. The preliminary findings from this pilot trial suggest that the combined effect of the educational video plus telecare may have a greater effect on outcomes than the video alone. We plan to study video plus telecare and video alone again in a larger trial. No attention control was included in the usual-care arm because the intent of the large study will be to determine if the intervention improve outcomes when compared to what is usually done for these patients . We recoFor the primary outcome for this study, we used change from average pain prior to the ED visit to the average pain in the past week at 1 month follow-up. Average pain prior to the ED visit is a preferable measure of baseline pain than current pain in the ED because some patients will have received analgesics prior to the ED interview. A composite outcome measure of pain symptoms based on current pain and average, maximum, and minimum pain in the past week or a combination of pain and interference with enjoyment of life due to pain and with general activity may provide a more comprehensive characterization of the burden of pain experienced at 1 month , 33.The intervention may improve outcomes in several ways. First, the video may help prepare patients for informed conversations with emergency providers in the ED prior to discharge from them. In theory, this should enhance shared decision-making between patients and providers, an approach that has been associated with improved outcomes in this setting in observational studies , 25. TheThe intervention embraces two components identified as important in the ED discharge process in a recent report funded by the Agency for Healthcare Research and Quality: education and telephone follow up . Other cThere are several limitations to this study. A small sample size limits our ability to draw conclusions on the effect of the intervention. We did not collect information on health literacy. Although the video is designed to be informative across a broad range of health literacy, the effect of the intervention may differ by health literacy status . We alsoFindings from this pilot trial provide preliminary evidence of a possible benefit of an interactive video plus telecare intervention for older adults presenting to the ED with acute musculoskeletal pain. Results also indicate problems with follow up and suggest the need for adopting more aggressive methods for ensuring study participants can be reached at 1 month. A larger trial is planned to assess the efficacy of the intervention overall and in clinically important patient subgroups.


All indices from PSG excluding arousal index were significantly improved after treatment (p < 0.05). Thirty patients showed improved signs and subjective symptoms. Eight out of 12 subjects (66.7%) were successfully treated, achieving an apnea‐hypopnea index (AHI) < 10/h and >50% reduction in apnea‐hypopnea index. Of the 15 patients no longer using the OA, the primary reason for quitting was “no treatment effect” (n = 5). No indices from PSG recording differed between before and after treatment in the not‐using group. These results suggest that both subjective and objective signs and symptoms improved with use of the OA in the using group. However, no signs and subjective symptoms or indices of sleep quality differed between before and after treatment in the not‐using group. Device improvements are needed to achieve better treatment efficacy, and thus improve compliance. The present study evaluated relationship between utilization and treatment efficacy of a boil ‐and bite appliance for OSA patients. Device improvements are needed to achieve better treatment efficacy, thus improve compliance.Although oral appliances (OAs) have become widely used for the management of obstructive sleep apnea (OSA), side effects of OAs are generally related to poor utilization. The purpose of the present study was to evaluate relationship between utilization and treatment efficacy of a boil‐and‐bite appliance for OSA patients. A total of 135 patients with OSA who had used an OAs were mailed a questionnaire to determine whether they were currently using the OA. If so, they were asked about OA use, improvement of signs and subjective symptoms, and utilization. Otherwise, they were asked to indicate why and when they quit using the OA. Results of overnight polysomnography (PSG) before and after treatment were reviewed. Of the 48 responding patients, 33 patients were currently using the OA. The most common complication was excessive salivation ( Obstructive sleep apnea (OSA) is caused by partial or complete obstruction of the upper airway during sleep , or a two‐piece, titratable design (bibloc) are either custom‐made or non‐custom‐made  lasting at least 5 h, and performed at one of 13 medical institutions around Kitakyushu City. Before treatment, a clinical examination of the stomatognathic system was performed, including measurement of mandibular mobility, palpation of the temporomandibular joints and masticatory muscles, and recording of pain during jaw motion were performed . All patients read and signed an informed consent.TM appliance  at the 50% anterior mandibular position as the initial position, as measured with a George Gauge . The device consists of two trays of semi‐rigid thermoplastic material supported by a framework of harder, heat‐resistant polycarbonate , and arousal index from overnight PSG data before and after treatment were used to evaluate treatment effects of the OA. In addition, treatment efficacy was evaluated based on goals of AHI < 10/h and a percentage reduction in AHI of more than 50% compared with baseline , apnea‐hypopnea index (AHI), minimum hemoglobin oxygen saturation measured by pulse oximetry  was used to analyze the data. Data are presented as mean ± standard deviation. To compare characteristics between the using group and not‐using group, the unpaired Student's t‐test, Mann–Whitney test, and Pearson's chi‐squared test were used. To assess the statistical significance of differences before and after treatment in compliance and not‐using groups, the paired Student's t‐test was used. To compare the treatment efficacy between the using and not‐using groups, Pearson's chi‐squared test was used. Values of p < 0.05 were considered significant.n = 3) and death (n = 1). Of the 48 responding patients, 33 (68.8%) were still using the OA (using group). No significant differences in baseline data were seen between the using and not‐using groups . Four patients were not able to be contacted because of missing address information , “3–4 times/week” in 5 patients (15.2%), “1–2 times/week” in 3 patients (9.1%), and “1–2 times/month” in 6 patients (18.2%).The OA was being used at the 50% anterior mandibular position in 17 patients (51.5%), 3.0 mm forward in seven patients (21.2%), 1.5 mm forward in seven patients (21.2%), 1.5 mm backward in 1 patient (3.0%), and 3.0 mm backward in 1 patient (3.0%).Thirty patients (90.9%) showed improvement in signs and subjective symptoms, while two patients (6.1%) reported no improvement, and one patient (3.0%) provided no answer. Of these 30 patients, seven patients (23.3%) were using the device at 3.0 mm forward, six (20.0%) at 1.5 mm forward, 15 (50.0%) at the 50% anterior mandibular position, and one each (3.3%) at the 1.5 mm backward and 3.0 mm backward positions.n = 16 each), “number of apnea episodes” (n = 12), “daytime sleepiness” (n = 11), “difficulty waking” (n = 10), “duration of apnea” (n = 9), “nocturnal waking” and “hypertension” (n = 4 each), “nocturia” (n = 3), “morning headache” (n = 2), and “difficulty sleeping” and “difficulty breathing” (n = 1 each) , “dry mouth” (n = 8), “discomfort in the TMJ area” (n = 7), “discomfort” and “pain in the TMJ area” (n = 5 each), “ill‐fitting”(n = 3), “occlusal change” and “pain in the oral tissue region” (n = 2 each), and “TMJ noises” and “pain in the teeth” (n = 1 each). No compliant patient reported “pain in the ear” or “pain in the throat”  quit using the OA within the first month, one patient (6.7%) at 1–3 months, one patient (6.7%) at 4–6 months, two patients (13.3%) at 7–12 months, and two patients (13.3%) after 12 months, while four patients (26.7%) did not provide an answer.n = 5), “discomfort” and “discomfort in the TMJ area” (n = 4 each), “dry mouth” and “broken appliance” (n = 3 each), “changed for other treatment”, “ill‐fitting appliance after dental therapy” and “ill‐fitting appliance” (n = 2 each), “pain in the teeth”, “pain in the TMJ area”, “pain in the throat”, and “excessive salivation” (n = 1 each). No compliant patient reported “pain in the oral tissue region”, “occlusal change”, “TMJ noises”, or “pain in the ear” . However, arousal index did not differ significantly between before and after treatment. In the not‐using group, no significant improvement was apparent in any indices  were successfully treated, achieving an AHI < 10/h and >50% reduction in AHI. All eight patients were using OAs at the 50% anterior mandibular position. In the not‐using group, four out of seven subjects (57.1%) were successfully treated, achieving AHI < 10/h and >50% reduction in AHI. No significant difference in treatment efficacy was identified between the using and not‐using groups.This questionnaire‐based study presented a response rate of 35.6%, lower than previous studies  showed improvements in signs and subjective symptoms. Common improved symptoms involved snoring, apnea, and daytime sleepiness, which are frequent symptoms of OSA. These results were similar to those reported in most studies , while some studies have shown a relationship with increased side effects such as occlusal changes including tooth pain  were successfully treated, achieving an AHI < 10/h and >50% reduction in AHI. All eight patients were using OAs at the 50% anterior mandibular position. Even though the mandibular protrusion distance was small, our treatment success rate was similar to those reported from previous studies (Almeida et al. Larger mandibular protrusion will produce a larger decrease in OSA events (Clark et al. TM appliance might have led to loose contact with teeth or gingival tissue. A systematic review of the evidence has shown that custom OAs are more effective than non‐custom OAs (Ramar et al. Lindman and Bondemark  reportedIn the not‐using group, one‐third of patients quit using the OA within the first month and 40% within the first 3 months. The most common self‐reported reasons for quitting use of the OA were a lack of treatment effect or discomfort or pain on use, similar to the previous study (Clark et al. Marklund et al.  reportedNone declared.


P < 0.01). Dizziness as a side effect of pregabalin was observed in 21 and 11 subjects in intervention and placebo groups, respectively (P < 0.01). The present study showed that a single dose of oral pregabalin increases the duration of analgesia and maintains hemodynamic stability in orthopedic surgery patients.Treatment of acute pain and hemodynamic changes after surgery is extremely important. Various drugs for pain relief after surgery have been studied. The aim of this study was to evaluate the effect of a single dose of oral pregabalin on hemodynamic changes and duration of analgesia after spinal anesthesia in orthopedic surgeries of tibia fractures. This clinical trial was carried out on 120 patients with fractures of the tibia bone in 2014 in city of Zahedan. Sampling was conducted using randomized blocks and patients were placed into pregabalin (150 mg PO 1 h before anesthesia) and placebo groups. Duration of analgesia, severity of anxiety, mean arterial pressure, and pulse rate were evaluated in both groups. The mean age of the patients was 34.8 ± 21.7 years and 84 patients (70%) were male and 36 (30%) were female. There were no significant differences at baseline characteristics of the patients in two arms of the study. After surgery, mean arterial pressure, pulse rate and anxiety, were significantly lower in intervention group. Also the duration of analgesia was significantly longer in intervention arm (185.3 ± 4.9 vs 36.9 ± 13.9,  Cardiovascular events after surgery lead to increased complications, decreased physical ability, increased mortality as well as significant increases in health care costs .Increased activity of the sympathetic system increases blood pressure, heart beat, and activity of the clotting factors . This inPain is one of the most common and annoying problems of patients. Eighty percent of patients undergoing surgical procedures experience postoperative pain. Despite all efforts of pain forums in acute postoperative pain management, this issue is still considered as a serious clinical problem , 7. StudConsidering the necessity of pain management in spite of all efforts, there is still no effective method to control pain after surgery and there is need for further research in this area. Searching scientific literature shows that pregabalin has the ability to prevent and control postoperative pain .The best conditions for surgery should be provided in an ideal spinal anesthesia, such as creating necessary anesthesia level and loosening the site of surgery, the time of anesthesia should match the duration of surgery. Moreover, immobility time should not be too long and recovery should be at least in a short possible time. In addition, sufficient analgesia should be maintained for patients in the recovery room after the completion of surgery. Therefore, workflow of operating and recovery rooms will be faster and the cost will be lower in the case of achieving these results , 11.Spinal anesthesia is the best type of analgesia in the lower abdomen and lower limb surgery, especially in high-risk patients such as the elderly, obese, and pulmonary heart disease patients who have a higher risk of general anesthesia as compared to the other patients.Long-acting anesthetic medicines such as tetracaine and marcaine are used in surgical procedures that require a long time . IncreasPregabalin, an analog of gamma amino butyric acid has been designed as a more potent successor of gabapentin and is presented under the brand name Lyrica. It is used for the treatment of neuropathic pains, sleep disorders, anxiety, epilepsy and post-herpetic neuralgia, and diabetic neuropathy. Dizziness and drowsiness among its side effects (more than 10% of patients) and other side-effects (1-10% of patients) are blurred vision, double vision, increased appetite, weight gain, happiness, euphoria, confusion, changes in sexual desire, irritability, lack of balance, shifting attention, paramnesia, increased levels of creatine kinase, etc. , 13.Given that most studies in this field are related to general anesthesia and increase in the duration of analgesia after surgery, and a few studies have been conducted in the field of evaluating the effect of pregabalin on mean arterial pressure, pulse and duration of analgesia after spinal anesthesia, a research was conducted with the aim of determining the effect of a single dose of oral pregabalin on hemodynamic changes and duration of analgesia after spinal anesthesia in orthopedic surgeries of shin bone (tibia) fracture.In this randomized, double blinded, and placebo control clinical trial, 120 patients were selected from all the patients having tibial fracture and hospitalized in Khatam-Al-Anbia hospital in 2014 affiliated to Zahedan university of medical sciences, Zahedan, Iran. Inclusion criteria were ASA Class 1 non-emergency patients, aged 20 to 70 years, undergoing tibial fracture orthopedic surgery.Exclusion criteria were having diseases affecting the hemodynamic situations such as heart disease, diabetes, kidney disease, or a history of allergy to gabapentin or pregabalin, drug use, regular use of alcohol or smoking more than 5 pack year, neurological diseases, surgery duration more than ninety min after spinal anesthesia and patients who needed injections during the operation which affect hemodynamics, pregnancy, refusal of patients to participate in the study and spinal anesthesia, coagulopathy, infection in the area of spinal anesthesia and any digestive disorder that interferes with the absorption of oral medication, the need for paregoric for pain relief, abnormal bleeding during surgery, cardiovascular and cerebrovascular complications during surgery and abnormal pulse and mean arterial pressure.The study protocol was approved by ethics committee of Zahedan University of Medical Sciences. One hundred and twenty patients were randomly (using the blocked random sampling) divided into the pregabalin group (two 75 mg capsules) or placebo by controlling the dependent variables before and after the intervention. Patients received pregabalin or placebo one hour before spinal anesthesia. Mean arterial pressure, pulse rate and duration of analgesia after spinal anesthesia were recorded for each patient.For eligible patients, pressure cuff was attached to the left arm ninety minutes before spinal anesthesia and pulse oximeter was connected to the finger of the contralateral limb. Pulse and mean arterial pressure were recorded with the set of each 10 min for 3 times using vital signs monitoring device produced by Sazandegan Gostar Co. Research questionnaire was completed for them when no abnormal symptom was observed. Severity of anxiety was recorded before and after surgery using Visual Anxiety Severity (VAS) score. It was asked from the patient with adequate explanations on the method of answering this tool. The used VAS is in the form of a 100 mm horizontal line, which measures the level of anxiety from the lack of it to its most severe level. One h before spinal anesthesia, two 75 mg pregabalin capsules  or placebo were taken by the patients based on the randomization Table in the presence of a research assistant. All the patients received 10 mL/Kg Ringer fluid and then spinal anesthesia was performed by 25-gauge Quincke needles from L3-L4 intervertebral space with 3 mL of 0.5% Marcaine. Pain relievers were administered as needed based on the anesthesiologist opinion. The mean arterial pressure and pulse were recorded every 10 min using vital signs monitoring until the end of the surgery. The data were analyzed using relevant statistical tests by SPSS-16 software. One hundred and twenty patients (60 in each group) for orthopedic surgery due to fracture were recruited in this study. The mean age of the patients was 34.8 ± 21.7 years, 84 patients (70%) were male and 36 (30%) were female. There was no significant difference in demographic characteristics of the patients in two arms of the study .P = 0.01) in pregabalin arm and from 97.9 ± 7.2 mm Hg to 93.3 ± 6.7 mm Hg in control arm (P = 0.12). These reductions for pulse rate in pregabalin and control groups were 81.3 ± 8.4 to 70.2 ± 8.1 beat/min (P = 0.001) and 81.5 ± 14.2 to 78.4 ± 12.6 beat/min (P = 0.539), respectively. There were no significant differences between two groups in mean arterial pressure, pulse rate, and anxiety (measured by VAS) before surgery . After rP = 0.001). Frequency of nausea and vomiting was similar between the two groups but the dizziness was significantly higher in the Pregabalin group (P = 0.001). This difference is statistically significant . After operation, it was 58.3 ± 11.4 mm in the Pregabalin group and 69.7 ± 21 mm in the placebo group. This difference was statistically significant (P = 0.03)  .The results of this study showed that pain was lower in the pregabalin-treated group than the control group. Also, the patientꞌs blood pressure and, pulse rate and VAS were lower in the pregabalin group.Approximately, 80% of the patients experienced pain after surgery which is known as a predictor of persistent postoperative pain, 5-50% of the patients reported persistent pain. The pain is associated with symptoms such as tachycardia, hypertension, myocardial ischemia, and decreased pulmonary ventilation. It can also increase the susceptibility of neurons and the release of inflammatory mediators.A study by Kohli and colleagues in 2011 on the use of pregabalin orally one hour before hysterectomy surgery with spinal anesthesia showed that mean arterial pressure and pulse had a significant reduction in the pregabalin group as compared to the placebo . In a stIn a study in 2012, Sundar and colleagues showed that a single dose of 150 mg pregabalin undermined blood pressure response to tracheal intubation .et al. (2009) showed that Gabapentin and pregabalin reduced acute pain and opioid use after surgery when compared with placebo  showed that pregabalin significantly prolongs the analgesia of spinal block as compared to gabapentin  with the aim of evaluating the effect of a single dose of oral pregabalin in pain control and reducing the amount of drugs used after minor surgeries, it was shown that taking a single dose of oral pregabalin 150 mg before the minor surgeries can reduce the score of pain and opioid consumption which is consistent with the present study (In a study conducted by Alimian et al. 12 with tAccording to the results of this study and other studies reviewed, it seems that the use of pregabalin reduces pain and the amount of painkillers used after surgery and also leads to hemodynamic stabilization of patients. The present study showed that a single dose of oral pregabalin reduces pain and leads to hemodynamic stabilization of patients. Deterioration of the device can be pointed out as one of the study limitations.With the results of this study, the use of pregabalin is recommended in orthopedic surgery of patients with spinal anesthesia for reduction of pain and hemodynamic stabilization of patients.


To compare the postoperative pain following bipolar diathermy scissors tonsillectomy (higher temperature dissection) with harmonic scalpel tonsillectomy (lower temperature dissection).Sixty patients aged 7–40 years planned for tonsillectomy with no other concurrent surgery were randomised to either bipolar diathermy scissors or harmonic scalpel as surgical technique. Blinded to the surgical technique, the patients recorded their pain scores  at awakening and the worst pain level of the day in the postoperative period. All intake of pain medication was also recorded.No statistically significant differences were found between the two groups regarding postoperative pain levels or consumption of pain medication.Usage of the harmonic scalpel does not render less postoperative pain following tonsillectomy when compared with usage of the bipolar diathermy scissors. Many children and adults are affected by recurrent tonsillitis or tonsillar hypertrophy with upper airway obstruction. In these cases, tonsillectomy is often performed. The surgery causes considerable postoperative pain, often lasting more than a week after the procedure . TonsillThe use of hot dissection techniques is associated with low rates of early postoperative bleeding and are therefore useful in day-case surgery. There are different hot dissection techniques including bipolar diathermy, harmonic scalpel, coblation and monopolar cautery .The bipolar diathermy scissors coagulate at the same time as cutting, by applying an electrical current between the legs of the scissor. When using the bipolar diathermy scissors, the temperature in the tissue reaches 150–600 °C .The effect that the harmonic scalpel exerts comes from a hook that vibrates at ultrasonic frequency 55.5 kHz) at a distance of 50–100 μm. The rapid vibrations build up a pressure in the tissue, causing the tissue to divide. The energy that is transmitted to the tissue denatures proteins and coagulates blood vessels, causing minimal tissue damage , 5. In c5.5 kHz aIn theory, the harmonic scalpel causes less tissue damage than the bipolar diathermy scissors, by transmitting less energy to the surrounding tissues and thereby causing less pain after the operation, but previous studies are contradictory –10.The aim of the study was to determine whether the choice between the two surgical instruments, which work at different temperatures, affects the patients’ postoperative pain. The hypothesis was that the harmonic scalpel renders less postoperative pain than the bipolar diathermy scissors.α = 0.05 and a power of 80%. Taking probable dropouts in mind, a total of 60 patients (30 in each group) were to be included in the study.The power analysis was based on the data distribution from an initial pilot study and a mean difference between the groups of 2.0 on the visual analogue scale (VAS), which was the smallest difference that was considered clinically relevant. The power analysis was performed with The Regional Ethical Review Board in Uppsala approved the study (Ref. Dnr 2011/303).The patients were recruited from the department’s day-care unit and were given verbal and written information about the study during a clinic visit or by the surgeon on the morning of the day of surgery. Patients who fulfilled the inclusion criterion were eligible to participate in the study.The inclusion criterion was:Patients between 7 and 40 years of age, scheduled for tonsillectomy for recurrent tonsillitis or upper airway obstruction due to tonsillar hypertrophy.Exclusion criteria:Any concurrent surgical procedure, including adenoidectomy or insertion of transmyringeal ventilation tubes.Acute tonsillitis.Previous peritonsillar abscess.Inability to understand instructions .Bleeding disorder.Hypersensitivity/allergy to paracetamol or ibuprofen.If the patient or caregiver accepted inclusion, the surgeon as well as the patient or caregiver signed the informed consent form. In total, 60 patients were included.The patients were given oral oxycodone 0.20–0.30 mg/kg , 30 min before the operation. Children who could not swallow tablets were given liquid oxycodone 1 mg/ml, 0.1 mg/kg = 0.1 ml/kg.Children >30 kg and adults were anaesthetised with target-controlled infusions (TCI) of propofol and remifentanil. The initial targets were 6–7 µg/ml for propofol and 6–7 ng/ml for remifentanil, and the maintenance targets were 2–3 µg/ml and 2–3 ng/ml, respectively.Children ≤30 kg were also anaesthetised with propofol and remifentanil with dosages corresponding to those above, but without the TCI function.Anaesthesia induction could also be performed with sevoflurane inhalation via mask where the child refused an intravenous line. If so, anaesthesia was continued with propofol and remifentanil as soon as an intravenous line was introduced. All patients were intubated.The theatre nurse performed the randomisation by opening the non-transparent envelope with the lowest remaining randomisation number. The content of the letter stated which of the two surgical techniques was to be used. The surgeons had training in the use of both surgical techniques.The harmonic scalpel was set on a frequency of 55.5 kHz. The effect of the generator was set on power setting 3  as previously reported . When opPerioperatively, all patients were given glycopyrron (ca 5 µg/kg), fentanyl (2–3 µg/kg), betamethasone , intravenous paracetamol (10 mg/ml 1–1.5 ml/kg) and ondansetron 2 mg/ml 1 ml <30 kg, 1.5 ml 30–50 kg and 2 ml >50 kg. Furthermore, the surgeon, after removal of the tonsils, injected 5–10 ml of bupivacaine (5 mg/ml) in the anterior and posterior palatal arch.After the operation, the surgeon filled in the surgical form specifying the surgical method and method of haemostasis. The surgical form was then put in a binder in the surgical unit for safe storage. The surgical method that had been used was kept blinded to the patient (and caregiver in case of children) as well as for the staff of the postoperative unit to keep the study double-blinded.The patients stayed at least 3 h at the postoperative observation unit. Paracetamol 10 mg/kg and ibuprofen 5 mg/kg were given 4–6 h after the initial intravenous dose of paracetamol during surgery. Morphine was given intravenously if necessary and was noted on the reply form. Furthermore, patients received tablets of oxycodone in the same dosage as preoperatively to take at home in the evening and an additional prescription of oxycodone to pick up if necessary. Adults were prescribed oxycodone 5 mg one to four tablets twice a day and children were prescribed according to their weight: <30 kg, one tablet twice a day; 30–60 kg, one to two tablets twice a day; >60 kg, the same dose as adults.Postoperatively, the patients were asked to do a VAS scoring 30 min and 3 h after the operation. Instructions were given to the patient or caregiver before discharge on how to use the provided VAS-ruler and how to fill out the reply form. An ENT nurse called the patient or caregiver the day after surgery to make sure that the reply form was being filled out. The patient then filled out the reply form daily for 10 days, including the amount and sort of pain medication used, the degree of postoperative throat pain (by using the VAS) at awakening (before intake of pain medication) and the worst level of pain during that day. The patients also noted any additional contacts with health care for any reason and sent in the form. The ENT nurse called the patient approximately 20 days after surgery to remind the patient to send in the reply form, if it had not already been received.U test and dichotomous variables were analysed using Fisher’s exact test.The results were analysed using SPSS 23.0. Continuous variables from the VAS scale were analysed using the Mann–Whitney Forty-one patients returned the reply form. One patient in the harmonic scalpel group had been included in the study by mistake (higher age than the inclusion criterion stated) and was thus withdrawn from the analysis. In total, the results from 40 patients were analysed.n = 22 .In the harmonic scalpel group [In the harmonic scalpel group, 8 patients were operated due to chronic tonsillitis, 11 due to recurrent tonsillitis and 3 due to upper airway obstruction. In the bipolar diathermy scissors group, six patients were operated due to chronic tonsillitis, nine due to recurrent tonsillitis and three due to upper airway obstruction.p = 0.95) regarding the number of seconds bipolar diathermy was used for haemostasis after the tonsillectomy—21.2 s (SD 21.9) in the bipolar diathermy scissors group and 17.1 s (SD 12.8) in the harmonic scalpel group. Also, there was no difference between the groups when analysing only the patients for whom bipolar diathermy had been used for haemostasis, to exclude its possible interference with the results.No statistical significance was found .Also, there was no significant difference between the groups regarding the reported use of analgesics on postoperative days 1, 4 and 7  [For the pain assessment in the present study, the visual analogue scale (VAS) was used. In addition, the amount of analgesia used was recorded as a surrogate measure of pain. Psychometric studies of the VAS have shown that it has good validity and reliability (test–retest  = 0.95) . The VAS = 0.95) .The present study found mean VAS scores for the worst level of pain between 5.65 and 7.50 which is equivalent with the VAS scores found in a previous study of the harmonic scalpel and electrocautery for tonsillectomy on patients aged 6–15 years . That stNo differences were found between the two groups regarding postoperative pain at any time. The use of potent analgesics postoperatively could in theory have suppressed the pain levels in both groups resulting in reduced pain score differences between the two groups, masking possible differences in the pain that the two surgical techniques render. We consider the risk of such an effect as low, since both groups scored relatively high VAS values and at a level previously reported after controlled studies of tonsillectomy , 10.p values were relatively high, we consider this risk to be low. Other studies with smaller patient samples have found significant pain differences when testing the harmonic scalpel versus cold dissection techniques. In a study of 28 patients, Collison et al. found less early postoperative pain after the use of the harmonic scalpel [The possibility of having made a type II error, i.e. the risk of not detecting a clinically relevant difference between the groups due too small sample size, has been considered. Since the  scalpel . Akural  scalpel .The harmonic scalpel versus electrocautery has previously been studied in a few clinical trials regarding tonsillectomy. One non-randomised study comparing postoperative pain after the use of a harmonic scalpel versus electrocautery found no difference between the groups, except when rescue usage of electrocautery was needed to stop bleeding in the harmonic scalpel group, where more pain was noted . WhetherPrevious studies that most resemble the present study compare harmonic scalpel tonsillectomy with bipolar diathermy tonsillectomy in the paediatric age group. Kemal et al. found lower pain levels in the harmonic scalpel group . As in tThe clinical application of the present results is that none of the two surgical instruments is superior to the other in terms of postoperative pain. Regarding other differences between the surgical instruments, we did not find any reported health economy analyses on the use of different kinds of surgical instruments for tonsillectomy. Considering the result of the present randomised study and the lack of other studies showing an advantage of the harmonic scalpel for tonsillectomy, the use of the harmonic scalpel can be questioned from an economical point of view. The single-use disposable unit, used in this study, costs approximately 90 Euro per patient, compared with the manyfold lower cost of using multiple-use instruments.Tonsillectomy using the harmonic scalpel did not result in reduced postoperative pain compared with bipolar diathermy. This double-blinded randomised study found no differences in VAS scores between the groups; neither was there any difference between the groups regarding the amount of analgesics used postoperatively, which reinforces the results.


The objective was to compare and correlate disability, pain intensity, the impact of headache on daily life and the fear of movement between subgroups of patients with chronic temporomandibular disorder (TMD).A cross-sectional study was conducted in patients diagnosed with chronic painful TMD. Patients were divided into: 1) joint pain (JP); 2) muscle pain (MP); and 3) mixed pain. The following measures were included: Craniomandibular pain and disability , neck disability (Neck Dsiability Index), pain intensity , impact of headache (Headache Impact Test 6) and kinesiophobia .p < 0.001, d = 1.99; and p < 0.001, d = 1.17), craniomandibular pain and disability , and impact of headache . In addition, significant differences were observed between JP group and MP group for impact of headache . Neck disability was a significant covariate (37 % of variance) of craniomandibular pain and disability for the MP group . In the mixed chronic pain group, neck disability  and kinesiophobia  were significant covariate (33 % of variance) of craniomandibular pain and disability.A total of 154 patients were recruited. The mixed pain group showed significant differences compared with the JP group or MP group in neck disability (Mixed chronic pain patients show greater craniomandibular and neck disability than patients diagnosed with chronic JP or MP. Neck disability predicted the variance of craniofacial pain and disability for patients with MP. Neck disability and kinesiophobia predicted the variance of craniofacial pain and disability for those with chronic mixed pain. According to Medical Subject Headings, pain is considered chronic when it is an aching sensation that persists for more than a few months. It might or might not be associated with trauma or disease, and can persist after the initial injury has healed. Its localization, character and timing are vaguer than with acute pain.In general, Craniofacial pain and disability, is a health problem that affects a large population. Chronic temporomandibular disorders (TMD) are included in this classification, with a high prevalence  and painChronic TMD can present persistent, recurrent or chronic pain associated with temporomandibular joint dysfunction and/or muscles involved in the masticatory system . The etiTMD-related disability is one of the most important condition observed in chronic TMD . SimilarCiancaglini and Radaelli have shown that patients with chronic TMD are predisposed to headaches, thus it is of great importance to assess the impact of headache in these cases . The relThe authors of this article, hypothesize that disability, pain intensity, the impact of headache on daily life and the fear of movement could be different between subgroups of patients with chronic TMD. Therefore, the primary aim of this study was to compare mandibular and neck disability and its association with craniofacial pain intensity, the impact of headache in daily life and fear of movement between subgroups of patients with chronic TMD.To improve the quality of our study, we used the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) international guidelines .This is a comparative cross-sectional study. The research was approved by the ethics committee of La Paz University Hospital (LPUH code PI-1241), at which the study was developed between January and October 2014.Patients were recruited from the orofacial pain unit of LPUH. In the recruiting phase, each patient was assigned to one of the following groups according to their diagnosis, which was established by the DC/TMD: 1) chronic TMD with JP; 2) chronic TMD with MP; and 3) mixed chronic TMD . All parThe following were the exclusion criteria: 1) presentation of a systemic, rheumatic or central nervous system disease; 2) combined diagnosis of chronic migraine and chronic TMD; 3) fibromyalgia; 4) history of trauma or recent surgery on the head, face, neck or chest; 5) receiving physiotherapy at the time of evaluation; 6) younger than 18 years old; and 7) pregnancy. A total of 850 patients were excluded from the study due to the exclusion criteria.There were 5 variables considered, all of which were quantitative. First, the levels of craniofacial pain and disability were assessed using the Craniofacial Pain and Disability Inventory (CF-PDI), which has good psychometric properties. The CF-PDI consists of 21 items (range 0–63 points) based on two factors: pain and disability, and the functional status of the jaw . The MinSecond, neck disability was evaluated using the Neck Disability Index (NDI). The NDI comprises 10 items, of which only the first and sixth refer to pain, whereas the rest refer to activities in connection with that pain. Each item is scored from 0 (no disability) to 5  and can earn a maximum of 50 points . MDC andThe third variable considered was the impact of headache on daily life. This variable was evaluated by the Headache Impact Test (HIT-6), which is made up of 6 items evaluating a headache’s impact on the patient’s quality of life. This test has been shown to be both reliable and valid . The totFourth, the visual analog scale (VAS) was used to evaluate pain intensity. The VAS comprises a 100-mm horizontal line from 0 mm representing “no pain” to 100 mm representing “pain as bad as you can imagine”. The patient marked the line at the point they felt represented the pain intensity at the time, which was quantified by the assessor in mm. This scale has shown its reliability and validity for the measurement of pain intensity .Activity Avoidance and Harm [Finally, the level of fear of movement and re-injury was assessed using the short version of the Spanish validated Tampa Scale for Kinesiophobia (TSK-11). This scale consists of two factor models, called and Harm . In respTo avoid selection bias, established inclusion and exclusion criteria were defined to reduce differences between the study populations. To avoid classification bias, the patients received their medical diagnosis by a specialist in chronic TMD in order to be classified in the correct group. Another important bias could have been ingesting medication; to prevent this bias, the patients were reminded not to take any medication 24 h prior to measurement, apart from preventive medication. Finally, with the aim of preventing information bias, all the patients received comprehensive information about the study.An independent researcher and specialist in chronic TMD was responsible for the diagnosis of all patients according to RDC/TMD . A blindTo calculate the sample size, the G*Power 3.1 program developed at the University of Düsseldorf was used .A power calculation was used to detect differences between groups in pain-related disability and psychological variables. Because detecting differences between groups was our primary interest, a F- Test was employed. The calculation used a size effect f of 0.25 (moderate), based on a pilot study with a sample of 18 subjects, obtaining 80 % statistical power (1-β error probability) with an α error level probability of 0.05, and suggested a sample size of 159 participants. Added, given that the second aim of this study proposed the creation of a regression analysis to assess the association between variables, it was necessary to expand the sample, considering that we used 4 predictors. To meet this goal, a minimum of 40 participants per group was required; given the regression analysis, the rule of 10 cases per variable was applied to obtain reasonably stable estimates for the regression coefficients .All the data analyses were performed using SPSS for Windows, version 21.0 . Descriptive statistics were generated for the sociodemographic, psychological and pain-related disability variables. The results are expressed as mean, standard deviation (SD), with 95 % confidence intervals (95 % CI). A normal distribution of the data was confirmed with the Kolmogorov-Smirnoff test. The weight, education level and chronicity measures did not meet the normal distribution. However, a normal distribution for all the variables was assumed according to the central limit theorem. This theorem states that the distribution of the average of a large number of independent variables  will be approximately normal regardless of the underlying distribution , 37.2p) was calculated as a measure of effect size (strength of association) for each main effect and interaction in the ANOVAs, with 0.01–0.059 representing a small effect, 0.06–0.139 a medium effect and >0.14 a large effect [d effect-sizes were calculated for multiple comparisons of the outcome variables. According to Cohen’s method, the magnitude of the effect was classified as small (0.20–0.49), medium (0.50–0.79), or large (0.8) [A one-way ANOVA was used to analyze the group factor for pain-related disability and psychological variables . Significant ANOVA findings were followed up with a post hoc test using the Bonferroni correction. Partial eta-squared  were calculated to determine whether there were any multicollinearity issues in any of the 3 models. The strength of association was examined using regression coefficients (β), p > 0.05). Duration of symptoms (in months with pain related-diagnoses), showed statistically significant differences when comparing mixed chronic TMD with JP  and MP . No differences were found in duration of symptoms between JP and MP in chronic TMD.A total of 154 patients were recruited, of whom 57.11 % were men, with an average age of 45.19 (12.75) years (mean (SD)), with a weight of 66.81 (10.28) and a height of 1.64 (0.08). No statistically significant differences were found in age, weight and height between the groups for any of the values (p > 0.05) and the women distribution within subgroups was 55.8 % in JP, 42.4 % in MP and 32.7 % in mixed group. Statistically significant differences were observed in the groups for craniofacial pain and disability , neck disability , impact of headache  and pain intensity . No differences were found between groups for kinesiophobia (p > 0.05)  or compared with patients diagnosed with MP . The mixed pain group showed statistically significant differences compared with the JP group on the craniofacial pain and disability scale  and compared with the patients diagnosed with MP . The JP group also showed statistically significant differences  in neck disability compared with the group diagnosed with chronic MP. Regarding the impact of headache, statistically significant differences were observed between all the groups for multiple comparisons when comparing chronic mixed pain with JP , mixed pain with MP  or JP with MP . There were no differences between the groups in terms of fear of movement or kinesiophobia  and between kinesiophobia and neck disability . Regarding the chronic JP group, a moderate positive correlation was shown between craniofacial disability and pain intensity , between the impact of headache and pain intensity  and between the impact of headache and craniofacial disability .r = 0.535; p < 0.001), between kinesiophobia and craniofacial disability  and between kinesiophobia and neck disability .Finally, moderate positive correlations were observed in the mixed chronic pain group between neck disability and craniofacial disability (p < 0.001). Neck disability  and kinesiophobia  were significant covariate (33 % of variance) of craniofacial pain and disability for the mixed chronic pain group. In addition, kinesiophobia  was a significant covariate (9 % of variance) of craniofacial pain and disability for the JP group.A multiple linear regression model using the variable CF-PDI as the criterion is shown in Table In comparison with our study, Olivo et al. investigated women with chronic TMD, comparing MP and mixed pain groups with asymptomatic subjects. This study showed statistically significant differences between the MP group and the mixed pain and asymptomatic groups, but there was no difference between the other patient groups . This reA 2013 study of patients with chronic TMD, comparing with present data, did not find significant differences between subgroups with respect to jaw disability. A possible reason is the high percentage of patients they included in the chronic MP group (64.9 %), the use of other tools to assess disability (jaw disability check list) or the inclusion criteria of more than 6 months for a chronic condition .On the other hand, supporting our study, recent research on various patients with orofacial pain, including chronic TMD, determined that significant differences were obtained in craniofacial disability only when compared with articular and muscle pain groups .As for possible correlations between craniofacial disability and other variables, our study established moderate positive correlations between craniofacial disability, neck disability, impact of headache and pain intensity. However, we observed a low positive correlation between craniofacial disability and fear of movement. Similar to our results, numerous studies have found strong and very strong positive correlations between pain intensity and neck disability with respect to craniofacial disability , 43, 44.La Touche et al. found a strong positive correlation between neck disability and craniofacial pain and disability .Silveira et al. performed a study in which 20 women with a diagnosis of chronic TMD participated, although unlike our work, the patients were not classified into subgroups. Nevertheless, they observed a strong positive correlation between jaw disability and neck disability; thus, it is important to include the evaluation of neck disability in such patients .Neck disability was a strong predictor of craniofacial pain and disability in the MP group and conformed to a prediction model of kinesiophobia for the mixed pain group. These results have clinical implications. Treatment needs to be focused on neck and craniofacial areas because the improvement of one could have an influence on the other , 47.In our study, we found that patients with mixed chronic pain had a higher headache impact (56.38 points) than the patients in the JP and MP groups; this score represents an important impact on the patients’ quality of life. In addition, the MP group (51.21 points) showed more headache impact than the JP group (44.37 points).The results for the articular and muscle groups are similar to a recent study conducted for validation and development of a craniofacial disability questionnaire, in which they included patients with various types of chronic TMD and patients with primary headaches. They found a significant impact of 54.48 points . Any incIn a recent university study to determine the annual prevalence of primary headaches, Souza-e-Silva y Rocha-Filho found a severe impact of headache on quality of life. These results are similar to those obtained in the mixed chronic TMD group in the present study; therefore, the impact of headache on quality of life could be similar for people who suffer from primary headaches and people who suffer from mixed chronic pain .These results are supported by a recent study that found patients who have poorer results after receiving conservative treatment for pain, are those who had chronic TMD associated with headache . CertainPerhaps, future studies could assess the impact of headache among cases with a diagnosed headache attributed to TMD.In the present study, all the subgroups of patients presented a similar level of kinesiophobia, and although there were no statistically significant differences in this measure between various groups, they had a similar level as a recent study on other musculoskeletal pain .Few studies have researched the relationship between kinesiophobia and chronic TMD. However, in a 2010 study that evaluated the validity and reliability of the TSK-11 adapted to chronic TMD, Visscher et al. found that patients with chronic TMD who have more functional problems related to the jaw joint suffered a greater degree of fear of movement. Also, fear of movement is strongly related to mechanical jaw problems, such as sounds or blocks . That siThe score obtained in these groups with chronic TMD is similar to that found in patients with chronic widespread pain (28 points) and lower than that of patients with low back pain (33 points) . The scoStrong evidence suggests that kinesiophobia is a predictor of disability in patients with various types of chronic pain, including TMD , 53, 54.Recent studies support the idea that chronic TMD is a multifactorial disorder, in which psychological factors play an important role in the onset and development of the pathology. Finally, it is clinically important to emphasize that the vast majority of patients with chronic TMD have a mixed diagnosis (85 %) .Kinesiophobia was a predictor of craniofacial pain and disability in the JP group and conformed to a prediction model of neck disability for the mixed pain group. Thus, neck disability and kinesiophobia could be influencing craniomandibular pain and disability. Again, this situation has important clinical implications in the evaluation and treatment of these patients.Several limitations should be taken into account in the present study. It was not possible to compare our results with longitudinal studies because there is a lack of these types of studies in the literature. First, it is remarkable that 57 % of the study-population was men since almost all clinical samples women outnumber men (3–5 as many women as men); this may be due to a bias associated to consecutive bootstrapping used in this study. These results could have been different with a usual sex distribution. Our study did not collect physical variables such as craniomandibular range of motion, which could provide new and interesting information. Another important limitation is the lack of a Spanish version of the TSK-11 for TDM and it is recommended to developed it in further studies according translation and adaptation process . The scaThis study provides important information regarding psychosocial factors that appear in patients with chronic TMD, which could be disability predictors. Thus, we suggest considering these factors as likely predictors in the evaluation and treatment of these patients.Patients with mixed chronic pain diagnosis show greater craniomandibular and neck disability than patients with a diagnosis of chronic JP or MP. In addition, patients with mixed chronic pain show greater headache impact than the chronic JP or MP groups. Neck disability predicted a 37 % variance of craniofacial pain and disability in MP. Neck disability and kinesiophobia predicted a 33 % variance of craniofacial pain and disability for patients with mixed chronic pain.