Chronic conditions are the leading cause of disability throughout the world and the most expensive problem facing the health care systems. One such chronic condition is osteoarthritis (OA), a frequent cause of major disability.To describe the effect on joint pain for the first users of a newly developed Web-based osteoarthritis self-managing program, Joint Academy, and to examine whether these patients would recommend other OA patients to use the program.Patients with clinically established knee or hip OA according to national and international guidelines were recruited from an online advertisement. A trained physiotherapist screened the eligible patients by scrutinizing their answers to a standardized questionnaire. The 6-week program consisted of eight 2- to 5-minute videos with lectures about OA, effects of physical activity, self-management, and coping strategies. In addition, exercises to improve lower extremity physical function were introduced in daily video activities. During the course of the program, communication between physiotherapist and patients was based on an asynchronous chat. After 6 weeks, patients were able to continue without support from the physiotherapist. Patients reported their current pain weekly by using a numeric rating scale  as long as they were in the program. In addition, after 6 weeks patients answered the question “What is the probability that you would recommend Joint Academy to a friend?”The eligible cohort consisted of 53 individuals . With the continued use of the program, patients reported a constant change in pain score from mean 5.1 (SD 2.1) at baseline to mean 3.6 (SD 2.0) at week 12. Six patients participated for 30 weeks . Overall, the patients would highly recommend Joint Academy to other OA patients, suggesting that the platform may be useful for at least some in the vast OA population.Joint Academy, a Web-based platform for OA therapy, has the potential to successfully deliver individualized online treatment to many patients with OA that presently lack access to treatment. Chronic conditions are the leading cause of disability throughout the world and collectively they represent the most expensive problem facing health care systems . One preOsteoarthritis primarily affects the elderly. The prevalence in the age group 60 years and older is 10% among men and 18% among women [Like other chronic diseases, OA progresses slowly. Before individuals are eligible for total joint replacement (TJR) surgery, incubation time is some 10 to 15 years with increasing joint pain, decreasing function, and reduced quality of life. Accordingly, cross-sectional Swedish and UK data show that only 20% of the OA population qualifies for TJR in spite of debilitating symptoms -9. For tThe Swedish national initiative “Better Management of Patients with OsteoArthritis” (BOA), a national quality registry and an evidence-based supported self-management program for patients with OA, was developed to facilitate the implementation of guidelines ,14. Of SOne appealing method that leverages technology into health care is digital therapeutics. In this context, digital therapeutics can be viewed as software functioning as “medication” that is delivered via the Web. This treatment focuses on behavioral changes with long-term improvements in contrast to the short-term gain of taking a pill or other interventions presently used in health care. A crucial point to achieve the effect of any treatment is compliance. Using digital therapeutics that utilize the Internet to deliver cost-effective treatment around the clock has the potential to increase adherence. Allowing for people to administer their treatment at a suitable time point probably increases compliance and the likelihood of improved health and quality of life for patients with chronic conditions. An interesting and successful example is the translation of the Diabetes Prevention Program into an online treatment ,16. WithThe aim of this pilot study was to describe the effect on joint pain for the first users of a newly developed Web-based OA self-managing program, Joint Academy, and to examine whether these patients would recommend other OA patients to use the program. Collectively, the objectives aimed at deciding (1) whether it seemed feasible to deliver Web-based OA treatment and (2) whether the results would support further development of the platform.Participants with knee or hip joint pain were recruited from an online advertisement on the home page of the Swedish Rheumatology Association during two weeks in January 2015. However, single patients were eligible for inclusion until December 2015. The potential participants were directed to a website where they were asked to create a user account and fill in a screening questionnaire. Participants were not compensated for their participation but were enrolled in the program at no cost.A trained physiotherapist (CT) screened the questionnaires and, whenever relevant, asked additional questions to patients through their user interface. To be included, the physiotherapist ensured that described symptoms were in agreement with clinical OA according to national guidelines ,11,14. EParticipants were informed that the program lasts for 6 weeks. Included participants (referred to as patients subsequently) were asked to answer some demographic questions according to the International Consortium for Health Care Measurement (ICHOM) initiative as well as those in the BOA registry ,14,18 anThe basis for Joint Academy is the Supported Osteoarthritis Self-management Program (SOASP) used in BOA. The BOA program consists of theory sessions held by a physiotherapist, sometimes in collaboration with an occupational therapist and an OA communicator . After completing the theory sessions, patients can opt for an individually adapted and physiotherapist-supervised exercise program . The SOAThe Joint Academy program that was used in this study started on Sunday and ran for 6 weeks. The program consisted of eight videos of 2- to 5-minute lectures about OA, effects of physical activity, self-management, and coping strategies. After each lecture, the patient took a quiz to confirm that the take-home messages of the lecture were correctly understood. Parallel to these lectures, four neuromuscular exercises were introduced to improve lower extremity physical function. Each exercise had 3 to 5 levels of intensity. The level of intensity was based on an algorithm taking into account individual progress and the patient’s perceived ability to perform the exercise without exacerbating pain. The week’s exercises and lessons  were divided into daily packages and delivered in video format to the patient during the 6-week period by push email. In each email, there was a link to the embedded videos within the Web-based platform. These videos showed how to properly perform the exercises. The short video lectures also included key OA issues important for understanding the delivered treatment to be fully motivated for the exercises. Each package was designed to take no more than 5 to 15 minutes per day. After having performed an exercise, the patient registered it as complete. When needed, the patient was able to communicate questions to the personal physiotherapist. This communication between the physiotherapist and patient within the Joint Academy platform was asynchronous and based on a chat during the 6-week program. To have a comparable benchmark over time, pain was always reported on Sundays and referred to the average pain during the week. An “active week” was defined as a week when patients reported their pain level. If a patient reported pain values for four consecutive weeks, skipped two weeks, and finally reported pain for three additional weeks, this was defined as seven active weeks in the program.The software was compatible with all platforms and worked on personal computers, tablets, and mobile phones. It was built as a single-page Web app with a responsive user interface to facilitate user experience. The Web app was connected to our proprietary back-end service for OA treatment. The back-end was built on the framework Ruby on Rails and the front-end on Angular JS.The statistical analysis was performed using a longitudinal random effects model. A random intercepts and slopes model was fitted with using the restricted maximum likelihood approach and with the underlying assumption of an unstructured variance-covariance matrix and degrees of freedom estimated using Satterthwaite’s method. The calculations were performed using the mixed command in Stata version 14.Patients gave informed consent when entering the program.The study cohort consisted of 53 individuals . Of these 53 patients, 36 (68%) registered their pain levels for 6 active weeks . On averWe observed that 33 patients voluntarily continued using the program after 6 weeks utilizing the same weekly instructions as in week 6, but without the support of a personal physiotherapist.P=.002), which corresponds to a pain reduction of one unit every 14 weeks.Furthermore, 19 patients 36%) voluntarily continued to exercise and report their pain level for a total of 12 active weeks. After 18 and 24 active weeks, there were 12 and nine patients remaining, respectively, and six patients completed 30 active weeks in the program . The lon6% voluntAt week 6, 18 of the 36 active patients had a lower absolute value in pain score, eight were unchanged, and 10 had an increase compared to baseline. The mean NRS pain score for the 36 active patients changed from mean 5.1 (SD 2.1) at baseline to mean 4.5 (SD 1.8) . SixteenThe NRS pain data showed that at weeks 6 and 30, 47% (17/36) and 83% (5/6) were responders, respectively .In all, 31 patients  answered the question “What is the likelihood that you would recommend Joint Academy to a friend?” The median score was 10 (range 6-10).In this study, we demonstrate that Joint Academy, a Web-based platform for OA therapy, has the potential to successfully deliver individualized digital treatment to patients with clinical OA in the hip or knee. Many experienced an improvement in pain and would recommend the program to others. This is one of few exercise intervention studies following patients for a longer period of time ,21. ThisEven though several patients discontinued the program, results suggest that pain fluctuates over time . This isIn SOASP, patients rate their pain on a visual analog scale (VAS) at baseline and again after 3 and 12 months ,14. On aIn the United States, US $40 billion per year is allocated to the more than 600,000 TJR operations conducted annually, making TJR one of the most expensive interventions today . WithoutAnother common operative procedure in middle-aged patients with knee pain is arthroscopy. In the United States alone, 400,000 arthroscopies are performed annually due to the popular belief that pain in the degenerative knee is caused by a meniscal tear -30. As cTwo randomized controlled trials are of interest with respect to nonsurgical options to treat OA patients eligible for total knee replacement ,35. One To our knowledge, Joint Academy is the first platform to deliver digital health care to OA patients. The fact that the program may reverse the course of symptoms for some patients to the degree observed in the current study is very encouraging, suggesting that Joint Academy may be feasible at least for some OA patients. For the subgroup of the OA population volunteering for participation in this program, a pragmatic approach with 5 to 15 minutes of exercise a few days per week seemed sufficient to achieve significant results. Interestingly, the program motivated the patients to perform approximately 80 activities in a 7- to 8-week period. This suggests that Joint Academy may play an important role in OA treatment. In addition, Joint Academy may also increase equity in OA treatment by offering evidence-based health care for people living with clinical hip or knee OA in the developing world.That a digital health program may have significant effects on health is also shown by the Prevent program targeting patients with prediabetes. By combining weekly theoretical lessons and individualized health coaching, patients lowered their body weight as well as their blood glucose levels ,16. The There are limitations to this study. This is a pilot study without a control group and with a small study population, especially at later time points, limiting the establishment of a definitive cause relationship between length of participation in Joint Academy and improvement in pain. However, patient attrition over time is not due to demographic differences between those patients who discontinued the program and those patients that continued the program. When using this study design, there is a risk that the cohort is not representative of the general OA population. However, both the OA pathology and the clinical disease patterns are similar around the world. The relative ease with which you can enter the study , may result in a higher-than-average dropout rate. Alternatively, those signing up may be more motivated to change their present situation and/or have an interest in digital technology and, consequently, show better results. It can also be argued that patients that enroll in the program are currently experiencing an exacerbation in pain and, therefore, are more motivated than the average OA patient. However, this did not seem to be the case for all patients in this study. Patients that enrolled in Joint Academy had a baseline mean NRS pain of 5.1 (SD 2.1) meaning that the pain level of at least some patients was relatively low. Overall, we believe it can be argued that patients in the study cohort are well suited to be the future target group for digital OA management. Despite these limitations, the results encouraged us to further develop Joint Academy. In the current version, we have included extended assessments at inclusion and also during the course of the program. Furthermore, we have included a functional test, comorbidities, and additional demographics to enable an improved user definition in order to further individualize the program. With respect to the enormous OA population, we believe that Joint Academy has the potential to attract people who are more motivated by digital health than by visits to a primary care practice.In conclusion, we demonstrate that Joint Academy, a Web-based platform for OA therapy, has the potential to successfully deliver individualized Web-based treatment to many patients with OA who presently lack access to treatment.


Severe burns of hands and arms are complex and challenging injuries. The Standard of care (SOC) – necrosectomy with skin grafting – is often associated with poor functional or aesthetic outcome. Enzymatic debridement (ED) is considered one promising alternative but, until recently, results proved to be highly variable.Between 04/2014 and 04/2015, 16 patients with deep partial- to full-thickness burns of the upper extremities underwent enzymatic debridement (ED) in our Burn Center and were evaluated for extent of additional surgery, wound healing, pain management and functional parameters.Following ED, no further surgical intervention was required in 53.8 % of the study population. In patients who required surgical treatment, the the skin-grafted area could be reduced by 37.0 % when compared to initial assessment. Time from injury to ED was 24.4 h and patients were able to start physical therapy after 2.0 days but suffered from prolonged wound closure (28.0 days). Regionally administered anesthesia proved to be superior to pain medication alone as pain levels and consumed morphine-equivalent were lower. Post-demission follow-up showed good functional results and pain levels with low scores in two self-report questionnaires  but 3 patients reported increased susceptibility to shear stress. Based on these early experiences, we developed a 3-step algorithm for consecutive patients allowing appropriate and individualized treatment selection.We see a potential benefit for ED in the treatment of severely burned hands and forearms but further investigations and proper prospective, randomized controlled trials are needed to statistically support any outlined assumptions.The online version of this article (doi:10.1186/s12895-016-0045-2) contains supplementary material, which is available to authorized users. Burns are common injuries associated with substantial morbidity and mortality. Over 2000 cases have been treated in German Burn Centers in 2013 .Initial assessment of both burn extent and depth can prove to be difficult and inadequate. Additionally, burn wounds can progress and change over time, leading to an unanticipated need for surgery . In comb® (NXB) is an enzymatic debriding agent that was EMEA-approved in late 2012. Its active ingredient constitutes of a concentrate of proteolytic enzymes enriched in bromelain derived from the stem of the pineapple plant. It is indicated for enzymatic debridement in adults with deep partial- and full-thickness thermal burns [NexoBridal burns . ApplicaPrevious studies reported promising results. A large multi-center, randomized controlled clinical trial conducted on 182 patients between 2006 and 2009 postulated significant reductions in time from injury to complete debridement, need for surgery, autografting and area of burns excised when compared to SOC. In a subgroup of hand burns, additional benefit was seen as these patients exhibited earlier time to wound closure and better long-term results [In April 2014, we started using NXB on qualifying burns of the upper extremities as a possible alternative to surgical necrosectomy and skin grafting. We hypothesized, that these patients would benefit from reduced need for surgery and absent morbidity often associated with SOC, e.g. functionally impairing tissue loss and subcutaneous tissue damage. We also evaluated the time to onset of physical therapy (PT), wound closure and early functional outcome. Additional emphasize was put on pain management accompanying ED when comparing local to regionally administered anesthetic measures.With this article, we want to provide an overview of the problems, experiences and results gathered when using ED for deep burns of the hands and forearms.Between 04/2014 and 04/2015, all patients admitted to our Burn Intensive Care Unit (BICU) showing deep partial- to full-thickness upper extremity burns were treated by ED on not more than 15 % TBSA within the first 48 h after admission. Fingers and hands were prioritized even when injuries were exceeding proximally or included additional body regions.Upon arrival in the Burn Trauma Bay (BTB), standard admission protocol was performed which included complete undressing of the patient and initial debridement with opening of present blisters under antiseptic conditions. Standardized escharotomy by monopolar cautery was performed if injuries included circumferential burns. This was not regarded as exclusion criterion and ED was not performed as a replacement for surgical escharotomy. When wound bed was cleaned, a polihexanide gel was applied and sterile wound dressings were completed by multilayered greased gauzes, cotton and elastic bandages before admission to BICU. If burn depth on the upper extremities was categorized as potential deep partial- to full-thickness by the attending physician, dressings were opened and reassessed within 48 h Fig. . If the ™ 2, Serag-Wiessner, Naila, Germany) and soaked for 2 h before and after application of the actual debriding agent . We usually combined skin transplantation with spray application of fibrin sealant  to assure proper adhesion.Throughout their stay on BICU, pain levels were monitored every hour, objectified by numeric rating scale (NRS) and patients received pain medication as required. Brachial plexus catheters were removed when analgesic effect decayed to insufficient levels or determined to be dispensable. Wound healing, signs of infection or other complications were assessed every two days by the attending physician when change of dressings took place. Following ED, physical therapy was started as soon as dressings would allow treatment by a professional therapist.About 3 months after demission, patients were evaluated for remaining functional disabilities and pain levels using two German self-report questionnaires  as well as scar quality by a single physician .Sixteen patients  with burns of 20.1 (2–66) % TBSA were included in the study. On the upper extremities, 7.3 (2–15) % TBSA were classified as deep partial- to full-thickness and treated by ED 24.4 (5–47) hours after injury  % TBSA, equaling a 37.0 % reduction of transplanted skin area when compared to initial assessment. After ED patients were able to start PT after 2.0 (0–5) days but experienced prolonged wound closure with 28.0 (9–49) days on average.Seven patients had been intubated on admission due to the severity of their injuries and were fully sedated during ED. According to the severity of the injury, patients underwent either p.o./i.v. pain medication (n = 3) or a brachial plexus nerve block was applied (n = 6). Regionally administered anesthesia proved to be superior to pain medication alone. Pain level, objectified by numeric rating scale (NRS), was 3.4 1.1–5.2) in general analgesia and 2.9 (1.8–4.1) in plexus block group. This was accompanied by a 77.2 % reduction of morphine-equivalent consumed as general anesthesia group required 9.2 (0.0–17.2) mg/h and regional analgesia group required 2.1 (0.3–7.0) mg/h  were available for follow-up examination regarding remaining pain levels and functional outcomes. Results were within the lowest quarter of the scoring range with 23/100 (0–45) points on DASH and 22/100 (1–46) points on PRWE-G. Overall scar quality was assessed as 6/14 (4–8) points on VSS. All follow-up examinations were conducted by the same physician. 3 patients (37.5 %) complained about increased skin susceptibility of ED treated areas. Reports consisted of persisting lesioning , Integra™ , Suprathel™ and Biobrane™  are generally available and used in our Burn Center. Additional methods include allo- or xenografting and spray-on epidermal cells . These products will presumably further facilitate burn wound consolidation but their exact effect on NXB treated areas is unknown and something we tend to elucidate in future investigations.In our experience, ED does not necessarily require intubation and sedation, usually conducted in SOC. Pain is generally well tolerated by on ward anesthetic measures, with regionally administered analgesia being more effective when compared to p.o./i.v. medication alone. Ultrasound-guided placement of brachial plexus nerve blocks is safe and excludes morbidity possibly associated with intubation and sedation. These patients also exhibit decreased opioid doses essentially achieved by a continuously infused local anesthetic (mepivacaine or ropivacaine). Due to their additional anti-inflammatory properties, NSAIDs were given in both groups and were therefore not evaluated.Grafted areas are immobilized for at least 5 days to ensure proper skin adhesion. This unfortunately excludes these regions from PT and subsequently leads to contractures, movement restrictions and often prolonged functional recovery. With ED, patients benefitted from early onset of PT measures, mostly on the first or second day after admission. 3-month follow-up also yielded good functional outcomes and pain levels.st Assessment), preferably accompanied by regional anesthesia via brachial plexus blockage. Two days later, during dressing changes, the patient is again evaluated for areas of demarcated full-thickness involvement (2nd Assessment), which would then be treated by additional necrosectomy and skin grafting. Absence of these would rule out SOC and allow wounds to consolidate for at least 2 more weeks before surgery is again taken into consideration.In conclusion, we see a potential benefit for ED in the treatment of deeply burned hands and arms but careful observation must be assured as full-thickness involvement might require treatment adjustments, possibly neglecting associated benefits. We found regional anesthesia by brachial plexus catheter being superior to pain medication alone but availability might be limited as placement usually requires a skilled anesthesiologist. Some patients complained of persistent lesioning and hypertrophic scarring which we attributed to our prolonged waiting for reepithelialization. Based on these findings, the following protocol is currently applied at our Burn Center Fig. : All admWe hereby report our experiences in using ED on 16 patients with deep partial- to full-thickness burns of the upper extremities. Although group size is small and obviously lacking appropriate controls, we feel that our observations will be of interest to any NXB using burn surgeon. Certain problems and obstacles had us adjust our initial treatment protocol but this current standard is solely based on expert opinion and clinical experience. Further investigations and prospective randomized controlled studies will be required to statistically support our conclusions.®; PRWE-G, patient-related wrist evaluation score, German; PT, physical therapy; SOC, standard of care; TBSA, total body surface areaBICU, burn intensive care unit; BTB, burn trauma bay; DASH, disabilities of the arm, shoulder and hand; ED, enzymatic debridement; NXB, NexoBrid


Inflammatory response is one of the key components of pain perception. Continuous infusion (CWI) of local anesthetics has been shown to be effective in controlling pain and reducing postoperative morphine consumption, but the effect of adding a potent anti-inflammatory drug (such as a steroid) has never been addressed. In our study, we want to investigate the effect of CWI with local anesthetic + methylprednisolone on acute and persistent pain, correlating clinical data with biomarkers of inflammation and genetic background.After approval by their institutional review board, three hospitals will enroll 120 patients undergoing major abdominal surgery in a randomized, double-blind, phase III study. After a 24-h CWI of ropivacaine 0.2 % + methylprednisolone 1 mg/kg, patients will be randomly assigned to receive either ropivacaine + steroid or placebo for the next 24 h. Then, patient-controlled CWI with only ropivacaine 0.2 % or placebo (according to the group of randomization) is planned after 48 h up to 7 days . Morphine equivalent consumption up to 7 days will be analyzed, together with any catheter- or drug-related side effect. Persistent post-surgical pain (PPSP) incidence will also be investigated. Our primary endpoint is analgesic consumption in the first 7 days after surgery; we will evaluate, as secondary endpoints, any catheter- or drug-related side effect, genotype/phenotype correlations between some polymorphisms and postoperative outcome in terms of morphine consumption, development of the inflammatory response, and incidence of PPSP. Finally, we will collect, in a subgroup of patients, wound exudate samples by micro-dialysis, blood samples, and urine samples up to 72 h to investigate local and systemic inflammation and oxidative stress.This is a phase III trial to evaluate the safety and efficacy of wound infusion with steroid and local anesthetic. The study is aimed also to evaluate how long this infusion has to be maintained in order to maximize effectiveness. Our data are intended to quantify the amount of ropivacaine and methylprednisolone needed by patients undergoing major abdominal surgery, to be stored in a new nanotechnology device for sustained pain treatment after surgery. We also aim to clarify the roles of inflammatory response, oxidative stress, and genetic background on postoperative and persistent pain after major abdominal surgery.NCT02002663) on 24 Oct. 2013.The trial was registered on ClinicalTrials.gov ( Acute postoperative pain is a complex unresolved phenomenon sustained by various patho-physiological changes, potentially leading to postoperative morbidity and persistent post-surgical pain (PPSP) , influenPostoperative pain treatment involves different strategies; the paradigm of multimodal analgesia is to combine different techniques and drugs to improve efficacy and reduce side effects. The most challenging target is the reduction of opioid consumption because, beyond the well-known respiratory, cognitive, and digestive side effects, opioids may be associated with immune depression and distant malignant cell proliferation and expansion after oncologic surgery , 7.In this perspective, continuous wound infusion (CWI) has gained increasing interest in the last decade. CWI prolongs the action of local anesthetics, improving their efficacy, and has been shown to be effective in controlling pain and in reducing postoperative morphine consumption in major surgery . A furthNevertheless, postoperative pain is due to different components, and the inflammatory reaction and its non-resolution are now considered to be important factors underlying both acute pain and pain persistence after surgery , 9, 10. Despite the importance of analgesia, the genetic contribution is considered a determinant for PPSP development, and different studies have highlighted the role of genetic factors on postoperative outcome in terms of analgesic response and pain intensity , 18.ADRB2), a target for adrenaline, is characterized by some single-nucleotide polymorphisms (SNPs) predisposing patients to chronic pain [ADRB2 haplotypes modulate chronic pain conditions such as temporomandibular disorder [Literature data demonstrate that the gene codifying for the adrenergic receptor α-2 (nic pain . Diatchedisorder .OPRM1) encodes the main receptor of opioids, and its polymorphisms are correlated to a significant interindividual difference in the postoperative consumption of morphine [COMT) gene  has been associated with the variability of pain sensitivity in experimental, chronic, and postoperative pain [UGT2B7) is of particular importance for the metabolism of morphine [Also, μ opioid receptor-1  is the main determinant of the bioactivity of IL-1, and the corresponding gene is polymorphic: variants of this gene have recently been demonstrated to be associated with differences in opioid consumption in the first 24 h after nephrectomy .In our phase III study, we will investigate the analgesic effect of CWI with local anesthetic and methylprednisolone on acute pain and PPSP in the context of open abdominal surgery. Clinical data will be correlated with biomarkers of inflammation and to the genetic background in order to investigate (1) the role of both inflammatory mediators and oxidative stress in the genesis and maintenance of pain and (2) the contribution of gene polymorphisms on inter-individual differences in pain, response to analgesics, and inflammatory reaction after surgery.This is a multicenter, prospective, double-blind, phase III clinical trial. Three centers are involved in enrollment , and two centers will be in charge of genetic analyses  and oxidative stress analyses .The present study is part of a wider project approved by and funded with a grant by the Italian Health Ministry .This clinical study is locally approved by the institutional review boards of promoting and participating centers . The trial is registered on ClinicalTrials.gov .Patient eligibility is assessed at the pre-operative anesthesia consultation. All eligible patients must sign a specifically designed informed consent form.Male and females, American Society of Anesthesiologists I-II-III, from 18 to 85 years old, scheduled to use patient-controlled analgesia (PCA) with morphine for postoperative pain control after major abdominal surgery by laparotomy  are enrolled.Regular use of opioid analgesics, history of drugs or alcohol abuse (or both), postoperative hospitalization in intensive care with sedation or mechanical ventilation (or both), neurological disorders, any heart conduction disease, any cognitive or mental disorder hindering a patient from providing informed consent, body mass index of more than 30, diabetes (type I or II), allergy to study drugs, and use of epidural analgesia are exclusion criteria.On the day of surgery, patients come to the operating room and are provided with standard monitoring . General anesthesia is given using propofol and midazolam (as deemed appropriate by the anesthesiologist), opioids (fentanyl 0.2 μg/kg or remifentanil 0.1-0.25 mg/kg per min or both), and muscle relaxants (cisatracurium/rocuronium) and maintained with sevoflurane.A morphine bolus of 0.15 mg/kg is given 30 to 45 min before the end of surgery. An infusion catheter  is placed by the surgeon in the fascial plane between peritoneum and fascia trasversalis, and a 10-ml bolus of 0.2 % ropivacaine is administered immediately after muscular plane closure; the catheter is then connected to an electronic pump  to give a continuous infusion of pain medications.During the first 24 h, all patients receive ropivacaine 0.2 % + methylprednisolone 1 mg/kg, 10 ml/h  continuous wound infusion; additionally, either acetaminophen 1000 mg or ketorolac 30 mg every 8 h is prescribed.Treatment group: 10 ml/h continuous infusion of ropivacaine 0.2 % + methylprednisolone 1 mg/kgPlacebo group: 10 ml/h continuous infusion of saline 0.9 %.Regardless of treatment group, rescue analgesia in the first 48 h is provided by PCA pump with morphine .Random group allocation of patients is made through a computer-generated sequence. To maintain blinding, a research fellow who is not taking part in patient evaluation is in charge of preparing and programming all of the pumps used during the study: an opaque, sealed, sequentially numbered envelope is assigned to each patient and is opened by the same research fellow after the first 24 h of treatment.Patients and their anesthesiologists are blind to treatment assignment. A clinical resident, who is not involved with randomization, is in charge of all clinical evaluations as part of the daily clinical practice.The envelope is maintained apart from the patient’s case report form and is to be opened in every potentially harmful situation for the patient but only when care providers need to be aware of the patient’s treatment. All ropivacaine and methylprednisolone vials used during the study are registered with their code in order to be tracked and recognized in the future for any issue potentially hindering the validity of data.At 48 h, morphine PCA is removed, and all patients are treated with Patient-Controlled Intrawound Analgesia (PCA through the wound catheter) with either ropivacaine 0.2 % alone or saline according to the group of randomization up to a maximum of 7 days after surgery. The catheter is removed at the seventh postoperative day or after 36 h of non-use (no self-administered bolus). After PCA removal, rescue additional analgesia is provided by tramadol (100 mg or 50 mg according to patient’s weight of not more than or of more than 50 kg).All patients are evaluated at the end of surgery, at 3, 6, 12, 24, 36, and 48 h, and daily to the seventh postoperative day or until catheter removal by the Acute Pain Service and twice a day by the surgeons as part of their current clinical practice. Pain values, analgesic consumption, any drug-related side effect, and any catheter-related complication (such as occlusion or dislodgment) are recorded. Patients are also evaluated by surgeons after discharge, as in the current practice: any infection or healing retardation is monitored, together with any pain or sensorial abnormality to be signaled to the pain practitioners. Regardless, the Acute Pain Service investigates pain persistence at 1 and 3 months through a phone call, and patients with PPSP (patients experiencing pain at 1 or 3 months after surgery) are eventually referred to our pain clinic for evaluation and treatment.ADRB2, OPRM1, COMT, UGT2B7, and IL-1Ra genes in all patients by the Taqman SNP Genotyping Assays  in the Pain-OMICS core-lab of Azienda Ospedaliera of Parma.We will genotype several SNPs in The peripheral blood samples are collected during general anesthesia into EDTA-coated tubes. We extract DNA by using a QIAamp DNA Blood Mini Kit  from 200 μl of blood. DNA obtained are stored at −20 °C for subsequent TaqMan analysis. Amplification is performed in a volume of 5 μl containing 10 ng of genomic DNA, SsoFast Probes Supermix . Cycling and hybridization conditions are set in accordance with the instructions of the manufacturer.The amplification and genotyping discrimination are performed in a LightCycler 480 Real-Time PCR System . All assays are used in accordance with the instructions of the manufacturer . The SNP calling is made with LightCycler 480 Endpoint Genotyping software version 1.5.0.39 (Roche Diagnostics Ltd).Inflammatory response will be analyzed on the first 15 patients in each group . Before the end of surgery, the surgeon inserts a single-use and minimally invasive (diameter of 0.5 mm) micro-dialysis catheter in the fat adjacent to the surgical wound with sterile technique. The catheter has a cutoff membrane (length of 30 mm) of 100,000 Da, which allows the monitoring of inflammation in vivo. The catheter’s characteristics allow extended use without risk of breaking. The catheter will be connected to a slow-rate infusion pump with imposition of 3 μl/min of micro-dialysis liquid, a high molecular weight (30 g dextran 60/1000 ml) substance to facilitate the micro-dialysis that remains inside the catheter. The dialyzed liquid is collected in dedicated tubes directly in the infusion pump. Sampling will be performed at 1, 6, 24, 48, and 72 h. Serum samples at the same time points are collected to compare systemic and local inflammations. All samples are stored at −80 °C until analysis. Concentrations of ILs , interferon-gamma, and tumor necrosis factor-alpha are analyzed in dialyzed wound samples  and in serum (systemic inflammation). Cytokine levels in dialyzed liquid and in serum are tested by enzyme-linked immunosorbent assay (ELISA) by using a commercial kit.Oxidative stress will be analyzed on the first 15 patients in each group . Patients are sampled before surgery, before morphine bolus, and at 24 and 48 h after surgery.g for 15 min at 4 °C to obtain the plasma.Urine samples are directly aliquoted and stored at −80 °C; blood samples are collected in EDTA-containing vials and centrifuged within 30 min at 1000×Lipid peroxidation is analyzed through the determination of malondialdehyde with thiobarbituric acid assay in both plasma and urine. The 8-deoxyguanosine and poly(ADP-ribose) polymerase (PARP) are determined by commercial ELISA kits.The primary outcome of the study is to investigate whether a wound infusion of local anesthetic and steroid has a higher analgesic efficacy compared with placebo during 7 days following surgery, assessed as analgesic consumption: the primary endpoint will be the reduction of morphine equivalents required in the first 7 days after surgery.Secondary outcomes will include the differences in analgesia and side effects within 7 days after surgery. We will investigate any difference in pain at rest and movement  by Numeric Rating Scale , additional analgesic consumption, side effects , and incidence of persistent post-surgical pain. Differences in terms of wound healing or wound infections will be also assessed up to 3 months to assess any local side effect of steroid infusion. The degree of inflammatory response/oxidative stress between groups will be assessed to analyze the effect of CWI with either treatment or placebo. We plan to analyze the combined effect of some polymorphisms (by using a gene-candidate approach) of genes related to the development of PPSP, pain sensitivity, opioid response, and inflammatory reaction.Sample size calculation was made on the hypothesis that the average morphine equivalent consumption in patients receiving local anesthetic and steroids CWI will be reduced by 50 % as compared with those in the control group. This assumption comes from (1) our retrospective experience and audits about analgesic consumption in our institution and (2) data from previous literature ; they boWe will perform an intention-to-treat analysis, and all participants will be analyzed once enrolled. We consider a “dropout” to be any patient not completing the evaluation at 3 months (for any reason).For descriptive variables, we plan to use mean and standard deviation for normally distributed variables and average interquartile range for skewed distributions.t test or Mann–Whitney test for quantitative variables and Pearson’s chi-squared test for categorical variables. Inflammation, oxidative stress, and genetic background will be assessed to see whether they are biological markers that help modulate post-operative and persistent pain: the difference in inflammatory response and oxidative stress will be analyzed by means in a uni- and multi-variate regression model for repeated measures, including time, group, and their interaction. Variables will be transformed if needed to satisfy model assumptions. Post-hoc comparisons will include within-group changes over time and between-group differences at each assessment. The P value will be adjusted for multiple tests. Fisher exact test will be used to evaluate the impact of genetic background. The odds ratio and 95 % confidence interval will be computed with logistic regression. The P value to assess statistical significance will be corrected with the Bonferroni correction depending on the number of candidate genes tested.We will perform group comparison by using the Student’s Historically, care providers have considered pain a perioperative issue able to influence immediate morbidity, but in the last decade greater attention has been placed on the long-term effects of unrelieved postoperative pain, especially PPSP , 5. PostWhen clinicians deal with acute postoperative pain, the surgical wound is a pivotal target for analgesia; nociceptors located within the surgical incision are the origin of pain stimuli coming from the periphery, and their prolonged activation is one of the causes of central sensitization. Inflammation also is a main determinant of pain; a lot of mediators are increasingly expressed after tissue injury leading to primary hyperalgesia , and IL-Peripheral administration should minimize systemic adverse effects by reducing bioavailability and plasma concentration; otherwise, any data about pharmacokinetics and potential side effects of continuous infusion of steroids are available: we therefore decided to exclude patients with any disease potentially precipitating after steroid systemic absorption, primarily diabetes (type 1 or 2).In regard to local side effects, the main concerns are about wound healing and infections potentially associated with immune-modulatory action of steroids. Most of the existing data deal with high doses of systemic steroids , 30. Up We decided to treat all the patients with 24-h CWI of ropivacaine and methylprednisolone. This will enlarge the sample size for the phase III trial (120 patients) and will allow us to investigate the differences in locally released cytokines according to suspension of local anti-inflammatory treatment after the first 24 h. This, in our opinion, does not configure a methodological bias, as our primary endpoint is analgesic consumption at 7 days, and we will take care to evaluate any statistically significant difference in morphine consumption at 24 h to eliminate any confounding factor this kind of study design may potentially imply.Furthermore, an ethical issue arises: because CWI with local anesthetics is already documented as a valuable analgesic strategy , switchiWe decided to analyze both local and systemic inflammatory response for the following reasons. First, systemic inflammation is advocated to be a risk factor for postoperative and persistent pain , but fewThe maintenance of CWI up to 7 days could also be questioned because we traditionally consider the first 48 h after surgery to be the most challenging and to be associated with the highest pain values, and most of the studies consider a 2-day infusion after surgery; otherwise, studies on incisional pain have demonstrated that sensitization processes tend to restart after suspension of analgesia . TherefoWith this study, we aim to validate the use of methylprednisolone for CWI to reduce morphine consumption and associated side effects as well as PPSP after abdominal surgery. Moreover, we want to investigate whether genetic polymorphisms might be biomarkers for postoperative pain and opioid consumption. These results should be used to define delivery times and dosages for the new nanotechnology platform we are currently developing for sustained postoperative pain relief to be used in clinical practice and should be able to improve perioperative and long-term outcome for patients.The trial is currently running, all three centers are currently involved in enrollment, and we have enrolled 46 patients so far.


Background: Pain on mid sternotomy incision site after Coronary Artery Bypass  Graft  Surgery (CABG) is a common problem that causes sleep disturbance, delayed wound healing, and increased use of analgesic drugs. Massage therapy which is mostly performed by healthcare providers is a non-pharmacological approach for managing this pain. The present study aimed to determine the effect of massage therapy by patient’s companion on the severity of pain in post CABG patients.Methods: In this randomized single-blind clinical trial, 70 post CABG patients were randomly divided into an intervention and a control group. The intervention group received massage by one of their relatives who was trained by an expert nurse. The control group, on the other hand, received routine care. The pain intensity was assessed by Visual Analogue Scale (VAS) before and immediately, 30, 60, and 120 minutes after the intervention. Then, the data were entered into the SPSS statistical software (version 16) and analyzed using repeated measures ANOVA and post-hoc test (Scheffe).Results: At the beginning of the study, no significant difference was found between the two groups regarding the pain severity. In the intervention group, the pain severity significantly decreased in all the four time points after the intervention (P=0.001). However, no significant difference was observed in this regard in the control group.Conclusion: Massage therapy by patient’s companion trained by a nurse was an effective strategy for pain management in post CABG patients. This could also promote the patient’s family participation in the process of care.Trial Registration Number: IRCT201208218505N3. Although these therapeutic methods are effective, many sufferers may need vascular repair. Coronary Artery Bypass Graft surgery (CABGs) is one of the common and effective treatments for reduction or removal of cardiac angina.3-5 In spite of the noticeable growth of technology, musculoskeletal pain has remained as one of the psycho-physical health problems because it cannot be completely relieved by medicine.6 At present, narcotic sedatives are being used to relieve the pain, but they can lead to respiratory suppression and wide and non-preventable painlessness. Although using narcotic drugs in the patients who undergo heart surgery is necessary primarily, application of large amounts of such drugs delays the recovery and also increases the length of hospital stay.7CABG is sometimes accompanied by some complications and problems, especially deep visceral and continuous pains that usually continue until two days after the surgery and then will be reduced gradually. These pains can delay the recovery and cause patient dissatisfaction.8 Therefore, finding new methods to deal with such challenges is necessary for these patients.9 Massage therapy is accounted to be one of the methods of complementary medicine as well as one of the oldest methods of healthcare. The origin of massage therapy has been found in old texts of ancient China as well as in Hippocrates’ writings.10 Massage therapy was considerably spread during the last two decades. Studies have shown that massage therapy alone or accompanied by other complementary treatments was beneficial in reduction of pain and psychological distress.11 Massage has been used to reduce challenges, such as pain and stress which are the causes of anxiety in hospitalized patients.12,13 Yet, contradictory results have been obtained regarding the effect of massage therapy on pain. For instance, the results of a research showed that foot massage did not have any significant effects on pain among the patients undergoing heart surgery.14 Another research, however, reported the positive effect of foot reflexive massage on the sternotomy site on the severity of pain after CABGs.15 Therefore, more studies are required to be conducted on the effect of massage therapy in the patients undergoing cardiovascular surgery.16By recognition of risky patients and prevention of the side-effects, nurses play important roles in control of pain.6,16,17 However, patients’ companions did not have any roles in doing the massage in any of the previous studies. Also, no studies have been performed on the effect of massage therapy by patients’ companions on the severity of pain caused by sternotomy after CABGs. Participation of relatives in the process of care has positive effects on the length of hospital stay as well as provision of care.18 The presence of family also constitutes an important source of support for better recovery.19,20 Of course, this will be effective if relatives are adequately informed about the patients’ conditions and appropriately trained by the medical and nursing staff.21 The present study aims to determine the effect of massage therapy by patients’ companions on the severity of sternotomy site pain in the patients undergoing CABGs.Up to now, several studies have emphasized the effect of massage on reduction of pain and anxiety in cardiac patients.This randomized, single-blind, controlled trial was conducted on the patients hospitalized in open heart surgery wards of Nemazee and Shahid Faghihy teaching hospitals, Shiraz, Iran between November 2012 and March 2013. Considering the power of 0.8 and Altman monogram, a 70- subject sample size was determined for the study. Nevertheless, considering the probable loss during the study, 78 eligible patients were enrolled into the study and divided into two groups. Among these patients, 6 were not willing to participate in the study and 4 discontinued their participation due to severe pain and need for analgesic drugs.Based on consultation with the patients’ physician the day before the operation, the researcher recognized if the patients met the inclusion criteria and invited them to take part in the research. The inclusion criteria of the study were being candidate for CABGs, being willing to participate in the research, being 18-70 years old, being hospitalized for at least 3 days after the operation, being oriented to time, place, and person, not having used narcotics and alcoholic drinks during the last two months, not having the history of nervous, neurovascular, psychiatric, and respiratory disturbances, and not suffering from coagulation disorders. On the other hand, the exclusion criteria of the study were reduction of level of consciousness, instability in hemodynamic status, unwillingness to continue cooperation, presence of coagulation problems , increase in the period of connection to pump to more than four hours, and suffering from chronic and malignant pain. The subjects were selected using convenient sampling and those who met the inclusion criteria were allocated to the intervention or control groups through block randomization. At first, the objectives of the research were explained to the patients and written informed consents were obtained. On the third day after the operation, the patients were examined by their physician and, in case of confirmation, were included in the study. 22 This instrument is like a ruler numerated from zero to ten. Accordingly, scores of 1-3, 4-6, 7-9, and 10 represent mild, moderate, severe, and intolerable pain, respectively. The instruction for use of VAS was explained to the patients on the first day of hospitalization. In the intervention group, massage therapy was carried out by Thailand classic method by patients’ companions under the nurse’s supervision in a private room for 30 minutes. The procedure was carried out by soaking hands with sweet almond oil which is the most common oil applied in massage therapy23 and massage was done at back, lumber, shoulders, arms, forearms, the palm and fingers of both hands, thigh, foreleg (except for donor places), soles, insteps and fingers of feet, abdomen, and neck muscles according to the patients’ tolerance. The severity of the patients’ pain was reassessed and recorded immediately, 30 minutes, 60 minutes, and two hours after the intervention. The control group, however, received the routine care on the third day of operation and their pain scores were recorded at the same time intervals as the intervention group. Of course, the nurse and the patients’ companions were present at the patients’ bedsides for 30 minutes to provide similar conditions to the intervention group. It should be mentioned that pain was assessed by a researcher who had no information about the study groups. In addition, the ward’s routine care was performed for both groups  whose validity and reliability have been confirmed previously. VAS is a beneficial tool to evaluate patients’ pain after surgery.h groups . The intAfter all, the data were entered into the SPSS statistical software (V. 16) and analyzed using independent t-test, paired t-test, and repeated measures Analysis of Variance (ANOVA) with schefe post hoc test. Besides, P<0.05 was considered as statistically significant.Ethical ConsiderationsThis study was approved by the Research Vice-chancellor and Ethics Committee of Shiraz University of Medical Sciences  were male and 32 (45.7%) were female. The mean age of the study samples was 59.77±7.28 years and 91.4% (n=64) of them were married. The mean age of the patients in the intervention and control groups was 59.28±7.11 and 60.25±7.52 years, respectively. Most of the participants’ companions in the research (68.6%) were the patients’ children and the remaining were other relatives. At the beginning of the study, no significant difference was observed between the two groups regarding the demographic characteristics, including age, sex, level of education, and marital status . In addiAll the patients in the intervention group were satisfied with massage therapy; such a way that 60.0% and 40.0% of these patients described their satisfaction rate as “very much” and “much”, respectively. 6,16,17 In another study, massage therapy was performed on 53 inpatients at medical, surgical, and obstetric wards for a period of 30 minutes in one session or more. The results showed that the intervention was effective in reduction of pain and improvement of quality of sleep, tranquility, recovery period, and healing process.24 Also, numerous studies on massage therapy in cancer patients have demonstrated its significant effects on perceived stress, quality of life, and common symptoms, such as pain, nausea, anxiety, mood disturbance, fatigue, and disturbed sleep. A large study on 1,290 patients revealed that a single massage reduced the symptoms levels by 21-52 %.25The results of this study showed that offering the patients’ companions to participate in taking care of the patient after being sufficiently trained regarding massage therapy was effective in reducing the severity of pain in post CABG patients. This finding has been supported by other researches, as well. Some studies conducted on heart surgery patients have indicated the significant effect of massage therapy on reduction of stress, anxiety, and pain.26,27 The results of two studies carried out in this area reported that massage therapy by companions as well as nurses was effective in reduction of anxiety, systolic blood pressure, heart rate, and respiratory rate among the male patients hospitalized in CCU.28,29 The results of another study indicated that doing acquainted sensory stimulations by patients’ companions during the first six days of admission of patients with brain trauma at ICU increased the level of consciousness compared to the control group.27 Also, use of organized sensory stimulation by family members led to a significant increase in the level of consciousness and cognitive behavior state in brain injured patients.30Moreover, several studies have shown the significant effects of patients’ companions’ participation in care process on the quality of life and the related indexes in hospitalized patients.31 The findings of the current study showed that participation of the patients’ relatives in the care process eliminated the pain, eventually increasing the patients’ and companions’ satisfaction. According to the results of the previous studies, the active support of relatives in the treatment process is highly valuable.32 In our socio-cultural context, familial relationships influence the whole dimensions of life of individuals, especially in illness and crisis.33The effect of interpersonal relationships as a contributing factor to the benefits of massage should also be considered. After experiencing a major surgery and a stressful situation in a surgical ward, patients can benefit from the attention of a family member providing support and comfort.34Furthermore, involvement of patients’ companions as family caregivers in massage therapy can lead to continuation of this effective intervention after discharging from the hospital. Of course, appropriate education and training must be considered by nurses with respect to patient safety and provision of effective care.This study revealed new information about the effectiveness of massage therapy by patients’ companions that could be observed by the nursing personnel in order to train the companions and recommend such treatments to patients. The study results showed that massage therapy could be safely and effectively delivered by the companions in cardiothoracic surgical ward, leading to significant reductions in pain and patient satisfaction. Yet, further studies are recommended to assess the effect of massage therapy on these patients’ severity of pain in longer time periods.


Evidence indicates a strong relationship between chronic nonspecific back pain and psychosocial risk factors. The Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) and the German Heidelberger Kurzfragebogen Rückenschmerz (HKF-R 10) are deemed valid in prediction of persistent pain, functional loss or amount of sick leave. This study provides and discusses validity criteria for these questionnaires using ROC-curve analyses. Quality measurements included sensitivity and specificity, likelihood-ratio related test-efficiencies and clinical utility in regard to predictive values.265 patients recruited from primary and secondary care units completed both questionnaires during the same timeframe. From the total, 133 patients returned a 6-month follow-up questionnaire to assess the validity criteria for outcomes of pain, function and sick leave.Based on heterogeneous cut-offs for the ÖMPSQ, sensitivity and specificity were moderate for outcome of pain (72%/75%). Very high sensitivity was observed for function (97%/57%) and high specificity for sick leave (63%/85%). The latter also applied to the HKF-R 10 (pain 50%/84%). Proportions between sensitivity and specificity were unbalanced except for the ÖMPSQ outcome of pain. Likelihood-ratios and positive predictive values ranged from low to moderate.Although the ÖMPSQ may be considered useful in identification of long-term functional loss or pain, over- and underestimation of patients at risk of chronic noncspecific back pain led to limited test-efficiencies and clinical utility for both questionnaires. Further studies are required to quantify the predictive validity of both questionnaires in Germany. At present, chronic non-specific back pain (CNSBP) is considered a complex, multidimensional phenomenon, whereas origin and development is often traced back to psychosocial components. Conceptualised as “yellow flags”  these arAbout 10% to 15% of individuals with NSBP develop persistent problems that cause up to 90% of all direct and indirect expenses for health care systems in European countries ,8,9. MajThe “Örebro Musculoskeletal Pain Screening Questionnaire” (ÖMPSQ)  and the A recent publication tried to evaluate the predictive validity of these in a German sample . It diffWe provided and discussed several validity criteria for the ÖMPSQ and the HKF-R 10 and aimed at a better understanding for the test properties of the ÖMPSQ. Quality Measurements included discriminatory power, test efficiencies in regards to likelihood-ratios and clinical utility for each of the questionnaires. No direct comparison was intended due to different items that assessed different outcomes . To replicate foregoing results and to allow for the comparability to the work of Linton and Boersma, we employed similar methodological strategies. Because of Country specific differences according to the health care system, we slightly modified the eligibility criteria. For the HKF-R 10, specifications followed correspondence with the study authors.The ethical review committee of the University of Heidelberg approved this study in April 2012. Data were collected between May 2012 and February 2013 as well as between November 2012 and August 2013. Primary and secondary care units were asked to participate by written or oral enquiry. Orthopaedic specialists, rehabilitation facilities and private physiotherapy practices were selected to reflect upon the typical scenario for help-seeking patients. Data collection was not limited to a specific geographic region; moreover, units in several Federal States of Germany were chosen. After obtaining the units’ consent, sealed envelopes with questionnaires were sent out. Units were instructed to recruit patients who met the following eligibility criteria to participate: age > = 18 years; lower or upper back pain in first or second episode that requires further treatment; if in second episode, a required pain-free interval of 12 or more months between treatment of first and second episode; pain in acute or sub-acute stage (duration < three months); amount of sick leave < 6 month during the past year; adequate German language skills. The “required pain-free interval” criterion was used to preclude patients in a chronic/chronic recurrent state of NSBP .Participating patients completed the questionnaire that combined all individual items of the HKF-R 10 and a German translation of the ÖMPSQ respectively. In line with specifications and approvement of the ethics review committee, this questionnaire contained two additional pages: a declaration of consent that must be signed by the participants and an information page to provide global information about this study. Futhermore, to prevent missing items an additional instructions page was also added to help patients in cases of uncertainty. Completed questionnaires were sent back to ER by the participating institutions. Following this, and after exclusion of questionnaires with non-signed declarations of consent random alphanumeric assignments were given to anonyms the individual data sets. The patients’ data and date of receipt were stored separately in electronic form. Six months’ later envelopes containing a follow-up questionnaire and a second envelope were sent to the participating patients directly. These did not contain any patient data except the alphanumeric assignment.The ÖMPSQ is a widespread screening-questionnaire first developed in Sweden  to assesTo evaluate the predictive validity for the ÖMPSQ we used a German translation developed by T. Kohlmann, C.O. Schmidt and M. Pfingsten in 2007. Development is based on international recommendations for self-reported measurements , whereasThe HKF-R 10 from 2006 . It consAbout our study approach to replicate the ÖMPSQ in a German sample, we strictly followed the methodology of the original study in defining the key items and assessing the outcomes of pain, sick leave and function after six months. Regarding the HKF-R 10 , specifications set by EN were used to assess the outcome of pain.The follow-up questionnaire was designed to assess the outcomes referenced above. It included all individual items of both questionnaires at first data collection to provide additional information if needed. Items to assess the outcomes read as follows.Sick leave for the ÖMPSQ was assessed by adding self-reported days of sickness related absenteeism during the follow-up period . For function, the activity related items 21–25 were used.Pain was assessed by pain intensity and pain frequency during the last 3 months (items 10+11).For the HKF-R 10 item 5 considering the average pain intensity during the last week was used to assess outcome of pain. As mentioned previously, this item was excluded from scoring at baseline.Outcomes for the ÖMPSQ were defined as follows.Self-reported sick leave was divided into three groups: individuals with no sick leave (0 days), with short-term sick leave (1–30 days) and long-term sick leave (> 30 days). Defining sensitivity and specificity is prevented by using variables with non-dichotomous characteristic attributes. Therefore, ordinal or metric endpoints of outcome variables with more than two categories were artificially dichotomised to classify patients as “test-negative” (recovered) or “test-positive” (not recovered) only. Although loosing subgrouping information we dichotomised self-reported sick leave to divide patients with no sick leave (0 days) from those with short or long-term sick leave (> 0 days).For function the scores of items 21–15 were summed (possible range 0–50) and a cut-off point at 45 was set to separate recovered from non-recovered patients . Pain for the ÖMPSQ was defined by multiplying items 10+11 (possible range 0–100). The cut-off was set at 17 to separate recovered from non-recovered patients . For the HKF-R 10 we used a cut-off set at 30 to separate recovered from non-recovered patients .For input and processing, such as computing of total scores and sub-scores MS Excel 2013 for Windows was used. Each data set contained items of both questionnaires and was divided into two partial data sets to handle raw data validation and further statistical analyses for each of the questionnaires. Missing values were not allowed for the HKF-R 10. For the ÖMPSQ we followed Linton’s approach to allow total score mean substitution . RegardiIBM SPSS Statistics 20.0 and XLSTAT 2013 for Windows were used for calculations. The statistical significance level was set to 5% (α = 0.05) and the confidence interval (CI) to 95%.Preliminary analyses of variance (ANOVA) were conducted to evaluate relationships between scoring levels at baseline and the characteristic attributes of the outcome variables. The level of mean differences between a low or a high total score at baseline (indicating a lower or a higher risk of CNSBP) and the outcome classification at follow-up (recovered/not recovered) indicates a missing or existing relationship.To evaluate the discriminatory ability of both questionnaires, ROC curve analyses (Receiver Operation Characteristics) were conducted. The area under the curve (AUC) has been deemed as the most common measure of quality of information ,28,29. AClassifications of test efficiencies concerning likelihood-ratios and its relationship to prevalence and predictive values are based on references that were found elsewhere ,33,34. QIn total, 11 physiotherapy practices, 7 orthopaedic practitioners and 2 rehabilitation facilities agreed to participate. During the first data collection, 435 questionnaires were sent out of which 270 were completed. Unsigned declarations of consent (n = 4) and written withdrawal from study (n = 1) reduced the total number of questionnaires at baseline to n = 265. Raw data validation reduced the total amount of valid partial data sets at baseline to n = 241 for the ÖMPSQ and n = 242 for the HKF-R 10.During follow-up, 133 questionnaires were returned. Missing mandatory case-boundaries of the total score at baseline and non-empty values of key variables at follow-up led to sub-samples with a reduced sample size. The sub-samples were as follows: HKF-R 10 pain (n = 128); ÖMPSQ pain and function (n = 122), sick leave (n = 108). Tables Total mean substitution was applied to 69 of 93 incomplete data sets for the ÖMPSQ. 46 substitutions were traced back to participants who indicated that they were currently “not working” by ticking the respective box for one or all of the three work related items. In 16 cases, neither the scales nor the checkboxes were ticked. It should be emphasised that this item group was often commented on by participants (n = 50 of 265).For the ÖMPSQ (n = 241) the mean age was 43 years, 65% of this distribution were female and 49% were full-time working. 63% of the participants reported multiple pain sites. Sickness-related absenteeism due to pain for more than a minimum of one day during the past year was reported by 37% of this sample. Pain duration of more than one week was reported by 94% of all participants and 15% reported pain durations of longer than 24 weeks. Mean pain intensity during the last week was 5.5 and 4.8 during the past 3 months. Mean pain frequency during the past three months was 6.Distributions for the HKF-R 10 (n = 242) read as follow: 67% were female and 42% reported O-Level graduation. Pain duration of more than 8 days was indicated by 88% of the participants and multiple pain sites were stated by 59%. Pain relief after massage was reported by 52%. The mean pain intensity during the last week was 53.2 (range 0–100), and the best pain intensity was 27.9; mean accepted pain intensity after successful treatment was 11.6.Tables A-E in Preliminary analyses of variance revealed a strong relationship between scores at baseline and the outcome attributes of pain, function and sick leave after six months . Full ANOVA related calculations are outlined in Tables F-H in As indicated in With a total score related cut-off of 84 in prediction of pain, moderate and balanced values were observed for the ÖMPSQ . Prediction of function showed very high sensitivity (97%) and low specificity (57%) with a total score cut-off of 71. In contrast and with inversed proportions, a total score cut-off of 92 predicted sick leave with low sensitivity (63%) and high specificity (85%). The same applied to prediction of pain for the HKF-R 10  with a total score cut-off of 46. Predictive ACC levels for outcomes ranged between low for the HKF-R 10 in pain, moderate for the ÖMPSQ in pain and sick leave and close to high in function. As seen, our results revealed clearly lower cut-offs for the ÖMPSQ in outcomes of pain and function than by Linton and Boersma . For theAs quality of LR’s rely on levels of sensitivity and specificity as well as on balanced proportions between both; the resulting test efficiencies could be classified as moderate at maximum for all outcomes of the questionnaires , agreement to Linton and Boersma exists in a moderate discriminative ability to identify patients at risk or no risk of persistent pain symptoms. Our results did not confirm their findings that tried to underline a high discriminatory power for sick listing.Although sensitivity for outcome of function was very high, specificity was low and slightly above chance. This combination tends to overestimate patients at risk of CNSBP due to a rising number of false-positive results. An inversed proportion however, tends to underestimate the number of patients at risk by a rising amount of false-negatives. This is seen in prediction of sick leave for the ÖMPSQ and of pain for the HKF-R 10. In this regard, power of discrimination seems to be ambiguous and should be considered with care. To get around this, the provided cut-off example of 84 for all outcome groups should be favoured. This cut-off increases utilisation by unifying three different cut-offs, balances proportions and provides at least an overall moderate discriminative ability for the ÖMPSQ. Similarly, a cut-off of 37 for the HKF-R 10 that equals the original study should be recommended.Predictive validity of a screening-tool should include quality measurements of test efficiencies and clinical utility. Test-efficiencies regarding the intent of these questionnaires describe the power of LR’s to change the pre-test probability at risk of CNSBP to a sufficient PPV if the test result was positive. PPV’s will always be low if pre-test probabilities  are low—regardless of the power of LR’s. Compared with an established prevalence in the German population, inadequate representation of prevalence’s within our sample led to inadequate PPV’s. This is seen in our findings when trying to re-calculate the PV’s. In these cases, we encourage recommendations to use the prevalence independent LR’s instead. At least, these were moderate for all outcomes of both questionnaires.Although strict eligibility criteria were chosen to minimise the amount of individuals’ that were in (recurrent) chronic state of NSBP at baseline, a potential selection bias could not be ruled out. This was indicated by reported pain duration for the ÖMPSQ of more than 24 weeks by 15% of all participants . In addition, selection of participating patients by physicians and physiotherapists was maybe biased by their subjective view that patients were willing to cooperate and/or had an already existing higher risk of CNSBP. This may explain high prevalences within the sub-samples. Furthermore, by conducting ROC-Curve analyses that require dichotomised values, we lost subgrouping information that were originally available by graded classifications of both questionnaires.Applying the methodological approach of Linton and Boersma in 2003, our study suffers from the same limitations. Some of the dependent variables have not been assessed by independent variables. This was true for the outcomes of function and pain. As already mentioned by Linton and Boersma, assessment by items that were part of the questionnaire itself (and were included in scoring) may inflate statistical results.As seen, heterogeneous cut-offs within our sample for ÖMPSQ outcomes impede evaluation for examiners. These are traced back to different sub-sample sizes caused by negative raw data validation at baseline and/or missing replies to the key items at follow-up. The three work-related items were left empty several times. Uncertainties due to an inadequate reflection of the actual situation should be considered here. Furthermore, allowing for missing values (ticking checkboxes) led to an increase of potential dropouts . The meaOur results agreed with the referenced study in underlining a strong relationship between levels of pain, functional loss, sickness related absenteeism and existing yellow flags at earlier stage of non-specific back pain.The ÖMPSQ showed moderate discriminative abilities with a joining cut-off of 84 and may be recognised for early identification of patients at risk of persistent pain and functional loss. The computed cut-off was lower than by Linton and Boersma in 2003. This might be explained by German specific differences in the health care system, ethical and socio-cultural backgrounds. Although underlined in the referenced study, high quality in prediction of sick leave could not be replicated. All determined cut-offs for the HKF-R 10 in prediction of pain revealed quality measurements that must be reviewed with care. Additionally, it seems to be questionable whether outcome of pain alone is a meaningful predictor of chronic non-specific back pain.It should be stated that high sensitivity at cost of some specificity may be considered for both questionnaires in general. By adding progressive time pressure and need of saving expenses, costs for unnecessary and time-consuming examinations and treatments would be likely for individuals without risk. On the other hand, and in case of applied multimodal treatment models it could be argued that these costs after identification of individuals at risk of CNSBP  are in a much lower proportion compared to secondary costs arising from failed recognition of this group. A Swedish study demonstrated savings of about 90.000 Euro per head in a period of 7 years , whereasIn the light of clinical utility, the use of predictive values should be avoided in our study population due to inadequate representations of positive post-test probabilities. Likelihood-ratios should be used instead, which were moderate for all outcomes of the questionnaires.Furthermore, some scoring properties of the ÖMPSQ should be used with caution as they actually contain a potential risk of statistical bias while trying to evaluate this questionnaire. We recommend no admittance of missing values and double entries. That means control of the filled out questionnaire and explanation for some items in addition. This however, will become a difficult task for examiners in regard of existing time pressure.In summary and in inclusion of all mentioned aspects of the predictive validity criteria, recommendation for use of these questionnaires is limited. Low to moderate discriminative power and moderate clinical utility will require additional tests in a triage setting to rule-in chronicity due to long-term pain, functional loss and the amount of sick leave.Concerning the use of total score dependent cut-offs for both screening-tools, some authors critically reviewed and discussed this approach for the ÖMPSQ. Instead, calculation of correlations and weights between single items or item groups and an external outcome criterion were recommended. In line with usage of prediction rules, a more specific risk profile was suggested that could also be employed to determine the treatment strategies . HoweverS1 Data(DOCX)Click here for additional data file.S2 Data(DOCX)Click here for additional data file.


Acute pain assessment in the emergency department (ED) is important in particular during the triage process. Early pain assessment and management improve outcome. The objective of this study was to determine the effects of documentation and display of patient's self-assessment of pain using numerical rating scale (NRS) on analgesic use among adult trauma patients in ED.A randomized control trial was conducted recruiting 216 trauma patients who presented to ED of two tertiary centers. Pain score was done using NRS for all patients. They were randomized into pain score display group or not displayed in the control. The outcome measured were proportion of patients receiving analgesics and timing from triage to analgesic administration.p > 0.05).The proportion of patients who received analgesics when pain score was displayed was 6.5% more than when pain score was not displayed. This difference was however not statistically significant. However, stratified categorical analysis using chi-square showed that the displayed severe pain group was 1.3 times more likely to receive analgesics compared to the non-displayed group. The mean timing to analgesic administration for the displayed and non-displayed groups were 81.3 ± 41.2  and 88.7 ± 45.4 , respectively (The proportion of patients who received analgesics increased when NRS was displayed. However, the pain display has no significant effect on the timing of analgesics. The usual scenario in the emergency department (ED) is an overworked doctor, carefully putting history together, examination, and investigations, to arrive at a diagnosis. This is often done with much time constraints and poor attention paid to acute pain management. However, a physician's primary duty is to comfort, manage, and reduce the suffering of patients. This study attempted to address this contradiction, by introducing a simple intervention in the ED. This is an effort to evaluate the effect of displaying pain score, without any other intervention, on analgesic use. As pain score is recommended as a vital sign in many international protocols, it is in a way asking if we can improve acute pain management if we implement the pain score display at triaging in the ED.The main aim of this study is to determine the effect of documentation and display of patient self-assessment of pain using numerical rating scale (NRS) on analgesic administration. Specifically, we are looking into the effects of numerical pain score display on the proportion of patients receiving analgesics and the timing of analgesic use.This was a cross-sectional randomization study in the ED of two tertiary teaching hospitals with an average annual patient attendance of 140,000. This study was granted ethical approval by the research and ethical committee of the institution.The following were the inclusion criteria:(a) Adult ≥ 20 years old(b) Patients complaining of acute pain secondary to trauma(c) Patients triaged to non-critical zone only(d) GCS 15/15The following were the exclusion criteria:(a) Patients with language barrier(b) Patients who were intoxicated(c) Patients with altered mental status or psychiatric illness(d) Patient under police custody(e) Patients with potentially life-threatening diseases or injuries(f) Non-traumatic causes of acute painPatients were carefully selected among whom who have likelihood of presenting with significant acute pain secondary to trauma, while avoiding interference with evaluation and care of patients with potentially life-threatening illness or injury. All patients attending the ED would be triaged by a triage officer at the entrance of the department. Critical patients would be admitted to the resuscitation bay immediately after the triage decision had been made. The semi-critical and non-critical patients would be triaged further including the pain scoring assessment. Acute pain assessment by using NRS is a part of a vital sign monitoring parameter included into the triage protocol of the department. Patients would be given analgesics at the triage counter if they presented with moderate to severe pain. Patients would be up-triaged and admitted to the treatment cubicle if they developed worsening of pain while waiting to be seen by doctors. Only patients who were able to give consent and had a clear mind to understand and do pain assessment were included in the study. Randomization was done prior to selection of patients. Patients were assigned to display pain score and non-display pain score groups, using a computer-generated randomization method, in blocks of four. These randomized selections were sealed in opaque brown, non-transparent, numbered envelop and arranged in ascending order. The envelopes were opened only after pain assessment was done and documented by researcher. The researcher and the triage officer were blinded to the randomization while doing the pain score and initial data collection. This was important to avoid bias when pain score was being performed. Verbal consent was obtained from each patient.α = 0.05 (95% CI), study power = 0.8 (80% ), two proportion samples Po = 0.5 and Pi = 0.3, and M = 1.The sample size was calculated by using the following parameters:The sample size required were 220 patients (110 per arm) including the 10% dropout.The NRS was used as the pain scale assessment tool as this has been assessed as the best tool to be used among trauma patients in the ED. Figure  1]. A b. A b1]. Pain assessment was done at triage after chief complaint and vital signs were assessed. This was done by the patients, without relying on physicians' impression. This is as suggested by the Canadian Association of Emergency Physicians (CAEP) consensus document on emergency pain management .Instructions on how to do a pain score was explained to the patients by the researcher. Instruction was given by using local languages and dialects. Relatives were discouraged from translating or trying to answer for the patient. The numerical rating scale was shown to the patient. Patients were asked to give pain score value according to their own assessment of pain severity. They were excluded from the study if they did not understand the instructions after being repeated twice. The data was entered into the data collection form. Based on the previous study carried out by Silka et al., we decided that the NRS score of 7 to 10 is severe pain, NRS score of 4 to 6 is clinically significant moderate pain, and any score of 3 and below is mild pain.p value of less than 0.05. Data exploration was done using descriptive statistics and presented as charts and tables for each variable.Data entry and analysis were done using Statistical Packages for Social Science (SPSS) version 12.0.1 software which was registered by the institution. Numerical pain score was converted to categorical variable. Chi-square test was used in the analysis of the differences of analgesic administration between the displayed pain score and not displayed pain score groups. The confounding effect of pain severity on this relationship was analyzed by using Mantel-Hanszel estimate. Timing to analgesics was presented as mean and analyzed by using ANOVA test. Statistical significance was considered at p > 0.05). Majority of patients who presented with acute pain in this study group were in the range of 20 to 29 years of age . The distribution of the pain score groupings in the displayed NRS group for the mild, moderate, and severe pain are 12.9% (n = 13), 46.5% (n = 47), and 40.6% (n = 41), respectively. Likewise, the distribution of the pain score groupings in the non-displayed NRS group for the mild, moderate, and severe pain are 17.2% (n = 17), 49.5% (n = 49), and 33.3% (n = 33), respectively. The proportion of patients who received parenteral analgesics for mild, moderate, and severe pain in displayed group was 7.7%, 21.7%, and 47.6%, respectively (p < 0.05). Likewise, there is an increment of proportion who received analgesics in the non-displayed group from 23.5% to 31.3% with increasing pain severity (p < 0.05). The proportion of patients who received analgesics when pain score was displayed was 6.5% more than when pain score was not displayed. This difference was however not statistically significant (p = 0.30)  in the study group and 99 (49.5%) patients in the control group after exclusion due to various reasons. The general demographic data comparison between the two study groups is as shown in Table p = 0.538). The distribution of timing of analgesics according to the severity of pain is as shown in Table The mean timing (in minutes) to analgesic administration for the displayed and non-displayed groups were 81.3 ± 41.2  and 88.7 ± 45.4 , respectively (Painful suffering is neither a diagnosis nor a disease. Nevertheless, it is a condition experienced by patients posttrauma that needs to be attended to attentively. Over the last few years, there has been much progress in the understanding of the pathophysiology of pain and its effect on disease and healing. More importantly, evidence has emerged on the detrimental effect of neglecting pain on disease progression and patient recovery ,4]. The. The4]. Few studies had shown the positive effects of pain score display on analgesic use in the ED. In a retrospective study by Nelson, the effect of introducing a mandated verbal numeric pain scale on the incidence and timing of analgesic administration in trauma and non-trauma patients in the ED was studied. Analgesic use increased from 25% to 36%, and analgesics were administered more rapidly after the scale was introduced ,10]. Co. Co10]. However, in this study, the displayed pain score did not affect the timing to analgesics compared to when pain score was not displayed. The study by Silka also showed no difference in the timing to first analgesics when comparing those patients with or without VPS. Pain assessment using NRS at the time of triage and prominent display of the pain score in patient medical record did not alter the timeliness of analgesic administration. Time to analgesics has not been studied in the ED in this country previously as far as the author's awareness. There is no nationwide system currently in place to triage a patient with a high pain score to see the doctor earlier. There are also no guidelines to administer analgesics earlier in patients with high pain score, while they wait for doctors. These are the measures that could be introduced to reduce the time the patient is in pain while waiting for analgesic administration.The main limitation of this study is the practice of analgesic administration in the ED being influenced by the awareness that the study is going on. The presence of the researcher in the triage and the new sticky label on the medical case notes with the pain score developed the awareness that they were being monitored. Perhaps this created some pressure to give more analgesia than usual or otherwise. This inevitable Hawthorne effect was counterbalanced by the utilization of a control group. Notably, patients and physician were blinded to the study null hypothesis. Only patient factors that influenced pain score and analgesic administration were studied. Factors regarding the doctors' experience or knowledge of pain management were not analyzed. These factors could not be studied as there was a high turnover of doctors in the ED and many different doctors work for the three shifts. Other factors that may influence analgesic administration include the number of doctors on duty and the number of patients on the days of study or particular shift. If there were many patients and the doctors were very busy, they might ignore the pain score and try to work fast in their limited time per patient. The time of the day when the study was conducted may also affect the outcome. These were not considered in the study.This study has determined the effect of documentation and display of patient self-assessment of pain using NRS on analgesic administration. The proportion of patients who received analgesics increased when NRS was displayed. However, the pain display has no significant effect on the timing of analgesics.The authors declare that they have no competing interests.NHR involved in the conception of the study and preparing the manuscript. CA involved in data collection and statistical analysis. Both authors read and approved the final manuscript.