Background: The analgesic properties of ketamine are associated with its non-competitive antagonism of the N-methyl-D-aspartate receptor; these receptors exhibit an excitatory function on pain transmission and this binding seems to inhibit or reverse the central sensitization of pain. In the literature, the value of this anesthetic for preemptive analgesia in the control of postoperative pain is uncertain. The objective of this study was to ascertain whether preoperative low-dose ketamine reduces postoperative pain and morphine consumption in adults undergoing colon surgery.Methods: In a double-blind, randomized trial, 48 patients were studied. Patients in the ketamine group received 0.5 mg/kg intravenous ketamine before surgical incision, while the control group received normal saline. The postoperative analgesia was achieved with a continuous infusion of morphine at 0.015 mg∙kgˉ¹∙hˉ¹ with the possibility of 0.02 mg/kg bolus every 10 min. Pain was assessed using the Visual Analog Scale (VAS), morphine consumption, and hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. We quantified times to rescue analgesic (Paracetamol), adverse effects and patient satisfaction.Results: No significant differences were observed in VAS scores between groups (P>0.05), except at 4 hours postoperatively (P=0.040). There were no differences in cumulative consumption of morphine at any time point (P>0.05). We found no significant differences in incremental postoperative doses of morphine consumption in bolus, except at 12 h (P =0.013) and 24 h (P =0.002). The time to first required rescue analgesia was 70 ± 15.491 min in the ketamine group and 44 ± 19.494 min in the control (P>0.05). There were no differences in hemodynamic parameters or patient satisfaction (P>0.05).Conclusions: Preoperative low-dose-ketamine did not show a preemptive analgesic effect or efficacy as an adjuvant for decreasing opioid requirements for postoperative pain in patients receiving intravenous analgesia with morphine after colon surgery. Because the severity of early postoperative pain relates to residual pain after some types of surgery, perioperative pain management can considerably influence the long-term quality of life in patients3.In spite of the techniques we have at our disposal and the elementary nature of incisional pain, optimal pain management remains a challenge4, confirming the presence of a central factor of post-injury pain hypersensitivity in experimental research. After this, experimental studies showed that various anti-nociceptive methods applied before injuries were more effective in reducing post-injury central sensitization in contrast to administration after injury5.Woolf, in 1983, first introduced the theory of preemptive analgesia to attenuate postoperative pain7. ‘Wind up’8, another mechanism activating spinal sensory neurons, is seen after reiterated stimulation of C-fibers. These sensitizations produce c-fos expression in sensory neurons9, and are related to the activation of N-methyl-D-aspartic acid (NMDA)9 and neurokinin receptors11. These genes produce long-lasting changes in the pain-processing system, resulting in hyperexcitation. According to Wall, protection of sensory neurons against central sensitization may provide relief from pain after surgery12. Based on this assumption, preemptive analgesia has been recommended as an effective aid to control postsurgical pain14. NMDA antagonists have been demonstrated to block the induction of central sensitization and revoke the hypersensitivity once it is established15.After activation of C-fibers by noxious stimuli, sensory neurons become more sensitive to peripheral inputs, a process called central sensitization16. Since ketamine is an NMDA-receptor antagonist, it is supposed to avoid or revoke central sensitization, and thus to attenuate postoperative pain17.Ketamine is an old drug that is increasingly being considered for the treatment of acute and chronic pain. Its pharmacology and mechanism of action as an NMDA receptor antagonist are adequately known, but in clinical practice it presents irregular results-1∙min-1 when given as a constant infusion19.This antihyperalgesic action can be achieved by smaller doses than those required for anesthesia. Small-dose ketamine has been specified as not more than 1 mg/kg when given as an iv bolus, and not higher than 20 µg∙kg21. According to one study19, a single dose of ketamine 1 mg/kg, when administered in conjunction with local anesthetics, opioids or other anesthetics, provides good postoperative pain control17.Low-doses preemptive ketamine administered iv seem to reduce postoperative pain and/or analgesic consumption24, clinical reports are mixed29; some authors have described positive effects30 while others have not31.Regardless of the overwhelming effectiveness of preemptive ketamine in animal experiments32, there is still conviction among researchers and clinicians in the effectiveness of preemptive analgesia5.While early reviews of clinical findings were mostly contradictoryTo our knowledge, no prior controlled study has determined the effectiveness of preoperative low-dose iv ketamine as contrasted with placebo in adults after open colon surgery. Thus, this clinical trial was designed to examine the postoperative analgesic effectiveness and opioid-sparing effect of single low-dose iv ketamine in contrast with placebo administered preoperatively.After receiving authorization from the Institutional Ethics Committee (Protocol code MK334037) and according to Helsinki, Tokyo, and Venezia statements, 48 patients undergoing general anesthesia for open colon surgery at the C. Hospitalario Arquitecto Marcide - Profesor Novoa Santos, were studied. This was a randomized controlled clinical trial, ClinicalTrials.gov identifier: NCT02241278.Study candidates were identified from the surgery schedule and contacted for consent 1–7 days before surgery. All patients gave written, informed consent, after explanation about the objectives, methods and potential risks of the study. Procedures included open colon resections, right hemicolectomy and left hemicolectomy.Inclusion criteria were age between 18 and 75 years, normal Body Mass Index (18.5–24.9), ASA class I, II or III, elective surgery, surgery time between 60–150 min, understanding of the Visual Analog Scale (VAS), lack of allergies or intolerance to anesthetics and absence of psychiatric illness. Exclusion criteria included cognitive deterioration, inability to use the Patient-Controlled-Analgesia (PCA) device, history of chronic pain syndromes or chronic use of analgesics, sedatives, opioids or steroids, liver or hematologic disease, history of drug or alcohol abuse and intolerance to ketamine or Paracetamol.Patients were instructed preoperatively on the use of the VAS for pain assessment and the PCA device. The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).Randomization was based on computer-produced random-block codes maintained in successively numbered envelopes and organized in a double-blinded manner. Pharmacy-prepared 50 mL solutions containing either ketamine (0.5 mg/kg) or placebo were given to anesthesiologists. The anesthesiologists and patients were not aware of the treatment groups. The investigator, unaware of the treatment groups and not implicated in patient’s intraoperative care, performed postoperative assessments.All subjects were premedicated with metoclopramide 10 mg and ranitidine 300 mg v.o. the night before and at 07.00 h on the day of surgery, and with diazepam 5–10 mg v.o. the night before surgery. In the operating room, the anesthesiologist administered 0.5 mg/kg of ketamine chlorhydrate in 0.9% saline iv to patients in the ketamine group and 50 mL of 0.9% saline to the control group 30 minutes before surgical incision. Besides routine monitoring, the patients were monitored with spectral entropy through an Entropy Module  and muscle relaxation (M-NMT module).-1∙min-1 iv (0.25 µg∙kg-1∙min-1 in patients over 65 years old), muscle relaxation with succinilcoline 1 mg/kg or cisatracurium 0.15 mg/kg. Anesthesia was maintained with nitrous oxide 50% and sevoflurane 0.5–1% in 50% oxygen, remifentanyl in continuous infusion at 0.5–1 µg∙kg-1∙min-1, and neuromuscular blockage with cisatracurium in bolus of 0.06 mg/kg on demand. Anesthesia was adjusted to keep arterial blood pressure and heart rate within 20% of preinduction levels. 30 min before surgical closure, 0.10 mg/kg of morphine was administered iv; a continuous infusion of morphine (PCA) was initiated at 0.015 mg∙kg-1∙h-1 and planned to deliver a bolus of 0.02 mg/kg of morphine on demand, with a lockout interval of 10 min. The infusion of remifentanyl was stopped at the end of surgery. Decurarization if necessary was achieved with atropine 0.01 mg/kg and neostigmine 0.03 mg/kg. The use of opioid reversal agents, different analgesics to the ones studied and other treatments that could interfere with the pain evaluation was not permitted. Patients were extubated in the operating room and moved to the Post-Anesthesia Care Unit (PACU).After premedication with atropine 0.01 mg/kg if necessary, general anesthesia was induced with propofol 1–2 mg/kg , remifentanyl at 0.5 µg∙kgPain severity was evaluated at time 0 (at entrance in the PACU), and at 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. Pain was graded using the VAS. If VAS >5, a rescue dose of Paracetamol 1 gr iv was given as rescue analgesia. The cumulative amounts of morphine administered through the PCA as a basal infusion and the incremental supplemental bolus required by the patient were documented at these same time points. Hemodynamic parameters such as Blood Pressure (BP) systolic, BP diastolic, heart rate and respiratory rate were measured at these same time points. The time interval for the first demand of analgesia and the number of times a rescue dose was injected in the first 24 hours were recorded. Global patient satisfaction (0–3), regarding pain control, was measured 24 hours after the operation. All adverse effects and their characteristics were recorded.Prior to the study, we calculated the sample size needed for justifying the assumption that postoperative pain (VAS) would be less in the ketamine group than in the control (primary outcome measure). A mean difference in VAS scores of 2.05 (assuming a target of 20.5% reduction in VAS scores) between groups in the first 24 hours postoperatively was defined as clinically relevant. This criterion was based on the results of a previous pilot study at our institution using the same surgical population and the same outcomes. The required sample size to reveal clinically relevant reductions was estimated to be 24 patients per category, giving a statistical power of 0.80 and a type I error protection of 0.05.We performed a descriptive analysis, presenting the numerical variables as mean ± standard deviation and the categorical variables as integer values and percentages.Categorical variables were contrasted between groups with the Chi-square test. Numerical variables were compared between groups, after checking the assumption of normal distribution with the Kolmogorov-Smirnov test, with the Student’s t-test test or the Mann-Whitney U-test accordingly.Variables in the different time points were compared with the Friedman test for related groups. The level of significance was established at P<0.05. Data were examined utilizing SPSS statistical software (v.19.0).Data on the effect of preoperative low-dose ketamine in opioid-naïve patients undergoing colon surgery when nitrous oxide is usedThe file shows in the ketamine and control groups the original patient’s demographic data, intraoperative analgesic data and duration of surgery, the Visual Analog Scale (VAS) scores from time point 0 to time point 7, and the hemodynamic parameters (blood pressures systolic (tad) and diastolic (tas) in mmHg, respiratory rate (fr), and heart rate (fc)) from time point 0 to time point 7.Variables: Sex: 1=male, 2=female; VAS score between 0 to 10; Remifent (ml): 1 ml=0.01 mg of remifentanil; Morf (mg): morphine administered at the end of surgery.Click here for additional data file.A total of 48 patients were recruited during 8 months and completed the study. All patients were discharged and no patients presented any severe postoperative complications.No significant differences were observed between the two groups in demographics such as ASA group (P=1.000), sex (P=0.745) or age (P=0.177). However, they were different in weight (P=0.015) . The twoThere were no statistically significant differences in VAS scores between the groups, except at 4 hours of arrival to the PACU, when the scores in the ketamine group were higher than in the control group (P=0.040). We could see a significant effect of time in pain scores for each group separately (P<0.001) . On arriNo significant differences were assessed between the two groups in cumulative consumption of morphine at any time point during the first postoperative 24 hours .The effect of time on morphine consumption through PCA in the entire postoperative period was not statistically significant (P>0.05). .The amount of incremental postoperative doses of morphine consumption in bolus from the PCA was comparable in the two groups. We found no statistically significant differences among groups, except at 12 h (P=0.013) and 24 h (P=0.002). It seems the need of additional boluses of morphine over the basal infusion rate of the PCA was slightly higher in the ketamine group at all time points, except immediately after arrival at the PACU . The totNo discordances in patient satisfaction were detected between the groups (P>0.05). The majority of patients rated their pain control as excellent across the 24 h after the operation.Secondary effects encountered in the ketamine group were nausea (5 patients), urinary retention (1 patient), vomiting (1 patient), incoercible vomiting (1 patient). In the control group they were nausea (3 patients) and urinary retention (2 patients). The differences among groups were not significant (P>0.05). No patient encountered any side effects interpreted as severe .When evaluating the hemodynamic parameters as an indirect measure of pain, we found the following results. The BP systolic at all time points during the postoperative 24 h was very similar between both groups . We could appreciate a slight increase of BP systolic on arrival at the PACU, with a progressive decrease over the 24 h until final stabilization. The BP diastolic was comparable between both groups, with no major statistical deviations, except at 0 h (P=0.026), 8 h (P=0.02) and 24 h (P=0.02), being higher in the ketamine group. These differences did not appear to be clinically significant. The respiratory rate showed no differences between both groups, except at 0 h, being higher in the placebo group (P=0.027), but this difference was not clinically significant. There were no significant differences among groups in heart rate .33. Studies have shown a preemptive effect34 and others have not36. Some authors found a 40% decrease in PCA morphine consumption21 and a decrement in hyperalgesia 48 hours37 and 7 days38 after surgery. Barbieriet al.39 recorded lower VAS results until 24 hours after elective laparoscopy for ovarian cysts in patients given 1 mg/kg im ketamine before surgery. Fuet al.15 contrasted the analgesic effect of a presurgical loading dose (0.5 mg/kg), followed by a constant infusion (10 µg∙kg-1∙min-1) with a single postsurgical dose (0.5 mg/kg). They found a significant decrease in PCA morphine consumption 48 h after surgery in the preemptive group26.Demonstration for a clinically significant preemptive analgesic effect of low-dose ketamine is questionableWe can deduce from our results that no significant intergroup distinction was encountered in the pain scores. Neither a morphine-sparing effect nor a lower mean supplemental dose of morphine through the PCA was demonstrated at any point in time in the ketamine group.Despite these results, we observed good analgesia in the immediate postoperative period; as reflected in the pain scores, which were low in both groups and within the maximum limits of VAS 3–4.5; these scores are usually assumed as adequate. As clinically evaluated, there was no activation of the sympathetic nervous system induced by pain in the postoperative period, evidenced by the lack of significant rises in blood pressure, heart rate or respiratory rate. Also, the incidence of adverse effects was low.18. However, we cannot unequivocally conclude that ketamine has no preemptive effect from the above information.Still, we expected that if ketamine had a preemptive analgesic effect, this would have become apparent in the immediate postoperative stage, with significantly lower consumption of morphine and lower pain scores in that group40 and Dahl41, examinations on preemptive substances should attempt to clarify whether these substances have a postoperative analgesic effect when clinically pertinent anesthesia, including perioperative opioids, have also been delivered. In all patients, anesthesia was induced and maintained with remifentanil. This may have hidden the preemptive analgesia of ketamine26.A possible explanation is the anesthetic procedure. As debated by Katz43. Since even short phases of C-fiber stimulation from surgical injury can lead to sensitization of the central nervous system44, it seems that the constant intraoperative administration of opioids would be superior to reiterated boluses. In our study, the perioperative administration of opioids (remifentanil and morphine) could have blocked, at the presynaptic opioid receptors at the terminals of the C fibers, the release of afferent transmitters involved in pain transmission. Thus, the administration of an NMDA receptor antagonist may have been redundant18.Animal and human investigations propose that the use of adjuvant drugs as part of general anesthesia can act on the central sensitizing effects of surgical stimuli, making it more complex to discern a preemptive effect45 and to show a preemptive analgesic effect42. Experimental evidence exists in rats that nitrous oxide does block spinal sensitization42, perhaps by the same mechanism as opioids46. However, Gotoet al.42 demonstrated that halothane and isoflurane47 moderately antagonize this effect equally. Nevertheless, some studies using oxygen/nitrous oxide have exhibited a preemptive analgesic effect49.Moreover, anesthesia was maintained with nitrous oxide in both groups, which has been shown to diminish nociception-induced spinal sensitization in rats26.Another potential problem was the small dose of drug administered, which might have caused a deficient afferent antinociceptive blockade in the preemptive group. This small dosage has a brief length of action, and central sensitization may have been generated when the pharmacological action of ketamine ended26. Nonetheless, the psychomimetic effects of ketamine limit the clinical value of large-dose ketamine50.Sensitization is a persistent phenomenon, conditional to the amplitude and length of the nociceptive stimulus. Our study centered on major surgery, where deep noxious stimuli continues during surgery and may even extend postoperatively. The best method to avoid sensitization may be to intercept any pain from the time of incision until final lesion recoveringet al.51, ketamine acts primarily on opened ionic channels to prevent neuroplasticity52. When the drug is given prior to surgery, the channels are not in an open phase, because no noxious stimulus is present. Therefore, it is conceivable that ketamine, because of its brief length of action, must be given as a continuous infusion to inhibit the intraoperative noxious stimuli and the ‘wind up’ occurrence51.As suggested by the study of Subramaniamet al.53 described in their work that postoperative morphine need was not diminished when 0.5 mg/kg ketamine was given preemptively. Ngan Keeet al. illustrated that the postoperative analgesic demand was diminished when 1.0 mg/kg was given in their study54. In spite of this, in other studies 0.5 mg/kg of ketamine was useful for alleviating postoperative pain after abdominal surgery15, and in others the need for analgesia after cesarean section was diminished with administration of a low dosage of 0.15 mg/kg56. In another article the morphine demand was similar in three categories of cesarean section subjects given 0.25, 0.5, or 1.0 mg/kg of ketamine57; hence, it is plausible that the preemptive analgesic action of ketamine might not be dose conditional58.Reza33. Laskowskiet al.59 concluded from their study that the efficacy of ketamine was superior in upper abdominal operations, thoracotomy, or if the VAS score was ≥ 7, in contrast to lower abdominal surgery or if the VAS score was < 4. After colon surgery, pain intensity is moderate and may not create adequate highly noxious stimulus to ascertain any clear differences between groups26.The choice of surgical procedure may also help to explain our results. Low intensity noxious stimuli during surgery may not incite sufficient central sensitization to create a clear difference between the study groupsIn conclusion, this study failed to exhibit a preemptive analgesic effect of 0.5 mg/kg iv preoperative ketamine, showing no significant advantage on postoperative pain and analgesic consumption. Thus, further comparative and controlled studies of the effects of higher doses in larger study sizes are required before definitive recommendations can be presented.Patient enrollment for this clinical trial took place during the years 2001 and 2002. The study was not registered prospectively prior to patient enrollment because at the time the trial began enrollment of subjects (years 2001–2002) it was not mandatory the registration of clinical trials on account of the Spanish regulations. The trial was registered on 09/11/2014.10.5256/f1000research.5258.d3561660F1000Research: Dataset 1. Data on the effect of preoperative low-dose ketamine in opioid-naïve patients undergoing colon surgery when nitrous oxide is used, The authors have investigated the role of preoperative ketamine on analgesia in opioid-naive patients undergoing open colon resection. This was a negative study, showing no significant differences in VAS or opioid consumption over the first 24 hours postoperatively.Overall it was a well conducted study. Perhaps the authors could comment on why epidural analgesia was not utilized for open colon resections (though it is unclear whether this would have affected the outcome measures). The dose of ketamine given preoperatively is low. It would be interesting in future studies to use an infusion of ketamine and to include opioid tolerant patients as a study population.I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. This is a useful paper insofar as it seems to indicate that a short-term administration of ketamine does not improve postoperative pain control. The evidence in the literature is contradictory and more data is needed.Study DesignType of surgery and anesthetic technique were homogenous. The exclusion of prior chronic pain syndromes or use of pain medication also helps make the study population more homogeneous, although I would question whether there might be some added benefit of ketamine in patients who are taking chronic opioids.I wish the authors briefly gave the results of their pilot study, especially the standard deviation that was used to calculate the sample size.As the authors say in their discussion, 0.5 mg/kg ketamine is a relatively low dose. With a t 1/2 of 10 -15 min and an active metabolite that has 1/3 efficacy and also a relatively short t 1/2 of 2.5 h, it is questionable whether the objective of modulating the NMDA receptor response was achieved, and that is probably why there was no benefit of the ketamine administration. Maybe the authors should consider repeating the study using a ketamine infusion.Second, the administration of a continuous postoperative morphine infusion of 0.015 mg/kg/h may have created some "background noise" and obscured a difference in VAS score or difference in the amount of self-administered morphine.Article contentThe study is well conducted. Data is complete and well analyzed. The discussion is well conducted and addresses the study rationale, findings, and main limitations.There are a few typos: remifentanil, succinylcholine, psychotomimetic.We have read this submission. We believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.


The ExAblate system is a non-invasive thermal ablation device that has been used for the ablation of tissue. This system combines a focused ultrasound surgery delivery system and a conventional diagnostic 1.5 T MRI scanner (MRgFUS/MR guided focused ultrasound surgery). Starting from 2009 up to 2012 our Institute participated in the clinical randomized multi-site study to evaluate safety and efficacy of MRgFUS for palliative treatment of Bone Metastasis. This study was approved by FDA at 18 October 2012.InSightec, Haifa, Israel) at Petrov Research Institute of Oncology, St. Petersburg, Russia. And 10 patients had a placebo treatment. Immediately after procedure patients were examined for any adverse events and after a brief recovery discharged. Patients were followed up on 1 and 3 days, 1 and 2 weeks, 1, 2 and 3 months post treatment. During each visit, treatment safety was evaluated by recording and assessment of device or procedure related adverse events. Effectiveness of palliation was evaluated using the standard pain scale (0-no pain/10-worst pain imaginable) and by monitoring changes in the intake of pain-relieving medications. A reduction of 2 points or more on pain scale was considered a significant response to treatment. 5 patients were male and 32 female. Mean age was 58 years old (19-79). The primary cancers were: 29 breast, 2 rectum, 1 stomach, 1 bronchus, 1 bladder, 3 other. Targeted lesions were 6 osteolytic 31 mixed. 23 were pelvis metastases, 4 were located in the femoral bone, 2 were located in the upper extremity bones and 8 were located in the ribs.In our study were recruited 37 patients with painful bone metastases. 27 patients had a real treatment with the ExAblate® system (No significant device or procedure related adverse events were recorded. 2 patients died during the follow-up period due to disease progression, thus 3 months follow-up data includes only results of 35 patients. All 27 patients from real treatment group were reported significant improvement in pain with no change in their medication intake. Mean worst pain score at baseline, 1 day, 3 days, 1 week, 2 weeks, 1, 2 and 3 months post-treatment was 6.9, 6.1, 5.1, 3.5, 2.6, 1.8, 1.2 and 0.9.Results of the study that was performed, palliation effects are significant in terms of mean improvement, the number of treated patients who reported symptomatic improvement and in their potential durability. Based on the above ExAblate treatment has a potential to be treatment of choice for radiation failure patients.


Damaged connective tissue commonly leads to lower extremity injuries. These injuries can result in inflammation, reduced mobility, and chronic pain. Conservative treatment may include orthotics, offloading the injury, physical therapy, and/or NSAIDs. If conservative treatment fails, surgical intervention may be required. Even after successful surgery, these procedures often result in reduced joint mobility and tendon or ligament strength.A novel flowable tissue matrix allograft, derived from human placental connective tissue, has recently been made available for minimally invasive treatment of damaged or inadequate tissue  .Based on the universal role of connective tissue in the body, and its reported antimicrobial, anti-adhesive, and anti-inflammatory properties, we assessed the effects of using this placental tissue matrix in the treatment of a series of lower extremity injuries.In this pilot study, 9 of 10 patients reported pain levels of 2 or less by week four using the VAS pain scale. This short-term pilot study effectively shows that injectable, flowable amniotic allografts can be used for orthopedic sports injuries of the lower extremities. Damaged connective tissue commonly leads to lower extremity injuries. These injuries can result in inflammation, reduced mobility, and chronic pain . ConservA novel flowable tissue matrix allograft, derived from human placental connective tissue, has recently been made available for minimally invasive treatment of damaged or inadequate tissue  .Based on the universal role of connective tissue in the body , and itsConnective tissue is one of the four fundamental types of biological tissue found in the human body . It is tConnective tissue is found under the skin and all epithelia; in the outer covering of nerves; around organs; in the fascia between muscles; in the fibrous sheath around bones; and creates tendons, ligaments, cartilage and bones .All connective tissue consists of three main components: Fibers, Ground Substance and Cells. The cells of connective tissue are embedded in an ExtraCellular Matrix (ECM). The ECM, in turn, consists of the fibers embedded in a featureless ‘ground substance’ .The function of connective tissue in the body includes the binding of organs, structural support, physical protection, immune protection, and movement .The human placenta is a potentially rich source of biological tissue, comprising the placenta, the amniotic membranes, the amniotic fluid, the umbilical cord, and the umbilical cord blood .The extracellular matrix (ECM) components of these tissues include collagens , fibronectin, nidogen, laminin, proteoglycans, and hyaluronan, as well as growth factors .Placental tissues have been reported to be non-immunogenic, providing a tissue source that elicits little or no immune response in the patient, reducing the risk of rejection, and graft failure -14. FurtHistorically, most clinical reports on the use of placental tissues have discussed the use of amniotic membranes for an array of clinical applications since the 1920’s -19. ThesThe investigator contracted with Midlands IRB for this study. Midlands IRB ruled that this pilot retrospective study review of existing patient records was exempt from IRB review in accordance with 45CFR46.101B. The data collected was without identifiers or link to identifiers. Additionally, the investigator who would normally have access to the records as part of the patients’ routine clinical care conducted the records review. Patients were consented to treatment prior to engagement of the injection protocol.A retrospective pilot cohort study of 10 patients were selected from the treating physician’s own patient population at a single clinical site. Male and female patients were randomly selected without bias to gender. Patients were identified as having a musculoskeletal injury involving the lower extremity. All patients were initially screened using the Visual Analog Pain Scale. Patients were identified with either acute or chronic tendon or muscular injuries of the lower extremities, including: posterior tibial tendonitis, peroneal tendonitis, anterior tibial tendonitis, extensor muscles of the foot,  plantar musculature of the foot excluding the plantar fascia, and Achilles tendonitis.Exclusion criteria included joint arthritis, plantar fasciitis, cellulitis of the lower leg, infection of the lower leg, or hypersensitivity to amniotic tissue products.The qualifying patients were then identified as having the acute or chronic tendon injury defined through history and physical and musculoskeletal advanced ultrasound imaging by the treating physician. Visual pain scales were used on a weekly basis to assess patient’s self-reported pain level starting at week 0 and followed through to week six. Ultrasound non-vascular extremity examinations were performed at week 0 at the time of injection of the flowable allograft tissue matrix and again at week four and week six. Images were recorded in real-time and assessed in both longitudinal and transverse planes. The investigator on every patient performed the injection technique of the allograft tissue. The technique included a mixture of 1.0 cc Bupivicaine 0.5% plain and 0.5 cc of the ambient temperature, flowable allograft tissue matrix. The injection was performed under a sterile field condition using ultrasound guidance to target the injection material to the area of injury. Patients were then dispensed a pneumatic short leg ankle walking boot (Ossur) and instructed to utilize the boot for weight-bearing for two weeks post-injection. Patients were instructed how to use the walking boot properly and effectively for off-loading and stabilization post-injection.In addition, demographic, injury history, and previous treatments (if applicable) were obtained. This included age, gender, ethnicity, smoking history, and BMI. Table Age ranges were from 23 to 77 with a median of 52.5. Seven patients were female and three were male. Almost all (nine) of the patients were white, non-Hispanic. BMI ranged from 15.55 to 37.32 with a median of 27.79. Posterior tibialis tendonitis was the predominant injury treated (n=4), followed by Achilles tendonitis (n=2), flexor hallucis tendonitis (n=2), anterior tibialis tendonitis (n=1), and abductor digiti minimi tendonitis (n=1). Table Overall, all 10 patients improved to pain scores of 0 by the end of the evaluation period. Nine of the 10 patients declined as expected with their pain ratings. Only one patient had an increase of pain, and that was due to another area of the posterior tibialis tendon becoming pathologic outside of the injected target area. By week three, in nine of the 10 patients enrolled, all had pain levels improved 75% or greater by week three.Eight of the 10 patients reported VAS pain score of 0 by week 4.Pre-injection pathology is shown in Figure Figure Overall, all ten patients resolved their pain by week five. Based on the VAS pain scores reported, these 10 patients show a strong correlation for using amniotic tissue allograft injection to resolve acute tendon injuries rapidly.  Further research would be needed to compare the use of amniotic allograft tissue injections versus corticosteroid injections head-to-head, and further larger studies, including randomized controlled trials, may elucidate the reasons for these differences.In patients with acute tendon or musculoskeletal injuries of the lower extremities, the use of this newer injectable amniotic tissue allograft shows efficacy in reduction of pain within six weeks of injection. This particular therapy shows extensive promise in the ability to keep patients adherent to treatment regimens with a higher retention rate of success than standard tendon injury treatment techniques. In most cases of acute on chronic tendon injury, the need for regenerative medicine modalities only increases as the population increases in age and activity level. With the advent of more active older adult lifestyles, the need for these types of therapies will be more in-demand than in years past. As technologies advance with better sports gear and equipment, so must our need as physicians to improve the outcomes of patients whose motives are for a quicker return to activities without the need for advanced surgical treatments. The need for advanced medical alternatives to surgery must be paramount in the treatment of these patient populations now and in the future.Due to the nature of this single-center, single investigator study, further research is needed with a larger sample of patients to verify the VAS pain score ratings encountered here in this pilot study. While there was bias from a single investigator, the author was very careful with regard to moderating the scoring system used by the patients to report their pain. Also, the author made every attempt to reduce bias by standardizing the injection technique, the administration of local anesthetic in similar amounts to each patient, and the utilization and interpretation of ultrasound guidance.Due to the nature of only a few injectable amniotic tissue allografts in the market, it is necessary for qualified health professionals choose the proper therapy for patients with acute tendon injuries. As with all injectable treatments, the standards of care should be used in conjunction with newer allograft techniques to obtain optimal results.


Aloe vera-containing, transdermal fentanyl matrix patch (Fentavera), for its analgesic effects, patients' quality of life (QoL) effects, tolerability, and adhesiveness. Study outcomes were mean changes from baseline of patient  and physician  ratings. After 1 and 2 months treatment, there were significant (P < 0.0001) decreases in patients' ratings of pain intensity, and impairment of walking, general activity, sleep quality, and QoL. For each parameter, the patient response rate was >30% at 2 months . In a large majority of patients, the physicians rated the matrix patch as good or very good for analgesic effect, systemic and local tolerance, and adhesiveness. There were 30 adverse events in 4.2% of patients and analgesic comedications were reduced during treatment compared to before treatment. It is concluded, from this population-based data, that the proprietary, transdermal fentanyl matrix patch is effective and safe for chronic pain management in clinical practice, with significant positive analgesic and QoL effects, while being well tolerated and exhibiting good or very good adhesiveness.Fentanyl is considered to be an effective, transdermal treatment of chronic, cancer, and noncancer pain. This noninterventional, clinical practice-based study, on 426 patients attending 42 practices, assessed a proprietary,  Chronic pain is defined as pain occurring for longer than several 3–6) months. Its incidence has been estimated as being close to 20% of the population and presents a large financial burden in terms of cost of treatment and loss of productivity and seriously affects the quality of lives of affected individuals –3. The p–6 monthsOpioids are already the mainstay of cancer pain treatment , with abFentanyl is a potent opioid and a treatment option at the top (step 3) of the WHO pain treatment ladder . It is an = 657) or noncancer pain (n = 563) showed that both fentanyl and morphine are effective by transdermal application [Transdermal application of opioids has been developed to allow a long-term, continual, and stable level of analgesia, while avoiding the gastrointestinal adverse effects of oral opioids . In prollication , with imlication  and in tlication . Transdelication  and may lication . Aloe vera, which is a herb that is widely-used in skin cosmetic products [The adhesive polymer-matrix system of the transdermal patch used in this study differs from the standard reservoir transdermal patches and may be associated with a reduced risk of drug leakage. Matrix patches have been shown to be safe and efficacious in treating cancer pain , 23–25 aproducts  and has products . The adh Aloe vera extract. The study aimed to include large number of adult patients with chronic pain that was responsive to opioid treatment. The effectiveness of transdermal fentanyl (Fentavera) matrix patches was assessed in terms of effects on the patients' pain intensity, their mobility, their sleep, and their QoL, using standard 11-point numerical rating scales. Additionally, the tolerability, safety, and adhesiveness of the patches were assessed using standardised questionnaires. The cause and location of the pain were recorded but were not inclusion or exclusion criteria. A fixed period of about six months  was selected for recruitment. During this period, a total of 426 patients from 42 centres (from across the whole of Germany) were observed and included in the study.This was a multicentre, noninterventional, open-label study conducted in Germany. The objective of the study was to assess the effectiveness, in normal clinical practice, of a proprietary transdermal matrix patch containing fentanyl and anThe study was conducted according to German law on medicinal products (AMG) , which sThe transdermal patch that was used throughout the study was the product Fentavera , which is a matrix patch, not a reservoir patch, and is available containing a range of amounts of fentanyl base. The patch allows a slow, constant release and transdermal absorption of fentanyl, at a rate of 12, 25, 50, 75, or 100 microgram/hour  that is The fentanyl dosages received by the patients in this study varied, as would be expected according to the product label , which sThe study parameters, which were recorded at the start and after one and 2 months of treatment, were (i) pain intensity (type and origin of pain were recorded at the start of the study); (ii) fentanyl dosage; (iii) impaired mobility; (iv) impaired sleep; (v) impaired QoL; (vi) overall effectiveness of treatment; (vii) tolerance to the treatment, systemic and local (skin); (viii) adhesiveness of the matrix patch; (ix) comedications; (xi) adverse events (safety). The degree of algesia (pain intensity), impaired mobility , impaired sleep, and impaired QoL (“lust for life” and mood) were subjectively rated by the patients, using an 11-point scale from no pain or impairment (=0) to most extreme pain or impairment (=10). The overall effectiveness, systemic and local (skin) tolerability, and adhesiveness of the patch were subjectively rated by the physician, using 5-point scales .The attending physician was requested to record all adverse events and was provided with forms for noting all the relevant details.The mean change from baseline of the patients' subjective point scores for each outcome was tested for statistical significance using comparison of the 95% confidence intervals (CI) of the mean change from baseline at one and 2 months.n = 119; 28%) patients who were opioid-naïve at the start of the study  decreases in the patients' rating of both their impaired walking ability  decreases were recorded in the patients' perception of the levels of disturbed sleep  matrix patch at one month and 2 months treatment and 86.38% and 91.03%, respectively, of cases exhibited “very good” or “good” systemic tolerance, while <3% exhibited “poor” or “very poor” tolerability.The physicians assessed the local tolerability of the transdermal fentanyl (Fentavera) patch at one month and 2 months treatment. At both assessment intervals, more than 90% of cases exhibited “very good” or “good” local tolerance, while there were rare cases of “poor” or “very poor” tolerance.The physicians assessed the adhesiveness of the transdermal fentanyl (Fentavera) matrix patch at one month and 2 months treatment. At both assessment intervals, more than 87% of cases exhibited “very good” or “good” adhesiveness, while there were rare cases of “poor” or “very poor” adhesiveness.Thirty adverse events were reported in 18 (4.2%) of patients . The advThis large multicentre observational study provides a comprehensive real-life assessment of the effectiveness of the transdermal fentanyl (Fentavera) matrix patch in patients with chronic pain.There are a few other noninterventional studies that have been published and these have shown the efficacy of transdermal fentanyl in cancer and noncancer pain , 34, 35. Aloe vera, which is a common ingredient of skin cosmetics. The only selection criteria for patients entering the study were that they were adult and had chronic pain, and that their pain was responsive to opioids. Mostly, the patients had pain due to cancer or cancer treatment and had various sources of pain, the most frequent of which were bone (66.0%) and neural tissue (46.2%) (μg/hour.The patch tested in this study was a matrix patch designed to provide a reliably constant and fixed rate of delivery of fentanyl and contained an extract of (46.2%) . A wide  (46.2%) , includiP < 0.0001) decrease in pain intensity, as rated by the patients, and this was consistent with the physicians assessment that a large majority of patients (68%) exhibited a “good” response or better. Subanalyses (data not shown) revealed that, for all causes of pain, the mean pain reduction was at least 24% of baseline. The effective analgesia was also indicated by the drastically reduced number of patients taking analgesics during treatment with transdermal fentanyl (Fentavera) matrix patches compared to that at the start of the study (P < 0.0001) decreases in impaired walking and impaired general activity.All patient-rated outcome parameters showed a similarly significant mean degree of improvement following transdermal fentanyl (Fentavera) treatment after one month . For allhe study . The decP < 0.0001) improvements in both of the QoL outcomes that were assessed, “lust for life” and “mood.” Impaired sleep was also significantly (P < 0.0001) improved. Sleep is not often considered in health-related QoL surveys [Fentanyl is a well-established WHO-designated level 3 analgesic but its effectiveness in terms of improving QoL of the patient with chronic pain has not been extensively documented. Our findings indicate significant  matrix patch indicated good or very good systemic (in close to 90% of patients) and local tolerance (in over 90% of patients) and a good or very good adhesiveness (in close to 90% of treatments), with rare cases of inadequate adhesiveness being reported. Adhesiveness is an important issue, not only for effective treatment and patient compliance but also in regard to preventing accidental opioid abuse. The overall safety of the transdermal fentanyl (Fentavera) patches was very good with few patients (4.2%) reporting any adverse events .The study has certain limitations. There was no statistical correction made for multiple outcomes. The study was purely noninterventional and so lacked any control arm and was not designed to analyze any placebo effect. Selection of patients and their treatment regime was solely the responsibility of the attending physician and there was no recording of possible opioid addiction and no systematic monitoring of compliance or possible treatment abuse.The data presented here consists of a broad range of measures of effectiveness and clearly indicates that, in clinical practice, transdermal fentanyl is an effective and safe treatment for chronic pain management. In addition to positive effects on pain, mobility, sleep, and QoL, the proprietary transdermal fentanyl patch that was tested here was well tolerated and exhibited good or very good adhesiveness.


This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline  than in the WL Group . The same differences were observed 3 months post-intervention . The proportion of patients who reported ≥50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients’ experience.ISRCTN14526380International Standard Randomized Controlled Trial Number Register  Fibromyalgia syndrome (FMS) is a chronic disorder of unclear origin. Growing evidence suggests a combination of interacting neurophysiological, genetic, and psychosocial mechanisms as the cause of FMS ,2. This There is currently no cure for FMS nor is there a “gold standard” of treatment. Management of this disorder is therefore aimed at reducing symptoms and maintaining optimal functioning ,8. InterProgramme d’Apprentissage deStratégieSd’Auto-GestionEfficaces (Training Program of Efficient Self-Management Strategies).Based on the Interactional School of Low Back Pain ,18, BarcThe aim of the present study was thus to evaluate, quantitatively and qualitatively, the efficacy of the PASSAGE Program—a multicomponent interdisciplinary group intervention for the self-management of FMS. It was expected that the Program will lead to improvements in the clinical condition of patients suffering from this disorder.The French version protocol for this trial (as well as the English translation of the Methods section) and supporting CONSORT checklist are available as supporting information; see Comité d’éthique de la recherche sur l’humain du Centre hospitalier de l’Université Sherbrooke, Sherbrooke, Quebec, Canada  and by the Comité d’éthique de la recherche avec des êtres humains de l’Université du Québec en Abitibi-Témiscamingue (CÉR-UQAT), Rouyn-Noranda, Quebec, Canada . The study was registered at the International Standard Randomized Controlled Trial Number Register #ISRCTN14526380 .The research protocol of the present study along with the patient informed consent form were reviewed and approved by the Six adjustments were made to the protocol prior to enrolment. First, the upper age limit (65 years) was withdrawn. Second, patients suffering from chronic pain disorders other than FMS  were not excluded from the study as long as the pain associated with FMS was their predominant complaint. Third, potential participants had to accept to not introduce new pain medications or other new therapeutic modalities for pain management during the 11 weeks of the intervention because such a change in treatment could have biased our estimation of the intervention efficacy and made difficult to isolate its effects). Fourth, an additional training session for the health care professionals acting as facilitators was conducted to clarify some issues, answer questions, review the procedures, and insure uniformity between study sites. To minimize costs, this session was conducted via video conference due to the large distance between the two study sites. Fifth, research assistants were instructed to calculate the participants' scores on the Beck Depression Inventory (BDI) upon reception of their questionnaire. If a score > 30 was found and/or that participant reported suicidal ideas (question 9 of the BDI), the research assistant was instructed to contact the patient by phone and encouraged him/her to make an appointment with his/her treating physician (or psychologist) or to go the hospital emergency department. Finally, focus groups were added to the research protocol in order to document and further capture the patients’ experience.A mixed-methods, multicenter, open label, randomized, wait-list controlled trial with both a quantitative and a qualitative component was carried out in two university-affiliated settings between September 2009 and March 2011: 1) Sherbrooke, a suburban city located in the south of the province of Quebec (Canada), and 2) Rouyn-Noranda, a small city in the north of the province of Quebec (Canada). Study sites were chosen because of the clinical expertise of local teams with the ISF. Subjects were eligible for participation in the study if they: a) were aged 18 years or older, b) were able to read, understand, and complete questionnaires in French, c) had a medical diagnosis of FMS based on the American College of Rheumatology (ACR) classification criteria  for at lRecruitment was conducted through announcements in local newspapers in both study sites between September 2009 and October 2009. Interested subjects were invited to call the research coordinator who explained the study, reviewed some of the eligibility criteria, and fixed a first appointment with the potential participants one month prior to the beginning of the intervention. At the time of the first appointment, a pain physician established the FMS diagnosis using the ACR criteria , and a pth final session was carried out 6 months later to review progress and gain maintenance. The first two sessions were partly devoted to the establishment of a contract with the patient where she/he: 1) fixed three personal outcome goals to be met by the end of the intervention program, 2) determined the minimally acceptable changes to be expected, and 3) agreed to participate in all group sessions and to devote time during the week to the tasks prescribed at the end of each session—i.e., about 45 minutes/day, 6 times/week. Patients were informed that they will be excluded from the program if they missed 2 sessions.As mentioned earlier, the PASSAGE Program is a structured multicomponent interdisciplinary group intervention aimed at reducing FMS symptoms and maintaining optimal function through the use of self-management strategies and patient education. The intervention consists of 9 group sessions with 8 participants lasting 2.5 hours each. As shown in The sessions were always conducted in a well-equipped exercise room with mattresses, pillows, exercise balls, mirrors, sound system and computer equipment for Power Point presentations. These sessions were interactive and led by two health care professionals who both acted as facilitators, one being mainly responsible for the psychological aspect of the intervention and the other for its physical aspect. Patients were viewed as the “experts” of their condition, and were given a role of active partner in the management of their FMS. Except for Session 1, the others always started with customized exercise routines (15 min), including correction of posture and movements when needed. Participants were then asked to discuss their experiences with the prescribed tasks of the preceding week (including the practice of new self-management strategies) (15 min). Then, the two facilitators started the education part of the session during which various topics related to FMS symptoms and their management were covered see . Particito-do” and “not-to-do”, etc), and the second part took the form of a practicum with presentations of scenarios, role playing, and video demonstrations. The comprehensive course manual used during the training and given to each facilitator also contained a detailed description of the content of the sessions along with an annotated paper copy of the slides to be used in each session. A second training session was held via videoconference to clarify some issues, answer questions, and review the procedures.In order to ensure uniformity and standardization of the intervention program in both study sites, all health care professionals acting as facilitators attended a one-day structured training session which was held in Rouyn-Noranda . The first part of the training was devoted to theory  by a health care professional with experience with the ISF and who participated in the development of PASSAGE Program. Conference calls involving the researchers and study coordinators from each study site were also made on a weekly basis to review the procedure, discuss issues raised during the sessions, and ensure uniformity.Participants randomized to the WL Group were instructed to continue their treatment(s) as usual until they could take part in the PASSAGE Program—i.e., 3 months after the INT Group had completed the program. Changes in pharmacological or non-pharmacological treatments were allowed during this period in the WL Group .0), after the INT Group completed the 8 sessions of the PASSAGE Program (T1), and 3 months later (T2) (1), and 3 months later (T2), thereby providing efficacy data from another cohort of patients. Additional follow-up measures were also collected in the INT Group at 6 (T3) and 12 (T4) months after the completion of the PASSAGE Program so longitudinal data (T0 to T4) were available to assess the long-term benefits of the intervention in this group.Data were collected in both study groups at baseline (Tter (T2) . PatientData were collected at each time point with a self-administered questionnaire which was mailed to the patients along with a stamped return envelope to be mailed back to the research team within the next 7 days. Reminder phone calls were made if the questionnaires were not returned on time. Upon reception, questionnaires were carefully verified, and a research assistant contacted the patients if any information was missing or if their depression scores on the BDI was > 30 and/or they reported suicidal ideas (question 9 of the Beck Depression Inventory) (see Section Protocol and Adjustments).verbatim), and annotated with the interviewer’s field notes.In order to document and further capture the patients’ experiences, face-to-face open-ended narrative qualitative group interviews were conducted in each study site. Interviews took place 6 to 9 months after completion of the PASSAGE Program, and were conducted by the same interviewer in both sites. The interviewer had an extensive experience in qualitative research interviews and was, until then, unknown to the study participants. Nine patients from the Sherbrooke site  and 7 from the Rouyn-Noranda site  volunteered to participate in the group interviews. The same interview guide was used in both study sites and it included open-ended questions aimed at covering three main topics related to the research objectives. Participants were asked to talk about 1) their experiences during the intervention, 2) its impact on their daily life, and 3) their general appraisal of the intervention. The group interviews lasted between 60 and 90 minutes, and were audio-taped, entirely typed-written  where 0 indicated “no pain” and 10 “worst possible pain” ,24. At eThe choice of the secondary outcomes was based on the characteristics of the FMS symptomatology, the rational/objectives of the proposed intervention, and the IMMPACT Group recommendations ,21 as weThe first set of secondary outcomes measured specific symptoms or dimensions of the patients’ condition prior to the beginning of the intervention (T0) and at follow-up times—i.e., T1 and T2 in both groups, and T3 and T4 in the INT Group only.www.myalgia.com/FIQ) and ranges from 0 to 100, where a higher score indicates a greater impact of FMS.Severity of FMS was measured with one of the most widely used tool in this research field, the Fibromyalgia Impact Questionnaire (FIQ) which is a disease-specific instrument designed to evaluate the impact of FMS by providing a multidimensional assessment of the overall severity of FMS ,26. The The extent to which patients’ pain interfered with various aspects of their daily living was assessed with the 10 interference items of the Modified Brief Pain Inventory (BPI) ,28. ThesConsidering the high frequency of sleep problems in FMS patients and the potential interrelations with pain ,30, the The Coping Strategy Questionnaire (CSQ) ,33 was uThe Beck Depression Inventory (BDI) Version 1 ,38 was uHealth-related QOL was assessed with a generic instrument—the Standard SF-12v2  . This quOur second set of secondary outcomes was oriented towards patients’ global impression regarding changes in their condition and overall perception regarding their treatment responses in terms of pain relief. These measures were collected in both groups at T1 and T2, and at T3 and T4 in the INT Group only.Participants were asked about their global impression of change in the past 3 months regarding their 1) pain, 2) level of functioning, and 3) QOL, using a modified version of the Patient Global Impression of Change (PGIC) Scale . The scaPatients’ overall perceptions of their treatment responses in terms of pain relief was assessed on a 0 to 100% Pain Relief Scale where 0% represents no pain relief and 100% represents complete pain relief 42]. Pat. Pat42].The sample size was calculated for the primary outcome  based on testing the inequality of two means in a repeated measures design. Previous reviews –46 estab0) sociodemographic and pain characteristics between the INT and WL Groups were carried out with parametric and non-parametric tests depending on the type of variables and their distributions . To detect if significant differences in continuous outcomes over time  were due to the intervention (Group x Time interaction effect), linear mixed models for repeated measures were used: 1) unadjusted model, 2) gender and study site adjusted model, and 3) fully adjusted model . When interaction effects were detected, post hoc pairwise comparisons using t-tests or Wilcoxon rank-sum tests were carried out with a Bonferroni correction. Effect sizes are presented as raw group differences (mean differences) and their 95% confidence intervals (95% CI). A negative effect size value indicates that the intervention was superior to the control group on negatively oriented outcome measures . A positive value indicates the intervention was superior to the control group on positively oriented outcome measures .Comparisons of the baseline (T1) and 3 months post-intervention (T2) using Chi-square tests and Fisher exact tests where appropriate. Effect sizes were computed as odds ratios (OR) and their 95% CI.Categorical outcomes such as the PGIC (proportion of patients reporting improvement) and pain relief (proportion of patients reporting ≥ 50% of pain relief) in the past 3 months were compared between the two study groups at the end of the intervention  were conducted. When significant differences were detected, post hoc comparisons were carried out using t-tests or Wilcoxon signed rank sum test. Raw effect sizes between T0 and T4 measures are presented as mean differences and their respective 95% CI.With the 12 months follow-up data from the INT Group, additional analyses were carried out to assess the effect of the treatment over a longer period of time. One-way ANOVAs with repeated measures on one factor  who then compared and reviewed their results until a consensus was reached.A thematic analysis of the qualitative data was conducted using the methodology proposed by Mucchielli . All ver2 measures: 20/43 received the intervention and 23/43 were on the waitlist. As mentioned earlier, this last group received the intervention at the end of the trial and were assessed up to 3 months post-intervention (17/23 patients completed follow-up).As shown in Socio-demographic and pain characteristics of the randomly assigned participants are presented in Group x Time interaction was found (P > .05). Effect sizes of -0.13 (95% CI: -1.37 to 1.11) and -0.55 (95% CI: -1.82 to 0.72) were found between study groups at T1 and T2 respectively.As shown in 0, T1, and T2. The mixed models results revealed no significant interaction between time and group assignment on the majority of these outcome measures. In other words, when compared with the WL Group, patients in the INT Group did not show more or less improvements over time with regard to the severity of their FMS condition , the extent to which their pain interfered with their daily living, the quality of their sleep, the type of strategies they used to cope with their pain, their tendency to catastrophize in the face of pain, the physical component of their health-related QOL , and their psychological well-being . The only Time x Group interaction effect that reached statistical significance was on the Ignoring Pain Sensations Subscale (P = 0.010) of the Coping Strategy Questionnaire. Although these results were suggestive of positive impact of the intervention on this measure, the results of the post-hoc analyses were not statistically significant after application of the Bonferronni correction.1 (end of intervention). Specifically, the likelihoods of reporting overall improvement in pain , level of functioning , and QOL  were higher in the INT Group than in the WL one. As shown in 0 and T1 compared with 8.0% (2/25), 12.0% (3/25) and 20.0% (5/25) in the WL Group. Furthermore, patients in the INT Group continued to perceive significant improvements in the 3 months following the intervention . When compared to the patients of the WL group, those of the INT Group were significantly more likely to report improvement in pain , level of functioning , and QOL . As for these three outcomes respectively, 61.9% (13/21), 42.9% (9/21), and 38.1% (8/21) of the patients in the INT Group continued to perceive improvements compared with 13.0% (3/23), 13.0% (3/23) and 8.7% (2/23) in the WL Group (2 but not at T1). As previously mentioned, additional PGIC ratings were collected in the WL Group (17/23) at the end of the trial once they also completed the PASSAGE Program. Close to 60% of them reported improvements in their pain , functioning , and QOL  between T0 and T1, while the percentage of those who continued to improve on these indicators 3 months following the intervention was 35.29% (6/17), 23.53% (4/17), and 29.41% (5/17) respectively.A different pattern of results emerged in the second set of secondary outcomes—i.e., measures of patients’ global impression of change (PGIC) regarding changes in their condition and overall perceived pain relief. Comparisons of the PGIC ratings revealed statistically significant differences between the two study groups at TWL Group   than in the WL Group  . Three months later (T2), one third  of the patients in the INT Group reported ≥ 50% pain relief compared to only 4.3% (1/23) in the WL Group . Once the WL Group completed the PASSAGE Program, 23.5% (4/17) of them reported ≥ 50% pain relief, and this percentage remained the same 3 months later.Significant group differences were also found in the measure of patients’ overall perceptions of pain relief. The proportion of patients reporting ≥ 50% pain relief between T3) and 12 months (T4) after the completion of the PASSAGE Program. One-way ANOVAs with repeated measures on one factor (time) revealed statistically significant mean differences across the different follow-up times (T0 to T4) regarding the NRS measure of average pain intensity in the past 7 days (P = .0263), the Fibromyalgia Impact Questionnaire (P = .0041), the Reinterpreting Pain Sensations subscale of the Coping Strategy Questionnaire (P = .0071), and the Pain Catastrophizing Scale (P = .0007) (0) and those at 12 months post-intervention (T4) only for the Reinterpreting Pain Sensations subscale of the Coping Strategy Questionnaire  and the Pain Catastrophizing Scale .A total of 18 patients (64.5%) assigned to the INT Group completed additional follow- up measures 6 (T= .0007) . Althoug3) and 12 months post-intervention (T4). In fact, at T3, 33.3 to 47.6% of the patients still reported improvements as experienced in the preceding 3 months while 23.8 to 38.1% reported being stable. Twelve months post-intervention (T4), 11.1 to 16.7% of patients reported improvements as experienced in the preceding 3 months while 16.7 to 38.0% reported stable levels. When asked about the percentage of pain relief experienced in the past 3 months, more than one quarter (28.6%) of the participants reported ≥ 50% pain relief at follow-up 6 months (T3) while 5.6% did so at follow-up 12 months (T4).On the global outcome measures, a good proportion of patients continued to report improvements or remained stable as revealed by their scores on the PGIC scales  at 6  support “I didn’t know that so many people suffered from FMS, now I feel less lonely”; and 3) motivation “Motivation of others helped maintain my own motivation.”; “The effect of the group stayed even when I was home. That is why I exercised even when I wasn’t in a mood to do so.” and “Even if I didn’t feel like going to the meeting, I went because I knew I would feel better.”The second emerging theme was GROUP cohesion. It appeared that being part of a group was more important than the participants expected it would be specifically in terms of the opportunity for: 1) sharing “They gave me tools to gain control over my symptoms and to understand how to do it.”; “They helped me realize that I did too much exercising. I learned to manage my energy.“; and “I learned how to say no and to accept my limits.”. The intervention also brought some behavioural changes among the participants: “Now when I talk to my friends, I am not talking only about my disease. I ask them how they are feeling.” and “I now have leisure activities, I go out with friends.”.The last emerging theme was INCREASED EMPOWERMENT. Participants described that the impact of the intervention went beyond the symptoms themselves in that they acquired new knowledge and learned how to self-manage their condition. “At the beginning of the intervention, I realized that my pain was like a budget. I understood that I will always have the same amount of money but I will now manage it differently. This is really different. When you manage your pain, it is less present, less intense”.Finally, the following verbatim provides a meaningful and insightful illustration of the global impact of the intervention: “The results of the present study suggest that the PASSAGE intervention had a positive short-term impact on patients’ overall perceptions of their condition as revealed by their scores on the PGIC  and pain relief scales compared to the patients who were assigned to the waitlist during this same period. Additional follow-up measures in the INT Group also showed that patients continued to improve or remained stable at 6- and 12-months post-intervention. For instance, at 6 months post intervention, between 57% and 85% of the INT participants were either stable or still noticing improvements on the PGIC outcomes and the pain relief measure. Results of the qualitative component of the study further supported the quantitative findings by showing that the intervention was effective in helping FMS patients gain an impression of control over their symptoms. However, no improvements were found on the primary outcome (NRS pain intensity) and the secondary specific outcome measures. The present study has a number of implications which are discussed below.The hypothesis of the present study was that a multicomponent interdisciplinary self-management intervention would lead to a reduction in pain intensity and a lower impact of pain and FMS symptoms on various aspects of daily living including sleep quality and emotional well-being (depression), improved health-related QOL, less tendency to catastrophize in face of pain, and better pain coping strategies. However, no significant differences on these measures were found between the INT and the WL Groups. Nevertheless, significant improvements were observed on patients' global impression of change in pain symptoms, functioning, and QOL, as well as improvements in their perceived pain relief. It is thus possible that a measure assessing patients' global impression of change may be more reflective of the impact of an intervention like the PASSAGE Program than the primary outcomes generally used.Numeric scales, like the 0–10 pain intensity scale, are often considered as the primary outcome in pain treatments clinical trials , althougSimilar conclusions have being reached by other researchers as PGICs are increasingly being used as a gold standard in chronic pain treatments clinical trials ,48. For The results of the qualitative and quantitative components of this study further suggest that the PASSAGE Program was highly successful in teaching patients to self-manage their illness and to take control over their pain management. One fascinating analogy emerged from the qualitative interviews where one participant described the management of his pain as one would describe the management of a budget. This participant mentioned that even though she will always have the same amount of money  what really matters is how she manages it. The better you manage your money , the less poor you feel . The empowerment described by this patient and many others shows that the PASSAGE Program was successful in helping patients improve the self-management of their pain through the learning and implementation of new strategies. Furthermore, the quantitative results regarding the improvements of coping strategies and the increased ability to ignore pain sensations further demonstrate that the program was successful in this regard.Elements of the PASSAGE Program such as patient education and aerobic exercise could have had a positive influence as they are known to increase global well-being and physical functioning as well as to decrease pain  on the PGIC scales and perceived pain relief were found among the patients of the INT Group. In addition, the average pain intensity in the last week, impact of FMS on daily life, pain catastrophizing and some coping strategies also appeared to improve over time. As in most quasi-experimental studies, we cannot determine if these changes were due to the intervention, to the effect of time or simply to the mere participation in a study. Time effects (independent of the intervention) were found on different follow-up outcome measures which suggests that the participation in the study, taken alone, can bring improvement in the medical condition. These preliminary results support the long-term effect of the PASSAGE intervention, but future randomized controlled studies are nonetheless needed.Although the absence of a WL group at the TTo our knowledge, this study is the first which evaluates the clinical impact of a multicomponent interdisciplinary self-management intervention for FMS patients using a two-site mixed-methods design. Such a design  insured appropriate triangulation of the data , and allSome limitations to the present study should nonetheless be addressed. The sample size remained relatively small and might have limited the detection of some group differences (Type II error). Although a Bonferroni correction was applied in some analyses, the possibility of type I error resulting from the high number of statistical tests that were conducted cannot be excluded. Also, the actual usage of the strategies taught to the patients during the intervention was not assessed which limits our ability to determine in which way the strategies were helpful or not. Another limitation is the self-report nature of all the measures used in the present study. Future research should include methods such as observation-based assessments of patients' functioning .Finally, although the baseline characteristics of the patients were similar to what is found in the general population of FMS patients, it should be remembered that the present RCT had strict selection criteria which may lead to the selection of patients that are not representative of the general population. For example, participants in the present study had to report moderate pain intensity (≥ 4/10) in the seven days prior to enrolment leading to the exclusion of a number of mild FMS patients. In fact, the recruitment of participants with pain ≥ 4/10 may explain the limited impact of the intervention on the 0–10 intensity of pain numeric scale considering the difficulty to improve outcomes in more severe FMS patients .Our next step will be to evaluate the clinical impact of our interdisciplinary self-management intervention in a pragmatic trial conducted in many clinical settings of the province of Quebec, thus providing further evidence for the effectiveness of the intervention in “real-life” settings . The PASIn conclusion, our new multicomponent interdisciplinary self-management intervention for FMS was found to be effective in improving the patients’ global impression of change in terms of pain, functioning and QOL as well as in increasing their perceived pain relief. We suggest including this type of measures in future clinical trials on FMS as they appear to capture an important aspect of the patient experience. Further research on the long-term efficacy of the PASSAGE Program is nonetheless needed as well as studies involving primary care physicians in the intervention.S1 CONSORT Checklist(PDF)Click here for additional data file.S1 Dataset(SAS7BDAT)Click here for additional data file.S1 Protocol(PDF)Click here for additional data file.S2 Protocol(PDF)Click here for additional data file.


More than one hundred million people around the world undergo a surgery annually. Although, the surgery itself is a treatment method to relieve pain and discomfort, it can be considered as one of the important factors to make a pain too. Perception and diagnosis of the pain is the most important duty of nurses. Effective pain management after surgery facilitates the patient’s recovery, decreases the length of hospitalization and increases the patient satisfaction. This study aims to investigate the patients and nurses’ perception of the quality of pain management in the patients undergoing an abdominal surgery.The current study is a descriptive research that has been conducted on 204 candidate patients for the abdominal surgery and the nurses who care them in the departments of surgery of Rasht hospitals by using the Simple Random Sampling method. The necessary tools in gathering data for the questionnaire consist of demographic characteristics. Idval, E et al’s Questionnaire for evaluation and pain perception, numerical and visual evaluation tools for the patient and nurse satisfaction with pain relief. Statistical analysis has been made through the 16 version of SPSS software by using descriptive statistics, average and standard deviation.The results show that the level of patient satisfaction with providing necessary care to relieve pain was 29.1% (maximum), 20.8% (minimum) and 78.7% to the confidence, environment and all areas, respectively. For the nurses, this level was 32.4% (maximum), 16.4% (minimum) and 77.1% to the performance, environment and all areas, respectively. The maximum level of patient perception of satisfaction with pain relief was 49.1% and for the nurses, it was 37.7% (good level).The results indicated that the patients’ perception of providing necessary cares to relieve pain and their satisfaction with the pain relief are more than the nurses and in a good level. According to the annual reports of centers for disease control and prevention, one people out of 4 has suffered from pain for a long term period in the last six months and one people out of 10 suffers from pain that it lasts for one year or more. More than 20% of all medical visits and 10% drug sales are related to the pain  that has been one of the most common facts and events of human life and one of the most important concerns of human from the beginning to now  and its the pain . Today, the pain . More ththe pain . Althougthe pain . Acute pthe pain . Statistthe pain . Pain dithe pain . Almost the pain . Effectithe pain . Pain mathe pain . A true the pain . The difthe pain . Anotherthe pain . Becausethe pain . TherefoThis study is a descriptive research that has been conducted from the beginning of November to the second semester of January in 2012 . The study samples selected randomly include 204 patients undergoing abdominal surgery in the first 24 hours after surgery and 204 nurses who work in the departments of surgery of Rasht hospitals.The necessary tools in gathering data for the questionnaire include three sections as follows:- Personal information of nurses (8 questions) and patients (7 queations)- Idval, E et al.’s Questionnaire for evaluation and pain perception of the patients (with 14 questions that consisted of four areas in communication (3 questions), performance (4 questions), confidence (4 questions) and environment (3 questions) and nurses - Assessment tool of patient satisfaction with pain relief .In this study, the content validity index was used in order to consider the scientific validity of the questionnaire. Also, the questionnaire was administered to 40 people of the study samples (20 nurses and 20 patients) within 7 days to determine the stability. For the questions about the quality of pain management, Cronbach’s Alpha was calculated 0.82 and 0.87 for the nurses and patients, respectively. The research methodology was that after going to selected hospitals’ departments of surgery  and providing some necessary explanations, the questionnaires were administrated to the patients undergoing an abdominal surgery (24 hours after surgery) and the nurses who cared them. Then, the questionnaires were gathered after twenty minutes. Sample respondents were asked to complete the items, if they were uncompleted. For the illiterate elderly patients without any attendant, the questionnaires were read and explained by the researcher and the sample respondents’ answers were recorded. Data analysis was carried out using descriptive statistics including the relative frequency distribution tables, average and standard deviation. The data were analyzed by using the 16 version of SPSS software.The study findings suggest that most of the patients were male (56.9%), 29.9% of the patients were between 31-50 years old, 59.8% were hospitalized in the public hospitals, 60.8% were domiciled in the city, 26.5% were the holder of diploma degree from high school, 68.6% were married and 33.8% of them were housewife.For the nurses who worked in the departments of surgery, the findings suggested that most of them (95.6%) were female, 47.5% of them were between 31-40 years old, 51.4% were married, 96.1% were the holder of BSc degree, 59.8% worked in the public hospitals, 38.2% had an employment contract with their employers, 60.8% had a working experience between 1-9 years and 68.1% worked in shift.For the nurses’ responses to the questionnaire for providing necessary cares to relieve pain, the maximum response rate of “strongly agree” (51%) was related to the item No. 3 (in area of communication) and the maximum response rate of “strongly disagree” (39.7%) was related to the item No. 7 (in area of performance) .In the questionnaire for the patients, the maximum answer rate of “strongly agree” (54.4%) was related to the item No. 3 (in area of communication) and the maximum answer rate of “strongly disagree” (40.2%) was related to the item No. 7 (in area of performance) .For the four areas of communication, performance, confidence and environment, the performance has the maximum score of 32.4% and the environment has the minimum score of 16.4% among the all scores of nurses’ questionnaire . In the questionnaire for the patients, the confidence has the maximum score of 29.1% and the environment has the maximum score of 20.8% .For investigating the level of patient satisfaction with the post-surgical pain relief, the nurses and patients were satisfied 37.7 and 49.1%, respectively .For the nurses’ responses to the questions about providing cares to the patients undergoing surgery, the area of communication (question No. 3) had the maximum score of 51% with the response of “strongly agree”.“From the beginning of the creation of the humans, they have communicated with each other. Communication is to transfer and exchange ideas and opinions between two people or more by using the proper signs and symbols in order to impact and guide each other ,” said Zolfaghari .Moreover, the maximum score of 39.7% in the area of performance belonged to the question No. 7 with the response of “strongly disagree”. In a study conducted by Heydari, in most cases, the nurses have used the verbal descriptors and the visual chart was not used in any cases. It is probably due to the fact that the nurses have just used their belief as a scale to care the patient and they didn’t use the pain assessment tools, and descriptive pain intensity scales have not yet be used in the departments of surgery practically .For the nurses’ responses to the questions for providing necessary cares to relieve pain of patients undergoing an abdominal surgery, the most strongly agreed responses were related to the area of communication (48.6%). According to the results obtained from a study conducted by Hajinezhad, the average score for the nurse-patient communication was 4.25 and the standard deviation was 1.14 (the maximum average is 6). Paying attention to the social-psychological aspects of care and especially making an effective communication with patients lead to a higher level of patient satisfaction than the technical aspects of care . For theIn a study conducted by Nazari, the satisfaction with therapeutic environment was (p = 0.847). Improving the physical space conditions and observing the physical fitness standards is an appropriate base to achieve therapeutic standards, which in turn improve the patients and employees satisfaction .The method of nurses’ responding to the questions for the level of patient satisfaction with the post-surgical pain relief indicates that most of the patients (37.7%) were strongly agreed. In a study conducted by Moghaddasi, the average of satisfaction with pain was 8.87 (the range of 10 to 0) that is in accordance with the current study .For the scores of the patients undergoing an abdominal surgery to the questions for providing necessary cares to relieve pain, the question No.7 of the area of performance was given the maximum scores with the “strongly disagreed” responses (40.2%). The question No. 3 of the area of communication was given the maximum scores with the “strongly agreed” responses (54.4%), which the results are in accordance with Guninberg research .For the patients’ responses to the questions about providing necessary cares to relieve pain, the maximum scores of “strongly agree” were related to the area of performance (56.9%). “A close relationship between the patient and therapeutic staff is needed to relieve pain,” said Eghbali (2007). The maximum response rate of “strongly agree” was related to the area of performance (40%). In the A. Duval research, the score was 3.5 that is not in accordance with this study. The area of confidence had the maximum response rate of “strongly agree” (44.3%). This result is not in accordance with the average of 3.9 in a study conducted by Taylor said, “One’s environment and the presence or absence of the people who care him/her can impact on how to experience the pain. Being unfamiliar with the healthcare environment, especially the lamps, noise, lack of sleep and doing a fixed activity can impact on the pain. Failure to comply with environmental conditions can decrease the patient ability to cope the pain.For the responses to the questions about the patients’ satisfaction with their post-surgical pain relief, most of the sample respondents chose the “strongly satisfied” option (49.1%). According to a study conducted by Yazdi Moghaddam et al. on the post-surgical nursing and recovery care, approximately 49.1% of the patients were dissatisfied when leaving the hospital. The young people were the most satisfied and the elderly patients were the most satisfied persons. According to Tavakoli et al., pain tolerance of women is more than men and the level of women satisfaction is significantly lower than men (p = 0.004).Results indicated that the maximum scores (32.4%) and the minimum scores (16.4%) belonged to the areas of performance and environment, respectively. With respect to the scores given by the nurses (9435 scores= 77.1%) compared to the whole scores of questionnaire (12240 scores = 100%), the nurses’ perception of providing the necessary cares to relieve the pain was in a good level. For the patients, the maximum scores (29.1%) and the minimum scores (20.8%) belonged to the areas of confidence and environment, respectively. With respect to the scores given by the sample respondents (11247 scores = 78.7%) compared to the whole scores of questionnaire (14280 scores = 100%), the patients’ perception of providing the necessary cares to relieve pain is in a good level.37.7% of the nurses and 49.1% of the patients were satisfied with the post-surgical pain relief.


However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term.Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms ( Temporomandibular Disorder (TMD). It is a conjunct disease that affects masticatory muscles, temporomandibular joint (TMJ), teeth, and periodontal and orofacial associated structures [ructures , 2. Inflructures , 3, 4. Iructures , 3, 4.TMD has demonstrated severe symptomatic manifestation in 2–10% of the population, most of it in women 83.7%) –7. Among% –7. AmoAcupuncture Analgesia/Ear Acupuncture. Acupuncture analgesia has been highly remarked in scientific research on acute and chronic disorder studies [ studies –14. West studies , 15, 16. studies , 18. The studies .Ear acupuncture is an important part of the Traditional Chinese Medicine (TCM) , based o Yang Ming, hand's Tai Yang, and the hand's Shao Yang are closely related to the outer ear. In addition, all three Yang channels of hands and feet are closely related to the ear in their path; by turns, the Yin channels relate to one another through different channels [ Qi and Xue movement. According to Gonzáles Garcia [According to Wang , the tenchannels , 22. Anas Garcia , occlusiSeveral studies have evaluated acupuncture therapeutic approaches aimed at relieving facial symptoms. They consider acupuncture as a simple, potentially effective, and useful technique for TMD treatment . They ha Shen Men, handle, lung, and dermis to assess the pain threshold. Thus, patients who have received the actual therapy showed positive results in comparison with those in the placebo group.Few studies describe the specific analgesic effect of the ear acupuncture technique. One of them  uses lasStudies report the analgesic efficacy of traditional acupuncture in the treatment of chronic orofacial pain. However, studies on ear acupuncture that consider this specific theme are scarce. This study aims to evaluate the evolution of painful symptoms within a month, in women with TMJ and masticatory muscle pain, who have been submitted to adjuvant ear acupuncture together with occlusal splint treatment, and compare their results with those of patients who have been treated only with occlusal splint. Furthermore, it aims to assess which group of patients was able to have their pain reduced more rapidly and which one had better results at the end of interventions.This study was approved by the Research Ethics Committee of the Federal University of Juiz de Fora under number 1456.147.2008.Twenty women were selected from the School of Dentistry of the Federal University of Juiz de Fora without distinction of race, ages between 18 and 56. The volunteers have been selected and submitted to therapy from March to June 2012. They agreed to participate in the study and signed the consent form.Patients had been diagnosed with TMD through RDC/TMD and selected after palpation of the TMJ and masticatory muscles . The patThe 20 patients were randomly divided into two groups: G1 (control), with ten patients who were treated exclusively with the occlusal splint; G2 (study) also composed of ten patients who were treated with auricular acupuncture associated with the occlusal splint .The same dentist was responsible for the occlusal adjustment on the acrylic splints  of both  Shen Men ; Mouth ; Kidney ; Liver ; Spleen ; Maxillary and Jaw regions ; and San Jiao  [We adopted the following ear points:innitus) , 28, 29  Ba Gan Bian Zheng [After localization, there was an electrical stimulation of sedation or toning of the corresponding areas in one of the ears. We considered physical symptoms during Traditional Chinese Medicine (TCM) anamnesis and clinical signs observed by physical examination, pulse study, and tong evaluation, based on the eight-principle diagnostic technique,an Zheng , 28, 29. De Qi sensation during electrical stimulus or the sensation of the touch of the needle.After electrostimulation, intradermal needles were inserted into the antagonist ear and secured with hypoallergenic tape. Needle retention lasted 5–7 days. Each session, the right and the left ear were alternately submitted to electrostimulation and needle insertion. The volunteers were warned about adverse effects, asEach week, patients in both groups were submitted to a subjective assessment of pain, with a Visual Analog Scale (VAS) after palpation of orofacial structures. Patients were asked about the intensity of the pain, “10” being the maximum level of bearable pain and “0” being the absence of pain. The same blinded examiner performed muscle  and joint  assessment, applying 2.0 kg force in each muscle and 1.5 kg in the joints . For thiStatistical Analysis. The evolution of symptoms, as well as the effectiveness of each therapy, was verified by an intragroup evaluation, with the submission of the results of the average VAS to an analysis of variance (nonparametric Friedman test), in order to verify if the values obtained during the period of treatment were statistically distinct. In order to compare both groups, we used the independent variables test (nonparametric Mann-Whitney). The significance value was 5%.The distribution of volunteers in each group, according to baselines variables, is demonstrated in The evaluation of symptoms during anamnesis by TCM with clinical signs observed by physical examination, pulse study, and tong evaluation showed the initial eastern diagnosis of patients .p < 0.05) in muscle and joint symptoms during treatment in both established therapeutic modalities  at first (T1) and statistically different (p < 0.05) at the end of the evaluation (T5). There was a significant reduction in symptoms in the study group, in comparison with the control group from the second assessment .Pain improvement results in better quality of life. With faster and more expressive results, there are better adherence to treatment, better prognosis, and better physical and psychological responses for patients. This can be explained by analgesia results provided by acupuncture's action on central nervous system neurotransmitters (western view) or by restoring the flow ofAccording to the results, we have concluded that, in short-term treatment, ear acupuncture adjunct therapy has reduced pain symptoms of muscle and joint TMD, more rapidly and more significantly than isolated occlusal therapy.