The evidence of undertreatment of pain in patients with dementia is inconsistent. This may largely be due to methodological differences and shortcomings of studies. In a large cohort of patients with incident dementia and age- and sex-matched controls we examined (1) how often they receive diagnoses indicating pain, (2) how often they receive analgesics and (3) in which agents and formulations.Using health insurance claims data we identified 1,848 patients with a first diagnosis of dementia aged ≥ 65 years and 7,385 age- and sex-matched controls. We analysed differences in diagnoses indicating pain and analgesic drugs prescribed between these two groups within the incidence year. We further fitted logistic regression models and stepwise adjusted for several covariates to study the relation between dementia and analgesics.On average, patients were 78.7 years old . The proportions receiving at least one diagnosis indicating pain were similar between the dementia and control group . The proportion who received analgesics was higher in patients with dementia in the crude analysis , but was significantly lower when adjusted for socio-demographic variables, care dependency, comorbidities and diagnoses indicating pain . Analgesics in liquid form such as metamizole and tramadol were more often used in dementia.Our findings show a comparable documentation of diagnoses indicating pain in persons with incident dementia compared to those without. However, there still seems to be an undertreatment of pain in patients with dementia. Irrespective of dementia, analgesics seem to be more often prescribed to sicker patients and to control pain in the context of mobility. Pain is a common symptom in older persons. Findings from clinical and experimental studies show that pain in patients with dementia is as frequent and intense as in patients without dementia, even if less reported . DementiHowever, there is evidence that pain in dementia may remain undetected due to difficulties in communication -8. AlongThe diverging results of the cited studies may largely be due to methodological differences and shortcomings. The two more recent Scandinavian studies were population based with a high number of included patients ,18. All The aim of this study was to investigate in a large cohort of newly diagnosed dementia patients compared to age- and sex-matched controls• the occurrence of pain (and types of diagnoses indicating pain),• the prescribing of analgesics (and which agents and formulations) and• factors associated with the prescription of analgesics within the incidence year.For this study, we used pseudonymized claims data of the Gmünder ErsatzKasse (GEK), a statutory health insurance company which insured 1.7 million people located in all regions of Germany during the study period (2% of the German population). The data used in this study are not publicly available. Patients with a first diagnosis of dementia in ambulatory medical care between the first quarter of the year 2005 and the first quarter of 2006 were identified. Quarters had to be chosen because they form the basic time period for coding diagnoses in ambulatory care in Germany and only the quarter in which a diagnosis occurred is available in claims data. Patients with incident dementia were included if the following criteria were fulfilled:• age of at least 65 years,• at least one ICD-10 code for dementia from the following list  in ambulatory medical care in at least 3 of 4 consecutive quarters,• at least 4 quarters free from this diagnoses before and• continuous insurance period of four quarters before and after the first code was recorded.Furthermore, we matched up to four controls for each patient with incident dementia using the nearest neighbour matching method of the matchit package of the statistical software ‘R’. Matching criteria were sex, year of birth, amount of contacts with physicians, and the number of consulted physicians four quarters before incidence. Thus patients with and without dementia are comparable with regard to ambulatory health care utilisation. Further requirements for the control group were the absence of dementia diagnoses and a continuous insurance period within the 2 years of observation. The quarter in which one of the codes indicating dementia appears for the first time is called the ‘incidence quarter’. The incidence quarter of the controls was that of the case. This and the following 3 quarters are referred to as the ‘incidence year’, forming the study period for all of our following analyses.The selection of patients and controls has been described in more detail elsewhere -21.The International Classification of Diseases (ICD-10) lists only few specific pain diagnoses. Thus, relying only on these diagnoses for the identification of patients with pain in claims data would probably underestimate its occurrence. Freytag et al. used classification and regression trees (CART) for the identification of patients with pain based on health insurance claims data . They de• Cancer pain ,• Pain due to arthritis or osteoarthritis ,• Pain due to fractures ,• Pain due to multimorbidity and care dependency ,• Headache ,• Neuropathic pain ,• Back pain  and• Pain, not elsewhere classified (ICD-10: R52).At least one of these diagnoses indicating pain had to be documented in ambulatory medical care within the incidence year, or the respective year in controls.The prescription of drugs within the German statutory health insurances is allowed for all physicians  working in the ambulatory sector. The hospital sector does not play a notable role in the prescription of drugs. Prescriptions relate to both community-dwelling persons and those living in nursing homes. With some exceptions including over-the-counter (OTC) medications, prescribed drugs are reimbursed by the statutory insurances requiring a co-payment of 10% of the price with a minimum of 5 € and a maximum of 10 € for each prescription. However, co-payment exemptions are available for the chronically ill.We identified all drugs according to the so-called analgesic ladder of the World Health Organization (WHO). However, acetylsalicylic acid (ASA) and paracetamol were not included in the analyses because both drugs are not reimbursed by the statutory health insurances and are solely bought OTC in Germany. We also studied the route of administration with a special focus on liquid oral and transdermal formulations.We used two measures of comorbidity: (1) levels of care dependency and (2) the number of prescribed medications. Services from the German long term care insurance are provided to those who require support in their activities of daily living including personal hygiene, eating, mobility and – separate from personal care – housekeeping. There are three levels of care dependency related to the estimated time required for assistance indicating moderate (level I), severe (level II) and severest care dependency (level III) ,25. If cOur main focus lies on differences between patients with and without dementia. After a descriptive characterisation of the study cohort, the proportion of patients with at least one diagnosis indicating pain in the incidence year of dementia or the respective year in those without dementia was estimated. We further compared the agents prescribed to the two groups within the incidence year. The proportions of patients prescribed analgesics were compared on the basis of at least one prescription per patient. We grouped analgesics according to the WHO analgesic ladder as well as to the route of administration. Differences in proportions between the dementia and control group were analysed with the chi-square test.To study the relation between the prescription of at least one analgesic drug and incident dementia, we fitted logistic regression models and stepwise adjusted for several covariates. First, an univariate analysis was performed (model 1). In model 2, we adjusted for demographic variables and care dependency including age ; sex ; level of care dependency (4 categories) and place of residence . For model 3, further comorbidity measures and diagnoses indicating pain were entered in the multivariate model: the quartiles of the numbers of prescribed medications (4 categories) as a proxy for the severity of comorbidity as well as the 8 different pain types . Crude and adjusted odds ratios (OR) with 95% confidence intervals (95% CI) were estimated.We performed all statistical analyses with SAS for Windows version 9.2 .The study was conducted according to the principles expressed in the Declaration of Helsinki. The use of health insurance claims data for scientific research is regulated by the German Code of Social Law (SGB X) and no informed consent has to be obtained. According to the Good Practice of Secondary Data Analysis, a national guideline for the use of administrative databases, no approval of an ethical committee is required .Baseline characteristics of the 1,848 patients with dementia and 7,385 controls are shown in Table Although there are pain types from which patients with dementia suffer more often than controls , the proportion of patients receiving at least one diagnosis indicating pain is similar in both groups  . This difference is mainly due to a higher prescription prevalence with WHO step II opioids and liquid oral substances in the dementia group . This finding might contradict the widespread perception that pain or conditions associated with it often remain undetected in dementia -8. HowevIn contrast to other studies examining the treatment of dementia patients with analgesics -16, we iPrevious efforts to improve the management of pain in patients with dementia focused on recommendations for a better detection of pain by physical examination and the assessment of pain using self-report and observational methods ,32. In oThere were noticeable differences in the prescribing habits of analgesics between the two groups with liquid oral substances like metamizole and tramadol as well as transdermal opioids more often used in dementia. The latter finding is in line with the study of Bell et al. . AlthougUsing claims data for research has many advantages but also disadvantages. On the one hand selection bias is reduced, as claims data allow us to study diagnoses indicating pain and analgesics prescriptions in dementia patients irrespective of their current state of health, communication problems, old age, frailty, institutionalisation or location. Also we could control for further patient related factors such as level of care dependency, and the number of prescribed medications as comorbidity measures.On the other hand, validity of diagnoses should be considered . AlthougIt should further be kept in mind that we analyzed diagnoses indicating pain and not pain itself. We do not know if these persons really are in pain and for which indication analgesics were prescribed. Therefore, it was not possible to study the quality of analgesic prescribing and we only used the indicator ‘at least one analgesic’. Furthermore, we do not know whether drugs were prescribed as permanent, acute or as-needed medication, which could be relevant in the case of pain medication . ParacetOur findings show a comparable documentation of diagnoses indicating pain in persons with incident dementia compared to those without. However, when taking comorbidity into account, there still seems to be an undertreatment of pain in dementia. This might indicate an awareness/recognition problem. Irrespective of dementia, analgesics seem to be more often prescribed to sicker patients and to control pain in the context of mobility. Special attention concerning pain medication should therefore be paid in immobilized patients, as immobilization can lead to a (justified or not) reduction of pain medication. Prescription of analgesics in transdermal or liquids forms may be alternatives in demented patients who suffer from swallowing disorders, but might cause other problems. Our findings raise the question what further reasons might lead to the undertreatment of pain in dementia and what changes occur in the progression of the disease. This longitudinal perspective should be taken up in further research.The authors declare that they have no competing interests.FH and HK conceptualized the study design and wrote the paper. FH and BW performed the statistical analyses. All authors interpreted the data, critically revised the manuscript, read and approved the final version. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2318/14/20/prepub


Central post-stroke pain (CPSP) is a neuropathic pain syndrome associated with somatosensory abnormalities due to central nervous system lesion following a cerebrovascular insult. Post-stroke pain (PSP) refers to a broader range of clinical conditions leading to pain after stroke, but not restricted to CPSP, including other types of pain such as myofascial pain syndrome (MPS), painful shoulder, lumbar and dorsal pain, complex regional pain syndrome, and spasticity-related pain. Despite its recognition as part of the general PSP diagnostic possibilities, the prevalence of MPS has never been characterized in patients with CPSP patients. We performed a cross-sectional standardized clinical and radiological evaluation of patients with definite CPSP in order to assess the presence of other non-neuropathic pain syndromes, and in particular, the role of myofascial pain syndrome in these patients.CPSP patients underwent a standardized sensory and motor neurological evaluation, and were classified according to stroke mechanism, neurological deficits, presence and profile of MPS. The Visual Analogic Scale (VAS), McGill Pain Questionnaire (MPQ), and Beck Depression Scale (BDS) were filled out by all participants.Forty CPSP patients were included. Thirty-six (90.0%) had one single ischemic stroke. Pain presented during the first three months after stroke in 75.0%. Median pain intensity was 10 (5 to 10). There was no difference in pain intensity among the different lesion site groups. Neuropathic pain was continuous-ongoing in 34 (85.0%) patients and intermittent in the remainder. Burning was the most common descriptor (70%). Main aggravating factors were contact to cold (62.5%). Thermo-sensory abnormalities were universal. MPS was diagnosed in 27 (67.5%) patients and was more common in the supratentorial extra-thalamic group (P <0.001). No significant differences were observed among the different stroke location groups and pain questionnaires and scales scores. Importantly, CPSP patients with and without MPS did not differ in pain intensity (VAS), MPQ or BDS scores.The presence of MPS is not an exception after stroke and may present in association with CPSP as a common comorbid condition. Further studies are necessary to clarify the role of MPS in CPSP. Central poststroke pain (CPSP) is a neuropathic pain syndrome associated with somatosensory abnormalities due to central nervous system (CNS) lesion following a cerebrovascular insult. CPSP pain has been reported since the end of the XIX century. ClassicPoststroke pain (PSP) refers to a broader range of clinical conditions leading to pain after stroke, but not restricted to pain of central neuropathic nature (CPSP). PSP affects from 11 to 55% of patients following a CNS vascular event-10. It iMPS can also serve as a peripheral pain generator and alter the function of descending modulatory pathways as has been recently reported in other chronic pain conditions. BesidesWe performed a cross-sectional standardized clinical and radiological evaluation of patients with definite CPSP in order to assess the presence of MPS in this sample.Forty CPSP patients were evaluated in the Pain Center of the Hospital das Clínicas in the University of São Paulo. All patients presented at least one stroke affecting the somatosensory pathways, as documented by brain MRI or CT scans.Inclusion criteria were adults > 18 years), presenting definite neuropathic pain with sensory deficits in the same topographic area related to a lesion to the somatosensory system[ years, pAll patients signed an informed consent to participate in the study. The protocol was approved by our local Ethics Review Board. Patients were asked to keep current medications and were assured to have their treatment continued during and after the end of the study.Data on associated health conditions, time between stroke and pain onset, and duration of pain were recorded during a structured interview.Patients were instructed to indicate the site of their neuropathic pain in a human body template and to identify the presence and location of the other painful areas.Bedside physical examination was performed with the following tests: vibration detection threshold was performed with a 128 Hz vibrating tuning fork applied to the first finger and to the toe bilaterally. Thresholds were defined as the time elapsed from the beginning of the exam to the point where the patients ceased to detect the vibration stimulus. Hyperalgesia was assessed with a pinprick. Mechanical dynamic allodynia was assessed with a soft brush slightly stroke for 6 cm 2 cm/sec. Tactile non-painful stimulus was investigated with a cotton swab. Thermal sensitivity was assessed with hot (40-45°C) and cold (5-10°C) water-filled tubes. Thermal allodynia was defined as the presence of pain to the contact of a glass tube containing water at 20°C in the absence of mechanical allodynia. Each sensory test was performed in predetermined cutaneous points five centimeters apart from each other from the face to the feet bilaterally . The difBrain MRI was performed in 24 patients (65%) or CT scan in 16 (35%). Lesions sites were classified as thalamic, thalamic-capsular, supratentorial extra-thalamic, brain stem or undetermined by a blinded experienced neuroradiologist. Patients with multiple encephalic lesions were stratified according to main site of the lesion anatomically related to the sensory deficits.Patients were on regular pharmacotherapy for pain control when data were collected. They used, as mono or polytherapy, the following medications: heterocyclics antidepressants in 33 (82.5%) patients and anticonvulsants in 21 (52.5%)  or median (range) according to the distribution of the variables. Qualitative variables were analyzed according to Fisher’s exact test. The χForty patients were evaluated . Thirty-six (90.0%) had ischemic stroke (s). Thirty (75.0%) patients had one single and six (15%) had more than one ischemic vascular event. Three (7.5%) patients presented intra-cerebral hemorrhage and one (2.5%) subarachnoid hemorrhage followed by vasospasm in the territory of the left middle cerebral artery. Thirty-four (85.0%) patients had systemic arterial hypertension, 7 (17.7%) diabetis mellitus, 5 (12.5%) cardiopathy, 2 (5.0%) hypercholesterolemia, 1 (2.5%) migraine. Major neurologic deficits were motor pyramidal motor syndrome in 17 (42.5%), cranial nerves deficits in 6 (15.0%) cerebellar syndrome in 5 (12.5%), choreoatetosic movements in 3 (7.5%), sensory ataxia in two (5.0%) and hemianopsia in one (2.5%) patient.Pain onset was insidious in 31 (77.5%) patients and presented during the first three months after stroke in 30 (75.0%) (Table Median pain intensity according to VAS was 10 (5 to 10) and the average pain duration period was 5.73 (±4.39) years. There was no difference in pain intensity among the different lesion site groups. Neuropathic pain was continuous-ongoing in 34 (85.0%) patients and intermittent in the remainder. Burning was the most common descriptor (70%), followed by electric shock-like paroxysms 22.5%). Nineteen (47.5%) patients had more than one descriptor for their neuropathic pain. Main aggravating factors were contact to cold (62.5%), mood swings (52.5%), movement of the painful limb (37.5%), and contact to heat (20%). There was more than one aggravating factor in 33 (82.5%) patients (Table 2.5%. NinPainful shoulder syndrome was diagnosed in 4 10.0%) patients and shoulder-hand syndrome in 1(2.5%). MPS was diagnosed in 27 (67.5%) patients and was more common in the supratentorial extra-thalamic group (P <0.001) Table . It was 0.0% patiWe performed a clinical-radiological evaluation of a group of CPSP patients focusing on the co-occurrence of PSP syndromes other than CPSP, in particular the role of MPS in these patients. CPSP was diagnosed according to the definite revised neuropathic pain criteria. The preTo our best knowledge, the prevalence of MPS in patients with CPSP has not been described previously. Interestingly, the presence of MPS was not associated with more intense pain or pain associated mood disorders in CPSP patients, however, this can be due to some limitations of the study, such a small number of patients and a ceiling effect related to the high pain intensity of these highly refractory individuals. Also, we did not quantify the intensity of MPS, which could help better understand its relationship to pain intensity and disability. In our sample of CPSP individuals the mean pain duration period was high (5.73 years), the pain scores, as well as the depression rates, were elevated, indicating a condition of high chronicity, psychosocial stress and refractoriness to treatment. The limited access of the stroke patients to a physical therapy program, performed in only five 12.5%) patients could have increased the incidence of MPS in this series. Moreover, a comparative analysis of the CPSP series with a control group was not performed. Still, our data suggest that MPS should be viewed as a common comorbid condition co-occurring with the CPSP syndrome complex. Similarly, we found painful shoulder in four (10.0%) patients and shoulder-hand syndrome in one (2.5%). Shoulder-hand syndrome is caused by glenohumeral joint subluxation due to motor paresis and is commonly associated with painful shoulder and is one of the possible presentations of the complex regional pain syndrome in PSP patients.5% patie,33. AutoNeurological deficits add more suffering to that already caused by pain and psychosocial problems related to handicap. Chronic suffering and incapacitation often lead to, or facilitate the onset of depression. There is a close relationship between pain and depression,36 and tWe diagnosed MPS in more than two thirds of CPSP patients. It was more common in patients with lobar and thalamic-capsular lesions although no association was found between motor deficits and a higher prevalence of MPS. The presence of MPS is not an exception in CPSP and may represent a common comorbid condition. The impact of MPS in pain treatment, prognosis and its role in rehabilitation of these patients remain to be determined. Our results should provide insights on the current diagnostic criteria of CPSP and draw attention to the different pain syndromes in the PSP syndrome complex.The author(s) declare that they have no competing interests.RAAO participated in study design, data collection, manuscript writing and review; DCA participated in statistical analyses and manuscript review; AGGM carried out data entry and analyses; MJT participated in study design and manuscript review. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/12/89/prepub


Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial.150 patients (87 women) treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B) and 74 to ropivacain and oxycodone (group R). Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred.The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R). Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p < 0.0001). Motor blockade was most frequent on day 1, occurring in 45% of the patients with no difference between the groups. Both regimes gave good pain control with average VAS under 40, but the pain relief was statistically better in group B. The number of pain breakthrough episodes did not differ between the groups.Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks. The postoperative pain level after posterior instrumented lumbar spine fusion surgery is generally high, thus an efficient pain control regime is required. Continuous epidural analgesia (CEA) with bupivacain, epinephrine and fentanyl for three days followed by oral analgesics is an effective postoperative treatment option ,2. This CEA with ropivacain combined with oral slow release oxycodone has theoretical advantages to CEA with bupivacain, epinephrine and fentanyl. Avoiding epidural opioids may decrease the incidence of pruritus. Additionally, the motor block effect of ropivacain is considered to be lower than that for bupivacain. Furthermore the risk for pain breakthrough episodes at time of epidural removal is lower if the patient already is treated with an oral slow release opiate when the CEA effect wears off.In an unpublished small non-randomized pilot study comparing CEA with bupivacain, epinephrine and fentanyl to CEA with ropivacain combined with intravenous opiates, we saw a decrease in pruritus and motor blocks and fewer problems with pain breakthrough episodes during treatment and at discontinuation when ropivacain was used. Therefore a randomized trial would be of value to investigate whether the postoperative period could be significantly improved for lumbar spine fusion patients, using a different epidural analgesia protocol.The aim of this study was to compare the effectiveness of two different pain control regimes after posterior instrumented lumbar fusion surgery for degenerative conditions in a randomized trial.The study was approved by the Regional Ethics Committee in Stockholm (2007-001417-41), and written informed consent was obtained from all subjects.Included were patients between 18 and 70 years of age, being treated with one to four level posterior instrumented lumbar spine fusion for degenerative conditions. Exclusion criteria were: use morphine analgesics before surgery, known allergy for any of the used drugs, any known contraindication to CEA, psychiatric disease or language problems, which would have led to great difficulties understanding the instructions or communicating the results.The series consisted of 150 patients (87 women and 63 men), with a mean age of 51 ± 11 years. Seventy-six were randomized to group B and 74 to group R after having received written information and given consent. The baseline demographics, indications for surgery, and preformed procedures are listed in Table One hour before the operation the premedication was given. The patients were operated under general anaesthesia. In both treatment groups an 18 G epidural catheter was inserted openly with the tip at the lower thoracic region towards the end of the operation. The CEA was continued for three days. The patients in both groups adjuvant paracetamol 1 g × 4 was included in the treatment. For the detailed CEA protocols see Table Pruritus was the primary variable of interest. In our pilot study pruritus was present in 40% of patients receiving CEA with bupivacain, epinephrine and fentanyl. A decrease to 10% would be considered a clinically successful reduction. With 5% significance level and 80% power 49 patients would have to be included in each group. Corresponding figures for motor blockade is 35 patients and for pain breakthrough episodes 67 patients. As CEA presumably must be terminated in several cases because of a lack of effect we chose to include 75 patients in each group to cover for these and other losses.Randomization was done using numbered closed envelops which were filled in accordance to a computer generated randomization list. The patients were given envelopes consecutively as they were entered into the study. The envelope was opened and the patient informed when the premedication was given just before the patient was brought to the OR.Pruritus was measured according to an arbitrary scale: 0 - no pruritus; 1 - mild pruritus not requiring any medical treatment; 2 - moderate pruritus requiring medical treatment; 3 - severe pruritus leading to discontinuation of the treatment. The highest score for each day was used for the further analysis.Motor blockade was registered according to Bromage [ Bromage : 0 - FrePain was measured with a visual analogue scale (VAS) from 0 (no pain) to 100 (worst possible pain) [le pain) . A mean All patients were evaluated on a set time schedule every fourth hour for five days. However, if the patient was sound asleep during the night the analgesia effect was considered satisfactory and he/she was not awakened for data acquisition. In addition an extra registration was done at six hours after surgery.pain breakthrough episode was defined as VAS ≥70 and the number of these events was registered for each patient, as was the number of extra doses of opiates given.A The primary variable pruritus was dichotomised as absent, i.e. score 0 or 1, or present, i.e. score 2 or 3, registered at any time during the study period. The two study groups were then compared using Fisher's exact test. Presence of pruritus was also compared between the treatment groups with repeated measurement ANOVA, as was presence of motor blockade and pain scores. The number of pain breakthrough episodes and extra doses of opiates were compared with non-parametric tests. P < 0.05 was considered significant.One-hundred-and-fifty patients were included in the study; 76 were randomized to group B and 74 to group R. The CEA treatment could not be initiated in 7 patients: one patient in group B developed a stroke and died shortly after the operation; a further investigation ruled out any association to the applied pain treatment. The epidural catheter was not functional in 6 cases most likely due to occlusion or dislocation.pruritus  was present in 74% in group B compared to 17% in group R, P < 0.0001 . In group B: 3 patients due to severe pruritus and 2 patients due to unsatisfactory pain control. In group R: 2 patients due to motor blockade and 1 patient due to unsatisfactory pain control. In addition 3 patients, all in group R, were discharged home already on day 4 because they were fully mobilized and no longer in need of hospital care. No data were collected on day five for these patients. The parameters for all these patients were included in the group analysis for the time they were available for the study.There were no gender differences.In the presented randomized trial dramatically lower pruritus levels were found if epidural use of opioids was avoided. This confirms the findings in the recently published randomized trial of Prasartritha et al  who founApart from good pain control the application of CEA is advantageous in multiple regards: First the lung function and blood flow in the legs are improved. Then the neuro-endocrine stress reaction and the myocardial oxygen consumption are reduced and intestinal motility is stimulated. This leads indirectly to a reduction in pulmonary complications, thromboembolic episodes, as well as other complications, shortens the hospital stay, and decreases hospital costs . The besTo avoid the side effects an ideal postoperative pain regime would combine CEA using a drug with less motor blockade effect than bupivacain with an opiate administered in a way not leading to pruritus, i.e. not epidurally. Ropivacaine has a milder side effect profile with less risk of motor blockades but with equal pain control potential as bupivacain , which mBeing the most common side effect, leading regularly to an early termination of CEA, pruritus was chosen as our primary variable. We could demonstrate that pruritus could be decreased to a great extent, but not be eliminated when avoiding epidural morphine. Therefore it is likely that postoperative pruritus is influenced by further variables. For instance lying in bed for many hours with wound dressings taped to the skin, in unfamiliar bed sheets washed with unfamiliar detergents may still contribute to itching sensations even after the pharmacological effect of epidural opiates have been removed.In our previous pilot study we saw motor blockades quite frequently in CEA with bupivacain, epinephrine and fentanyl (unpublished data). Because of its different pharmacological properties we hypothesized that this complication would have been less frequent when using ropivacain. However motor blockade was reported by almost half of the patients irrespective of treatment. Thus, it seems like this complication is a rather unavoidable part of CEA. Beyond that, the presented data could not confirm a lesser effect on motor function of ropivacain compared to other local anaesthetics, as claimed by the manufacturer. Attempts to decrease this effect by reducing the dose of ropivacain will most likely also decrease the pain controlling effect.The pain level was significantly higher in the new treatment compared to the traditional one, which is still an unaddressed problem of this oral opioid medication. However, the pain levels in both groups were generally low, with the mean value well below 40 VAS-units. The increased pain level in group R never constituted a clinical problem. The difference between the groups were in the range of 10-14 VAS-units with is hardly of clinical relevance. We have not found any reference values for the minimally clinically important difference (MCID) after surgery, but for low back pain patients it has been estimated to be 18 of 100 VAS-units . The smaThe pain control regime consisting of CEA with ropivacain combined with oral slow release oxycodone reduced the problem with pruritus when compared to CEA with bupivacain, epinephrine and fentanyl, probably due to the elimination of epidural opiates. The reduction in pruritus was associated with an increase in pain score. Low grade motor blockade was equally frequent during CEA treatment in both groups even though more severe grades seldom occurred. The claim by the manufacturer that ropivacain results in less effect on motor function than other local anaesthetics could not be confirmed.The authors declare that they have no competing interests.EG, CS, KR, and CO were clinical investigators of this study. EG, CS, and CO analysed the data and wrote the manuscript, and CO and YR critically revised it. All authors read and approved the final manuscript.


The aim of this study was to assess whether partially absorbable monofilament mesh could influence postoperative pain and recurrence after Lichtenstein hernioplasty over the long term.Patients were randomized into two groups that were treated with lightweight (LW) or heavyweight (HW) mesh in 15 centers in Poland. A modified suture technique was used in the lightweight mesh group. Clinical examination was performed. A pain questionnaire was completed five years after the surgery.P = 0.493). There were 24 deaths in the follow-up period, but these had no connection to the surgery. The patients treated with LW mesh reported less pain in the early postoperative period. After five years of follow-up, the intensity and the presence of pain did not differ between groups (5 patients in the LW and 4 patients in the HW group). Average pain, (VAS score), was also similar in the LW and HW group (2.25 vs. 2.4) at the fifth year postoperatively.Of the 392 patients who underwent surgery, 161 (90.81 %) of 177 in the HW group and 195 (90.69 %) of 215 in the LW group were examined according to protocol, a median of 62 (range 57–66) months after hernia repair. There was no difference in the recurrence rate (1.9 % LW vs. 0.6 % HW; The use of partially absorbable mesh reduced postoperative pain during the short-term postoperative period. No difference in pain or recurrence rate was observed at 60 months. Tension-free mesh repair currently represents the gold standard in inguinal hernia surgery . To dateMeshes built of dense woven propylene, the substance most commonly used in the production of prosthetic materials in hernia surgery, are characterized by low biocompatibility . This feThe aim of this study was to assess whether partially absorbable monofilament mesh could influence postoperative pain and the recurrence of pain after tension-free hernioplasty (Lichtenstein method). Results obtained during the first month demonstrated a decreased rate of pain and no increase in the risk of recurrence. However, longer observation will be required to adequately assess the rate of recurrence.Patients aged between 20 and 75 years diagnosed with primary, unilateral inguinal hernia were eligible to participate in the study. All the exclusion criteria were published previously . PatientAll patients were operated upon by experienced surgeons using the standard Lichtenstein procedure. Investigators could not participate in the study unless each had performed a minimum of 200 Lichtenstein procedures. Before the start of the study, a workshop related to operative technique and its modification was conducted for all trial participants.2. The other alternative was a lightweight, braided, monofilament mesh with large pores made from poliglecaprone and polypropylene . Analyzing the properties of Ultrapro mesh, we noted that after shaping the mesh, the pores of some margins seemed to be closed. Suturing and straining can unravel those pores and rip the suture. Based on these findings, and on the mesh elasticity, three suturing modifications were applied to the basic Lichtenstein technique in the lightweight group. A larger suture margin (minimum four pores of lightweight mesh) and about a two times shorter distance between the steps (maximum 1 cm) was used for running suture on the inguinal ligament. One additional suture was placed to fix the mesh near the pubic bone between the pubic tubercle and the middle line.The heavyweight polypropylene mesh  that was used weighed over 80 g/mThe specific anesthesia, prophylactic antibiotics, postoperative analgesic procedures, and drugs used have been published previously .All data were collected on paper forms by a blinded surgeon during planned follow-up visits. Filled forms were sent to the steering committee secretary in Gdansk. The information therein was entered into the computer database by one of the investigators. Before closing the database, all files were checked to find any additional unreported complications or serious violation of the study protocol. The immediate and short-term postoperative results were published in a previous publication .After five years had elapsed from the time of the surgery, all participating patients were contacted by telephone or in person by one of the investigators. Patients reporting groin pain or foreign body sensations, as well as those suspected of recurrence, were physically examined. If there was any doubt, USG was performed. The VAS scale (1–10) was used to assess pain.The hypothesis was that using lightweight mesh would result in less pain during the short- and long-term follow-up periods.The number of patients required for statistical power in each group was calculated under the assumption that a reduction in pain incidence from 20 to 10 % at three months would be clinically significant. With this assumption, 80 % test power, and an alpha level of 0.05, it was determined that 210 individuals were needed in each group. Ultimately, 300 patients were included in each group due to the anticipation of patient losses. The details relevant to patient allocation were previously published  and the presence of pain before the operation noted in 3 month [P = 0.0007] and 6 month [P = 0.0017] after operation.In a multivariate analysis made for the whole group of patients, two factors were found as influencing the presence of pain after the operation type of the mesh used  in comparison to tension methods. Acute pain affects up to 20 % of patients who undergo surgery with mesh –11. Expe months iOver recent decades, the use of prosthetic material has reduced the recurrence of hernia. The development of new materials has renewed focus on the topic. In some studies, the recurrence rate was higher among patients treated with lightweight mesh, but this trend was significant 5.6 %) in only one group  % in onl. It is iWe believe that presented trial adds also a new material potentially influencing the guidelines in inguinal hernia surgery . AuthorsData collected after 60 months of observation did not show any significant difference in recurrence and pain between the lightweight mesh and heavyweight mesh groups, confirming previously published conclusions about its use. When considering short-term follow-up as a primary endpoint, a lightweight material should be the first choice, despite the lack of any benefit for patients over the long term.


To assess the efficacy of pregabalin by showing differences in the neuronal activities of fibromyalgia (FM) patients before and after longitudinal treatment using functional magnetic resonance imaging (fMRI).t-test. Changes in clinical features were also assessed with the Fibromyalgia Impact Questionnaire (FIQ), Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), Widespread Pain Index (WPI), Symptom Severity Scale Score (SSS), and State-Trait Anxiety Inventory (STAI).In total, 21 female patients with FM and 11 age- and gender-matched healthy controls participated. FM patients underwent fMRI at baseline and following pharmacological therapy with pregabalin to diminish their pain. Pressure-pain stimuli were delivered on the subject’s thumbnail bed during fMRI scans. Brain activation regions in fMRI were evaluated for longitudinal changes using a paired p < 0.05). Brain activation post-treatment was significantly lower than that pre-treatment in 13 regions of the brain (p < 0.001).Clinical scores were reduced significantly following therapy with five of the six clinical tests (FIQ, BFI, BDI, WPI, SSS; Our findings confirm that pregabalin influences aspects of the whole pain matrix, using fMRI, inducing longitudinal changes in neuronal activity during the pain state, and that it reduces pain and other core symptoms of FM. This method could be applied to other longitudinal clinical trials of pharmacological treatments for FM. Fibromyalgia (FM) is characterized by chronic widespread musculoskeletal pain and allodynia . Other sIt is well known that functional magnetic resonance imaging (fMRI) is an invaluable tool for neuroscientific research because it provides a functional view of the brain at the system level . Stimula2-δ  subunit of the voltage-dependent calcium channel in the central nervous system (CNS) and decreases the release of neurotransmitters, such as glutamate, noradrenaline, and substance P [Presently, treatment of FM is symptom-based, seeking to alleviate pain, increase restorative sleep, and enhance physical and social functioning . Pharmacstance P . This mestance P . Accordistance P . Thus, iWe hypothesized that the clinical improvements in the pain state of FM patients were related to the effects of the medication, pregabalin, in the central nervous system. The fMRI technique was used to characterize the pattern of increased brain activation produced when subjective pressure-pain stimulation was applied to the thumbnail bed of FM patients and healthy control subjects. These patterns of brain activation were compared before and after pregabalin treatment.In this study, 21 female patients  with FM and 11 age- and gender-matched  healthy controls participated. Patients underwent routine clinical treatment using PGB. Patients were divided into two groups, responders and non-responders, according to decreases in their visual analog scale (VAS) scores for pain of above 50% after the treatment. Nine patients responded to the drug and were considered ‘responders,’ whereas 12 patients did not, ‘non-responders.’ The study protocol was approved by the Institutional Review Board at Inje University Haeundae Paik Hospital (No. 2011-009). All participants agreed to participate in the study and provided written informed consent.2 and then increased until either the subject’s level of pain tolerance or a maximum pressure of 2.81 kg/cm2 was reached. Following the ascending series, eight pressure-pain stimuli  were delivered during 5 s and each subjective pain intensity was recorded on a Gracely Box Scale (GBS) sheet [Pressure-pain stimuli were delivered using a specially designed hydraulic device capable of transmitting controlled pressure to a surface placed on the subject’s thumbnail bed. As in other studies , a hydraS) sheet  to deterMRI scans were conducted using a 3-T whole body clinical scanner  with a 32-channel SENSE (SENSitivity Encoding) head coil. Three-dimensional T1-weighted MRI scans using a turbo field echo (TFE) sequence  = 240 mm, slice thickness = 1 mm) were performed for anatomical information, followed by two functional MR scans using multi slice echo planar imaging (EPI) acquisition .Imaging data were analyzed with Statistical Parametric Mapping 8  implemented in MATLAB 2010 . Motion artifacts in functional images were corrected throughout the processing of realignments, coregistering, and smoothing. Spatial normalization was conducted using a 12-parameter affine transformation to match each image volume to the template-volume image by minimizing the residual sum of squared differences between the image and the template using 152 Montreal Neurological Institute (MNI) template images as a standard space model. The spatially normalized images were smoothed with a 6-mm FWHM isotropic Gaussian kernel to improve the SNR. After regression analysis of preprocessed fMRI data, using a hemodynamic response function (HRF), correlation verification was conducted. Statistical analysis to evaluate the brain activation in each group was carried out at the subjective pain intensity. Clusters were defined as a volume of activations with more than 50 statistically significant voxels. Significant activations according to the stimulation were assessed by one sample t-test. In group analysis, two-sample t-test was used to compare the brain activation between FM patients and healthy control (corrected p < 0.05), responder and non-responder (uncorrected p < 0.01). Additionally, comparison between pre- and post-treatment was performed using paired t-test (uncorrected p < 0.01)The analysis was conducted using the Statistical Program for the Social Sciences version 12.0 . To compare clinical scores and pain threshold between the groups t-test for independent groups was used, and between pre- and post-treatment Wilcoxon signed rank test was used.vs. 2.46±0.02; p < 0.01). Furthermore, the pre-treatment group showed significantly higher pressure-pain sensitivity than the post-treatment group .For the pressure-pain stimulation delivered on the left thumbnail bed, the FM patient group had significantly lower pressure-pain thresholds than the healthy control group (pressure pain: 1.67±0.28 p < 0.001). However, there was no significant difference in STAI1 or STAI2 scores. In p < 0.05) versus those pre-treatment . FIQ and WPI scores demonstrated up to a twofold change and BDI scores showed the least difference, a 1.3-fold change. In contrast, STAI1 and STAI2 were slightly, but not statistically significantly, changed.As shown in The pressure-pain stimulation delivered to the healthy control group resulted in a significantly increased fMRI signal in nine brain regions . The actfMRI data were acquired from seven female responder subjects (54.43±3.51 years) before and after pregabalin treatment . The pressure-pain stimulation delivered to the pre-treatment patients resulted in significantly increased BOLD signal in 13 brain regions , and theAs shown in After acquiring baseline fMRI data, FM patients were divided into 9 responders (52.56 ± 3.89 years) and 10 non-responders (49.83 ± 10.10 years) by considering effect of medication therapy. And it was analyzed to compare difference of brain activation delivered painful stimulation between both groups. Intensity of stimulation was not significantly different between responders and non-responders. The aim of this study was to evaluate alterations in neuronal activity during applied pressure-pain stimulation in FM patients following pharmacological treatment. Our findings demonstrated that abnormal neuronal activities were decreased following appropriate longitudinal drug therapy. These results support the hypothesis that FM is caused by alterations in neuronal pain processing and that pregabalin restricts the release of neurotransmitters in the pain-processing path.The efficacy of pregabalin was evaluated in terms of decreasing pain and related clinical scores in FM patients ,15,16. TThe pain threshold in FM patients was significantly lower than that of healthy controls, but brain activation evoked by the same subjective intolerable pressure pain in both groups was similar. These same subjective pain conditions resulted in the common brain activation areas in both groups: the bilateral cerebellum, contralateral supramarginal gyrus, IFG, and MFG. In contrast, the FM patient group showed significant activation in 13 areas but the healthy control group showed them in only nine areas. These results showed that FM patients were more sensitive than healthy controls to the same subjective pain condition. Gracely et al. , and incPregabalin was used as the pharmacological therapy in this study. In the pre-treatment group, we observed brain activation in the SII, IFG, putamen, and cerebellum region . In part3 receptor antagonist tropisetron reduced rCBF in the contralateral primary somatosensory (SI), posterior insula, and ACC. Their result is also consistent with our findings of a reduced fMRI signal evoked in the insula, thalamus and precuneus (somatosensory association cortex). Functional magnetic resonance imaging experiments have revealed that the insula plays an important role in acute experimental pain [In pre- versus post-treatment group, we found that pre-treatment shown greater activation than post-treatment at thalamus, postcentral gyurs, IPL, calcarine, MFG, MCC, precuenus including insula. According to another study, Koeppe and colleagues  reportedtal pain –26. The tal pain . The redtal pain . The redtal pain . Furthertal pain . From thPregabalin is known to effect primarily by modulation of calcium channel and it have been shown to be effective in neuropathic pain, but patients with chronic pain respond well to treatment and others show poor response –33. SimiIn conclusion, our findings suggest that pregabalin has an influence on aspects of the whole pain matrix. This method can be applied to longitudinal clinical trials of other pharmacological therapies for FM. Longitudinal changes in brain connectivity resulting from drug therapy will be included in a future study, which will clarify the mechanisms of the pain matrix.


The purpose of the study was to assess and validate the CCI, and to examine the correlations between the new instrument and stress responses measured by the Impact of Event Scale (IES) and the Post-traumatic Stress Scale-10 (PTSS-10)Peritraumatic psychological- and sensory impressions in victims of civilian accidents are only partly understood. This study scrutinizes the level and duration of perceived psychological threat at Three hundred and fifteen injured, conscious, hospitalised patients were assessed with a self-report questionnaire. The CCI consists of eight items including sensory impressions and well-known psychological responses to trauma.The internal consistency of the CCI was solid . A factor analysis revealed two components, "perception" and "dissociation". The instrument correlates significantly with the Impact of Event Scale (r = 0.47 - 0.54) and the Posttraumatic Stress Scale-10 (r = 0.32 - 0.50). The explained variance is high both at the scene of injury (61%) and in the hospital (65%). Dissociation and perception either used as a two-factor solution or as a sum score measured in the hospital, gave the strongest prediction for later psychological distress.The CCI appears to be a useful screening instrument for, at an early state, identifying patients hospitalized after a physical incident at risk for subsequent psychological distress. The authors of two meta-analyses recommended further research on peritraumatic responses [Patients who are hospitalized because of physical traumas may perceive varying degrees of psychological threat during the incident. A physical accident can be viewed as a chain of connected moments--the moment one realize that something bad is about to happen, when it happens, waiting for help, transportation to, and treatment in hospital. This process may be defined as esponses ,2. Ôzer the scene of injury and in hospital in order to get a measure of the duration of the responses. By measuring perceived threat at two time points, it is possible to see whether those with a high level of perceived threat both at the scene of injury and in hospital are at greater risk than those who are equally afraid in one of these situations, i.e. a measure of the duration of experienced threat.Most instruments are developed to measure posttraumatic stress, such as the Impact of Event Scale , the TraThe main contributions of the new instrument are the ability to measure peritraumatic sensory perception and the ability to compare the relative contribution of the sensory perception and items representing fear, dissociation and lack of autonomy (feeling stuck) for subsequent posttraumatic symptoms.The purpose of the present study was to assess and validate the CCI, and to examine the correlations between the CCI and stress responses measured by the Impact of Event Scale (IES) and the Post-traumatic Stress Scale-10 (PTSS-10).the scene of the injury and in the hospital. Demographic characteristics were obtained, and for the IES and PTSS-10 the patients were asked to answer referring to the last seven days. Ulleval Trauma Registry provided data on the physical traumas.The CCI was tested on physically injured, conscious patients admitted to the emergency room at Oslo University Hospital Ulleval. The cross-sectional data was collected after discharge. Participants received a consent form, self-report questionnaire, and stamped return envelope approximately one - two weeks after discharge, with a reminder after one month. For the CCI they were asked to recall impressions and psychological responses experienced at The respondents had to be between 18-65 years. Measuring perceptions at scene of injury and in hospital required conscious patients and a Glasgow Coma Score (GCS)  equal tothe scene of the injury and in the hospital. The CCI contains eight items: fear, pain, visual, auditory and olfactory impressions, feeling emotionally stuck (i.e. lack of autonomy), feeling as if the situation was unreal and emotional numbness. This reflects a combination of psychological responses and sensory impressions, all based on how one may perceive a physical incident. The last two items were taken from the IES and represent responses related to dissociation more than avoidance. Response alternatives ranged from 1  to 5 (to a very high degree). The combination of items was collected to study if responses other than dissociation and fear have an impact on posttraumatic stress.A study group that consisted of a liaison psychiatrist, one medical doctor  and a trauma nurse developed the CCI. In this paper perceived threat reflects how the patient experiences impressions and responses during the incident, and the level of perceived threat both at IES has six response alternatives, from 0 (never) to 5 (a high degree), with scores ranging from 0 to 75. Seven items measure intrusion, and eight measures avoidance. It has been used in previous Norwegian studies on a similar sample of patients [The Norwegian translation of the patients ,15-17.PTSS-10 is a 10-item scale, which measures posttraumatic stress symptoms including hyperarousal on a Likert scale where 1 represents "never/seldom" and 7 represents "very often", with scores ranging from 10 to 70 [10 to 70 ,18,19.t tests, and a principal components analysis with orthogonal (Varimax) rotation. A two-by-two-by-two analysis of covariance was performed to study demographic data and the CCI. The internal consistency of the scale was examined with Cronbach's alpha and correlation between "Item-score- Total-score". If no more than one item had a missing value, the mode of the other items replaced the missing value. One missing value per subscale was permitted. Data are presented as means, medians, 95% Confidence Intervals (CI) and SDs. Five percent of CCI data for at the scene of the injury questions and 3% of the data for in the hospital questions was missing.Statistical analyses were performed with SPSS, version 15.0 and included Spearman's rho, Student's The Norwegian Data Inspectorate and The Regional Ethics Committee approved the study.Three hundred and fifteen of 541 eligible physically injured patients (58%) admitted to the Emergency Room (ER) participated. The mean age was 38.7 years (range = 18-65), and 65% were men. Approximately half of the participants were married and 39% had custody of children. Over 85% were occupied in work or studies. The mean value of Glasgow Coma Scale was 14.9 (95% CI 14.8 - 14.9). Sixty-six percent were motor vehicle accidents, 17% falls, 8% assaults and 9% other incidents. The mean time between the trauma and the assessment was 29.4 days (95% CI 26.8 - 32.0) and median time was 22.0 days (range = 1-131). One quarter responded within two weeks and 62% had answered the questionnaire between two and eight weeks. The mean length of stay in hospital (LOS) was 4.0 days (95% CI 3.4 - 4.7) and median LOS was 2.0 days (range 0 - 52).pain and feeling emotionally stuck, both at the scene of the injury and in the hospital  to in the hospital , t(298) = 6.67, p < .001 (two-tailed). Correlations between Item-score and Total-score were high both in the hospital and at the scene of the injury (range .45-.75). Correlation between both measurement time points was .69 and Cronbach's alpha was strong at both measurement points. We entered the mean scores for the CCI at place of injury and in hospital (data not shown), and found that the CCI value in hospital was a stronger predictor for PTS symptoms.The highest mean scores occurred for the variables al Table . A paireTable the scene of the injury. In hospital, the eigenvalues were 4.06 and 1.10, explaining 51% and additionally 14% of the variance, respectively. Cattell's scree plot revealed a break after the second component, confirming the two-factor structure. For dissociation the mean value was 2.6 (95% CI 2.4 - 2.8) at scene of injury and 2.3 (95% CI 2.1 - 2.5) in hospital. Mean score for perception was 2.5 (95% CI 2.4 - 2.7) at scene of injury and 2.3 (95% CI 2.2 - 2.4) in hospital. Using a sum score for dissociation and perception, the mean was 2.5 (95% CI2.4 - 2.7) at scene of injury and 2.3 (95% CI 2.2 - 2.4) in hospital. The Kaiser-Meyer-Olkin value was .81 at the scene of injury and .83 in the hospital. Bartlett's test of sphericity reached statistical significance, supporting the factors. Cronbach's alpha for the perception factor was .83 at the scene of the injury and .84 in the hospital. The corresponding figures for the dissociation factor were .74 and .80, respectively. To address a possible problem using two items from IES in the CCI a sum score without the two items were made. The CCI was compared with the IES both with and without the dissociation items, showing no significantly different correlations. The Cronbach's alpha for perception without the items was quite similar to the sum score with the items . The corresponding Cronbach's alpha for dissociation was .43 at scene of injury and .48 in hospital without the items and .47 at scene of injury and .52 in hospital with the items.Factor 1 (perception) had eigenvalue of 3.73 and explained 47% of the variance. Factor 2 (dissociation) had eigenvalue of 1.14 and explained additionally 14% of the total variance at r = .32-.54) and highly significant (p < .001).The Cronbach's alpha for IES was .94 , .93 (intrusion) and .90 (avoidance). For the PTSS-10 the Cronbach's alpha was .92. The correlations between the CCI and measures of posttraumatic stress . ln this study, the level of fear however, loaded on the same factor as the perception items. It remains to be seen whether perception will be a stronger predictor for later PTS. The explained variance is high both at the scene of injury (61%) and in the hospital (65%). This means that about two-thirds of perceived threat is explained by the CCI and the instrument appears to be valid. The internal consistency of the CCI was somewhat lower compared to the IES and PTSS-10. Examining the association between the CCI score and the scores on IES and PTSS-10 was important to see whether the instruments assessed different phenomena. Since the correlation was < .7 the new instrument (CCI) can give further contribution when predicting posttraumatic stress symptoms.The CCI showed a two-factor structure of perception of the incident (6 items) and dissociation (2 items) with good internal consistency both at the scene of the injury to the hospital. Even though mean scores for the sensory impressions were low, both the total scale and the factor perceptions showed strong internal consistency. This indicates that, in addition to dissociation, sensory impressions  are important to screen for when identifying who is at risk of developing clinically significant posttraumatic stress. Pain may both be a sensory perception as well as a psychological reaction and related to fear; this may explain the strong impact in this findings. It is possible that an activated stress response makes a person more vulnerable to sensory impressions. Therefore, the problem may involve a combination of high levels of sensory impact and heightened vulnerability to sensory impressions. In clinical work a screening of sensory impressions may also indicate which specific sensory channel  to address in treatment of posttraumatic stress. Perception may have changed over time during the hospital stay and even after discharge. We have no data to address this issue, which may be a focus of future studies.Among the sensory impression scores, pain had the highest mean score. Fear decreased the most from The CCI has some conceptually common items with other measures  and some related phenomena . It would be pretentious to address this as convergent validity, but the commonalities are great enough to warrant studying the relationship between the CCI, the IES and the PTSS-10. The correlations with these stress measures were significant, indicating that the CCI can be used as a predictor for posttraumatic stress after injuries. It might have been interesting to assess the convergent validity with other measures of peritraumatic responses like the Peritraumatic Distress Inventory (PDI). However, the main focus of this study was the sensory perception.the scene of the injury than in the hospital, but there was a stronger explained variance measured in hospital. The mean score of dissociation and perceptions were quite similar at both measurement points. Measuring the responses in hospital seems to be sufficient in identifying those at risk of developing posttraumatic stress.The assessments at two time points made it possible to study changes in perceived threat during the casualty chain. The level of perceived threat was moderately but significantly higher at the scene of the injury and about the participants' stay in the hospital.The CCI showed strong internal consistency and a two-factor scale, despite the fact that the participants were drawn from a physically injured population with a broad range of stress symptoms. Accordingly, the instrument can be used in conscious patients admitted in the ER following a physical incident to see who may be at risk for subsequent posttraumatic stress. It examined a large sample from a region surrounding the capital of Norway. The duration of the threat was assessed by questions about The participants completed the questionnaires some weeks after their accident. The time of assessment (weeks after the accident) raise questions regarding the CCI's ability to identify patients at risk. Even though a recall bias may be present, those with symptoms after some weeks are most likely at greater risk for symptoms also at a later stage. Analysis showed no significant difference in stress score (IES) between patients answering close to the accident compared to those answering several weeks after the event. This may confirm that the ability to remember feelings and responses in certain situations should not be underestimated. In the pilot study, patients were assessed within a few days post trauma while admitted to hospital. For most patients the self-assessment was difficult at this time point. Some were sleepy, some stressed and some were cognitively not able to concentrate. This was a major reason for postal assessment after discharge. In the same vein, it would have been troublesome for physically traumatized patients in this study to answer questions at the scene of injury and on arrival at the hospital. A number of patients underwent acute surgery. All patients were admitted to an ICU, but some left shortly after admission. In order to make the assessments in a physically stabilized stage of recovery, all patients completed the assessments after discharge.The CCI measured at two time points was answered at the same time and together with the IES and the PTSS-10. This may have influenced patient's responses by reporting more similar answers at the two measure time points, when analyzing 3 and 12-month data together with baseline data this will no longer represent a problem.The CCI measured in hospital appears to be a useful screening instrument for identifying patients at risk for posttraumatic stress symptoms.The authors declare that they have no competing of interests.LaSk, EH and OE conceived and designed the study. LaSk collected the data, and drafted the manuscript. LaSk and LeSa performed the analysis. All authors critically performed interpretation and revision, and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-227X/11/6/prepub


P < 0.05), while no effect 6 months later. No side effects were observed. It is concluded that LPNIR is an effective and safe modality to treat various chronic pains, which has synergic effects with NB or LB.In order to study the efficacy of linear-polarized near-infrared light irradiation (LPNIR) on relieving chronic pain in conjunction with nerve block (NB) or local block (LB), a 3-week prospective, randomized, double-blind, controlled study was conducted to evaluate the pre- and post-therapy pain intensity. Visual analogue scales (VASs) were measured in all patients before and 6 months after therapy visiting the pain clinic during the period of August 2007 to January 2008. A total of 52 patients with either shoulder periarthritis or myofascial pain syndrome or lateral epicondylitis were randomly assigned into two groups by drawing lots. Patients in Group I were treated with NB or LB plus LPNIR; Group II patients, for their part, were treated with the same procedures as in Group I, but not using LPNIR. In both groups, the pain intensity (VAS score) decreased significantly immediately after therapy as compared to therapy. There was a significant difference between the test and control groups immediately after therapy ( Nerve block (NB) or local block (LB) has conventionally been the main stream in treating chronic pain due to its reliable effects and convenience to apply. Repeated injections of the anesthetics and steroids at the same points, however, may cause local muscle damage and scarring. In addition, in many cases one-time injection may not provide a lasting effect to relieve chronic pain. Therefore, it is expected to develop a method to enhance the effects of NB or LB to obtain a better outcome, while reducing the times of injection. Recently, a noninvasive method, the linear-polarized near-infrared light irradiation (LPNIR), has been used effectively to relieve chronic pain from frozen shoulder, osteoarthritis, rheumatoid arthritis, postherpetic neuralgia, and other disorders –3. We hyA prospective, randomized, double-blinded study was conducted in our pain clinic from August 2007 to January 2008. Patients with chronic pain due to shoulder periarthritis, back myofascial pain syndrome, or lateral epicondylitis were randomly classified into two groups by drawing lots. Group I were treated with NB or LB plus LPNIR; Group II treated with the same procedures as in Group I, but without switching the machine on. A curtain was placed between the patient and the LPNIR machine, which is quite quiet when it is working. Therefore, both the patients and the administrator of the treatment did not know which arm the patient was in. The study protocol was approved by the Ethics Committee of the Third Hospital of XiangYa School of Medicine. An informed consent form was obtained from each patient after the subject was informed about the purpose of the study, the protocol, possible side effects of the administered agents, and risks and benefits of participation in the study.Each potentially eligible subject who visited the pain clinic during the trial period was examined by the physician responsible for the trial to determine the suitability for inclusion in the study. Inclusion criteria were age > 18 years, chronic pain persisted for >3 months due to shoulder periarthritis, myofascial pain syndrome, or lateral epicondylitis, and with VAS scores > 5 . Patients with VAS scores < 5, or with existing contraindications for NB or LB, or simultaneously treated with other analgesic drugs or methods were excluded from participation in the study. Data from the patients that failed to follow up after the initiation of treatment from both of the study arms were analyzed using the last value before losing followup.The following are the diagnostic criteria for the three diseases investigated in the current study:Patients around their fifties, more likely to be female than male, mostly physical laborers;Pain around shoulders, especially at night and often chronic onset, always induced by weather changes and fatigue;Movement of glenohumeral joint is limited by pain, which may gradually become less painful but more restricted in motion;Atrophy of the shoulder muscle, tenderness in anterior, posterior and lateral aspects of the shoulder, marked limitation of shoulder abduction with typical shoulder carrying;X-ray examination usually shows negative outcome, but osteoporosis may occur with chronic duration.Muscle pain with specific “trigger” or “tender” points which can be made worse with activity or stress. Trigger points can be identified by pressure to an area of a person's body;Potential subjects can suffer from depression, fatigue, and behavioral disturbances.Pain that radiates from the outside of the elbow into the forearm and wrist;Pain when touching or bumping the outside of the elbow;A weak grip;X-ray finding is negative.t-test using the program MedCalc version 11  when it is applicable. The changes were estimated to be normally distributed. The effect of gender and age was also evaluated with the same method. A P value of <0.05 was considered significant.The differences between the two groups before therapy, and those within the same group obtained pre- and post-therapy, as well as the means of the differences pre- and post-therapy between the two groups—means of the treatment effects in the two groups were compared by unpaired or paired 52 patients suffering from shoulder periarthritis, back myofascial pain syndrome, or lateral epicondylitis were enrolled in this study. Among them, there were 36 females and 16 males, age from 19 to 79 years old. By drawing lots, they were assigned randomly into two groups. The demographic data of the two groups were shown in In Group I, subjects received LPNIR near pain points 3 times a week as well as NB or LB once a week. The mixture of lidocaine (1%), bupivacaine (0.375%), and methylprednisolone acetate (0.25%) was used in LB or NB. In the cases of lateral epicondylitis and shoulder periarthritis, 4 mL and 6 mL of the mixture were injected into the pain points or “trigger” points, respectively, whereas in the back myofascial pain syndrome, the intercostal nerve involved was targeted with 8 mL of the mixture.The LPNIR with a wavelength of 830 nm produced by LX-PZ99  was set to the therapy model that irradiation circle was 2 : 3 (irradiation 2 seconds followed by 3-seconds pause). Each pain point was irradiated 10 min at 80% power output and treated for 3 weeks. The maximum power output is 1800 mW at a wavelength of 600 to 1600 nm.In Group II (the control group), the medicines and the therapeutic procedures were the same as in Group I, just without switching on the LPNIR.The pain relief effects were evaluated by comparing the visual analogue scales (VAS) scores prior to, immediately and 6 months after the treatment. VAS scores were graded as 0 with no pain and 10 as most pain imaginable.The demographic data for the 52 subjects enrolled in the study were described in The VAS scores of two groups at different time points were displayed in P > 0.05). There was no effect of age or gender on treatment effect. There was not enough data to analyze the effect of disease type. No thermal injury or other complications were observed in the study.There was no significant difference in the effect at the point of 6 months after therapy that nearly reached the same levels at pretherapy (The major finding of this study is that the LPNIR as an add-on method to NB or LB has synergistic effect on relieving pain of shoulder periarthritis, myofascial pain syndrome, or lateral epicondylitis in the acute phase.Previous data show that LPNIR is safe and effective in relieving chronic pain and other conditions. Basford et al.  investigIn line with these findings, we found that LPNIR had synergic effect with NB or LB in treating chronic pain from shoulder periarthritis, back myofascial pain syndrome, or lateral epicondylitis.This is within expectation in view of the following findings: first, LPNIR treatment near the stellate ganglion results in the increase of blood flow velocity similar to that caused by stellate ganglion block ; second,Local heating has long been proved to have pain-relieving effects and can increase elasticity of connective tissue and joint range , 9. The The infrared light is a form of electromagnetic radiation with wavelengths longer than visible light, which is generated by objects that produce heat, such as human beings. According to its wavelength, infrared light is subdivided into: near-, mid-, and far-infrared light. Polarization can give it a predictable fashion with respect to the propagation direction in which way energy is focused.The infrared rays with wavelength of 600–1600 nm in LPNIR are capable of reaching the deeper tissues, not readily reflected, dispersed, or absorbed at the surface of the body , and theIndeed, Kashima et al.  observedIt seems that in our settings the effects of the treatment can last no longer than 6 months.In accordance with the previous observations, we did not observe any side effects related to the treatment of LPNIR in any of our patients.The limitation of this study is that the number of patients of each type of diseases is too small to allow us to draw a conclusion on the effect of disease type. Further larger trial is needed to clarify this.Our study shows that LPNIR is an effective and safe modality to treat various chronic pains, which has synergic effects with NB or LB.


To report results obtained by combining risk sharing tools with post-adoption surveillance mechanisms in order to control quality of care and implement a value-based reimbursement scheme for Neuro-reflexotherapy (NRT), a non-pharmacological treatment proven effective for neck pain (NP), thoracic pain (TP) and low back pain (LBP).Pre-post prospective cohort study in routine clinical practice, carried out in primary care centers in the Spanish National Health Service in the Balearic Islands . Eight-hundred and seventy-one subacute and chronic NP, TP and LBP patients treated in Ib-Salut, who underwent NRT during 2011. A shared risk contract (SRC) was developed, where payments for NRT were linked to results on patients’ clinical evolution, reduction in medication and proportion of patients undergoing spinal surgery. Main outcome measures were local pain , referred pain, LBP-related disability and NP-related disability, measured using previously validated instruments at referral and 3 months later, use of medication assessed at referral and discharge, and rates of spinal surgery prescription after undergoing NRT.Median improvements at discharge corresponded to 57.1% of baseline value for local pain, 75.0% for referred pain, 53.8% for LBP-related disability and 45.0% for NP-related disability. Patients taking medication at discharge represented 29.0% of those taking it at referral. The proportion of patients in whom spinal surgery was prescribed after undergoing NRT was 0%. These results were consistent with those from previous randomised controlled trials (RCTs) and studies in routine practice, and complied with the standards set in the SRC.It is feasible and effective to enhance post adoption surveillance methods with risk sharing tools to improve quality control and support value-based reimbursement decisions for NRT. The feasibility of generalising this approach to other settings and to other non-pharmacological treatments should be explored. Clinical use of health technologies depends on regulatory frameworks which vary across countries. Nevertheless, the inappropriate use of both pharmacologic and non-pharmacologic procedures is widespread all over the world, leading to patients being unnecessarily exposed to potentially harmful procedures and risks, and to superfluous health costs -12.The objective of shared risk contracts (SRCs) is that payers and providers share the risks deriving from the uncertainties associated with using a given health technology in routine practice. To this end, SRCs link payments to providers to whether results in practice reach pre-established goals. Providers may include health care providers or, more commonly, providers of products . The pre-established goals can be defined by levels of usage of a given technology, appropriateness of use, and/or clinical outcomes -18. For Typically, SRCs have been developed as a pragmatic way of ensuring coverage for new drugs, usually highly expensive ones, designed to treat serious conditions, when: a) existing treatments have not shown to be effective, b) the evidence on the effectiveness and cost/effectiveness of the new drugs is either lacking or of low quality, and c) conducting high quality randomised controlled trials (RCTs) within a reasonable timeframe is unfeasible. Examples include conditions with a relatively low incidence or for which long follow-up periods are necessary for results to be clinically meaningful -21.In these cases, SRCs allow the health system to provide treatments which are potentially effective or more cost-effective than existing alternatives, while: a) gathering data to assess whether the corresponding investment actually leads to expected outcomes , b) providing information for value-based pricing, c) limiting potential wastage of payers’ resources, by sharing costs with providers in the event that the technology does not reach expected outcomes, and d) strengthening post adoption surveillance.When pharmacological or non-pharmacological technologies are implemented in routine practice, application conditions often vary from those used in RCTs. These differences may include training standards, indication criteria (such as “off label” use and other forms of treatment extension effects), and variations in compliance. As a result, outcomes (including adverse events) in clinical practice can deviate from those in previous RCTs.Non-specific neck (NP), thoracic pain (TP) and low back pain (LBP) represent a major clinical, social and economic burden in industrialised countries ,22-28. INeuro-reflexotherapy (NRT) is one of the few LBP treatments supported by high quality evidence -35. It iThe Spanish National Health Service (SNHS) provides free health care to every resident in Spain. The SNHS is managed at the regional level and fully financed by taxes, although regional governments can implement local taxes or copayments to provide additional funding. Decisions on coverage of non-pharmacological technologies can be made at the regional or national level.In 2004, NRT was implemented in routine practice of the SNHS in the Balearic Islands  for treating subacute and chronic patients with non-specific NP, TP and LBP, in the same applications conditions and under the same post-adoption surveillance methods in which it had been previously assessed and test-piloted -35,40-43The implementation of NRT was based on a fee-for-service; the Ib-Salut paid providers a fixed amount for each patient referred for NRT who underwent the procedure, and a different amount for each patient who was referred but did not receive NRT . However, in 2010, the Ib-Salut and providers agreed to enhance post-adoption surveillance methods by using risk sharing tools in order to improve quality of care and to support value-based reimbursement decisions, starting January 1st, 2011. The objective of this study was to describe these tools and their results one year after their implementation.In accordance with the referral protocol used in previous studies Figure  34,40,4,440,41, Patients with “red flags” suggesting that pain might be caused by fractures or systematic diseases (such as fever or unexplained weight loss), could be referred to NRT only once these conditions had been discarded Figure  22,29,3,34,40,41All patients undergoing NRT following referral from Ib-Salut during 2011, and discharged before December 31st, 2011, were included in this study. Patients in whom adverse events required early extraction of the surgical material, were identified and excluded from the analyses.Following the clauses established in the contract, the provider invoiced the Ib-Salut 48.57 € for each patient referred for NRT when the procedure was not performed, and 615.28 € for each NRT intervention. These prices match those which the Ib-Salut is invoiced for in routine practice. They were based on the costs associated with NRT in the RCT which showed this technology to be cost/effective , and havFixed payments represented 50% of the amount invoiced. Variable payments corresponded to the remaining 50%, payable only if results reached the standards defined in the contract.The variable amount broke down as follows: reaching the standards for clinical evolution implied payment of 50% of the variable amount; reaching the standards on the reduction of use of drugs, 30%, and reaching the standards on rates of spinal surgery, 20%. For instance, if results did not meet any of the standards, only 50% of the invoice (the fixed amount) would be paid; if only the standards on pain and disability were met, only 75% of the invoice (the fixed amount plus 50% of the variable amount) would be paid.The Ib-Salut defined three sets of standards; clinical standards for patients’ clinical evolution; standards for the reduction of medication intake; and standards for the proportion of patients in whom spinal surgery was prescribed after undergoing NRT.Clinical standards focused on the most important clinical outcomes for patients with NP, TP or LBP: local pain , referred pain, and disability . The staStandards for reduction in medication and for the proportion of spinal surgery among NRT patients, were established in three phases. Firstly, the Ib-Salut defined the ideal standards which, if met, would generate savings above the cost of NRT. Subsequently, the person designated by the Ib-Salut for developing this SRC (CC-A), In collaboration with the first author of the RCTs on NRT (FMK), verified that these standards were realistic, based on the effect size reported for NRT in: these RCTs, previous studies conducted in routine practice, the Cochrane systematic review, and the evidence-based clinical guidelines ,39-43,50Standards for the use of medication focused on patients’ intake of non-steroidal anti-inflammatory drugs (NSAIDs), steroids, non-opioid analgesic, codeine, other opioids, anti-epileptic drugs, and muscle relaxants. Only use for NP, TP or LB was considered. The Ib-Salut established these standards as either: a) for each type of drug, the number of patients using it at discharge was ≤ 80% of those using it at baseline, or b) the number of patients using any of these drugs at discharge was ≤ 80% of those who did so at baseline.Decompressive spinal surgery has proven effective for patients in whom conservative treatment fails to significantly improve radicular pain caused by disk herniation within 6 weeks, or caused by spinal stenosis within 3–6 months ,51-56. AStandards were assessed when patients were discharged, 3 months after having undergone the NRT treatment. Reaching the standards for each of the clinical outcomes  implied payment of 12.5% of the variable amount. Disability was not taken into account among TP patients because validated instruments to measure TP-related disability do not exist. Reaching the standards for reduction of medication intake implied payment of 30% of the variable amount, and reaching the standards for the proportion of NRT patients in whom spinal surgery was subsequently prescribed implied payment of 20% of the variable amount.Following the application conditions in which NRT had proven effective, safe, and cost-effective ,51,57, sIn the event of experiencing adverse events , patients were instructed to contact the specialised unit or their primary care centre ,35,40,41The outcome assessment was based on previously validated post-adoption surveillance mechanisms which are used in routine clinical practice ,41. PrimOn patient’s first visit the following data were gathered: gender, age (date of birth); reason for referral ; time elapsed since first diagnosis (days); duration of the current pain episode (days); and date of referral for NRT.On the first and all subsequent visits to the primary care centre and the certified NRT Unit, the following data were gathered: severity of local pain (LP) and referred pain (RP), disability, employment status ; pregnancy; comorbidities; involvement in work-related claims; involvement in litigation; diagnostic tests undergone ; test results , and therapeutic procedures prescribed .Data on pain and disability were provided by patients. They rated these variables on their own and without assistance or interference from clinicians or auxiliary personnel. Separate 10-cm VAS were used for local pain  and referred pain (RP) . The SpaData were introduced into a database by auxiliary staff independent from the clinicians. Clinicians had access to these data , but could not alter them.Every month, patients who were discharged were identified, and data on their clinical status, drug use and prescription of surgery during the follow-up period were transferred to the team in charge of analysing results.Analysis of results was performed by a team who had no contact with the clinicians involved in performing the interventions or with the administrative staff in charge of payments at the Ib-Salut.Absolute and relative frequencies were calculated for categorical variables. Values for continuous variables were described through their median and interquartile range (IQR).According to the available evidence, data on duration of the current pain episode were categorised as subacute (14–90 days), and chronic pain (> 90 days) ,62. TherAnalyses were limited to data from patients who had undergone NRT, excluding those who had been referred for the procedure but did not undergo it , and those in whom adverse events required early extraction of the surgical material implanted. The total number of these patients was registered.At the design phase of this study, it was decided that the number of patients with missing values for data relevant to assess whether the standards had been met  would be registered and, if ≥ 10%, a sensitivity analysis would be performed assuming that all missing data had been failures.LBP) and NDI scores for NP-related disability (including only data from patients referred to NRT for NP). The number of patients who were using NSAID, steroids, non-opioid analgesic, codeine, other opioids, anti-epileptic drugs, and muscle relaxants when referred for NRT and at discharge, was determined. The number of patients using any kind of drug at baseline and discharge, was also identified. Finally, patients in whom spinal surgery had been prescribed for the reason why they had previously been referred to NRT, were identified.In order to assess whether standards were met, the following procedures were used. The median and IQR of VAS scores for local pain  at baseline and at the end of the follow-up period were calculated. The same procedure was repeated for the VAS scores for referred pain, the RMQ scores for LBP-related disability  was also identified.Since outcome assessment occurred 3 months after performing the NRT intervention, variable payments related were delayed for at least that period. Therefore, in order to prevent delays in payments which might have compromised feasibility of the contract, invoicing and preliminary assessment of results were performed monthly from April onwards, based on the data from patients discharged during the previous month. Analyses comprising all data of patients treated during 2011 were repeated in April 2012, when data and outcomes for all NRT interventions performed during that year became available.Each month, the analysts assessed whether the standards had been met and listed the names of the patients discharged, grouping those who complied and did not comply with each of the standards, separately. The administrative staff of the Ib-Salut had full access to the database containing all patients’ data, checked that data on patients’ use of medication and prescription of surgery coincided with those from the Ib-Salut’s database, double-checked that lists of patients complying and not complying with the standards was correct, and verified that the global assessment of whether each standard was met, was correct. It had been planned that if discrepancies or doubts arose, providers, analysts and the administrative staff of the Ib-Salut would meet to discuss them. All data were transferred to the person designated by the Ib-Salut to monitor results from NRT (CC), who authorised the administrative of the Ib-Salut to pay the amount corresponding to the standards which had been met.According to the post-adoption surveillance mechanisms, data were routinely captured in daily practice ,41. TherDuring 2011, 909 patients referred by the Ib-Salut for NP (244 patients), TP (61) and LBP (604), underwent NRT and were discharged before the 31st of December 2011. All patients complying with indication criteria for NRT, signed their informed consents.Adverse events required early extraction of the surgical material in only 38 (4.2%) patients. All adverse events consisted of skin reactions; in 7 patients, they were triggered by a previously unknown allergy to metal, and in 31 cases they consisted of recurrent or persistent local skin infection, despite topical treatment with an antibiotic cream. None of the cases required systemic treatment and the reaction disappeared after the surgical devices were extracted in all cases.Therefore, 871 patients were included in this study. Their characteristics are shown in Table Some patients did not respond to the questionnaires on baseline severity of local pain (one patient), LBP-related disability (two patients) and NP-related disability (six patients). At discharge, some patients left some questionnaires unanswered; the VAS for local pain (one patient), the VAS for referred pain (three patients), the questionnaire assessing LBP-related disability (RMQ) (three patients), and the one assessing NP-related disability (NDI) (16 patients). Some patients left some questionnaires unanswered at baseline and discharge. The numbers for VAS for local pain, VAS for referred pain, RMQ and NDI were one, two, two and five, respectively. In total, twenty-four patients (2.8%) failed to respond to at least one of the questionnaires. Data on medication were checked against invoicing data held at the Ib-Salut, and data on prescription of surgery were checked against hospital registries. Therefore, there were no missing data for these variables.Standards established in the contract on patients’ clinical evolution, use of drugs and surgery, were met, both at the yearly analysis Tables , 3 and 4There were no discrepancies between providers, analysts and the administrative staff of the Ib-Salut. Given these results, the Ib-Salut paid 100% of the amount invoiced for NRT interventions.Shared risks contracts (SRCs) have taken center stage in the regulatory framework related to the adoption of new technologies, and numerous publications have described them in depth, reporting many obstacles for their generalisation into routine practice -70. ThesNRT was selected for exploring the feasibility and effectiveness of using risk sharing tools for quality control and value-based reimbursement of a non-pharmacological technology in Spain, because it complied with the following three requisites: a) the efficacy, effectiveness and cost/effectiveness of the procedure had been assessed through high quality RCTs and studies in clinical practice -35,40-43Many treatments for NP, TP and LBP, such as some rehabilitation or surgical procedures ,30, are The follow-up period in this study was 3 months, which may be seen as relatively short. However, NRT focuses on treating the current pain episode, not on preventing relapses, and this period appears to be clinically relevant and appropriate for this purpose. In fact, the prognosis of chronic low back pain is determined by changes in pain and disability occurring in the initial period . MoreoveValidity of data determining whether standards established in the agreement have been met Tables , 3 and 4High rates of excluded patients, losses to follow-up and missing data, may introduce bias; in this study, less than 5% of the patients who underwent NRT were excluded because adverse events required early extraction of the surgical material, there were no losses to follow-up, and missing data were below 3% Tables , 3 and 4The provider of NRT for the Ib-Salut is a not for profit institution which specialises in NP, TP and LBP research and, in fact, is responsible for most Spanish research in this field . The staRandomised controlled trials (RCTs) are the gold standard for assessing the efficacy, effectiveness and cost/effectiveness of any health technology. In an ideal world, all health technologies would be assessed through high quality RCTs before being used in the clinical environment, and post-adoption surveillance methods would be applied from the start of their use in routine practice. However, strong incentives against this approach exist and, as many examples show, many technologies are implemented in routine practice in the absence of such an evidence, or even disregarding the evidence against implementation ,3,80. NoThis approach is especially needed for technologies which lack the support of robust evidence on efficacy, effectiveness. In the field of NP and LBP this includes, for instance, ultrasound for LBP, most forms of conservative treatment for lumbar spinal stenosis or spinal fusion for common LBP ,73,81,82The absence of guidelines regarding the use of SRC and the expected increase in its use in the near future in Spain, calls for regulatory action. Some preliminary work has been done in this direction .Results from this experience show that it is feasible an effective to combine post adoption surveillance methods with risk sharing tools for controlling quality of care and support value-based reimbursement decisions for NRT. The feasibility of generalizing this approach to other settings and to other non-pharmacological treatments should be explored, since this is likely to improve the efficiency of health resources.The authors declare that they have no competing interests, and that no funds were received for conducting this study.The authors have contributed equally to the design, analysis, interpretation and conclusions of this study. Both authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/13/181/prepub