Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin.A randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay.This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures.NCT02279225. Registered 27 October 2014.ClinicalTrials.gov Identifier:  Fibromyalgia (FM) is a chronic syndrome characterized mainly by pain, nonrestorative sleep, fatigue, morning stiffness, depression, and cognitive disorders , 2. PatiA key issue is the association of FM with other musculoskeletal comorbidities, such as temporomandibular dysfunction (TMD) . It has Phototherapy, such as low-level laser therapy (LLLT) and light-emitting diode (LED) therapy, are recently developed options to treat FM and TMD . LLLT isA comprehensive review of the literature revealed no studies evaluating the role of phototherapy with multiple light sources (LLLT and LED) on the same device in the pain condition in patients with FM and TMD. In addition, there are no prior data involving a combined intervention of phototherapy and exercise training in patients with FM and TMD. The hypothesis of the proposed study is that combined intervention is capable of improving chronic pain in patients with FM and TMD. Knowledge regarding the clinical effects of these interventions can contribute to improved rehabilitation and quality of life among such patients.In this trial, we seek to assess the potential role of exercise training plus phototherapy to reduce chronic pain in women with FM and TMD.The EXTRAPHOTO trial  is a multicenter randomized controlled clinical trial comparing the use of exercise training, phototherapy, and exercise training plus phototherapy for pain control in women with two comorbidities (FM and TMD). As part of a simultaneous recruitment process, in the EXTRAPHOTO trial we will identify participants with target disorders in a database of the Unified Health System of Sao Paulo, Brazil. A preliminary analysis showed that patients at three centers with FM specialties are eligible: 1) the Rheumatology Clinic of Nove de Julho University, Sao Paulo, Brazil; (2) the basic health center of Sao Paulo, Brazil; and (3) the basic health center of Sao Paulo in Sao Bernardo do Campo, Brazil. The study procedure will follow the guidelines of the Consolidated Standards of Reporting Trials statement. All participants will receive data on the study aims and experimental procedures. We will obtain signed, written informed consent forms from each patient before inclusion in the study. The trial scheme is detailed in Fig.  the RheuIn a literature review, we found that FM prevalence is higher in women between ages 35 and 60 years than in men . All womA total of 60 women will be randomized for this trial, with 20 women allocated per group.The recruitment methods include direct referral of patients who consult for FM, in which TMD also will be investigated. A rheumatologist and a dentist will make the diagnoses of FM and TMD, respectively. A physician at each FM medical center will participate. A compatible diagnosis of FM will be obtained on the basis of evaluation criteria similar to those previously well defined . The recThe EXTRAPHOTO trialists will enroll patients immediately after diagnosis of the two comorbidities and referral from recruitment centers. Patient enrollment and randomization, as well as data management, will be carried out by the Program in Biophotonics Applied to Health Sciences of the Nove de Julho University. The blinding will be applied to patients receiving phototherapy and a researcher reported to guide the exercise training. Thus, a researcher will be responsible for programming the phototherapy device, which can be turned on (phototherapy) or off (placebo) prior to application based on the randomization. A second researcher will guide the exercise training and will be blinded for phototherapy and/or placebo procedures. A third investigator will be blinded to allocation and will independently assess the outcomes. The statistical analysis will be performed by a fourth researcher, who will also be blinded to allocation of the patients.Control (CON): patients not subjected to any intervention; the phototherapy device will be turned off (placebo) as a blinded procedure for these participantsPhototherapy (PHO): patients subjected to phototherapyExercise training (EXT): patients subjected to aerobic exercise; the phototherapy device will be turned off (placebo) as a blinded procedure for these participantsPhototherapy plus exercise training (PHO + EXT): patients subjected to phototherapy and aerobic exercise trainingThe eligible participants will be instructed not to change their lifestyle or pharmacologic therapy during the study and will be randomized to one of the following groups:The trial will be 10 weeks long, during which time patients will undergo two sets of phototherapy, exercise, or placebo procedures per week. Phototherapy will be applied 30 min before each exercise bout, and treatment sessions will be carried out Tuesdays and Thursdays each week. For eligible patients, the research will record outcome parameters at baseline prior randomization and 48 h after the last day of intervention. This evaluator will be blinded to the allocation of the patients into the respective groups.Two therapists will guide the interventions at each basic health center. To ensure the feasibility of the study and the reliability of the results, all therapists and researchers will be trained in data collection procedures before the start of the trial. Moreover, the results will be analyzed by an independent investigator without knowledge of the allocation of patients to their experimental groups.Phototherapy will be carried out with a PainAway™ nine-diode cluster portable device . This portable device was specifically designed for pain relief and has two operating modes: mild and severe. Because of the characteristics of pain that patients with FM, we decided to use the device at the mild setting. The device has two identical application hand pieces—one active tip and the other for placebo procedure without energy, both equipped with a similar sound device. These equipment pieces are required to blinding applicator research and patients. Thus, the researcher who will apply phototherapy and the patient will not know which tip was used (active or placebo). The irradiation will be applied only in the tender points in which pain has been reported by the participants. These tender points can be occipital, cervical (near the C7), trapezius, supraspinatus, second costochondral joint, lateral epicondyle and gluteal/sacrum, and greater trochanter on the medial knee border. The temporomandibular joint  will be another irradiation target because of TMD. Each point will be irradiated for 300 s, in which 39.3 J of total energy will be delivered for each irradiation point. An independent researcher will be responsible for controlling the on or off phototherapy device because therapists and patients will be blinded to the procedure. The applicator researcher and patient will be wearing eye protection devices. The CON group will be subjected to the same procedures as the groups subjected to the PHO intervention. The phototherapy device to be used is shown in Fig. The EXT protocol will be carried out according to the guidelines of the American College of Sports Medicine , and a pExercises for TMD will be carried out as reported in detail elsewhere . ExercisThe outcome parameters described below will be evaluated at baseline and 24 h after the last day of the experimental protocol.We will collect data on participants’ occupation, education level, marital status, social security number, home address, age, body weight, and height.To assess overall parameters of pain, we will gather information on daily duration of pain, pain tender points, number of days with a high pain level, sleep quality, main features that show accentuation or worsening of pain, incidence of stiffness and pain, jaw locking, and morning fatigue.no pain and worst pain possible. The patient will be instructed to report the level of pain sensation to a point along this line, with the scores ranging from 0 to 10 and obtained by measuring the distance between the end anchored by the term without pain and the point marked by the participant [We will use a visual analogue scale (VAS) to assess pain level. The VAS consists of a limited strip of 10 cm in length. This strip has at its ends the anchor terms ticipant . Additioticipant .2 in direct contact with the skin. A gradually increasing pressure will be applied to all points until the patient reports feeling pain, at which point the researcher will stop applying pressure and display values will be recorded. The procedures will be performed only once to each point, and a 30-s rest period will be given between readings [A digital algometer  will be used to evaluate pain sensibility through the application of pressure. The algometer will be positioned to read specific FM tender points and TMD joints using the rubber tip measuring 1 cmreadings .Outcome parameters will be evaluated with the FIQ. The FIQ is a multidimensional instrument developed to assess several FM symptoms  . The MedConcentration of serotonin in the saliva is relevant to nociception and the pathogenesis of chronic pain syndromes seen in FM . Thus, mP value <0.05 will be considered significant. The intragroup and intergroup comparisons will be carried out with two-way repeated-measures analysis of variance with post hoc Bonferroni correction or the Kruskal-Wallis test with a post hoc Dunn test. The choice of tests will be based on the distribution  of the data by the Shapiro–Wilk test. For categorical data, χ2 statistics will be used.Pain will be the primary endpoint and will be determined using a VAS, an algometer, the FIQ, and the McPQ. Quality of life as assessed by SF-36, salivary serotonin level, and overall parameters of pain will be secondary endpoints. Statistical analysis will be performed using IBM SPSS software , and a two-sided The ethics committee of the Nove de Julho University  reviewed and approved this study protocol (protocol number 419.828/2013). The trial was conceived and will be conducted according to the principles set forth in the Declaration of Helsinki . All patThe findings this trial are predicted to offer evidence regarding the role of phototherapy and exercise training as well as a combined intervention in a multimodal management program for patients with FM and TMD. This is a target population because TMD prevalence is higher in patients with FM . Pain isIt has been proposed that chronic pain disorders are driven mainly by alterations in the central nervous system in which serotonin is considered the most important neurotransmitter that modulates endogenous mechanisms . BecauseThe EXTRAPHOTO trial is the first randomized controlled study evaluating the role of phototherapy, exercise training, and a combination of these interventions for chronic pain in patients with FM and TMD. In fact, the results of this trial will provide valuable clinical evidence for objective assessment of the potential benefits and risks of procedures. The results will be published after the trial is completed.The proposed study is presently under development, and individuals are being allocated in the experimental groups.


Palliative radiotherapy (RT) is an effective treatment for symptomatic bone metastases. Pain flare, a transient worsening of the bone pain after RT, has been described in previous reports with different incidence rates. The aim of the study was to prospectively evaluate the incidence of pain flare following RT for painful bone metastases and evaluate its effects on pain control and functionality of the patients.Between June 2010 and June 2014, 204 patients were enrolled in this study and 135 patients with complete data were evaluable. Pain flare was defined as a 2- point increase in worst pain score as compared with baseline with no decrease in analgesic intake or a 25 % increase in analgesic intake as compared with baseline with no decrease in worst pain score. All pain medications and worst pain scores were collected before, daily during, and for 10 days after RT. The Brief Pain Inventory (BPI) was filled out on the pretreatment and at the 4 weeks follow-up visit.There were 90 men (66.7 %) and 45 women (33.3 %). Mean age was 66 years (SD 9.8). The most common primary cancer site was lung in 42 patients (31.1 %), followed by prostate in 27 patients (20.0 %). Forty-two patients (31.1 %) patients received a single fraction of 8 Gy and 83 (61.5 %) received 20 Gy in five fractions.The overall pain flare incidence across all centers was 51/135 (37.7 %). The majority of pain flares occurred on days 1–5 (88.2 %). The mean duration of the pain flare was 3 days (SD: 3). There were no significant relationships between the occurrence of pain flare and collected variables.All BPI items measured four weeks after end of RT showed significant improvement as compared with pretreatment scores (p < 0.001). No significant differences in BPI time trends were found between patients with and without flare pain.Pain flare is a common event, occurring in nearly 40 % of the patients that receive palliative RT for symptomatic bone metastases. This phenomenon is not a predictor for pain response. Bone metastases are a common distance manifestation in advanced oncologic patients with a rising incidence due to longer survival of cancer patients. It is the most common cause of cancer-related pain and the most frequent symptom that requires treatment in cancer patients .Palliative radiotherapy (RT) is a well-established and effective treatment alternative for symptomatic bone metastases. Depending on the criteria used, complete response of the pain could be achieved from 10 % to 35 % of patients, with overall pain response rates approaching 70 % .Several randomized controlled trials (RCT) –7 and thAlthough RT for bone metastases is associated with limited side effects, a transitory aggravation of bone pain after treatment in the irradiated site has been recognized in several published reports, with published incidence rates of this phenomenon varying between 2 % and 40 % –13.To date, the evidence in the literature evaluating prospectively the incidence of pain flare is scarce. Few prospective observational studies, with a low number of patients, have explored the incidence of pain flare , 14. TheTherefore, the objectives of this prospective multi-center observational study were to determine the incidence of pain flare after palliative radiation for painful bone metastases and to evaluate the impact of the pain flare on the pain control and the functionality of the patients.Subjects eligible for the study were patients with bone metastases treated with External Beam RT. Criteria for patient eligibility were: age 18 years or older with radiological evidence of bone metastases from a solid tumor, single lesion or multiple metastases were both accepted, pain intensity attributable to the bone lesion measured by Visual Analogue Scale (VAS) of 0–10 and patients capability and willingness to sign informed consent and complete the daily diary.The radiation dose schedules permitted in the study were those administering 8 to 20 Gy in 1 to 5 daily fractions.The protocol was initially approved by the Ethics Committee of the coordinating center , and ethics approval was subsequently requested and obtained at each participating center .The pre-treatment evaluation consisted of a full history and physical examination, administration of Brief Pain Inventory (BPI), record of analgesic consumption within the previous 24 h and provision of the patient´s diary with oral and written instructions on how to fill it on a daily basis during treatment and 10 days after termination of RT. This diary recorded worst pain scores , analgesic usage  and pain perception as compared with baseline pain .A follow-up visit was scheduled 4-weeks after the end of the RT. At this time the BPI was again administered, and analgesic consumption within the previous 24 hours was recorded.Pain response was measured using the International Bone Metastases Consensus from 2002 . CompletSince most previous studies concerning pain flare have used the definition by Chow , we alsoPain flare was defined (a priori) as any two-point increase of the pain scale of 0–10 in the daily diary compared to baseline levels with no decrease in analgesic intake or a 25 % increase in analgesic intake employing daily OMED with no decrease in pain score. If the baseline pain was nine, pain flare was defined if the follow up pain score was 10 accompanied with a response of current pain perception worse than the baseline pain. If the baseline pain was 10, pain flare was defined if the follow up pain score was 10 with current pain perception as worse than the baseline pain. To distinguish pain flare from progression of pain, we required the pain score and analgesic intake to return back to baseline after the flare .Descriptive statistics were used for demographic, clinical and treatment characteristics.Continuous variables are expressed as the mean and standard deviation or median and range for quantitative variables, depending on distributional characteristics, whereas categorical variables are presented as frequencies and percentages.Associations between categorical variables were assessed using Chi square or Fisher exact tests depending upon expected cell frequencies.To assess changes in BPI items scoring between follow-up and baseline visit, T-tests for paired samples were used. To compare changes of BPI scores over time between patients with and without pain flare, T-tests for independent samples were used. All statistical analyses were conducted using SPSS v22 for Windows . Statistical significance threshold was set at 5 %.Between June 2010 and June 2014, 204 patients from ten Radiation Oncology Departments in Spain participated in this prospective observational study. From this cohort, 135 patients (66.2 %) completed the daily diary, 127 patients (62.2 %) the 4-weeks follow-up visit and 118 patients (57.8 %) completed both, the daily diary and the follow-up visit. These patients are labeled as evaluable patients and are the subject of statistical analysis. Reasons for incomplete data are: 25 patients experienced a deterioration in their performance status, 21 patients did not complete the pain diary, there were 16 unknown reasons for incomplete data and 15 patients requested removal from the study.The relevant demographic, clinical and treatment characteristics of evaluable and no evaluable patients are shown in Table Based on the Chow definition , 51 of tPain response to RT at 4 weeks was available for 127 of the 135 assessable cases. Fifteen patients (11.8 %) achieved a complete response and 64 (50.4 %) a partial response. Stable disease was found in 34 patients (26.8 %) and pain progression in 14 (11 %).No significant relationships were found between the occurrence of pain flare and baseline variables, such as gender type, radiation dose, radiation site, primary cancer site, bisphosphonates use and dexamethasone use Table .Table 2Rp < 0.001). A median decrease of 4 points compared to the pre-treatment setting was found for the “worst pain”, “activity”, “mood”, “walking ability” and “normal work” domains.Changes in the BPI scores were assessed at 4 weeks after RT. For evaluation purposes, the BPI responses were assigned to two different dimensions, pain severity (sensory dimension of the pain) and pain interference (reactive dimension). There was a significant reduction in all BPI scores after RT (There were not significant differences in BPI changes between baseline and 4 weeks follow-up visits between patients with or without flare effect.p < 0.05) except for sleep (p = 0.549).The BPI scores for those who responded (CR or PR) were compared with those who did not respond (SD or PD) to RT. There was a significant difference between the two groups in all functional interference items .This multisite prospective observational study shows that pain flare is a common event after palliative RT for painful bone metastases, affecting to almost 40 % of these patients. To our knowledge the current study is, up to the present time, the largest clinical cohort prospectively followed to determine the incidence and characterize the pain flare phenomenon. The use of a well-defined pain flare definition and the use of OMED values and verbal description of the pain in our investigation may have improved our capacity to identify a flare when compared with previous studies , 16.Published articles have reported a wide range of the flare phenomenon, which vary between 2 % and 40 %. This difference could be at least partly explained by inconsistent definitions of pain flare, use of different radiation dose schedules, lack of adjustments for steroid medication or opiate medication, and variations in the time periods at which pain intensity was recorded to capture the flare event .There are several reports , 14, 17 A study published by Pan et al. , found iThe pain flare incidence observed in the studies mentioned is higher than might be expected from clinical experience. In the study published by Chow et al. , there wBased on our results apparently the advent of the pain flare is more common in the first days after the initiation of RT. Indeed, the flare occurred between days 1–5 after RT in 45/51 patients (88.2 %) and between days 6–15 in 6/51 patients (11.8 %). Hird et al.  reportedThe physiopathology of the pain flare is largely unknown. It has been suggested to arise through edema of the periostium of the irradiated bone resulting in nerve compression or the release of inflammatory cytokines . Thus, dThere is an ongoing RCT comparing two different dose schedules of dexamethasone and placebo led by the University Medical Center Utrecht. With an accrual goal of 411 patients, this study will help elucidate whether dexamethasone is an effective option in the prevention of pain flare after palliative radiotherapy for bone metastases .Regarding pain response to RT, we found similar response rates to those reported by a range of RCT evaluating response to RT with different dose schedules. Foro , Chow 22, HartseA secondary objective of our study was to evaluate the impact of the palliative radiotherapy on the pain control and the functional ability of the patients. The BPI is a well-known instrument, and has been shown to be a reliable and valid tool in depicting pain severity and the extent to which pain from bone metastases interferes with patient functioning. In the present study, significant changes in all BPI scores were found over time, decreasing from baseline to week 4.Nguyen et al.  found inIn our study we have found a significant difference in all BPI items after RT (p < 0.001) with larger difference (4 points) for the “activity”, “mood”, “walking ability” and “normal work” domains.Most importantly, these observed significant differences in BPI items after RT have real impact on quality of life (QOL) and function, and provide clinically meaningful data to guide clinical decision-making .In the interpretation of this study some limitations are acknowledged. These include a small sample size of 204 patients recruited and a reduction of the effective sample for final analysis to 135 patients. Loss to follow-up is a common problem in patients with metastatic disease. Furthermore, the limited BPI follow-up of 4 weeks after radiation impedes evaluation of long-term outcomes.Our study demonstrates that pain flare is a common event in patients that receive palliative RT for bone metastases. Despite its frequency, it does not seem to have detrimental effect on the degree of pain control at 4 weeks. Our study has shown high rates of pain response and more importantly, a significant improvement on the functional interference dimension. Further studies evaluating whether simple interventions, such as prophylactic dexamethasone or short-acting opioids contribute to the prevention or amelioration of the flare phenomenon are warranted.Pain flare is a common event, occurring in almost 40 % of the patients that receive palliative RT for symptomatic bone metastases. RT for symptomatic bone metastases is a very effective palliative treatment, in terms of pain control and functional interference, even if the patient experiences in the short-term a pain flare.


There is a growing amount of evidence that alteration in pain processing by the peripheral and central nervous system play a role in osteoarthritis pain, leading to neuropathic-like symptoms. It is essential to identify knee and hip osteoarthritis patients with a neuropathic pain profile in order to offer such patients education and additional treatment options besides conventional pain treatment. The painDETECT Questionnaire is a self-report questionnaire developed to discriminate between nociceptive and neuropathic pain. This questionnaire was modified to fit patients suffering from knee osteoarthritis. The aim of this study was to translate and cross-culturally adapt the modified painDETECT Questionnaire to the Dutch language and to provide a modified version to fit patients with hip osteoarthritis. Reliability for internal consistency, repeatability and floor and ceiling effects were subsequently assessed. A total of 278 patients were included in the reliability study and 123 patients in the repeatability analysis. The Dutch modified painDETECT Questionnaire shows good internal consistency and small relative measurement errors, represented by a good intraclass correlation coefficient. Absolute measurement error, represented by the Standard Error of Measurement, was acceptable. However, a measurement bias might be present when it comes to repeatability. To our knowledge, this study is the first to provide a Dutch modified painDETECT Questionnaire to fit hip and knee osteoarthritis patients and to assess internal consistency, reliability and agreement. International guidelines were followed in the translation process and this study has ample sample size with an adequate time interval for repeatability. Based on this study, the Dutch modified painDETECT Questionnaire seems to be fit as a discriminative tool to identify knee and hip osteoarthritis patients with a neuropathic pain profile. Whether it is also suitable as an evaluative tool to record changes over time or after an intervention remains open to further investigation. Osteoarhtritis (OA) is the most common arthritic joint disease, affecting mainly older adults –3. Its wFor most patients with OA, pain is the main reason to seek medical consultation and treatment. Over time the pain often transforms from intermittent weight-bearing to persistent, chronic pain ,7. The eIt is essential to identify knee and hip OA patients with a neuropathic pain profile in order to offer such patients education and additional treatment options besides conventional pain treatment. A reliable and valid tool for assessing neuropathic pain symptoms in OA patients is therefore of great importance. Besides diagnosis by a specialized pain physician, there are several tools to assess neuropathic pain symptoms, ranging from self-report questionnaires to a more objective tool like Quantitative Sensory Testing (QST) –24. For The painDETECT Questionnaire (PDQ) is a self-report questionnaire that has been developed to discriminate between nociceptive and neuropathic pain. Originally it was developed for patients with chronic low back pain . With a No Dutch-language version of the mPDQ is currently available. It should be noted that the mPDQ only considers knee OA, it is not modified to fit patients suffering from hip OA. Hence the aims of this study were: 1) to translate and cross-culturally adapt the mPDQ to the Dutch language, 2) to adjust the Dutch mPDQ to fit patients with hip OA, and 3) to assess the reliability of the Dutch mPDQ.This study consists of two stages. First, translation and cross-cultural adaptation of the mPDQ took place. In this stage the mPDQ was also adapted to fit patients suffering from hip OA. Secondly, internal consistency, repeatability and floor-ceiling effects were evaluated. The study was approved by the Medical Ethical Committee of University Medical Center Groningen (no. METc2014/087). Informed consent was considered obtained if the patient granted our request to participate in the study by returning a set of completed questionnaires. If patients did not want to participate in the study they were requested to return the blank set of questionnaires. Patients were informed of this way of obtaining consent by an information letter. In this information letter they were also informed of the voluntary nature of the study, and that all data was processed anonymously. The Medical Ethical Committee specifically approved this consent procedure.The international guidelines proposed by Beaton et al. were followed during translation and cross-cultural adaptation of the mPDQ into Dutch . ForwardAfter this translation and adaptation process, comprehensibility of the pre-final mPDQ-NL was tested in a pilot study. Thirty patients suffering from knee or hip OA who had an appointment at the outpatient clinic of the Department of Orthopedic Surgery of University Medical Center Groningen were asked to complete the questionnaire. These patients were asked to report any problems filling out the questionnaire and to give their comments. This resulted in a few minor adaptations to the questionnaire like underscoring some items to enhance interpretability. See Patients suffering from idiopathic hip or knee OA who were receiving conservative treatment or were on the waiting list for Total Hip or Knee Arthroplasty (THA/TKA) were eligible to participate. A random sample of 604 patients who had visited the outpatient clinic between July 2013 and May 2014 was obtained from the Departments of Orthopedic Surgery of University Medical Center Groningen, Martini Hospital Groningen and Medical Center Leeuwarden . Exclusion criteria were: age below 18 years; hip or knee surgery in the past six months; severe neurological, cognitive or psychiatric disorders; and inadequate understanding of written Dutch.Eligible patients received an information letter, the mPDQ-NL hip or knee, a questionnaire on demographic characteristics and comorbidities, and a pre-paid reply envelope by mail. Patients were requested to complete the questionnaires. It was explained in the information letter that returning a set of completed questionnaires was considered as informed consent to participate in the study. If patients suffered from OA in more than one joint they were asked to complete the questionnaire for the hip or knee joint that was most symptomatic. To assess repeatability, a second mPDQ-NL was sent to participants after an interval of two weeks. The second mailing included an anchor question on the global rating of change, in which patients could indicate if their symptoms had changed over the last two weeks. Only patients who reported that their symptoms had not changed were included in the repeatability analysis. If returned questionnaires were incomplete, several attempts were made to reach patients by telephone in order to complete the missing items. Data collection took place from April to June 2014.burning sensation, tingling or prickling sensation, pain at light touch, sudden pain attacks, pain at cold or warm stimulus, numbness and pain at light pressure. The final three items rank pain intensity on a 0–10 numeric rating scale (NRS), where 0 represents “no pain” and 10 represents “excruciating pain”. These final three items are about “pain at this moment”, “worst pain in the past week” and “average pain in the past week”, respectively. The total score ranges from -1 to 38 points; the final three items on pain intensity are not included in the score. Cut-off points were chosen in accordance with the original PDQ [The mPDQ-NL is a self-report questionnaire consisting of 12 items about neuropathic pain symptoms of the left or right knee or hip during the past week. The first item assesses the presence of pain radiation using a body map. The second item assesses the pain pattern, where patients have to choose between four figures representing distinctly described pain patterns. The following seven items rank pain quality on a 6-point Likert scale, 1 representing “never” and 5 representing “very strongly”. These items respectively assess inal PDQ . A scoreStatistical analyses were performed using IBM SPSS Statistics for Windows . Statistical significance was considered to be indicated with a p-value < 0.05 (two-tailed). If patients reported no pain on all three NRS of the mPDQ-NL, they were excluded from the analyses. Patient characteristics were reported using descriptive statistics.Internal consistency reflects the extent to which items of a questionnaire measure the same concept. Factor analysis should first be conducted to determine whether the items of the questionnaire form one single overall dimension or more than one . ExploraRepeatability concerns whether repeated measures in a stable person provide the same scores. Two parts are distinguished: agreement (represented by the absolute measurement error) and reliability (represented by the relative measurement error) ,31.diff) between baseline measurement and retest measurement by √ 2 [ind = 1.96 x SEM x √ 2. For a group the SDC with 95% CI can be calculated by using the following formula: SDCgroup = 1.96 x SEM x √ 2 / √ n. Absolute agreement was assessed using the methods of Bland and Altman [Agreement reflects the extent to which the scores of repeated measures are close to each other . Absolutt by √ 2 . The smad Altman . The meaReliability reflects the extent to which patients can be distinguished from each other, despite measurement errors . RelativThe percentages of patients with the highest and lowest possible scores on the total mPDQ-NL and on the individual pain quality items were calculated. If more than 15% of respondents have minimal or maximal scores, floor and ceiling effects are considered to be present . This reTranslation of the mPDQ into Dutch was successful. No difficulties were encountered during pilot testing. In total, 604 patients were invited to participate in the reliability study. The response rate was 336 participants (55.6%). Of these respondents, 278 (46.0%) were included in the reliability study. Ten patients were excluded from the repeatability analysis. Reasons were because they received THA/TKA before the retest could be conducted or because the first questionnaire was returned with a considerable delay that surpassed the retest period. The response rate for the repeatability analysis was 220 participants (82.1%), 123 (45.9%) of whom were included in the repeatability analysis. Exploratory factor analysis revealed two principal components with an eigenvalue ≥ 1. The first component had a Crohnbach’s alpha of 0.71, the second component 0.65. The general questionnaire showed a Crohnbach’s alpha of 0.77 and the seven Likert items on pain quality 0.80.ind 7.3 and the SDCgroup 0.7. For individual items, SEM value ranges were 0.5–0.9, SDCind ranges 1.1–2.6 and SDCgroup 0.1–0.3. For the total score, the mean difference between test and retest was 0.69 with a 95% CI of 0.03–1.36, which therefore did not contain zero. For individual items, the 95% CI contained zero for most individual items, except for radiation and sudden pain attacks. The Bland Altman plot is presented in pain pattern (ICC 0.52) and radiation (ICC 0.67).For the total mPDQ-NL score, no floor or ceiling effects were found as no patient had the highest or lowest possible total score (-1 or 38 points). For all individual Likert items, >15% of patients had the lowest score, indicating that floor effects were present; no ceiling effects were perceived .This study is the first to provide a Dutch mPDQ to fit hip and knee OA patients, as well as to assess internal consistency, reliability and agreement of the mPDQ hip and knee. Hence results from the present study can only be compared to reliability data of the PDQ, as no other studies on reliability of the mPDQ are available to our knowledge.For internal consistency, Crohnbach’s alpha for the overall score was 0.77, which is considered good . This scRepeatability was assessed in terms of agreement and reliability. For agreement, SEM seems acceptable with 2.6 points, as the mPDQ ranges from -1 to 38 points. The mPDQ-NL might be better at detecting changes between groups of patients than at the individual level, considering that the individual SDC in the overall score was 7.3 points and the SDC at the group level was 0.7 points. However, to properly assess the value of these SDC figures they should be compared to the minimal important change (MIC), which could not be determined from the current data.When assessing agreement according to Bland and Altman, it should be mentioned that the 95% CI did not contain zero for the overall mPDQ-NL score, although it almost reached zero (0.03–1.36). This means that a systematic measurement bias between the test and retest might be present. Even though only subjects who reported that their pain had not changed over the last two weeks were included in the analysis, the overall mPDQ-NL values were consistently slightly lower at retest. Patients may have had some difficulty estimating the global rate of change of the pain they experienced in the previous two weeks. The Bland and Altman plot shows an equal scatter of the difference in mPDQ-NL though, which means that no actual trend can be observed .Reliability of the mPDQ-NL was good (ICC: 0.90), so it seems able to distinguish patients from each other despite measurement error. This is in line with previous PDQ reliability studies. For the Japanese PDQ an overall ICC of 0.94 was found, but only 11 subjects were included in their repeatability analysis. For the Spanish PDQ a repeatability analysis was conducted on 26 patients and an overall ICC of 0.93 was found.No significant floor or ceiling effects were encountered for total mPDQ-NL scores. However, floor effects were found for all the individual Likert items. As only a subset of knee and hip OA patients experience neuropathic pain symptoms, it is understandable that floor effects were found. Considering that these floor effects for individual Likert items were not represented in the overall mPDQ-NL scores, it is likely that patients with subtle neuropathic symptoms can be distinguished from each other. This is important for the mPDQ-NL in order to identify subtle neuropathic symptoms within the broader spectrum of OA symptoms.numbness), it is possible for patients with a low NRS for general pain intensity to reach a considerable mPDQ-NL score. Therefore, if patients reported even the least amount of pain (NRS >0) they were included in the study in order to evaluate neuropathic pain for the total range of symptomatic OA patients. Even in this population sample consisting of patients with different degrees of OA pain, 35.9% of hip OA patients and 44.4% of knee OA patients suffer from possible or likely neuropathic pain. The magnitude of these figures might support current literature on the importance of sensitization in OA pain [Because the mPDQ-NL considers symptoms other than actual pain Click here for additional data file.S1 Text(PDF)Click here for additional data file.


Cubital tunnel syndrome represents the second most common compression neuropathy of the upper limb. For more than four decades there has been a controversy about the best surgical treatment modality for cubital tunnel syndrome. In this study the results of 28 patients with simple ulnar nerve decompression are presented. Data analyses refers to clinical examination, personal interview, DASH-questionnaire, and electrophysiological measurements, which were assessed pre- and postoperatively.28 patients  were included in this study. The average age at time of surgery was 47.78 years (31.68–73.10 years). The period from onset of symptoms to surgery ranged from 2 to 24 months (mean 6 months). The mean follow-up was 2.11 years (0.91–4.16 years).Postoperatively there was a significant decrease in DASH score from 52.6 points to 13.3 points (p<0.001). Also the electrophysiological findings improved significantly: motor nerve conduction velocity increased from 36.0 m/s to 44.4 m/s (p=0.008) and the motor nerve action potential reached 5,470 mV compared to 3,665 mV preoperatively (p=0.018). A significant increase of grip strength from 59%  to 80% was observed (p=0.002). Pain was indicated by means of a visual analog scale from 0 to 100. Preoperatively the median level of pain was 29 and postoperatively it was 0 (p=0.001). The decrease of the two-point-discrimination of the three ulnar finger nerves was also highly significant (p<0.001) from 11.3 mm to 5.0 mm. Significant postoperative improvement was also observed in the clinical examination concerning muscle atrophy (p=0.002), clawing (p=0.008), paresthesia (p=0.004), the sign of Froment (p=0.004), the sign of Hoffmann-Tinel (p=0.021), and clumsiness (p=0.002).Overall nearly 90% of all patients were satisfied with the result of the operation. In 96.4% of all cases, surgery improved the symptoms and in one patient (3.6%) the success was noted as “poor” because the symptoms remained unchanged. In 35.7% the success was graded as “moderate”, in 10.7% as “good” and in 50.0% as “very good”. The cubital tunnel syndrome (CTS) is a frequent diagnosis for neuropathy of the upper limb. It is characterized by pain at the ulnar part of the forearm, paresthesia, and hypesthesia, accompanied by sensitive and motoric dysfunction. This leads to a severe disability and restrictions in daily life.There are multiple treatment options concerning surgical interventions but still without an academic level of evidence for one of them. The investigators of this study present a long-term follow-up with a complex clinical and physiological testing scale after single decompression of the ulnar nerve in cubital tunnel syndrome.During a three year period 56 single decompression operations caused by cubital tunnel syndrome were performed in the institution. 28 patients could be randomized into the study. The mean follow-up was 2.1 years after operation and was realized by an extensive protocol of examinations. The patients were evaluated by a questionnaire, including the DASH score, visual analogue scale, and a general assessment on the subjective benefit of the operation and its effect. Furthermore, we examined the patients focusing on the parameters: grip strength (Jamar dynamometer), range of motion, functional thumb adduction (Froment sign), static two point discrimination, nerve irritation (Hoffmann-Tinel sign), and electroneurophysiological parameters.There was an equal distribution of sex . The mean age was 48 years and the persistence of symptoms until operation was 6 months (2–24). Remarkable was the affliction of the non-dominant hand:The DASH score  was significantly reduced post-operatively  as well as the pain-scale and the feeling of clumsiness of the hand. Preoperatively the median level of pain was 29 and postoperatively it was 0 (p=0.001).Concerning the technical examination grip strength measured by Jamar dynamometer showed an improvement. A significant increase of grip strength from 59%  to 80% was observed (p=0.002). Pain was indicated by means of a visual analog scale from 0 to 100. Preoperatively the median level of pain was 29 and postoperatively it was 0 (p=0.000). The decrease of the two-point-discrimination of the three ulnar finger nerves was also highly significant (p<0.001) from 11.3 mm to 5.0 mm. Significant postoperative improvement was also observed in the clinical examination concerning muscle atrophy (p=0.002), clawing (p=0.008), paresthesia (p=0.004), the sign of Froment (p=0.004), the sign of Hoffmann-Tinel (p=0.021), and clumsiness (p=0.002). Overall nearly 90% of all patients were satisfied with the result of the operation. In 96.4% of all cases, surgery improved the symptoms and in one patient (3.6%) the success was noted as “poor” because the symptoms remained unchanged. In 35.7% the success was graded as “moderate”, in 10.7% as “good” and in 50.0% as “very good” Figure 1 .Paraesthesia is one of the major symptoms and were found in 27 from 28 patients before the operation. This was also reduced significantly (p=0.004) by the operation, but 18 patients reported about any kind of paraesthetic feelings. Also the positive Hofmann-Tinel sign was persisting in 12 of 21 cases.The most important parameters, DASH score, pain scale, and grip strength are summarized in Figure 2 st century, there are multiple uncertainties in diagnostic and treatment methods of cubital tunnel syndrome. Up to 30% of patients suffering from cubital tunnel syndrome are idiopathic and then often correlated with an additional carpal tunnel syndrome. The diagnostics even in case of neurophysiological testing do not necessarily correlate with the clinical findings and symptoms . Th. Th7]. TThis study confirms the excellent outcome after single decompression of the ulnar nerve. The investigators propose this method as „gold standard“ in cases of cubital tunnel syndrome without anatomical pathologies that require further manipulation.The single ulnar nerve decompression is a safe and effective method to treat the cubital tunnel syndrome. It achieves significantly a reduction of pain and paresthesia, an increase of power and the motoric and sensitive function.The authors declare that they have no competing interests.


Women reported more pain than men (p = .009). Pain trajectories did not differ by education, employment, cohabitation, or any patient clinical and biochemical characteristics but were significantly related to preoperative anxiety (p = .029). Patients reporting moderate/severe pain prior to surgery also reported more hours in moderate/severe pain on days 0–3 postoperatively (p = .029). Patients with surgeries longer than 90 min reported more hours of moderate/severe pain compared with patients who had shorter surgeries (p = .008), and similar results were observed for ratings of pain with activity (p = .012). In this sample, only female gender, higher levels of preoperative pain and anxiety, and longer surgical duration were associated with increased pain after TKA.This study explores sociodemographic, clinical, and surgical factors in relation to pain trajectories during the first 3 days following total knee arthroplasty (TKA). 100 patients  consecutively admitted for uncomplicated primary TKA were prospectively included. Postoperative pain was assessed using pain diaries. Measures of preoperative pain, symptoms, daily functioning, quality of life, comorbidities, knee function, perioperative characteristics, and physical/biochemical parameters were also evaluated. All pain ratings decreased in the three days following surgery ( Total knee arthroplasty (TKA) is known to be a very painful orthopedic procedure . DespiteSurgeons try to reduce the tissue damage by shortening the length of skin, capsule, and extensor apparatus incisions, modifying the type of arthrotomy , reducing the amount of unnecessary soft-tissue releases, or optimizing tourniquet pressure and time . In addiAll of these options have established advantages and disadvantages both from clinical and economical points of view , 13, butThere is growing attention to cognitive and emotional patient characteristics that together with other multiple factors like age, gender, ethnicity, level of preoperative pain, and length of waiting time before the surgery may influence the amount of acute and chronic postoperative pain after knee replacement –17. NegaThus, the aim of this study was to explore sociodemographic, clinical, and surgical factors in relation to pain trajectories during the first 3 postoperative days following total knee arthroplasty (TKA).This study is the first report from a prospective longitudinal study of pain, symptoms, and health-related quality of life in 100 consecutive Caucasian patients receiving total knee arthroplasty. The study was conducted at the Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden (Vreden's Institute) in St. Petersburg, Russia. The study was approved by the local Ethics Committee at Vreden's Institute. Informed written consent was obtained from all patients.Patients admitted to Vreden's Institute for TKA were recruited for the study between April and September 2014. Patients were included if they were ≥18 years of age; were able to read, write, and understand Russian; and were scheduled for unilateral primary TKA. Patients were excluded if they underwent unicompartmental or revision surgery, had prior TKA on the contralateral knee, or had primary TKA complicated by one of the following conditions: extensive bone defects requiring substitution by graft or metal, collateral ligament insufficiency, frontal deformities over 30 degrees, hyperextension >15 degrees, fibrous or bony knee ankylosis, femur or tibia extra-articular deformities in more than one plane and over 10 degrees, extensor mechanism deficit, or hip fusion.Patients received written information about the study on the day of admission. Patients were admitted to the hospital between 1 and 7 days prior to surgery depending on comorbidities. Patients who met the inclusion criteria were invited to participate by the senior surgeons (NK and TK) on the day of admission. After obtaining written informed consent, patients completed a questionnaire that assessed demographic characteristics, preoperative symptoms, and psychological factors. Preoperative pain was assessed the day before surgery, and acute postoperative pain was assessed using a 4-day pain diary, which was completed every evening starting on the day of surgery (Day 0) until postoperative Day 3. The completed questionnaires and the pain diary were collected by the junior surgeons (AS and KM).The surgery, anesthesia, and postoperative pain management procedures were standardized. All patients received the primary cemented unconstrained posterior cruciate retaining or substituting implants for the TKA. A tourniquet was used during surgery in a minority of cases (21%). To avoid potential harm to the arterial or vein wall, tourniquet was not used in patients with comorbidities, such as varicose vein disease, atherosclerosis of peripheral arteries, diabetes, and other factors associated with increased risk of venous thromboembolism. Because the application of tourniquet within recommended pressure range is ineffective for patients with excessive subcutaneous fat in the middle of the thigh, tourniquet was also not used for obese patients. The low rate of tourniquet use was due to these contraindications. The less-invasive medial parapatellar approach was utilized in all patients without eversion or resurfacing of patella . Drains Neuraxial block with bupivacaine and sedation were used for anesthesia for all patients. Spinal anesthesia has been the method of choice for TKA patients in Vreden's Institute for the last two decades because it is safe, well tolerated by patients with comorbidities, and not only clinically effective, but cost-effective as well. In one patient, an incomplete effect of the spinal anesthesia was noticed, so general anesthesia was used as an adjunct because the patient refused a peripheral nerve blockade. Although prolonged epidural anesthesia was previously widely utilized in TKA patients during surgery and even for a few days after it, it is now rarely used at our institution for several reasons. First, the achieved block is more variable in strength and the failure rate of the technique may reach 28% . Second,For postoperative pain management, all patients received an intramuscular (IM) injection of ketoprofen 100 mg 3 times per day until discharge from the clinic. If this did not provide adequate pain relief on the first day, the second line drug was a single IM injection of opiate trimeperidine (Promedol) (0.01 mg). On the second and third days, the second line drugs were tramadol (100 mg IM twice per day) or Zaldiar (1 pill every 6 hours). This has been the standard pain management at our institution for many years. All patients received a single intravenous injection of Dexamed (Dexamethasone) (8 mg) just before incision.Mobilization and physical therapy were standardized. After surgery, patients spent several hours in the recovery room supervised by an anesthesiologist. Patients were then returned to the ward and remained in bed until the next morning when physical therapy was initiated. Beginning on postoperative Day 1, a physiotherapist mobilized the patients out of bed, assisted them with exercises, and helped them ambulate on crutches with partial weight bearing on the operated leg. During the following days, patients received daily physical therapy, which included ambulation as tolerated, and performed flexion and extension of the knee exercises two to three times daily. Most patients were discharged on postoperative Day 7.Data on brand of implant, American Society of Anesthesiologists (ASA) physical status classification , length The Brief Pain Inventory (BPI). Patients' level of preoperative pain and its impact on function were assessed using the BPI [ the BPI . The BPI the BPI . For thiPain Diary. Patients rated their acute postoperative pain every evening starting on the day of surgery and continuing through Day 3. Six different aspects of pain were rated , but this analysis emphasizes pain with activity and pain duration given their potential to impact physical rehabilitation [litation . PatientSeveral measures were used to assess patients' other symptoms. The 14-item Hospital Anxiety and Depression Scale (HADS)  was usedThe Knee Society Score (KSS)  and FuncThe Lawton Instrumental Activities of Daily Living (IADL) Scale  was usedThe EQ-5D-3L  was usedt-tests and chi-squared tests were used to compare groups on continuous and categorical variables, respectively. Fisher's Exact Test was used instead of the chi-square test when expected cell frequencies were below 5. Repeated measures analysis of variance was used to evaluate the within-subjects effect of time evaluated at 4 points  and various between-subjects effects . p value of <.05 indicated statistical significance.Descriptive statistics and frequency distributions were performed on the preoperative demographic and clinical sample characteristics. Independent sample Of the 241 knee arthroplasty patients evaluated for inclusion in the study, 14 were not eligible because they had had prior knee replacement, 12 were transferred to other departments due to the necessity of other surgeries prior to the TKA, 23 were discharged prior to surgery due to severe comorbidities, and 92 declined to participate. The remaining 100 patients were enrolled in the study and are included in the analysis. Demographic, clinical, and surgical characteristics are summarized in p < .001). Similarly, the reported number of hours per day in moderate/severe pain  decreased over time (p < .001). Given the similar trajectories for the different pain ratings, subsequent analyses focus only on pain with activity as a measure of pain intensity and hours in moderate to severe pain as a measure of pain duration or burden.As shown in p = .009), but with only 7 men in the sample, this may not be a robust finding. Age had modest negative correlations (range of −0.20 to −0.25) with pain ratings on Days 1 and 2 but was not correlated with pain ratings on Day 0 or Day 3. Pain trajectories did not differ by education, employment, or cohabitation status.Women reported more pain than men across Days 0–3 (average pain ratings of 5.5 (SD 1.62) for women versus 3.8 (SD 1.34) for men, p = .034). As shown in p = .029; interaction between anxiety and time, p = .046). Not surprisingly, patients who reported moderate to severe average pain prior to surgery also reported more hours in moderate to severe pain on Days 0–3 postoperatively (p = .029). However, preoperative average pain rating was unrelated to ratings of pain with activity on postoperative Days 0–3.Pain trajectories from the day of surgery through the first three postoperative days were largely unrelated to patient clinical characteristics. Pain ratings over time did not differ based on the patient's preoperative Knee Society Score, Function Score, their level of independence with activities of daily living, or their health-related quality of life. In addition, pain ratings did not differ based on patient ratings of preoperative sleep quality (PSQI), fatigue (FSS-7), or depression (HADS). However, pain ratings over time were significantly related to preoperative anxiety, with the patients who reported higher anxiety reporting more pain with activity, but only on the day of surgery, not on the subsequent three postoperative days . Excluding the one patient with TIVA did not alter any of the results. Medications administered to patients to manage postsurgical pain are summarized in p = .008). Similar results were observed for ratings of pain with activity (p = .012).The mean surgery duration was 95.6 (SD 23.6) minutes, with a median of 90 minutes. A comparison of shorter (<90 minutes) and longer (>90 minutes) surgeries indicated that longer surgeries were associated with higher postoperative pain ratings. As shown in p = .060), the less commonly used implants  were associated with slightly more hours in moderate/severe pain on Days 0–3 than the more commonly used implants   and NexGen  were only used 4 or 5 times each and were grouped with the LCS DePuy  for the purpose of analysis. The Sigma DePuy  and AGC  were the most commonly used implants and were utilized in 77% of the surgeries in this study. Although the difference did not reach statistical significance (and AGC) . The impp = .004) and the nonparametric Kruskal-Wallis test (p < .001) confirmed robust differences in surgery duration by implant type. Longer surgeries were also associated with more bleeding, but surgery duration was unrelated to tourniquet use. Longer surgeries were also associated with lower preoperative hemoglobin values, but surgery duration was unrelated to postoperative hemoglobin values. Surgery duration was also unrelated to creatinine and CRP values. Although surgeries longer than 90 minutes were not significantly associated with longer preoperative or postoperative stays in hospital, they were associated with longer hospital stays overall .As shown in Tables A primary finding of this study was that the pain management protocol implemented at our institution was providing insufficient pain relief for some patients. Patients reported mean levels of pain in the moderate to severe range (NRS ≥ 4) on the day of surgery and first three postoperative days. Patients also reported a mean of 9 hours per day in moderate to severe pain. As a result of these findings, new modalities, such as local infiltration analgesia during surgery and intravenous Perfalgan (paracetamol) , were recently added to the protocol. In addition, single-injection femoral nerve blocks are now also used more widely. The levels of pain reported by the patients in this study may have also impacted the study results. The factors evaluated may have somewhat subtle effects that might be more evident among patients with greater pain relief. Thus, due to the possibility of ceiling effects, negative findings should be interpreted with caution. Nonetheless, our study identified several factors as predictors of heightened pain experience, even in this more limited pain management context.Our study evaluated a variety of different psychological and clinical preoperative patient characteristics and found that only female gender and higher levels of preoperative anxiety and pain were associated with higher levels of pain reported in the early postoperative period after TKA. Anxiety is a recognized risk factor for persistent postsurgical pain . Roth etNumerous publications indicate that patients who are depressed preoperatively have worse results after TKA surgery in terms of pain, functionality, and satisfaction , 45, 46.p = .009), but the male subgroup consisted of only 7 patients, which reflects the typical gender distribution among primary TKA patients in our institution in recent years [p = .029), although preoperative pain was unrelated to postoperative pain in activity. Neuropathic pain was not addressed in the current study, but Lavand'homme et al. [Other reported predictors for increased postoperative pain include female gender, younger age, increased BMI, increased severity of preoperative pain at the surgical site, preoperative use of opioids, general anesthesia, preoperative use of anticonvulsants, and preoperative use of antidepressants . Among ont years . Patiente et al.  found thThe second finding of the study was that, among intraoperative variables, surgeries longer than 90 minutes were associated with more postoperative pain in activity, as well as more hours of moderate to severe pain. This finding is consistent with those of Niki et al.  that redThis study has several strengths and limitations that need to be considered. A strength of the study is that Vreden's Institute used a standard protocol for patient care, thereby limiting the number of potential variables that may have influenced the results. In addition, the study evaluated a fairly comprehensive set of factors, including demographics, psychological well-being, knee function, physiological parameters, and intrasurgical factors, as well as an array of pain measures, including a 4-day pain diary. However, the sample size was small and likely underpowered for the number of factors being evaluated, and the sample was relatively homogeneous, particularly with respect to gender. Although the sample's gender distribution is representative of the patient population admitted for TKA at Vreden's Institute, applying the study findings to male patients should be done with caution, given the small number of men included in the study and the observed gender differences in pain. The surgeries were performed by several different surgeons, which may have added some individuality in soft-tissue handling. Nevertheless, all were trained by senior surgeon (NK) to do the surgery methodically and in a manner corresponding to the principles of less invasive surgery, such as dissecting as little tissue as possible, minimizing the length of incision during approach, avoiding excessive tension by retractors, utilizing the principle of mobile window during all steps of TKA, avoiding eversion of the patella or full subluxation of the tibial plateau anteriorly, and keeping soft-tissue releases minimal but sufficient for correction of both alignment and contracture, as well as gap balancing. Finally, although the pain management protocol was standardized, with little variation in dosing, this study did not include an extensive evaluation of the patients' pain management, which seemed to provide inadequate pain relief for some patients. Future research is needed to evaluate the complex relationships between the timing and dosing of pain management medication and postoperative pain trajectories.Postoperative pain levels were generally high in this sample of TKA patients. Of the numerous previously reported medical and psychological comorbidities associated with pain following TKA, only gender, anxiety, and a higher level of preoperative pain were associated with increased postoperative pain after TKA in our cohort of patients. Among the surgical factors examined, surgery duration, which varied by the brand of implant, was associated with postoperative pain trajectories. Better understanding of which TKA patients are at greatest risk for postoperative pain will allow health care providers to individualize both preventive and protective analgesic peri- and postoperative treatments , 51.


Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee. During  in vivo . There a in vivo , 4. As r in vivo . PST  for 3-4 weeks depending on the diagnosis. Improvement of microcirculation and reducing fatigue are the clinical applications that have so far been confirmed.Aim of the study was to evaluate the effect of adjuvant BEMER therapy on pain, fatigue, and quality of life in patients with knee arthrosis and chronic low back pain. The primary outcomes were to assess the effect of BEMER therapy on knee and low back pain caused by degenerative changes. The secondary outcomes were to evaluate the adverse effects and to record the changes in fatigue and to investigate the effect on quality of life.This is a single-centre, randomized, placebo-controlled, double blind follow-up study. A total of 50 patients with chronic low back pain and 50 patients with knee arthrosis were enrolled in this study who had been hospitalized for 3 weeks at the Rheumatologic Rehabilitation Department of the Hospitaller Brothers of St. John of God.The patients signed an Informed Consent Form before the study. The study was approved by the Ethics Committee.In addition to complex standard physiotherapy, half of the patients also received additional BEMER therapy, while the other half received additional placebo BEMER therapy; patients could not tell the placebo treatment from the real treatment. Randomisation was conducted by an independent person (by means of drawing lots). During this study, neither the study doctor nor patients or study assistants knew the treatment given. Unblinding took place only after study completion.Demographics: average age was 67.29 years ± 5.44 years  and 66.7 years ± 7.73 years  in patients with chronic low back pain and 67.11 years ± 8.8 years  and 65.3 years ± 7.46 years  in patients with osteoarthritis of knee; with 2 and 3 exceptions, all patients with chronic lower back pain and with osteoarthritis of knee, respectively, were females. There were no differences in gender and age between the treatment and placebo group.Inclusion Criteria for Patients with Low Back Pain. These includepatients with chronic nonspecific low back pain with nonseverely reduced mobility;males and females of 20 to 80 years of age;nonspecific low back pain for at least 12 weeks;palpable tenderness of the paravertebral muscles and/or painful limited mobility of the lumbar spine;low back pain VAS  score of at least 30 mm on a 100 mm visual analogue scale during exercise;the patients have not received systemic or local steroid therapy or physical therapy or balneotherapy, within 2 months prior to the study; physiotherapy was allowed.Exclusion Criteria for Patients with Low Back Pain. These includeacute low back pain;organic neurological deficit associated with lower back pain;the underlying cause is likely to be vertebral compression fracture caused by osteoporosis or other factors;underlying malignancy;pain caused by inflammatory spine conditions;spondylolisthesis (grade 2 or higher);pregnancy.Inclusion Criteria for Patients with Osteoarthritis of Knee. These includemales and females of 30 to 80 years of age with mild or moderate knee arthrosis reporting knee pain characteristic of arthrosis for at least 3 months;diagnosis of knee arthrosis confirmed by imaging meeting ACR (American College of Rheumatology) criteria .Exclusion Criteria for Patients with Osteoarthritis of Knee. These includeinflammatory rheumatic conditions;palpable effusion in the knee;knee injury within 6 months prior to the study;intra-articular steroid within 1 month prior to the study;intra-articular hyaluronic acid within 6 months prior to the study;patients with femoral neuralgia or radiculopathy;NSAID  therapy or chondroprotective therapy modified within 1 month prior to the treatment;knee surgery within 6 months;pregnancy.Intervention. All patients were administered a standardized physiotherapy package during the study : underwater whirlpool massage (10 minutes), TENS therapy on the low back or knee (15 minutes every day), and aquagym (30 minutes every other day)).In addition to the standard complex physical therapy 50% of the patients received BEMER therapy, whereas 50% received placebo BEMER therapy. parameters evaluated: pain intensity on a visual analogue scale (VAS) of 10 cm; General Quality of Life Questionnaire SF 36 , 12; Facit Fatigue Scale (fatigue intensity ranged from 1 to 50) ; Oswestry Index for patients with low back pain , 15; WOMAC Index for patients with knee pain , 17.We used the data from only those patients who received at least 12 sessions of treatment (each patient completed 15 sessions).Each BEMER session lasted 20 minutes; parameters were using mattress applicator (B. Body Pro): 7–35 microTesla, intensive applicator (B. PAD): 60–100 microTesla, or mattress applicator (B. Body Pro) intensity levels 2-3-4–10, intensive applicator (B. PAD) intensity levels 6-7-8-9-10 and using vascular motion signal configuration . The device was a BEMER International AG (Liechtenstein) product. Accessories were mattress with therapy unit (B. Body), flexible, intensive, small surface unit (B. PAD) and B. SPOT (intensive point-like unit), and B. LIGHT unit as needed (may be connected to light therapy unit). The B. BOX Professional control units have 10 different levels of intensity and 3 predefined programmes. The intensity levels are applied during the general full body surface treatment according to the basic programme, while programmes P1–P3 are used gradually to achieve the “deep effect” during targeted treatments. Patients in both groups were treated in supine position while receiving B. BODY mattress applicator treatment. Low back pain patients received B. PAD therapy placed in the low back region at the same time as the full body treatment. Knee pain patients had the B. PAD applicator placed on their knees at the same time as the full body treatment. Therapy sessions lasted 20 minutes each with the B. BODY and B. PAD applicator, respectively:Study Procedure. It is as follows.Before starting the therapy, the physician takes a detailed history, performs a physical examination, checks whether the patient meets the inclusion and exclusion criteria, informs the patient about the study, obtains a signed Informed Consent Form, and administers the questionnaires .At the end of the therapy sessions, the physician examines the patient, administers the abovementioned questionnaires, and asks about the adverse effects.Follow-up period after 15 weeks .The analyses focused on pairwise comparisons among the two selected study arms based on the intention-to-treat (ITT) principle. The One-Sample Kolmogorov-Smirnov Test was applied for testing normality. Analysis of covariance (ANCOVA) was used with the analgesic as a covariate to measure effectiveness by comparing study arms. The significance level was set at alpha = 0.05 (two-tailed). All analyses were carried out using the R-software version 2.9.1 .Of the 25 patients with low back pain, 4 patients (2 cases with acute fever and 2 older patients have misunderstood how to fill out the questionnaires) and 6 patients (2 cases with acute fever and 4 patients had poor compliance) were excluded from the placebo group and the treatment group, respectively, after the second measurement. Of the patients with knee arthrosis, 2 patients (because of gastroenteritis) and 6 patients  were excluded from the placebo group and the treatment group, respectively. No adverse effects were seen. In the group with low back pain, the comparison of the results from the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores and the exercise VAS scores were close to the level of significance, while no changes were found in the Oswestry scores and Quality of Life see . Based oAs regards knee complaints, the comparison of the results of the first and second measurements showed no significant improvement in either parameter  see . Based oPreliminary data suggest that BEMER therapy may have a pain-relieving and fatigue-reducing effect in the treatment of chronic low back pain, even in the short term (studies conducted on large patient populations are required to confirm this). However, for long-term improvement, the therapy should be applied for a long period of time . There was no short-term beneficial effect during knee therapy, probably due to the fact that Program P2 should be used instead of Program P3 , although it was effective in the long term. In this study, we used BEMER therapy not as monotherapy but as adjuvant physiotherapy for inpatients. Many studies with pulse electromagnetic field (PEMF) in patients with locomotor diseases have been published. In patients with osteoarthritis of knee, PEMF was administered as adjuvant therapy in a total of 483 patients in 9 studies, which showed an improvement in the total clinical score . Based oThis is a pilot study. Unfortunately, many of the patients failed to return or misunderstood how to fill out the questionnaires during the three-month period for returning them, which led to a decrease in the number of cases. Furthermore, the Fatigue Scale includes many questions that are uncharacteristic of inpatients and can be evaluated only in outpatients: if, for example, a patient fails to answer Questions 2, 3, and 4, the entire questionnaire will be unevaluable (the software will ignore it). Some patients failed to completely fill out the SF 36 and the Fatigue Scale because they did not perform a specific physical activity during hospitalization. In the case of SF 36, patients failed to answer 1 or 2 questions in a number of item groups. They either did not understand the questions or were not allowed to perform a specific activity. Unfortunately, these cases also led to worse results because more significant improvements would have been possible in many cases in a larger study population.Our study suggests the possibility that BEMER therapy administered in combination with traditional physiotherapy procedures reduces chronic lower back pain in the short term and may be effective in the long-term treatment of patients with osteoarthritis of knee. However, well-performed studies with a larger sample size are required for a more exact evaluation of the abovementioned effects.


The aims of this study are to answer the following questions (1) How does the pain intensity of lumbar and cervical disc surgery patients change within a postoperative time frame of 5 years? (2) Which sociodemographic, medical, work-related, and psychological factors are associated with postoperative pain in lumbar and cervical disc surgery patients?The baseline survey  was conducted 3.6 days (SD 2.48) post-surgery in the form of face-to-face interviews. The follow-up interviews were conducted 3 months , 9 months , 15 months , and 5 years  post-surgery. Pain intensity was measured on a numeric rating-scale (NRS 0–100). Estimated changes to and influences on postoperative pain by random effects were accounted by regression models.Average pain decreased continuously over time in patients with lumbar herniated disc . In patients with cervical herniated disc a reduction of pain was observed, albeit not significant . Two predictors were associated with postoperative pain in lumbar and cervical disc surgery patients: the subjective prognosis of gainful employment (p<0.001) and depression (p<0.001).In the majority of disc surgery patients, a long-term reduction of pain was observed. Cervical surgery patients seemed to benefit less from surgery than the lumbar surgery patients. A negative subjective prognosis of gainful employment and stronger depressive symptoms were associated with postoperative pain. The findings may promote multimodal rehabilitation concepts including psychological and work-related support. Degenerative disc disease is commonly accounted as causal in acute and chronic back/leg pain in the general population –3. AboutStudies showed that surgery helps the majority of patients to overcome pain symptoms –9, but bEven though relevant factors have been discussed, postoperative longitudinal studies are sparse. Hence, little is known about the influence of these factors over time and about postoperative pain fluctuations. The identification of relevant factors may enhance the application of additional support for patients at risk of developing chronic pain syndromes. Chronic pain has been shown to reduce quality of life and results in considerable consumptions of medical resources .first objective is to examine the course of pain intensity in lumbar and cervical disc surgery patients over five years of time. The second objective is to identify relevant socio-demographic, medical, occupational and psychological predictors for postsurgical pain intensity in lumbar and cervical disc surgery patients over time.Moreover, most studies on postoperative disc problems focus on patients with lumbar disc herniation and do not include patients with cervical disc herniation. In a systematic review on treatment effectiveness for cervical disc herniation Gebremariam et al.  suggest This longitudinal cohort study was conducted according to the STROBE statement . The surBetween April 2007 and October 2008, 620 consecutive nucleotomy patients were asked to attend the study. Eighty-six patients declined participation, leading to a number of 534 patients (response rate 86%) included at baseline. Patients were recruited from three different hospitals in Leipzig and Halle  and had to fulfil the following inclusion criteria:Age between 18 and 55 years,Cervical or lumbar disc herniation as determined by radiological investigation ),Patients were suitable for rehabilitative care according to the decision of the physician in charge. This decision is based on guidelines of the German health care system on rehabilitation treatment, including the following criteria: First, patients are in need of postsurgical aftercare due to persisting symptoms such as muscular imbalance, persisting pain and/or sensomotoric deficits. Second, patients are physically and mentally able to participate in rehabilitative care. Third, the patients’ functional state is likely to be improved by rehabilitation .Patients were able to speak German sufficiently.Altogether, n = 422 patients underwent surgery for lumbar disc herniation and n = 112 patients were treated for cervical disc herniation. The majority of patients treated for lumbar disc herniation received standard lumbar microdiscectomy (94%). The remaining 6% were treated with discectomy without use of a microsurgical technique, minimally invasive techniques or other lumbar spine operations. About half of the lumbar disc surgery patients received additional radicular decompression. Most patients with a cervical disc herniation were treated with anterior cervical discectomy (74%). Of these, approximately two thirds received fusion through intervertebral cages. A small amount of patients received posterior cervical discectomy (12%) and in some cervical discectomy patients the surgical access was not specified. Furthermore, most patients were operated on one level (n = 482). The most frequently operated levels were L4/L5 or L5/S1 (n = 376) for the lumbar group and H5/H6 or H6/H7 (n = 87) for the cervical group.Data on the surgical procedure and number of levels treated could not be collected from all patients, because medical records were either not available or were lacking information. As a consequence, in 42 cases the surgical approach remains unclear. Concerning the number of levels treated, specific data are missing for 21 patients.The study has received ethics committee approval of the University of Leipzig (Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig). At the initial contact, participants were verbally informed about the purpose of the study. In addition they received a written study information form. All participants gave written consent to their study participation.The data collection consisted of an extensive and wide-ranging set of instruments at each measuring point. All questions asked at follow-up were equivalent for telephone interviews and written surveys.The primary outcome was the subjective pain intensity. It was assessed at each assessment point using a verbal single-item scale ranging from 0 to 100 (NRS 0–100). The Numeric Rating Scale is a commonly used pain scale and has been studied extensively ,34. The The following variables were assessed at baseline: age, gender, marital status and highest level of schooling completed.All patients were questioned at baseline about the disc herniation's localization. In addition, the patients were asked at all measuring points whether they had experienced any previous disc herniations and if they had any other chronic diseases. The length of hospital stay was retrieved from the patients' medical records. At T1 patients were asked if they received rehabilitation treatment.Patients were asked at all times of assessment whether or not they had been employed within the last three months. They were also questioned about their subjective prognosis of gainful employment with the SPE scale . This scAnxiety and depression were assessed at baseline and all follow-up surveys using the German version of the Hospital Anxiety and Depression Scale (HADS-D) . Higher p-value below 0.05 was considered statistically significant.Descriptive data are presented as mean±SD or percentages. Baseline differences between the lumbar and the cervical group were calculated via Pearson’s chi-square tests for nominal data and Wilcoxon-Mann-Whitney-tests for ordinal and metric data. Changes in and influences on postoperative pain have been evaluated using multilevel mixed-effects regression models in order to estimate the shape of trajectories of patients over time, while accounting for systematic and random variability . The anaDescriptive statistics showed that pain intensity decreased over time in both groups. The average reduction was larger in the lumbar group with a mean decline from 30.9 (SD 23.9) at T0 to 26.7 (SD 27.0) at T4 compared to a decline from 34.8 (SD 22.6) to 33.4 (SD 29.8) in the cervical group. Concerning the severity of pain, in the lumbar group 10% of the patients reported severe pain at baseline, compared to 14% at T1 and T2, 12% at T3 and 11% at T4. In the cervical group, the amount of patients reporting severe pain was 11% at T0, 15% at T1 and T2, 22% at T3 and 21% at T4.In the group of patients treated for lumbar disc herniation, the SPE presented the most influential predictor for pain over time: a one-unit increase in SPE increased the reported postoperative pain intensity by 32% . A seconThe same predictors were identified in the group of patients treated for cervical disc herniation: Higher scores on the SPE  and stronger depression  were associated with more intense pain . In addiIn the group of patients treated for lumbar herniated disc pain intensity decreased constantly within 5 years of surgery. The first significant reduction of the average pain intensity assessed at baseline was observed nine months after baseline showing further improvements until the final follow-up. Therefore, in clinical practice, it may be advisable to inform patients that after surgery has been performed it may take up to 9 months until they feel further reductions of pain. The amount of patients with lumbar disc herniation who still suffered severe pain varied between 10 and 14% over time. This goes well in line with other long-term studies with lumbar disc surgery patients using the same cut-off value for severe pain. These showed that the amount of patients who still had severe leg pain  or back The group of patients with cervical disc herniation experienced a slight reduction of pain after surgery, albeit not significant. The amount of patients reporting severe pain grew from 11% at baseline to 21% five years later. According to the current literature there is moderate to good evidence for the effectiveness of cervical surgery . HoweverTaken together, in both groups the overall estimated marginal pain intensity was mild suggesting that most patients benefitted from surgery. Nevertheless, the question arises why postsurgical pain was significantly reduced over time in patients with lumbar disc herniation but not in patients with cervical disc herniation. A possible answer to this question may lie in the fact that cervical discs provide the mobility of more fragile body areas such as head and neck, while lumbar discs mainly serve as a buffer for mechanical forces resulting from motion. Following this idea, the impairment of head movements may lead to stronger pain per se, but it may also be associated with increased fear of movement which may interfere with recovery. In addition, cervical disc herniation is less frequent than lumbar disc herniation and affected patients have a higher risk of developing spinal cord injuries. This in turn may lead to stronger insecurity and health concerns which may be expressed through higher pain ratings. Future research should deepen the understanding of pain-related outcome differences between lumbar and cervical disc surgery patients.Relevant associations with postsurgical pain were identified in both groups. The SPE and depression emerged as influential predictors on postoperative pain in both lumbar and cervical disc surgery patients.Patients with a worse SPE reported significantly stronger pain. This finding is supported by publications from Johansson et al.  and JungA relation between depression and pain in disc surgery patients was reported in numerous studies –27,48,49In addition to these factors, in the group of patients with cervical disc herniation, the number of previous disc herniations, the number of days in hospital and the rehabilitation setting influenced the patients’ pain ratings. A longer hospital stay may be the result of surgical complications or unsatisfactory recovery leading to more intense pain. Recurrent herniations may be an indication for a more complicated course of the disease and may indicate a stronger degree of degeneration. This in turn is associated with worse physical health  and may For the benefit of a larger sample size the baseline assessment was carried out after surgery as the presurgical time frame was too short to reach all consecutive patients. Hence, time of assessment may explain why significant changes in the short-term period did not become obvious. A second limitation is that the patients’ pain ratings are subjective in nature and accurate measures must rely on self-reports. On the other hand, the NRS is a frequently used scale for pain intensity and shows good evidence of reliability and validity . MoreoveThe objectives of this study were (1) to examine the course of pain intensity in lumbar and cervical disc surgery patients over 5 years of time and (2) to identify independent sociodemographic, medical, occupational and psychological predictors for pain.In the majority of disc surgery patients, a long-term reduction in pain was observed. However, the cervical surgery patients seemed to profit less from surgery than the lumbar surgery patients. In the long-term a considerable number of patients still reported high levels of pain. The most important risk factors for postsurgical pain were a negative SPE and depression. The results promote a multimodal treatment setting including psychological and vocational support for patients at risk of pain chronification. Finally, the present findings may be taken into consideration when it comes to developing screening instruments to identify patients at risk as well as to provide a better patient selection for surgical approaches.S1 Checklist(DOC)Click here for additional data file.


Nonetheless, the evaluation of LEP-related GBO might contribute to uncover residual pain perception even in those totally non-communicative patients, even though it is still debated whether or not GBO can be reliably assessed at single-subject level.Future studies should be fostered in an attempt to shed some light on the role of combined LEP-GBO analysis in pain perception assessment in DOC patients.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.