Introduction. We report the results of a series of 40 patients with chronic insertional Achilles tendinopathy treated with low-energy ESWT after the failure of a 3-month program of eccentric exercises alone. Methods and Materials. 40 patients, 28 (70%) males and 12 (30%) females, were treated between January and December 2014. All patients were previously treated with only eccentric exercises for a 3-month period. The treatment protocol included 4 sessions of ESWT with a 2-week interval, from 800 shots in each one , together with eccentric exercises. Visual Analogue Scale (VAS) and American Orthopedic Foot and Ankle Society (AOFAS) Hindfoot score were recorded. Results. At the 12-month follow-up, 26 (65.0%) patients did not complain about pain (VAS < 2), 11 (27.5%) patients got back to normal activities despite residual pain (VAS 2–4), and 3 (7.5%) of the patients still complained about pain (VAS > 4). There was no significative improvement in both scores after eccentric exercises alone. Mean VAS improvement was 5.8 ± 1.3 SD points (P < 0.001). Mean AOFAS Hindfoot score improvement was 19.8 ± 5.0 SD points (P < 0.001). Conclusions. ESWT is recommended, in combination with an eccentric exercise program, in patients with chronic Achilles tendinopathy being both insertional and not. Chronic Achilles tendinopathy is one of the most frequent injuries during sport and physical practice representing 5%–18% of all running injuries . Chronic International Classification of Diseases, 10th Revision procedure codes (code M76.6) [40 patients, 28 (70%) males and 12 (30%) females, were treated between 1 January and 31 December 2014 for chronic insertional Achilles tendinitis according toThe study was approved by local ethical committee and it is in accordance with the Declaration of Helsinki. The enrolled patients came from Outpatient Department of the Orthopedics Clinic, University of Catania . All the treatments were performed by two of us (V.P and L.Co.), the data were abstracted by two of us (A.Ds and G.T.) and the outcome measurements and statistical analysis were undertaken by one of us (L.Ca.).The mean age was 41.0 years (range 32–56). The right tendon was involved in 25 (62.5%) cases and the left in 15 (37.5%) cases . Before Patients started our protocol after at least 3 months of therapy with Non-Steroidal Anti-inflammatory Drugs (NSAIDs) for 4–7 days and stretching and eccentric exercises for 50 min a day four times a week. Before treatment with ESWT, 23 (57.5%) patients were treated with therapy and 17 (42.5%) with diathermic treatment.The overuse and the possibility of tendon-shoe friction were taken into consideration before starting treatment.The treatment protocol included stretching and eccentric exercises for 50 min a day four times a week, use of ice before and after every session, and treatment with low-energy radial ESWT. ESWT was carried out in 4 sessions, with a 2-week interval. Electromedical device OssaTron®, at a frequency of 4 Hz and a voltage of 14 KeV with 800 shots each session, was used for the treatment.Visual Analogue Scale (VAS) to measure pain and American Orthopedic Foot and Ankle Society (AOFAS) Hindfoot score, to evaluate alignment and functional outcome, were performed. VAS and AOFAS Hindfoot score were registered at the end of the eccentric exercises period, at the beginning of ESWT + eccentric exercises protocol, and then at 2, 6, and 12 months.Patients with cardiac disease, with pacemaker, in treatment with anticoagulants, in treatment or with chronic history of neoplasm, diabetes, or rheumatologic diseases, in treatment with corticosteroids, or with fluoroquinolones in the last 2 years and patients with vascular diseases of the lower extremities were excluded from the study.t-test was performed to compare the difference between VAS and AOFAS Hindfoot score along the study period. For statistical analysis, Ministat was employed.Two-tailed Student's Limits of the study were the small sample size and the absence of control group together with the short-term follow-up.At the 12-month follow-up, 26 (65.0%) patients did not complain about pain (VAS < 2), 11 (27.5%) patients got back to normal daily activities and sports despite residual pain (VAS 2–4), and 3 (7.5%) of the patients still complained about pain (VAS > 4).P > 0.05). At the beginning of ESWT + eccentric exercises treatment, VAS score was 7.6 ± 0.6 DS, 3.8 ± 0.7 SD at 2 months, 2.8 ± 0.7 SD at 6 months, and 1.9 ± 1.2 SD after 12 months, with a mean improvement at the end of treatment of 5.8 ± 1.3 SD points. The results observed were statistically significant (P < 0.001).Mean VAS value at the beginning of eccentric exercises program was 7.7 ± 0.5 DS and after eccentric exercises was 7.4 ± 0.6 SD (P > 0.05). Mean AOFAS Hindfoot score at the beginning of treatment was 71.4 ± 4.6 SD, 85.2 ± 4.1 SD at 2 months, 89.2 ± 3.6 SD at 6 months, and 91.3 ± 3.8 SD at 12 months, with a mean improvement of 19.8 ± 5.0 points (P < 0.001).Mean AOFAS score at the beginning of eccentric exercises program was 71.5 ± 5 SD and it was 71.0 ± 4.1 SD at the end  cases, calcification in the insertional region and, in 15 (37.5%) cases, the presence of Haglund's deformity were reported.Therapy with low-energy ESWT has been shown, in our series, to be effective in both reducing pain and function recovery after the failure of only eccentric exercises program and occasional NSAID treatment. The last 10 years' literature supports our conclusions .2, 50 Hz) in 4 sessions once a week. They explain the poor effect on pain with the earlier recovery to a full level activity. Simultaneously, between 2006 and 2008, Furia published two case-control trials [2; 8 Hz) [2; 8 Hz) were administered. Excellent results in terms of both pain and recovery were observed in both groups, with significantly better results in ESWT group compared with only eccentric exercises. Recently, a very interesting prospective study was published by Taylor et al. in 2016, who evaluate the effectiveness of ESWT in the treatment of refractory Achilles tendinopathy with a 24-month follow-up [In 2005, Costa et al. published a randomized clinical trial in which they verified the use of ESWT administered 1 time per month for 3 months . The stul trials , 10. The2; 8 Hz) . ImproveIf we summarize the results of these various studies, it is worth mentioning two meta-analyses. The first, by Al-Abbad and Simon in 2013, evaluated the effectiveness of ESWT in treating chronic tendinopathy Achilles [The ESWT is recommended, especially in combination with an eccentric exercise program and in association with other not invasive treatments of chronic Achilles tendinopathy that are both insertional and not. Further studies are needed requirements to establish the most effective protocol.


Aerobic exercise programs have been used for various health conditions, including musculoskeletal disorders. However, the literature is still limited regarding the effect of aerobic exercise on pain and disability in patients with chronic non-specific low back pain.https://www.embase.com), CINAHL, PEDro, Lilacs, and Cochrane Central Register of Controlled Trials (CENTRAL). We will include randomized controlled trials in any language or date of publication. The primary outcomes will be pain and disability. The methodological quality and statistical reporting of each eligible trial will be evaluated using the 11-item PEDro scale. The strength of the recommendations will be summarized using the using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.Search strategies will be performed in the following databases: PubMed, EMBASE  number CRD42017071945.The online version of this article (10.1186/s13643-019-1019-3) contains supplementary material, which is available to authorized users. This is a protocol of a systematic review of randomized controlled trials aimed to investigate the effects of aerobic exercise in patients with chronic low back pain on pain and disability outcomes.This review will follow all recommendations of the Cochrane Handbook of Systematic Reviews.The conclusions of this systematic review will be limited to the number and quality of the randomized controlled trials available.This systematic review will provide data that will aid in clinical decision-making for the use of aerobic exercise in patients with chronic low back pain. In addition, there is a potential for suggestions for new trials on this topic.Low back pain is one of the most prevalent and disabling musculoskeletal conditions in the adult population and is considered a major public health problem worldwide , 2. AbouPatients with chronic low back pain tend to seek treatment more often than patients with acute pain because the prognosis of these patients is not favorable . The latAerobic exercise programs have shown physiological, psychological, and articular benefits in patients with chronic diseases  . ChronicTo date, only two systematic reviews have been published on the effectiveness of aerobic exercise in patients with low back pain , 18. TheThe second systematic review published in 2016 aimed to review the effects of physical activity and exercise interventions  in patients with chronic non-specific low back pain . The autIn summary, neither reviews evaluated the isolated effect of aerobic exercise, adequately measured by randomized controlled trials , 18. ThuThis systematic review will be conducted following the guidelines of the Cochrane Handbook of Systematic Reviews . We follThere is no patient or public involvement on this protocol.This review will only include randomized controlled trials comparing the use of isolated aerobic exercise to any comparison group in patients with chronic non-specific low back pain. Non-randomized controlled trials will be excluded.We will include studies that evaluated patients over 18 years of age and with chronic non-specific low back pain defined as pain or discomfort lasting more than 12 weeks in the region below the last costal margins and above the lower gluteal folds, with or without symptoms in the lower limbs . If a stStudies will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies , previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back. In case separate data cannot be acquired, we will only include the articles with mixed population regarding duration and type of low back pain as long as most of the patients have chronic non-specific low back pain (> 75%).The experimental intervention investigated in this systematic review will be aerobic exercise with a duration of 15 to 60 continuous minutes and intensity of 60 to 90% of the maximum heart rate . We willThe primary outcome assessed in this review will be pain intensity. The secondary outcomes will be disability, quality of life, return to work, and kinesiophobia measured by any validated instrument , 21. Paihttps://www.ncbi.nlm.nih.gov/pubmed/), EMBASE (https://www.embase.com), CINAHL (https://www.ebscohost.com/), PEDro (https://www.pedro.org.au), Lilacs , and Cochrane Central Register of Controlled Trials (CENTRAL) . Manual searches will also be carried out through the reference list of previous systematic reviews on the topic and of the clinical trials included in this review. We will also search for ongoing or unpublished studies by searching on the International Clinical Trial Registry Search Platform . Searches will not be restricted by language or date of publication [Searches will be conducted in the following databases: PubMed  chrlication , and (3)lication .The studies will be assessed according to the eligibility criteria and the selection will be divided into two phases. The screening of titles, abstracts, and full texts will be screened by two independent reviewers. Any disagreement will be resolved by a third reviewer. If uncertainties persist as to the eligibility of an article, the authors may be contacted for clarification.A data extraction form will be used to extract data from each study. Data will be extracted on the size and characteristics of the sample , characteristics of the interventions , instruments used to evaluate the outcomes, and results of the included studies. Two independent reviewers will perform the data extraction, and the disagreements will be resolved by a third reviewer. When data are not available in the manuscripts or in case of uncertainty, the authors may be contacted for clarification.Risk of bias will be assessed with the PEDro (Physiotherapy Evidence Database) scale, which has good levels of validity and reliability and is strongly correlated with the Cochrane risk of bias tool , 25. TheThe total PEDro score ranges from 0 to 10 points, and the higher the score is, the better the article in terms of risk of bias and statistical reporting . For triThe treatment effects for continuous data will be reported as mean difference with 95% confidence intervals. If the outcomes are evaluated by different scales, we will calculate standardized mean differences and 95% confidence intervals. The treatment effects of categorical outcomes will be calculated using the risk ratio (RR) with 95% confidence intervals.When there are sufficiently homogeneous clinical trials in a comparison, a meta-analysis will be performed using the random effects model for the follow-up periods: short term (outcomes assessed closer to 4 weeks post-randomization), medium term (outcomes assessed closer to 6 months after randomization), and long term (outcomes assessed closer to 1 year after randomization) . In ordeI2 statistic (range from 0 to 100%) [I2 above 50% indicates significant heterogeneity and will result in a reduction of one level in the quality of the evidence due to inconsistency [The chi-square test will be used to identify the heterogeneity in the data from the studies. The magnitude of the heterogeneity will be confirmed by calculation of the to 100%) . An I2 asistency , 27.The quality of the evidence will be classified using the GRADE  approach  and accoMethodological limitations (risk of bias): the quality of the evidence will be downgraded if there are methodological limitations that indicate a greater propensity for biases, thus reducing confidence in the estimation of the effect of the studies . The eviInconsistency: the quality of the evidence will be downgraded if significant heterogeneity is observed in the results, even after any sensitivity analysis of the hypotheses . The eviIndirect evidence: the quality of the evidence will be downgraded when participants, interventions, or outcomes from the assessed studies are essentially different from those considered in the research question or the clinical guideline or when there are no direct comparisons between the interventions . The eviImprecision: the main criterion used by the GRADE system to define the accuracy of the estimates is the 95% confidence interval . The eviPublication bias: the funnel plot  used forThe initial classification of the quality of the evidence is defined according to the design of the studies. The randomized controlled trial is the most appropriate study design for questions related to intervention and its quality of the evidence starts as high according to the GRADE approach . The quaThis systematic review aims to provide the best available evidence on the effectiveness of aerobic exercise in patients with chronic nonspecific low back pain on pain and disability outcomes. All recommendations of the Cochrane Handbook of Systematic Reviews will be followed for the review to be of high quality. We believe that the findings of this systematic review will be important because aerobic exercise is affordable, cost-effective, and commonly used by the general population. To date, we are not aware of any systematic reviews that have attempted to investigate the effects of aerobic exercise alone compared to other therapies in reducing the pain and disability of patients with chronic nonspecific low back pain. Therefore, this evidence will inform healthcare providers and patients about the potential benefits of this intervention. Furthermore, this review has the potential to identify gaps in the literature that could be addressed in future studies.Additional file 1:PRISMA P - Preferred Reporting Items for Systematic review and Meta-Analyses Protocols. (PDF 568 kb)Additional file 2:Description of data: detailed search strategy. (PDF 283 kb)


Postoperative pain remains a challenge in the developed world, but the consequences of inadequately treated postoperative pain are particularly severe in low- and middle-income countries. Since 2011, reports have drawn attention to the poor quality of postoperative pain management in Ethiopia; however, our multicenter qualitative study was the first to attempt to understand the factors that are barriers to and facilitators of quality pain managment in the country. To this aim, the study explored the perspectives of patients, healthcare professionals, and hospital officials. We expected that the results of this study would inform strategies to improve the provision of quality pain management in Ethiopia and perhaps even in other low- and middle-income countries.This study used a qualitative, descriptive approach in which nine healthcare professionals, nine patients, and six hospital officials  participated in face-to-face, semi-structured interviews. Thematic data analysis was conducted, and patterns were explained with the help of a theoretical framework.The barriers identified ranged from healthcare professionals’ lack of empathy to a positive social appraisal of patients’ ability to cope with pain. They also included a lack of emphasis on pain and its management during early medical education, together with the absence of available resources. Enhancing the ability of healthcare professionals to create favorable rapport with patients and increasing the cultural competence of professionals are essential ingredients of future pain education interventions.Barriers to and facilitators of postoperative pain management do not exist independently but are reciprocally linked. This finding calls for holistic and inclusive interventions targeting healthcare professionals, patients, and hospital officials. The current situation is unlikely to improve if only healthcare professionals are educated about pain physiology, pharmacology, and management. Patients should also be educated, and the hospital environment should be modified to provide high-quality postoperative pain management. The number of patients undergoing surgery is rising worldwide . HoweverSurprisingly, at the time of writing this manuscript no qualitative data were available about the quality of postoperative pain management in Ethiopia, indicating that little or no attention is being paid to this topic. A decade ago, a nationwide study in Ethiopia reported that healthcare professionals (HCPs) believed that pain was undertreated because pain management was not standardized and analgesics, trained healthcare providers, and non-pharmacological treatment options were lacking . A studyWe decided to conduct the current study to find solutions for the above mentioned and other problems (e.g. the need to design and implement an effective intervention for QPM). The known barriers to and facilitators of postoperative pain management were mainly identified in studies conducted in the developed world and may not apply to low-resource settings or to other populations from different cultural backgrounds. Here, we present the views of patients, HCPs, and hospital officials interviewed at three hospitals in Ethiopia.Interview data were analyzed according to the theory of reciprocal determinism, a tenet of social cognitive theory (SCT). Reciprocal determinism has been recommended for pain management-related topics . It defiOur study was conducted as part of an ongoing quasi-experimental study to evaluate the effectiveness of an educational intervention for HCPs, patients, and hospital officials at three hospitals in Ethiopia: Yekatit 12 Medical College Hospital (Yk 12 MCH), Zewditu Memorial Hospital (ZMH), and Jimma University Medical Center (JUMC). ZMH and YK 12 MC are located in the capital city, Addis Ababa, which has more than 3.3 million inhabitants . JUMC isWe used a qualitative description design ,23 to exThe hospitals participating in the main longitudinal, quantitative, quasi-experimental study were also selected for this qualitative study. Purposive sampling with the maximum variation technique was used to select participants. The framework for maximum variation was based on baseline pain intensity , type of surgery , and sex. For instance, if one female gynecologic patient with mild pain, one female orthopedic patient with moderate pain, and one male patient with moderate pain who had undergone general surgery were selected from one of the hospitals, two orthopedic male patients with severe pain were selected from the other hospital, and so on. This was continued until the predetermined a priori sample of nine patients was obtained. In the same manner, first we defined a minimum of nine HCPs a priori  with as even a representation as possible of men and women and number of service years . Before the interview was started HCPs were informed that the ward door will remain locked for the duration of the interview. Family members were also agreed to leave the room for the duration of the interview. In cases where more than one patient was available in the patient wards, care has been taken to make sure the conversation remained laudable only for the patient and the interviewer. HCPs and hospital officials were interviewed in their respective offices. Interviews were conducted by the first author (MTE), a male lecturer and anesthetist with experience of working with postoperative patients; MTE received the necessary training in qualitative research as part of his PhD curriculum. The interviews were conducted in the local language, Amharic, and were audio recorded. We developed a semi-structured interview guide  on the bThe study was approved by the Jimma University Institutional Review Board, the Medical Ethics Committee of the Ludwig-Maximilians-Universität Munich, and by all participating hospitals. Before conducting the interviews, the interviewer briefly explained the study, including the risks and benefits of participation. The interview continued only after written informed consent was obtained, and participation was voluntary. The interviewer had no prior relationship with any of the participants. The study was performed in accordance with the established ethical standards in the Declaration of Helsinki (1964).Upon completion of each interview, a complete transcript was produced in Amharic. The interviewer read and reviewed the transcribed data to ensure that they were clear and compared the transcriptions with the original audio recordings for accuracy. Data were analyzed manually by Braun and Clarke’s six-step process of thematic analysis . We usedTwenty-four participants were interviewed. The sociodemographic and clinical characteristics and interview durations are summarized in Emerging themes were classified as barriers and facilitators related to HCPs, patients, and the health care system. These themes and respective subthemes are presented below, together with example quotes.All participants identified HCPs’ lack of empathy and lack of education as barriers to QPM. From the perspective of the HCPs and hospital officials, QPM was hindered by the failure to use pain rating scales to assess patients’ pain intensity and by the fear of side effects and dependence.The feeling that “I am on my own” was the thought most commonly shared by patients in the interviews. Patients frequently expressed how they felt neglected by the HCPs, who paid no attention to their level of pain after surgery. In the patients’ view, the HCPs seemed to have little interest in the patients’ wellbeing and not be willing to listen to the patients or treat pain after surgery.“Professionals should put themselves in our shoes. Whether the wound is big or small, it does not matter, the pain is the same to us. They [professionals] always say it’s ok, this is small. Doctors should be able to communicate with us…you know…we should be close to them. Professionals should have the attitude of servants, not masters. They [professionals] have to show us compassion.” Also, HCPs and hospital officials admitted a lack of empathy with patients in pain after surgery, and most HCPs had not yet undergone surgical interventions themselves.“Because we  never went through the operation, most of us have no idea what it is like to be in pain. What can you do? You cannot cut and suture them [professionals]? It is the way it is. Pain is related to experience; they don’t have the experience, so they will not cope with it.” Most professionals said that the topic of pain was neglected in undergraduate medical education, which strongly emphasized infections and other medical problems.“If one patient does not receive proper pain treatment, they [professionals] don’t understand the consequences. Then the patient suffers, develops chronic pain and is discharged with the pain. He will eventually return with pain as a complaint. Nobody will find the pain because you cannot find it in the laboratory. So, most likely he will end up in the psychiatric wards.” The duration of and access to in-service training were also not perceived as being satisfactory.For example, there are 500 nurses, and only 50 are selected for the training. Then, it is declared that the training has been given to all professionals. Moreover, the trained professional does not share what he or she learned from the training with the rest of the team. It is much better if the training includes all the nurses who are part of the care team” “HCPs and hospital officials frequently mentioned that pain rating scales were not used. They stated that most of them measured pain subjectively, instead of using a standard pain rating scale. HCPs mentioned using patients’ facial expressions and “general condition,” as they put it, to evaluate patients’ level of pain and make a decision about administering analgesics.“We take into consideration the type of surgery when giving analgesics. Most of the time, if the patient underwent thoracic surgery or had a bone fracture, we will use strong analgesics, if available. If it is an abdominal surgery, these are less painful, so we use weaker analgesics. We then follow the patients to see if they are complaining about pain. This is critical.…….this is to identify whether the pain is from the surgery itself or whether it is something else…….…like infection development or wound healing………you just have to take patients’ general condition and facial expressions into consideration to decide how severe their pain is. This what we use to measure pain in our setting.” The way in which the patient asks for pain medication is also crucial in HCPs’ decision whether or not the patient is in pain.“The way the patient asks for analgesics matters. Some exaggerate the smallest pain, while others bear the unbearable…If the patient nags you the whole day and complains a lot, we then ask his surgeon and senior physicians to respond.” HCPs were afraid of opioid-related side effects, in particular with respect to legal issues. To be on the “safe side” and avoid accountability, they mainly relied on nonsteroidal anti-inflammatory drugs (NSAIDs), despite the knowledge about their limited efficacy.“Narcotics are not available like other analgesics, but even if they are available, there is a worry. This worry concerns respiratory depression, because of the drugs. Professionals have to be on the safe side and avoid legal consequences, so they intentionally avoid them. Also, because these drugs are prone to abuse (addiction) the chance of these drugs reaching the hand of the professional is also rare.” Also, independent of the HCPs attitude towards opioids, most of them believed that it was not wise to give analgesics to the patient every time he or she complained because of the risk of side effects.“The surgery is part of the care, so there will always be pain. Even when the wound starts to heal, and the skin begins to close naturally, there is pain. So, every time the patient complains about pain I don’t think it is appropriate to give analgesics. Otherwise, there will be adverse effects.” Continuing education for HCPs was identified as a facilitator of QPM after surgery. HCPs stressed that the education should be carefully designed to improve their communication skills, cultural competency, and ethical norms to help them provide respectful, compassionate care.HCPs and hospital officials argued that the lack of emphasis on pain (or ignorance about it) and its management in undergraduate medical and nursing education can be addressed by the hospitals themselves when training young HCPs.“If possible, we need to intervene in the pre-service education. In the same way that we teach them to give anti-malarial drugs for malaria patients, they should be able to manage a patient’s pain after an operation. Especially during their internship period, a lot can be done. We need to start regarding pain as a disease.” Patients and some HCPs felt that the lack of a harmonious relationship between HCPs and patients affected patients’ mood and emotions. HCPs and hospital officials believed that, in order to create a favorable caring environment for the patient, HCPs should receive training in ethics and psychology, in addition to training in the physiology and pharmacology of pain.Patients are not mere bone and flesh. They have moods and emotions. I think pain management should start with this attitude. They are in pain. You don’t have to be an additional cause. You need to be considerate, and the best way to achieve this is to teach medical professionals about ethics, norms and compassionate care in addition to the usual anatomy and physiology.” “HCPs and hospital officials recommended adding cultural competency to the pain education curriculum because Ethiopian society consists of many different ethnic groups.“We need to increase the cultural competency of professionals. They have to know in detail for whom they are caring and who they are trying to cure. They should be familiar with their way of life, how they perceive, react to and treat pain. We are so diverse in culture and language, with…uh…about 83 different languages and 200 different dialects.” The socially anchored attitude towards pain and patients’ attitudes towards analgesics and dealing with pain rather than asking for relief were identified as barriers to QPM.Professionals stated that being able to cope with pain is usually viewed positively by people. Before patients are admitted to hospital, disease management commonly includes painful techniques, such as applying a red-hot iron to the skin. According to hospital officials, by focusing on the disease such traditions have played a large role in undermining pain treatment and making patients disregard pain.“Our society usually, when suffering from different diseases [pain], uses a red-hot iron that is applied to the skin. Besides, they don’t ask for analgesics, even if they want to, because they feel that the doctors or nurses might not view this behavior positively and it might end up affecting their relationship with the professionals and ultimately their care.” Most patients perceived postoperative pain as something simple and temporary that would go away with time and healing. They stated that, instead of worrying about the pain, they were preoccupied with wound healing and returning home as quickly as possible.“I have no idea. I let them [professionals] do as they wish to do. Also, they told me it’s minor pain. So, I didn’t care too much. I just want to heal and go back home.” Patients also preferred to tolerate and deal with even severe pain rather than use analgesics.“When I have pain, I forcefully close my eyes and sleep…I don’t ask for analgesics …oh…uh… because I don’t know… they [professionals] also told me it is a minor procedure, so I did not pay attention to it.” This idea was also found in some of the responses given by the participating HCPs. They stated that pain was not an alarming sign compared to other signs of infection, for example.“Our patients, actually we [professionals] and our people in general, can [try to] bear pain. For example, when someone says I have a fever and I have pain, we don’t react the same way. When you hear someone has a fever you tremble, if it is a pain you just take it lightly.” According to the HCPs, this kind of tradition was established in the hospital setting a long time ago.“There has been an existing trend for a long time that a patient has to be able to beat the pain and professionals will not respond quickly if the patient is in pain and groaning.” HCPs stated that patients also liked to wait for the pain to go away by itself or for the wound to heal completely rather than depend on analgesics.“Sometimes, they withstand the pain and say it will go away by itself. They don’t want to take drugs, especially those with a previous surgery history. They prefer to cope with it in their own way.” Some patients did not believe that analgesics were any help in healing the injury. They did not take analgesics because they would only take away the pain but would not cure the disease (wound).“They give me analgesics; I feel ok, then after a while I will again feel pain. Pain will not go away with drugs. You feel better when the wound heals.” Similar to HCPs, patients were afraid of the side effects of analgesics. Many would prefer not to take any drugs because of concerns about developing dependence or other side effects. In most patients’ view, analgesics have many complications and side effects and therefore it is better to recover without the help of drugs.“I don’t want my body to depend at all on drugs to heal. It is better to move around and forget about the pain than to take drugs every time you feel pain.” The HCPs also stated that the patients’ fear of side effects was sometimes a significant challenge when they wanted to treat the patients’ pain.“There are occasions when we offer pain medication and the patient themselves refuses because of a fear of addiction and side effects……even while the patient is in severe pain, they refuse to take drugs because of a fear of side effects.” Both HCPs and hospital officials agreed that educating patients could facilitate the provision of QPM.The typical response given by HCPs was that patient education would be important to improve QPM in the postoperative period. Most importantly, patients should consider pain management their right and should not hesitate to demand and insist on pain treatment.“Patients should say, “anti-pain treatment is my right!” They need to be trained, should be familiar with pain rating scales and encouraged to tell their feelings without any hesitation. Because most of them [patients] believe this to be part of the care, they tend to beat/bear the pain; we should first and foremost discourage such behavior.” were identified as health care system-related obstacles to QPM.Low physician- and nurse-to-patient ratios, a lack of resources, and health policy itself The physician- and nurse-to-patient ratios were among the most frequently mentioned barriers. Both hospital officials and HCPs stated that only a small number of HCPs were available on the wards for a large number of patients.“On the ward, there might be 40, 50 patients, and there are only 5 or 4 nurses. Imagine, how could you give better care …because of work overload you feel weary. When you work for many years, this leads to exhaustion and wears you down.” The high costs of narcotics and the lack of opioids were further significant challenges mentioned by the HCPs and hospital officials.“Take pethidine. It’s around 0.50 USD in the hospital pharmacy, but at the pharmacy outside it costs about 2.8 USD or 3.2 USD. Especially morphine, it’s unthinkable, it’s the cheapest analgesic in most other countries, from my experience, but in Ethiopia, a single injection ampule costs about 3.8–4.0 USD.” Hospital officials mentioned that Ethiopia’s health policy should pay as much attention to postoperative pain as it does to microbial infections and other infectious diseases.“There is a pain-free initiative just initiated by the ministry of health. This should be strengthened and continued. The commitment shown to infectious diseases should be extended to pain also.” Strict supervision of post-surgical pain management, an adequate supply of drugs, and the establishment of treatment protocols and standards of care were major recommendations by the HCPs. Hospital officials, on the other hand, recognized that an adequate supply of analgesics, continuous supervision, and the establishment of policies and standards of care were crucial factors.There was a demand for clear and even legal consequences if a patient’s pain is undertreated or untreated. Participants also stressed that HCPs who do not provide responsible care should be held accountable and responsible and that a task force should be established to develop a treatment guideline.“We need to have a clear policy of pain management in the hospital. That way you can influence professionals to be serious about it. And then you can hold responsible anyone who does not abide [by the policy]… there should also be a multi-disciplinary task force that researches the issue in detail and develops a guideline.” Improvement of the supply of analgesics (type and quantity) was the facilitator of QPM most frequently suggested by HCPs and hospital officials. The latter also suggested financial and budgetary support, which should explicitly aim to establish standard QPM.“There are drugs that are not even available on the market. They should be available. The country should also make sure these drugs are in the essential drug list…..some drugs are not being brought in by the ministry of health. We don’t have easy access to these drugs; we should.” HCPs and hospital officials suggested that the health care system should be involved in postoperative pain management because it directly affects the outcome of surgical patients. There should be a clear guideline that states explicitly how postoperative pain should be managed in hospitals.“Advocacy is the most important thing, but as a health system we should be able to develop a protocol and establish a policy….” The aim of this study was to explore the perspectives of post-surgical patients, HCPs, and hospital officials on the barriers to and facilitators of the effective delivery of QPM services. To our knowledge, this is the first multicenter study to qualitatively evaluate issues related to postoperative QPM in Ethiopia. This report provides unique information by incorporating the views of patients, HCPs, and hospital officials. Findings from such a variety of perspectives can inform the design and implementation of strategies to improve the delivery of QPM services to surgical patients. This is especially important in LMIC, where access to adequate treatment has been reported to be limited .In general, the patients in our study felt that HCPs’ lack of empathy was the main reason for undertreatment of postoperative pain. The HCPs agreed with this view and associated the lack of empathy with burnout resulting from the low ratio of professionals to patients on the wards. Indeed, a recent systematic review of cross-sectional studies confirmed a negative correlation between burnout and empathy , althougPatients also seemed in part not to be aware of the danger of untreated/undertreated postoperative pain and to perceive postoperative pain as a natural consequence of surgery. They regarded it as a minor phenomenon that would go away with time and tissue healing, without any long-term consequences. Patients’ belief that pain is “not harmful” has previously been identified as a significant barrier to QPM . BecauseHCPs also stated that they do not use standardized pain scales to determine whether a patient is in pain or not. Instead, they assess the level of pain on the basis of the patient’s facial expression and the nature and type of surgery. Early studies highlighted that relying on patient self-reports or HCPs’ personal evaluations of facial expressions and crying or moaning was a significant barrier to postoperative pain management in both developed countries  and LMICAll these mistaken beliefs about postoperative pain are the result of HCPs’ poor knowledge and skills and their attitude. A lack of education and training is the most common barrier to pain management identified by previous studies, particularly in low-resource settings, where there is a greater lack of individuals properly trained in pain management than in high-resource settings . HospitaRegarding factors that facilitate provision of QPM, participants suggested providing in-house/on-the-job training for HCPs as a first step. Hospital officials also felt that HCPs’ education should include topics that could enhance their cultural competency and skills and thus allow them to create a good rapport with patients. Participating HCPs said that patient education should also be part of the intervention. A randomized controlled study recommended preoperative patient information as a tool to decrease the intensity of patients’ postoperative pain and increase patient satisfaction .The most common facilitator suggested by participating HCPs and hospital officials was the establishment of guidelines, protocols, and accountability. Global evidence supports the development and implementation of guidelines for high-quality health care . EstabliOur findings suggest that to achieve sustainable improvement of postoperative pain management the whole of Ethiopian society needs to change their attitude to postoperative pain. Social norms can be systematically changed by educating patients and their families, for example. When HCPs face a demanding and aware patient, they will be forced to change their behavior .The above-mentioned barriers and facilitators can be best understood on the basis of Albert Bandura’s theoretical framework of reciprocal determinism. According to reciprocal determinism, any human behavior is the result of external environmental factors  and internal personal factors (through cognitive processes) ,53. In oFuture interventions should carefully consider these SCT perspectives. For example, if an intervention only targets HCPs, it might be unsuccessful because of external barriers, such as those relating to patients and the environment. Because barriers to and facilitators of postoperative pain management interact with one another, a multi-faceted intervention aimed at HCPs, patients, and the health system as a whole is more likely to be successful.Our results might not be generalizable to all surgical patients in all parts of Ethiopia because we included only patients undergoing elective general, gynecologic, or orthopedic surgery. Furthermore, this was not a quantitative study, i.e. there were no specific power calculations or assessments of statistical significance or effect size. Cultural, religious, and contextual differences in multi-ethnic countries such as Ethiopia could influence the results. Moreover, the validity might have been compromised because the interview transcripts were not shown to the participants. Although we used the reciprocal determinism theory to explain the reciprocal influence of the environment and personal factors on the HCPs’ practice of pain management, we did not specifically examine the individual constructs of SCT and did not measure the HCPs’ performance. The fact that the patient interviews were short (mean duration: 15 minutes) potentially limits the richness of the data and depth of the analysis. All patients preferred the bedside for the interview and the presence of other patients in the wards might have affected their response. However, patients were very comfortable throughout the interview and which might neutralize the possible bias. By using purposive and maximum variation sampling to include a diverse group of participants, however, we may have counteracted this limitation, as indicated by the fact that our findings are in line with previous reports ,47. NeveThis study illustrates the barriers to and facilitators of postoperative pain management from the perspective of Ethiopian patients, HCPs, and hospital officials. The findings provide probably the first qualitative insight into the factors that affect the management of postoperative pain in Ethiopia. Participants in this study believed that QPM is difficult under the current conditions, as a result of the above-mentioned barriers. From the perspective of the reciprocal determinism theory, the HCPs’ current poor provision of QPM is in part related to the HCPs themselves, i.e. to personal factors that are a result of poor training during their medical education and while working. In addition, patients’ attitudes and the lack of political will to make changes to the health care system (i.e. failure to make resources available and establish guidelines and lack of leaders’ insight that pain management is a priority compared with other “diseases”) have contributed to creating an environment in which HCPs continue to practice the way they have been practicing in the past. These findings call for holistic and inclusive interventions that target HCPs, patients, and hospital officials. The current situation is unlikely to improve if interventions educate only HCPs about pain physiology, pharmacology, and management and do not include the other stakeholders. To achieve high-quality postoperative pain management, we also have to educate patients and modify the environment.S1 Table(PDF)Click here for additional data file.S2 Table(PDF)Click here for additional data file.S1 File(PDF)Click here for additional data file.


Continuous epidural infusions are commonly used in clinical settings to reduce the likelihood of transition to postherpetic neuralgia via pain control. The purpose of this study was to compare the efficacy of conventional continuous epidural infusion to that of continuous epidural infusion in which the catheter is guided by electric stimulation to areas with neurological damage for the treatment of zoster-related pain and prevention of postherpetic neuralgia.We analyzed the medical records of 114 patients in this study. The patients were divided into two groups: contrast  and stimulation . In the contrast group, the position of the epidural catheter was confirmed using contrast medium alone, whereas in the stimulation group, the site of herpes zoster infection was identified through electric stimulation using a guidewire in the catheter. Clinical efficacy was assessed using a numerical rating scale (pain score) up to 6 months after the procedures. We compared the percentage of patients who showed complete remission (pain score less than 2 and no further medication) in each group. We also investigated whether the patients required additional interventional treatment due to insufficient pain control during the 6-month follow-up period after each procedure.P = 0.14). Patients in the contrast group were significantly more likely to require other interventions within 6 months of the procedure than patients in the stimulation group .After adjusting for confounding variables, the pain score was significantly lower in the stimulation group than in the contrast group for 6 months after the procedure. After adjustment, the odds of complete remission were 1.9-times higher in the stimulation group than in the contrast group (95% confidence interval [CI]: 0.81–4.44, Epidural drug administration to specific spinal segments using electric stimulation catheters may be more helpful than conventional continuous epidural infusion for improving pain and preventing postherpetic neuralgia in the acute phase of herpes zoster. Herpes zoster is caused by reactivation of the latent varicella zoster virus (VZV), which persists in the dorsal root ganglion after the initial infection. It causes irritation along the nerve distribution, abnormal sensitization of nociceptive receptors, and induces hyperactivity of the central nerve . The freEpidural, sympathetic, and paravertebral blocks are considered active treatments for acute episodes of herpes zoster. For acute herpes zoster, continuous epidural infusion is commonly used in clinical settings and is reported to reduce the likelihood of transition to PHN via pain control –10. For To improve the efficacy of continuous epidural infusion, it is important that the drug is administered precisely at the epidural level of the herpes zoster infection , 12, whiOur retrospective observational study adhered to the STROBE checklist (S1 checklist) and was approved by the institutional review board of our hospital .The medical records of patients who underwent continuous epidural infusion for herpes zoster-related pain from June 2010 to October 2017 were collected. Among these, only the medical records of patients who received continuous epidural infusion within 30 days of rash onset were included. The patients were divided into two groups depending on the type of epidural catheter used for continuous epidural infusion: the contrast group, which used standard epidural catheters, and the stimulation group, which used epidural catheters with electric stimulation. Patients had to meet the following criteria to be included in the present study: those older than 50 years of age with a numeric rating scale (NRS) score of 4 or greater; those who had only received standard drug therapy, including antiviral agents, until the administration of continuous epidural infusion; and those who underwent follow-up for a period of 6 months after continuous epidural infusion. The following criteria were used for exclusion: patients with insufficient medical records; patients who received other drugs (such as opioids) with epidural catheters; patients with immunosuppressed status; patients in whom the catheter was not maintained for more than 10 days after continuous epidural infusion; patients who did not receive standard medication  until the procedure was performed; and patients who discontinued the prescribed standard medication  because of adverse effects. Additionally, patients who had undergone other interventional procedures due to the exacerbation of herpes zoster-related pain within 6 months of continuous epidural infusion were excluded, and the requirement rates for interventional procedures were analyzed separately.Patients were placed in the prone position, and an aseptic dressing was applied to the procedure site. An 18-gauge Tuohy needle was inserted into the inter-laminar space three levels below the target level under the guidance of fluoroscopic imaging. The loss of resistance (LOR) technique was used to verify whether the Tuohy needle was placed in the epidural space. After confirming the epidural space, a 20-gauge epidural catheter  was inserted through the Tuohy needle, and diffusion of the contrast agent was checked to ensure that the catheter was placed in the proper position  allowing radiographic confirmation was placed at the target level through the Tuohy needle  of 0.11–15% ropivacaine at a rate of 4 mL/h using a portable balloon infusion device , for the entire duration of catheter insertion. Ropivacaine concentrations were adjusted according to the degree of pain relief or side effects. Additionally, anticonvulsants  and analgesics were administered to patients in both the groups. Anticonvulsants were prescribed by adjusting the drug dose according to age and renal function and were tapered according to symptoms. Oxycodone was administered as an analgesic starting with the minimum reported effective dose for PHN .Data on age, sex, involved dermatome, and days from the onset of rash to continuous epidural infusion, as well as history of hypertension, diabetes, liver disease, kidney disease, asthma, and amount of ropivacaine in the infusion device were collected. Pain was assessed with a pain score using an 11-point verbal NRS . Pain score data were collected from the patients’ medical records at different time points: at baseline (immediately before the procedure) and immediately after, 14 days after, and 1, 3, and 6 months after the procedure. Complete remission was defined as a pain score of less than 2 with no further medication required. The number of patients included in this category during the 6-month follow-up period was also recorded. Finally, we also investigated whether other interventional treatments were required due to insufficient pain control during the 6-month follow-up period after each procedure.We compared the baseline pain scores of both groups and assessed whether they were significantly reduced during the 6-month post-procedure period. To assess analgesic effects, we compared the pain scores of the two groups at baseline and immediately after, 14 days after, and 1, 3, and 6 months after the procedure, following correction for confounding variables. Additionally, we compared the percentage of patients who achieved complete remission in each group and the proportion of patients requiring additional nerve block due to inadequate pain control after each procedure.P < 0.05.Demographic data were assessed for normality using the the Kolmogorov-Smirnov test. Comparisons between the groups were made using an independent t-test for normally distributed variables, and non-normally distributed variables were compared using the Mann-Whitney U test. A repeated measures analysis of variance with the Bonferroni post-hoc test was used to determine whether the pain score was significantly reduced at each time point after the procedure compared to that at the baseline within each treatment group. After correcting for various confounding variables , we analyzed the differences in pain scores between the groups using covariance analysis. Between the two groups, multivariable logistic regression analysis was used to compare the odds of achieving complete remission and the odds of undergoing other interventional procedures within 6 months of the procedure. Data were reported as mean ± standard deviation or median (interquartile range) and were analyzed with the Statistical Package for the Social Sciences software . All statistical tests were two-tailed, and the threshold for statistical significance was set at We reviewed 209 patient records. Nine patients missed follow-up appointments or had inadequate medical records for the 6 months following the procedure. Twenty-five patients underwent other interventional procedures within 6 months of continuous epidural infusion. In one patient, the catheter could not be maintained for more than 10 days due to side effects associated with continuous epidural infusion. Two patients did not receive antiviral drugs at the beginning of the herpes zoster episode. During the 6-month follow-up period, two patients reported other painful diseases. The medical records of these patients were excluded from the final analysis. Additionally, eight patients stopped using anticonvulsants and analgesics due to drug-associated side effects after the procedure, and 48 patients received other drugs, such as opioids, via the epidural catheter. To prevent drug-induced bias, these patients were also excluded from the final analysis. Finally, the medical records of 114 patients were analyzed, with 57 patients each in the contrast and stimulation groups Fig. .Fig. 3FThere were no significant differences in baseline demographics between the groups Table . BonferrWhen the post-procedure pain scores of the two groups were compared, (after correcting for confounding variables), no significant differences were observed immediately after the procedure; however, there were significant differences in the post-procedure pain scores between the two groups after the 14th day and up to the 6th month Table .Table 3The difference between the post-procedure pain scores of the two groups was analyzed at each level. The cervical and thoracic level results were similar to those of the entire analysis, showing better pain control in the stimulation group than that in the contrast group. However, there was no significant difference between the two groups in the lumbar area, which was an affected site for a small number of patients Table .Table 4The odds of complete remission were 1.90-times higher in the stimulation group than in the contrast group Table .Table 5The odds of undergoing other interventional procedures within 6 months of continuous epidural infusion due to insufficient pain control were 3.62-times higher in the contrast group than in the stimulation group , pain scores were significantly lower in the stimulation group than in the contrast group. The odds of complete remission of herpes zoster up to 6 months after the procedure was 1.9-times higher in the stimulation group than in the contrast group. This suggests that administering the drug after confirming the correct VZV-containing dorsal root ganglion using epidural electric stimulation may be more effective in treating herpes zoster than the conventional continuous epidural infusion. The proportion of patients who received other epidural blocks because of the lack of pain control within the 6 months following the procedure, was approximately one-third lower in the stimulation group than that in the contrast group.There was also a difference in the drug injection site of the epidural catheter tip between the two groups. Reportedly, closed-tip, multi-orifice catheters are more effective for sensory blocks than open-tip, end-hole catheters. However, in our study, the stimulation group  showed greater pain reduction than the contrast group (in which closed-tip multi-orifice catheters were used) , 15. TheIn our study, there was no significant difference in pain reduction immediately after the procedure between the two groups. This is likely due to the spread of 8 mL of drug epidurally administered during the procedure. After administration, it is likely that the drug spread to adjacent dermatomes. Therefore, even if the epidural catheter was not precisely at the affected site, the drug may still have spread to the site of the herpes zoster infection, but this would occur only with a single epidural block. When the drug was administered continuously at the rate of 4 mL/h via a portable infusion pump, the spread of the drug decreased considerably. Therefore, precise administration of the drug to the correct site would have been possible only if the catheter was positioned in close proximity to the herpes zoster infection site. We suggest that the differences in pain scores at 14 days and 1, 3, and 6 months after the procedure were attributable to continued pain relief, despite reduced drug efficacy over the period of continuous administration, if the catheter was correctly placed in the target region.Due to the complexity of the pathophysiological mechanisms that contribute to the progression of acute herpes zoster to PHN, various preventive strategies have been proposed, including vaccinations and the use of antiviral agents, anticonvulsants, and corticosteroids. However, according to a recent systematic review and meta-analysis, the efficacy of these treatments in preventing PHN is limited –21. We fIn the current study, patients who could not maintain the inserted continuous epidural catheter for more than 10 days were excluded from the analysis because according to a previous study, a single epidural block may be effective in controlling herpes zoster-related pain, but it has limited efficacy in the prevention of PHN , 26.All the patients included in our study underwent continuous epidural infusion and simultaneously took anticonvulsants and analgesics. To avoid bias due to drug treatments, patients who discontinued the drug due to side effects from other treatments and those who were administered drugs other than local anesthetics and steroids via the epidural catheter, such as opioids, were excluded from the analysis.The complete remission rate in the present study was 51% in the contrast group and 72% in the stimulation group. Reportedly, the greater the severity of acute herpes zoster pain, the greater the likelihood of its progression to PHN . In our Epidural hematoma, infection, and abscess are the complications that make continuous epidural catheterization difficult, but no infections were reported after continuous epidural infusion in this study. This is likely due to the involvement of well-trained physicians who changed dressings daily and well-educated patients and caregivers. The incidence of epidural hematoma is low and was not observed in the present study. However, one patient experienced severe urinary retention after the procedure, which was resolved after the epidural catheter was removed .First, this was a retrospective study, and there may be an influence of unmeasured confounding variables. Thus, we conducted a covariance analysis with the baseline demographics and underlying patient disease as covariates to control for potential disturbance factors. Additionally, only the patients who took both anticonvulsants and analgesics along with continuous epidural infusion were included in the study to ensure consistent drug use across the sample set.Second, our research data were derived from electronic medical records, which may have led to an underestimation of the actual incidence of side effects. In the present study, continuous epidural infusion was discontinued in only one patient because of adverse effects, but side effects such as dysuria and motor weakness may not have been added to the medical record when the epidural block was maintained because of low symptom severity.Third, we excluded patients who were treated with other interventional procedures within the 6-month period, and this could have caused a selection bias in the study. Nevertheless, if we had included patients who experienced other interventions in the analysis, there would have been uncertainty regarding whether the patient symptoms improved due to receiving a continuous epidural infusion for the first time, or because they had other interventions. Therefore, we excluded patients with other interventions when calculating complete remission and 6-month pain scores and analyzed the ratios separately.Fourth, we investigated whether oral medications were administered simultaneously with continuous epidural infusion for herpes zoster, but the exact doses were not measured. The correct dose of oral medication may affect the incidence of PHN and pain in herpes zoster, which may limit the results of this study.Continuous epidural catheterization combined with standard drug therapy in patients with acute herpes zoster may be effective in preventing the associated pain and development of PHN. Furthermore, using electric stimulation to identify the specific epidural location affected by the herpes zoster infection and administering the drug via an epidural catheter enables continuous drug administration to the exact site of neurological damage. A well-planned, prospective study comparing the methods for preventing herpes zoster-related pain and PHN is required to validate the results of the present study.


Viscosupplementation is a minimally invasive technique that replaces synovial fluid by intra-articular injection of hyaluronic acid (HA). Although effective in some joints, there is not conclusive evidence regarding temporomandibular disorders. This case series described the efficacy of a viscosupplementation protocol in intra-articular temporomandibular disorders. Ten patients with a diagnosis of disc displacement and/or osteoarthritis by Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were submitted to four monthly injections of low or medium molecular weight HA. Pain, mandibular function, image analysis by tomography and magnetic resonance, and quality of life were assessed at baseline and follow-ups (1 and 6 months). Pain, jaw range-of-motion, mandibular function, and quality of life improved at follow-up evaluations. Osteoarthritis changes decreased, and 20% of patients improved mandibular head excursion after treatment. Resolution of effusion and improvement in disc morphology were observed for most patients. This viscosupplementation protocol reduced pain and symptoms associated with internal derangement of temporomandibular joint, improved quality of life, and showed benefits from both low and medium molecular weight HA in alternate cycles. Temporomandibular disorders (TMDs) are a heterogeneous group of disorders involving the temporomandibular joint (TMJ), the masticatory muscles, and associated structures –3. TMD aAccording to American Academy of Orofacial Pain (AAOP), diagnosis and classification of TMD are divided into two major groups: muscle and joint disorders, with their respective subdivisions . Among iViscosupplementation (VS) is a minimally invasive technique that involves replacement of synovial fluid by intra-articular injection of hyaluronic acid (HA) which restores its concentration and molecular weight in joint cavity . HA is aVS has been proven to be effective for knee and other large joints , and it Regarding TMD, there is not conclusive evidence –21. SeveBased upon clinical use of VS in joint disorders, including TMD, and the need of an efficient protocol for treatment, we describe a case series of four monthly injections of low and medium molecular weight HA in superior TMJ compartment and analyze TMJ dysfunction and quality of life through validated instruments and TMJ image analysis.This study was approved by the Ethics Committee of Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (CAAE-24911314.3.0000.5149) and registered in Brazilian Registry of Clinical Trials (RBR-6759yz). All procedures were performed in accordance with the ethical standards of institutional and/or national research committee and with the principles stated in the 1964 Helsinki Declaration and its later amendments. All patients provided written informed consent before inclusion in the study and received free and unconditional treatment.Ten consecutive patients fulfilling the following inclusion criteria were selected from university orofacial pain division or from a private orofacial pain clinic: age between 18 and 70, diagnosis of disc displacement with or without reduction, and/or osteoarthritis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD Axis I). Patients with rheumatologic diseases, neuropathic pain, or history of previous TMJ surgery, trauma, or fractures were excluded. No other treatment for TMD  was allowed during the study period, and anamnesis before each session was performed to control it.All ten selected patients underwent a cycle of four injections (1 per month) of 1 mL of HA in upper joint compartment of both joints as previously described . Low MW Clinical evaluations were performed by the same experienced operator after training and calibration by RDC/TMD examination protocol . The folThe patients' left and right joints were examined by cone-beam computerized tomography (CBCT) and by magnetic resonance imaging (MRI) at baseline and at final follow-up (6 months after treatment). Images were interpreted by a blind experienced radiologist and all available slices were evaluated. In CBCT, osteoarthritic (OA) changes were defined according to Ahmad et al.  by the pt-tests for comparing mean change or Wilcoxon signed rank test for comparing median change. Osteoarthritic changes between baseline and final follow-up (6 months) were evaluated by paired t-test for comparing mean change (erosion) or by Wilcoxon signed rank test for comparing median change . P values of 0.05 or less were considered significant. All graphs were created by GraphPad Prism 5.0 software.Statistical analysis was performed using MINITAB® software version 17. For clinical data, within-patient differences among baseline and follow-up values were assessed by paired Demographic characteristics  of sample are shown in n=5 patients) had myofascial pain according to RDC/TMD Axis I Group I (muscle disorders) (n=9 patients) were diagnosed with disc displacement with reduction (ADDR). Whereas, in RDC/TMD Axis I Group III (other joint conditions), 10% (n=1 patient) had arthralgia at rest and mandibular function and 20% (n=2 patients) had osteoarthosis/osteoarthritis diagnosis.At baseline, 50% of patients (sorders) . In RDC/One and 6 months after treatment, there was a significant change in patient diagnosis according to the RDC/TMD Axis I Group I, that is, no patient was diagnosed with myofascial pain. No changes were observed in RDC/TMD Axis I Group II, except for one patient. In RDC/TMD Axis I Group III, the patient with arthralgia became symptomless and one of the patients formerly diagnosed with osteoarthritis was diagnosed with osteoarthrosis.Mouth opening without pain improved at 1 month after treatment in comparison to baseline . CraniomMoreover, orofacial pain disability was improved at 1 and 6 months follow-up evaluations  and bettAt baseline, both TMJs of all patients were examined by CBCT and MRI. Osteoarthritic changes evaluation by CBCT showed significant decrease in presence of osteophyte, flattening, sclerosis, and erosion of mandibular head at 6 months after treatment . HypoplaSoft tissue evaluation by MRI before and 6 months after treatment showed the following: (1) all patients had disc displacement with reduction before and after treatment; (2) all patients had alterations in disc position in at least one of the views  after treatment; (3) one patient showed remission of right disc adhesion after treatment; (4) all patients (4 joints) who had effusion signal before treatment evolved to resolution of effusion 6 months after treatment . RegardiIn this case series, we evaluated the effectiveness of a protocol of four injections of low and medium MW HA on pain, mandibular function, signs of intra-articular disease by image analysis, and quality of life in ten patients with TMD.After treatment, disc displacement diagnosis by MRI or RDC/TMD was not changed, except for one patient, which was expected since TMJ discs cannot be replaced by minimal invasive technique . Disc poAll patients initially diagnosed with muscle pain , joint pain , or limited mouth opening have improved pain and function and those diagnoses were not observed at follow-ups. Pain relief was observed by a significant reduction of pain intensity and scores measured by NRS, McGill, and MOPDS. This may be attributed to different mechanisms regarding TMJ, such as anti-inflammatory effects of HA injection with consequent decrease of metalloproteinases and proinflammatory mediators in synovial fluid, as well as improvement of joint biomechanics –13. In tVS protocol tested here showed significant improvement in mouth opening amplitude both in clinical and radiologic evaluations. This outcome in clinical examination has also been shown in other studies of VS but with different protocols , 24, 25 Less severe dysfunction was observed after treatment. Evaluation of mandible function by MFIQ has also shown improvement. More importantly, patients' evaluation of quality of life has improved. Other studies have also shown beneficial outcomes of VS by mouth opening, pain intensity, and subjective parameters such as satisfaction with treatment , 24, 25.It is important to highlight that pain relief as well as improvement in mouth opening, mandibular function, and quality of life may also be a result of observed remission of myofascial pain itself. As mentioned, masticatory muscles and TMJ are structurally functionally related . MoreoveOnly a few studies have used image analysis to evaluate TMD treatment efficacy , 26. In Among studies that have shown efficacy of VS in TMD, different methods have been described and, as a result, there is an effort of researchers and clinicians to establish an effective protocol for treatment of TMD, as already established for other joints , 24, 38.The use of HA of different MW in alternated monthly injections is a new perspective of VS in TMD and allows association of biomechanical properties of high MW AH and biological effects of lower MW AH. Hence, this protocol of treatment is able to promote fast and sustained effects, as suggested by results.The literature describes different time intervals between applications , 38. We Although we show promising results regarding the described protocol for TMJ VS, we are aware of the limitations of this work. We believe its greater contribution may be the description of a new perspective to be tested in a well-controlled clinical trial in future research studies. Our small number of patients and the study design as an open label noncontrolled trial does not allow inference of VS positive effects to all TMD patients. However, case series is a descriptive work that illustrates novel features in clinical practice, its sample represents common clinical population, and generates new research questions . Hence, VS protocol shown here reduced pain and symptoms associated with internal derangement of TMJ and improved quality of life of TMD patients. Randomized clinical trials of this treatment protocol should deserve attention in future researches.


Pain is a common and burdensome complication in patients with acute stroke. We assessed the impact of impaired communication in stroke patients on pain assessment and treatment.We included 909  patients admitted to our stroke unit from 01/2015 to 12/2015 in the analysis. Patients were assigned to four groups: able to communicate (AC), not able to communicate prior to index stroke (P-NAC), due to focal symptoms of index stroke (S-NAC), due to a reduced level of consciousness (C-NAC). Pain prevalence, documentation of pain and use of analgesics were evaluated. C-NAC patients were excluded from analyses regarding analgesic treatment due to relevant differences in patient characteristics.p < 0.001). Pain prevalence was 47.0% (n.s. between groups). The use of analgesic medication increased from 48.7% in the AC group, to 76.0% in the P-NAC group, and 77.8% in the S-NAC group (p < 0.001). Opioid use was significantly more frequent in NAC patients (p < 0.001). The response to the treatment was poorly documented with significantly lowest rates in S-NAC patients (p < 0.001).746 patients (82.1%) were classified as AC, 25 (2.8%) as P-NAC, 90 (9.9%) as S-NAC and 48 (5.3%) as C-NAC. Pain was documented on the Numeric Rating Scale and in form of free text by nurses and physicians. Nurses documented pain more frequently than physicians (Our study suggests that post-stroke pain in patients with inability to communicate is not attended enough, not systematically assessed and therefore not sufficiently treated. Stroke is one of the leading causes of death and disability worldwide . Recent With prevalence estimates ranging from 10 to close to 50%, post-stroke pain (PSP) is common –8. The mImpairment or loss of the ability to communicate, which may be due to hearing, vision, speech, language or cognitive problems, is a common problem in stroke patients. At least one communication-related impairment was found in 88% of patients in an acute stroke unit . DisturbThere is a paucity of research investigating both the assessment and treatment of pain in patients post-stroke who are not able to communicate. To the best of our knowledge, only one dedicated study exists , which, n = 1055). Patients with a final diagnosis of ischemic stroke, intracerebral hemorrhage (ICH) or transient ischemic attack (TIA) were included. Clinical data including baseline characteristics, stroke syndrome, clinical scores , stroke treatment, and length of hospital stay as well as technical investigations were extracted from the stroke database. Information on pain assessment and medication was collected by analysing the patient charts. Pain assessment followed the standard of care on our stroke unit, comprising estimation of pain on the numeric rating scale (NRS) every 8 h. In addition, nurses and physicians documented the kind of pain the patients were suffering from, and whether it responded to analgesics or not (freetext). In patients unable to communicate, behavioral and physiologic parameters indicative of the presence of pain were utilized in pain assessment. These were: sounds (moaning), movement including guarding movements for certain areas of the body, facial expression, muscular tension, restlessness as well as vital signs suggestive of stress . Pain was divided into chronic pain, defined as pain syndrome with onset present at least three months prior to the index stroke [The patient cohort for this retrospective cohort study was extracted from our prospectively collected stroke database. All patients admitted to our comprehensive stroke unit (SU) between January 2015 and December 2015 were screened  if lack of communicability  together with an explaining comorbidity  was documented in the patient charts. Classification as not able to communicate as a consequence of focal symptoms of index stroke (S-NAC) required documented lack of communicability  together with an explaining stroke symptom  in patients with unimpaired consciousness. Patients with a Glasgow Coma Scale score of < 12 during more than 50% of the hospital stay were classified as not able to communicate due to a reduced level of consciousness (C-NAC). All remaining patients were subsumed under the category “able to communicate” (AC). C-NAC patients were excluded from analyses regarding analgesic treatment due to relevant differences in patient characteristics.Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS), version 24 . Data are reported as frequency (n) and percentage (%), mean and standard deviation SD) or median and interquartile range (IQR) as applicable.2-Test or in case of small cell sizes Fisher’s Exact Test for nominally scaled variables. In case of overall significant differences between the groups, two-by-two comparisons were done through 4-Fields- Chi2-Tests or Fisher’s Exact Tests. For metric variables we performed a one-way ANOVA, followed by post-hoc independent samples t-tests. A p value < 0.05 was considered to indicate statistical significance. Bonferroni correction was omitted due to the explorative character of the study.Group comparisons were calculated by a ChiWe included a total of 909 patients in our analysis, 507 (55.8%) male. Demographic data are presented in Table p < 0.001). In their medical history, both P-NAC and C-NAC patients had significantly more often suffered a prior stroke compared to patients of the AC group (p = 0.031). Likewise, the prevalence of dementia was highest in the P-NAC group (p < 0.001).Of all patients, 746 (82.1%) were classified as AC, 25 (2.8%) as P-NAC, 90 (9.9%) as S-NAC and 48 (5.3%) as C-NAC. Patients categorized as AC were significantly younger than patients of the other groups  of stroke events were ischemic strokes. In 51.2% the territory of the medial cerebral artery was affected, in 27.9% the territory of the anterior cerebral artery, in 29.5% the territory of the posterior cerebral artery , in 8.9% the brainstem and in 7.8% the cerebellum. In addition, there were 74/909 cases (8.1%) of ICH. Seventy-six patients (8.4%) had a final diagnosis of TIA. The C-NAC group had the highest proportion of ICH patients  while the AC group had the highest proportion of TIA patients . Accordingly, NIHSS at admission varied significantly between the groups with increasing values from AC patients (median NIHSS 3) over P-NAC and S-NAC patients  to C-NAC patients (median NIHSS 23). Stroke severity was further reflected in in-hospital-mortality rates, with 0.1% in AC patients compared to 11.1% in S-NAC patients, 20.0% in P-NAC patients and 77.1% in C-NAC patients. Severe aphasia and severe dysarthria were significantly more frequent in NAC patients. The highest proportion of severely aphasic patients was found in the S-NAC group (74.4%) whereas the C-NAC group included the highest rate of severely dysarthric patients (50.0%).p < 0.001). Pain documentation by nurses did not differ significantly between the groups whereas physicians documented pain significantly least often in the AC group (p < 0.001). NRS was implemented in 848 patients (98.5%) at any time point, least frequently in S-NAC patients  than in physicians’ records  than patients with ischemic stroke or TIA . The prevalence of headache also differed significantly between the aetiologies .402/861 patients (46.7%) suffered from pain during the hospitalisation after stroke. Headache was the most frequent pain syndrome , followed by musculoskeletal pain . Patients with ICH suffered significantly more frequently from pain . S-NAC patients also received more non-opioids than the patients of the AC group . P-NAC patients were significantly more often treated with a co-analgesic than all other patients (p = 0.002).Regarding the use of analgesia, 48.7% of AC patients received any analgesic medication. The proportions of patients receiving medication increased in the P-NAC and S-NAC groups, with 76.0 and 77.8%, respectively. The P-NAC and S-NAC group, in whom 20.0 and 17.8% of patients, respectively, were treated with opioids, differed significantly from the AC group (p = 0.000).The proportion of patients who received an analgesic because of manifest acute or chronic pain did not differ significantly between the groups. Moreover, the AC group received analgesics less often because of other effects like lowering fever (p < 0.001).Documentation rate concerning the clinical course of pain after the initiation of analgesic treatment in patients with manifest pain was overall low. Respective documentation was found in 49% of AC patients, but only in one of the three patients in the P-NAC group and in 9.1% of S-NAC patients (To our knowledge, this is the first study to analyse both the assessment and treatment of pain in post-stroke patients who are not able to communicate.Our main findings are that pain after stroke is a common phenomenon but inconsistently assessed in patients with limited ability to self-report pain. As a consequence, there are relevant differences with regard to the extent and type of analgesic treatment in these patients in comparison to others who are able to communicate normally.The American Society for Pain Management Nursing states that all persons with pain deserve prompt recognition and treatment. In patients who are unable to self-report pain, assessment strategies must be adapted . In the While nurses and physicians have been demonstrated to exhibit similar degrees of pain assessment accuracy , nurses Even with those limitations regarding pain evaluation, we found 47% of all patients were experiencing pain at any time point in the acute phase after stroke. This is in line with other studies in stroke populations . HoweverIn our cohort, pain was more frequent in patients suffering from ICH than from ischemic stroke or TIA. The prevalence of specific kinds of pain is not directly comparable to other studies, as those assessed either only chronic –7 or acuWe only analysed the number of patients whose records had at least one mentioning or description of pain in it. This parameter does not reflect the fluctuating course of pain syndromes with the result that recurrent episodes of pain may not have been recognized. A good indicator for this issue is the fact that many patients in the NAC groups had the ability to communicate pain at some point during their hospitalization and their doing so may suggest that they were in pain while being unable to communicate as well. An American study showed similar results: 47.6% of patients who were able to self-report pain on the day of hospital dismissal, but not on admission, had a pain score above zero . Pain inRetrospectively, we are not able to tell how many patients suffered from pain directly attributable to stroke. Since we analysed patient records from the hospitalisation for acute stroke, post-stroke pain occurring with greater latency, e.g. like most types of central post-stroke pain , went unWe noted relevant differences in analgesia use between groups of communication impaired and unimpaired stroke patients: the NAC groups received significantly more often at least one analgesic than the AC group. However, the indication for analgesia use was only to a small extent the treatment of pain. More often analgesics were prescribed with a different primary intention such as antipyresis. This may be in part explicable through the fact that medical complications such as post-stroke infections occur more frequently in severe strokes , which pHigher rates of analgesia in patients not able to communicate do not necessarily equal sufficient or adequate treatment of pain. One finding strongly suggestive of suboptimal pain management is the lack of documented response to treatment, with not even half of AC patients’ response to analgesia documented, and lowest rates in the S-NAC group. Similarly, a Canadian study investigating pain assessment of intubated patients also found a re-assessment rate of only 40% after an intervention intended to manage pain .Major limitation of our study is the retrospective character, allowing for several potential sources of bias. Nonetheless, the retrospective nature may best reflect the results from daily routine whereas prospective studies may yield optimistic documentation rates due to an attention bias. A further limitation is the arbitrary assignment to a NAC group if lack of communicability was comprehensible over more than 50% of the hospital stay. We are well aware that construct validity may be impaired by utilizing behavioral and physiologic parameters indicative of the presence of pain in a non-formalized way in patients unable to communicate and thus relying on nurses’ and physicians’ Gestalt perceptional impression. In addition, we did not formally assess treatment response to analgesia, which would certainly have been informative since this represents the major patient-related outcome of any intervention regarding the management of pain. The inclusion of a control group would potentially increase validity, which, however, was not possible on the basis of our retrospective body of data. Finally, as our study was conceived with an explorative character in order to generate hypotheses, we omitted a Bonferroni correction in our statistical analyses. Further prospective studies will thus be needed to corroborate our data.Our study suggests that pain in patients with limitations or inability to communicate is not attended to enough, not systematically assessed and therefore not sufficiently treated during hospitalisation for acute stroke. Strategies to improve recognition and treatment of pain in patients with inability to self-repost should comprise a bundle of measures: With different types of reasons for impaired communication in stroke patients, a particular challenge lies in the appropriate, systematic and consistent use of different types of pain scales adjusted to patients’ communicative skills as a crucial first step in improving management of pain; Best practice recommendations regarding pharmacological and non-pharmacological pain management should be established; Recognition and management of pain should be considered as an interprofessional team approach; Specialised pain nurse advocates may promote permanent and active involvement in the complex issue of pain management in stroke patients .