Although pain is frequently experienced by patients with cancer, it remains under-treated. The primary aim of this study was to estimate the prevalence of cancer-related neuropathic pain (CRNP) in patients with chronic pain who attended an outpatient clinic for standard care in Europe (irrespective of the reason or stage of the cancer). The secondary aims of this study were to characterise pain and cancer in patients with CRNP (including treatment) and to evaluate the usefulness of the painDETECT (PD-Q) screening tool to help physicians identify a potential neuropathic component of cancer-related pain.An observational, non-interventional, cross-sectional, multi-centre study of adult patients with cancer using patient and physician case report forms (CRFs). Patients with CRNP were identified by physicians’ clinical assessments after examining the completed PD-Q.A total of 951 patients visiting outpatient clinics across Europe were enrolled in this study between August 2010 and July 2011. Of these, 310 patients  were identified as having CRNP. Twenty-nine of 39 (74.4%) physicians who completed the CRF relating to the PD-Q considered it a useful tool to help detect CRNP in daily practice and 28 of 39 (71.8%) indicated that they would use this tool in the future for most or some of their patients. Data from physicians before and after review of the completed PD-Qs showed a shift in clinical opinion (either to positive CRNP diagnosis [yes] or negative CRNP diagnosis [no]) in respect of 142 patients; about half of which (74) were categorised with an initial diagnosis of unknown. Opinions also shifted from a no to a yes diagnosis in 10 patients and from a yes to a no diagnosis in 51 patients.Approximately one-third of adults with cancer experiencing chronic pain attending outpatient clinics as part of routine care were considered to have CRNP in the opinion of the physicians after considering scores on the PD-Q. While physicians did not consider the PD-Q to be a useful tool for all patients, shifts in diagnosis before and after the use of this tool indicate that it may help physicians identify CRNP, especially where there is initial uncertainty. There were an estimated 3.2 million new cases of cancer and 1.7 million cancer-related deaths in Europe in 2008 [Although pain is frequently experienced by patients with cancer, it can remain under-treated ,4 as a rIdentifying the type and source of pain in patients with cancer is complex. Sources of cancer pain vary from direct tumour invasion of bone, nerves, ligaments, etc.; metastasis of the disease; or side effects of treatment  . ApproxiCancer-related pain can either be nociceptive  or neuropathic. Neuropathic pain is defined by the International Association for Study of Pain as “pain caused by a lesion or disease of the somatosensory nervous system” . PatientIn the current study, in addition to physician assessment of neuropathic cancer pain, we used the painDETECT questionnaire (PD-Q), a validated screening tool that demonstrated high sensitivity and specificity for the detection of neuropathic pain . ,14. The The primary objective of this non-interventional study was to estimate the prevalence of CRNP in patients with cancer that experienced chronic pain and attended outpatient oncology clinics and palliative care services in Europe. The secondary objectives of this study were to calculate the prevalence point estimate of chronic cancer pain. The usefulness of the PD-Q screening tool  also wasThis was an observational, non-interventional, cross-sectional, multi-centre study of adult patients with cancer experiencing chronic pain. The study was conducted between 23 August 2010 and 22 July 2011 in outpatient oncology clinics in Denmark, Germany, Greece, Spain and the UK. One of the clinics in Spain was a palliative care clinic. Data from 63 physicians from 49 sites were collected in one consultation only (no follow-up) when patients visited the doctor as part of standard practice. Data regarding diagnosis and disease management were collected retrospectively. Where appropriate, the protocols were reviewed and approved by institutional review boards/independent ethics committees at participating sites. Denmark had general permission to conduct non-interventional studies from the Danish Data Protection Agency (Datatilsynet) and did not need approval by the Danish Medicines Agency/Ethics Committee.Participants were adults aged ≥18 years who had chronic cancer-related pain (defined as pain most days of the week for ≥3 months), attended the oncology unit for an outpatient consultation (irrespective of the reason or the stage of the cancer) and were willing to provide informed consent. Patients with chronic pain that was believed by the physician to be unrelated to cancer were excluded from the study.To obtain a representative sample of the oncology outpatient population seeking treatment for chronic pain in Europe, patients who attended oncology clinics from several centers in selected European counties were recruited. There was a flexible recruitment period to allow each physician to consecutively enrol up to 20 patients with chronic pain. In order to minimize any potential recruitment bias, identification and recruitment of patients eligible for the survey was consecutive. Each and every patient attending the outpatient clinic was considered for participation in the survey at the time that the patient consulted the doctor. In general, prevalence is calculated by dividing the number of individuals with a certain condition at a particular time point by the total number of individuals seen. It is therefore important to ensure that the inclusion of suitable patients by the doctor following recruitment of the first patient is consecutive, in order to estimate a valid prevalence of chronic pain in patients attending oncology clinics as well as the prevalence of CRNP in this population. The time of recruitment was recorded for all patients included in the survey and the prevalence was then calculated. The protocol was amended in May 2011 to allow the continued recruitment of patients by an additional physician at the same site  if a particular physician was no longer able to participate in the study.Eligible participants were identified and screened for chronic pain (defined in the Participants section above) by study physicians during consecutive appointments to minimise potential recruitment bias (i.e. every patient visiting the oncologist during the recruitment period was considered for participation in the study). A screening log was used to register all patients visiting the physician on an outpatient-basis during the consecutive screening and enrolment period. As some patients attending the clinics may have been receiving pharmacological treatment to manage their pain, the screening log also was intended to enable physicians to identify which patients would have been experiencing chronic pain had their pain not been effectively managed with pharmacological treatment.A summary of the study procedure is shown in Figure Physicians and patients with CRNP completed case report forms (CRFs) to record the characteristics of cancer and pain in the CRNP population. Questions on the CRFs related to the history and therapeutic management of cancer  and neuropathic pain . Patients with CRNP also completed a series of self-reported questionnaires and rating scales to assess the impact of their symptoms and pain.After all patients completed the study, physicians were asked to complete a physician-specific CRF relating to the usefulness and future use of the PD-Q and prevalence data.The PD-Q is a validated screening tool  developePatients responded to three preliminary questions that did not contribute to the PD-Q end score to document the intensity of their pain using a 0–10 rating scale.The description of pain  was recorded along with the presence (score = 2) or absence (score = 0) of radiating pain.The nature of pain was assessed in a series of seven questions . Responses were recorded on a 0–5 rating scale .PD-Q scores relating to the description and presence of radiating pain (maximum score of 3) and the nature of pain (maximum score of 35) were summated into a maximum PD-Q end score of 38. Higher end scores indicated a greater likelihood of neuropathic pain .The severity and interference of pain was assessed via the self-reported numeric rating scales  of the m-BPI-sf .Health-related quality of life was assessed in relation to: mobility, self-care, usual activities, pain/discomfort, anxiety or depression on a three-point response scale of the EQ-5D Health Questionnaire  combinedThe level of functional impairment in relation to work or school, social life and home life and family responsibilities was recorded on the SDS  using seThe primary endpoint was the proportion of patients experiencing chronic pain that were considered to have CRNP in the clinical opinion of the physicians following an examination of the completed PD-Q.The point estimate of the proportion of participants experiencing chronic pain was calculated from the total number of participants screened. However, owing to design flaws in the screening log, the information relating to patients whose chronic pain was controlled with pain medications was not reliably transferred to the physician-specific case report form (CRF). Consequently, the chronic pain calculations excluded patients who did not meet the chronic pain criteria owing to the use of pain medications.Other secondary endpoints included a description of the nature, characteristics and management of cancer and pain in patients with CRNP and the percentage of cancer specialists who found the screening tool a useful instrument to identify chronic neuropathic pain in daily practice.The projected sample size was changed from approximately 3900 patients to at least 800 patients in May 2011 owing to difficulty finding sites and physicians who were willing to take part. However, a sample size of at least 800 patients was still estimated to reliably identify the primary endpoint  based on the previously estimated prevalence of 39.7% . The preData used to estimate the prevalence of CRNP for all participants enrolled had an estimated precision of 0.03 . Continuous endpoints were summarised using descriptive statistics and discrete endpoints were summarised using frequency and percentage calculations for each response category .A total of 951 patients were enrolled in the study and 937 (98.5%) patients completed all or part of the study  was 32.6% . The number of patients considered to experience CRNP by the physicians before examining PD-Q scores was 335 . The sex and ages of patients with CRNP were proportionally similar to the all participants population , 583 met the criteria for chronic pain and were enrolled in the study and 172 patients met the criteria and declined participation  patients were considered to have pure neuropathic cancer-related pain and 146 (47.1%) patients were considered to have mixed cancer-related pain with a neuropathic component. Data were missing for 64 (20.6%) patients.While chronic pain was experienced by all participants for >3 months, the duration of neuropathic pain in the CRNP population varied from <3 months to >3 years. Only 28 (9.0%) patients with CRNP reported having the pain for <3 months, with the greatest percentage  having had the pain for 3–6 months. Fifty-five (17.7%) patients with CRNP reported having had the pain for 7–12 months, 45 (14.5%) patients had the pain for 13 months–3 years and 10 (3.2%) patients had the pain for >3 years. Data were missing for 58 (18.7%) patients.In the opinion of the physicians, the neuropathic pain experienced by patients with CRNP was due to the tumour itself in 197 (63.6%) patients and due to cancer-treatment in 90 29.0%) patients. Chemotherapy and surgery were each believed to account for neuropathic pain in 41 (13.2%) patients, respectively. The most commonly prescribed therapeutic treatments (previous and current prescriptions) for neuropathic pain in patients with CRNP were non-opioid analgesics, a strong opioid and/or anticonvulsants  on average compared with the all participants group for each of the following three preliminary PD-Q questions to assess pain: 1) “How would you assess your pain now, at this moment?”; 2) “How strong was the strongest pain during the past 4 weeks?”; and 3) How strong was the pain during the past 4 weeks, on average?”  for pain interference and 4.63  for pain severity based on numerical rating scales of 0 (no pain) to 10 (pain as bad as you can imagine). Data were missing for 58 and 54 patients for pain interference and pain severity, respectively. Mean scores for individual items on the m-BPI-sf in the CRNP population were all between 4.08 and 6.58, with the exception of pain at its least in last 24 hours  and/or radiotherapy treatment (53.9%) at the time of the study : neoadjuvant (cancer treatment given before surgery) = 36 (11.6%) patients; adjuvant (cancer treatment given after surgery) = 67 (21.6%) patients; advanced/metastatic  = 29 (9.4%) patients; palliative  = 17 (5.5%) patients. Ninety-five (30.7%) patients were not given surgical cancer treatments, treatment category data were missing for 39 (12.6%) patients and the surgery CRF page was missing for 56 (18.1%) patients.The mean health state score on the EQ-5D  for patiThe mean total score on the SDS for patients with CRNP was 18.67  based on functional impairment scales of 0–30 (higher scores indicate greater impairment). Data were missing for 116 patients. Mean scores for the individual items on the SDS are shown in Table Of the patients with CRNP, 76 (24.5%) recorded no visits to the doctor in relation to the management of neuropathic pain over the past 4 weeks, 180 (58.1%) patients recorded one visit or more and data were missing for 54 (17.4%) patients (Table Twenty-nine (74.4%) of the surveyed physician population (n = 39) responded yes to the question: “Did you find the painDETECT Questionnaire useful?” Seven of the other 10 physicians responded no and there were missing data for the remaining three physicians. For the question “Did the painDETECT Questionnaire help you evaluate if you think the patient has CRNP?”, of the patients identified to have chronic pain (n=951), physicians responded yes for 334 (35.1%) individual patients and no for 579 (60.9%) patients. Data were missing for 38 (4.0%) patients.In response to the question “In future would you use the painDETECT Questionnaire?”, none of the physicians indicated that they would use it for all of their patients, 13 (33.3%) indicated that they would for most patients, 15 (38.5%) for some patients and four (10.3%) for a few patients. Five (12.8%) physicians indicated that they would not use it. Data were missing for two physicians.Of the three scoring categories on the PD-Q, the greatest number of patients diagnosed with CRNP scored >18 (likely), followed by scores of 13–18 (possible); the fewest number of patients diagnosed with CRNP scored <13 (unlikely). The opposite trend was apparent in patients without a diagnosis of CRNP Figure .The shifts in the numbers of patients to either a positive or a negative diagnosis of CRNP following physicians’ examination of the PD-Q (distributed by PD-Q end scores) are shown in Figure A total of 951 patients experiencing chronic pain who visited oncology clinics across Europe were enrolled in this study. Approximately 94% of these patients were ≥45 years of age and the ratio of male to female participants was approximately 1.2:1.0. Of the 951 patients with chronic pain, 310 were identified as having CRNP in the opinion of the participating physicians after evaluating the PD-Q. The primary endpoint of this study, the proportion of patients with CRNP in patients with cancer experiencing chronic pain, was therefore 32.6% . The percentage of patients with CRNP identified in this study was in line with the international study estimation of 39.7%  and withVariations in estimates of CRNP may reflect different populations or stages of cancer. In this study, the percentage of patients with CRNP was determined from a sample of adult oncology outpatients experiencing chronic pain. The outpatients with CRNP included in the study presented with varied characteristics and stages of cancer; some experienced loco-regional progression and/or metastasis of the tumour (as shown in the CRNP population), while others had early stage cancer or were cancer survivors. However, the study results are limited by missing data and cannot be generalised to the cancer patient populations as a whole.Based on available data from the 5882 screened patients, the prevalence point of chronic pain in patients with cancer was estimated at 12.8%. This calculation is lower than previous estimates of chronic pain in patients with cancer at various stages of the disease (including patients who received curative treatment as well as those with advanced stages of the disease) . Other rIn the CRNP population, mean m-BPI-sf scores were >4 for each of the individual items  with the exception of pain at its least in the last 24 hours (mean = 2.92), indicating that pain in patients with CRNP was either not being effectively managed or was difficult to treat. As noted earlier, there have been reports of general under-treatment of pain in patients with cancer ,6. In paAverage higher scores for each of the three PD-Q pain assessment questions in patients with CRNP compared with the all participants population may indicate that CRNP is more difficult to identify and/or treat effectively than chronic pain without a neuropathic component and that physicians may traditionally choose analgesics primarily effective on nociceptive pain as first-line pain treatment. Indeed, patients with CRNP self-reported mean scores on the EQ-5D and SDS indicated that their symptoms of pain had a negative impact on many aspects of daily functioning and quality of life. Moreover, 45.5% of patients with CRNP indicated that their symptoms had an effect on their employment status, thus highlighting the need for future randomised controlled trials to establish the most effective treatment for neuropathic pain relief within cancer outpatient settings.The World Health Organization (WHO) guidelines for cancer pain relief state that it is necessary to evaluate the type and level of pain experienced by patients with cancer in order to treat it effectively . In addiThe most commonly prescribed treatments for neuropathic pain in the CRNP population in this study were non-opioid analgesics, a strong opioid and/or anticonvulsants. It should be noted that these patients also may have been receiving more than one therapeutic treatment and/or demonstrated a mixed pain profile. Of the available data in the physician study assessments, mixed cancer-related pain with a neuropathic component was evident in 47.1% of patients with CRNP and in 32.3% of those with pure CRNP. Data were missing for 64 (20.6%) patients with CRNP. Neuropathic pain was considered to be directly due to the tumour in 63.6% of patients with CRNP and due to cancer treatment in 29.0%. However, the types and characteristics of cancer in patients with CRNP in this study were varied, as were their experiences of therapeutic management and surgical treatment of the disease. These data highlight that neuropathic pain is not specific to patients with a particular cancer and/or treatment profile and demonstrate the need to screen for neuropathic pain in all patients with cancer, regardless of the stage or type of disease.A further objective of this study was to assess the usefulness of the PD-Q as a screening tool to help physicians identify neuropathic pain in patients with cancer. The usefulness of PD-Q for detecting neuropathic cancer pain has been previously assessed in comparison to the Edmonton Classification System of Cancer Pain (ECS-CP). Based on their initial categorization of patients as having a neuropathic component if their PD-Q score ranged from 13 to 38 (similar to our study) and the comparison to the ECS-CP, the authors calculated the sensitivity and specificity of PD-Q for the detection of cancer-related neuropathic pain as 53% and 77%, respectively . In the The majority (74.4%) of the 39 physicians who completed the physician-specific CRF indicated that they found the PD-Q a useful tool to help detect CRNP in daily practice and over 70% indicated that they would use this tool to evaluate most, or some, of their patients in the future. The PD-Q was initially developed to identify neuropathic pain in patients with back pain as a model for mixed pain conditions , and, asAs with all non-interventional studies, there are particular advantages and limitations of the design of this study. This large-scale multi-centre study allowed the opportunity to collect epidemiological data from patients with cancer across Europe and add to the literature relating to CRNP. The limitations associated with this study include the difficulties in recruiting investigators who were willing to participate. This proved more challenging than anticipated and impacted the enrolment of participants, thereby leading to a decrease in the planned sample size. Incomplete or missing CRF forms also were a consequence of the non-interventional methodology that may have impacted on the overall chronic pain prevalence estimates, which should therefore be interpreted with caution.This observational, non-interventional, cross-sectional, multi-centre study showed that a proportion of adult patients with cancer who were attending outpatient clinics in Europe were experiencing uncontrolled pain and almost a third had neuropathic pain. The results of this study highlight the wide range of patients with cancer experiencing CRNP and emphasise the importance of detecting neuropathic pain in order to treat it effectively. Screening tools like the PD-Q may help physicians identify neuropathic pain in patients with cancer for the purposes of effective pain management, which may ultimately impact the functional ability and quality of life of patients with CRNP.CI: Confidence interval; CRF: Case report form; CRNP: Cancer-related neuropathic pain; EuroQOL: EQ-5D Health questionnaire; m-BPI-sF: Modified Brief Pain Inventory Short Form; PD-Q: PainDETECT questionnaire; QOL: Quality of life; SDS: Sheehan Disability Scale; WHO: World Health Organization.Financial competing interestsC. Garzón-Rodríguez has disclosed acting as a consultant/advisor for Pfizer. L. Olay Gayoso, J. Sepúlveda, E. Samantas and U. Pelzer have declared no conflict of interest. L. Lyras, C. van Litsenburg and M. Strand are all employees of Pfizer, own Pfizer Stock and have Pfizer stock options. S. Bowen, previously an employee of Pfizer, was a paid consultant to Pfizer and owns Pfizer stock and has Pfizer stock options. The authors were not compensated for their work on the manuscript.Non-financial competing interestsThe authors have no political, personal, ideological, academic, intellectual, or commercial competing interests in relation to this manuscript, other than the financial competing interests declared above.CGR, LOG, JMS, ES and UP participated in the conduct of the study and contributed to data collection at one or more study site. They each contributed to the interpretation of the data and were involved in drafting and reviewing the manuscript for intellectual content. LL, CvL and MS participated in the design and conduct of the study, interpretation of the data and were involved in drafting and reviewing the manuscript for intellectual content. SB conducted the statistical analysis, and participated in the interpretation of data, writing and reviewing the manuscript. All authors discussed the results, commented on the manuscript, reviewed and approved the final version of the manuscript for publication.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-684X/12/41/prepub


P < 0.001), from 7.9 (95% CI: 7.1 to 8.6) at pretreatment to 2.7 (95% CI: 1.5 to 4.0) at 3 months. Back function improved 46% (P < 0.001), from 74 (95% CI: 69% to 79%) at pretreatment to 40 (95% CI: 33% to 47%) at 3 months. The percentage of patients regularly consuming pain medication was 70% at pretreatment and only 21% at 3 months. No adverse events related to the device or procedure were reported. RF-TVA reduces back pain severity, improves back function, and reduces pain medication requirements with no observed complications in patients with osteoporotic VCF.Vertebral augmentation procedures are widely used to treat osteoporotic vertebral compression fractures (VCFs). We report our initial experience with radiofrequency-targeted vertebral augmentation (RF-TVA) in 20 patients aged 50 to 90 years with single-level, symptomatic osteoporotic VCF between T10 and L5, back pain severity > 4 on a 0 to 10 scale, Oswestry Disability Index ≥ 21%, 20% to 90% vertebral height loss compared to adjacent vertebral body, and fracture age < 6 months. After treatment, patients were followed through hospital discharge and returned for visits after 1 week, 1 month, and 3 months. Back pain severity improved 66% ( Osteoporosis is a devastating disease characterized by low bone density, microarchitectural deterioration of bone tissue, and increased susceptibility to fracture. Vertebral compression fracture (VCF) is a common manifestation of osteoporosis in the elderly with an incidence of 700,000 cases per year in the United States alone . VCFs caConservative treatment of painful VCFs, such as bed rest, braces, and/or narcotic analgesic medication, has only modest short-term effectiveness and is associated with poor long-term outcomes, including exacerbation of bone loss, increased risk of subsequent fracture, decreased mobility, and increased mortality –7. PercuRadiofrequency-targeted vertebral augmentation (RF-TVA) is a novel percutaneous vertebral augmentation technique that was developed to address some of the limitations of BK while maintaining the benefit of vertebroplasty and BK. The purpose of this study was to assess the initial safety and effectiveness of RF-TVA in osteoporotic patients with symptomatic VCF.NCT01839682).All study procedures were conducted in accordance with the ethical principles stated in the Declaration of Helsinki, and this research was approved by the Institutional Review Board at the investigative site. All patients signed an informed consent before participation in any study activities. This study was registered at ClinicalTrials.gov  ≥ 21%, vertebral height loss between 20% and 90% compared to adjacent vertebral body, and fracture age < 6 months. Main exclusion criteria included primary tumor or metastasis, neurologic deficit associated with the index level, pedicle fracture, significant kyphosis (>30°) or translation (>4 mm), and active infection.Patients underwent a physical examination, complete medical history, and radiographic imaging studies including thoracolumbar lateral and anteroposterior radiographs to confirm the presence and characteristics of the VCF. Symptomatic levels were confirmed with radionuclide bone scan and computed tomography or magnetic resonance imaging. Patient-reported back pain severity was quantified using an 11-point 0 to 10) numeric scale. Back-specific functional disability was self-reported with the ODI (version 2) on a 0 to 100% scale [ numeric 2 Bone Cement) using the StabiliT Vertebral Augmentation System   . After pCA, USA) . The MidCA, USA) . The PMMCA, USA) . In caseCA, USA) .Back pain severity was assessed at discharge and at 1 week, 1 month, and 3 months posttreatment. ODI was measured at 1 week, 1 month, and 3 months posttreatment. Use of pain medications was reported according to the World Health Organization three-step analgesic pain ladder, a semiquantitative scale used to describe use of pain management drugs . CurrentData were analyzed using Predictive Analytics Software . All continuous data were verified to be normally distributed using the Shapiro-Wilk test. Continuous data were reported as mean ± 95% confidence interval (CI) using exact methods, and categorical data were reported as frequencies and percentages. Longitudinal changes in back pain severity and ODI values were assessed with repeated measures analysis of variance. Clinical success was defined as an improvement of ≥30% compared to pretreatment values for back pain severity and ODI, respectively , 13. Pain = 14), coronary artery diseases (n = 8), and diabetes mellitus (n = 5) (Twenty-three patients were enrolled in this study. Mean patient age was 79 (95% CI: 74 to 83) years. The most common type of VCF was a wedge fracture. Mean vertebral body collapse was 27% (95% CI: 21% to 33%). Patients had severe back pain  and dysfunction  at pretreatment. Most patients also presented with associated diseases, most commonly hypertension ( (n = 5) .Three patients were unable to receive treatment due to difficulty with placing a cannula in patients with a high body mass index. Ultimately, 20 patients underwent treatment with the RF-TVA system between June 2009 and February 2011. The procedures were performed with deep sedation and local anesthetic in 19 of 20 cases. Mean procedure time was 19 (95% CI: 14 to 23) minutes with average cement volume delivery of 4.0 (95% CI: 3.3 to 4.7) cc. No procedural complications or cement extravasation was identified. Hospital stay following the RF-TVA procedure was minimal, with same day discharge in 70% of patients and next day discharge in 30% of patients.P < 0.001) overall improvement (P < 0.001) overall improvement (Back pain severity rapidly improved from 7.9 (95%: 7.1 to 8.6) at pretreatment to 4.4 (95% CI: 3.1 to 5.6) at hospital discharge. Over 3-month follow-up, back pain continued to improve with mean scores of 2.7 (95% CI: 1.5 to 4.0) at 3 months, representing a 66% . One patient died from causes unrelated to the procedure before the 3-month follow-up visit.The RF-TVA system is a novel, safe technique for percutaneous vertebral augmentation in osteoporotic patients with symptomatic VCFs. Our early experience with this device demonstrates significant improvements in back pain severity and back function and reduced pain medication use with no observed complications.ex vivo biomechanical study of the RF-TVA system [The results of this study are consistent with outcomes observed in an A system . This stA system –17. The In vertebral augmentation procedures, PMMA cement may leak laterally to the soft tissues, superiorly or inferiorly into the adjacent disc space, or posteriorly, where it may involve the exiting nerve root or the spinal canal . The RF-Minimizing physician exposure to radiation during minimally invasive procedures for treatment of VCFs remains a concern. Although the use of methods such as shielding and intermittent fluoroscopy has dramatically reduced physician users exposure to radiation during traditional vertebral augmentation procedures , 25, whoStrengths of this study included the prospective design, use of validated measures of patient-reported outcomes, and strict inclusion/exclusion criteria. Limitations of this study include lack of a control group, inclusion of only single-level fracture cases, and a relatively short follow-up period.The results from our initial clinical experience showed that RF-TVA dramatically reduces back pain severity, improves back function, and reduces pain medication requirements with no observed complications in patients with osteoporotic VCF. Remotely controlled cement delivery may reduce physician radiation exposure during vertebral augmentation procedures. Overall, the initial clinical results of this prospective trial are promising and warrant further study in larger series with longer follow-up periods.


Variability in patients' postoperative pain experience and response to treatment challenges effective pain management. Variability in pain reflects individual differences in inhibitory pain modulation and psychological sensitivity, which in turn may be clinically relevant for the disposition to acquire pain. The aim of this study was to investigate the effects of conditioned pain modulation and situational pain catastrophizing on postoperative pain and pain persistency.Preoperatively, 42 healthy males undergoing funnel chest surgery completed the Spielberger's State-Trait Anxiety Inventory and Beck's Depression Inventory before undergoing a sequential conditioned pain modulation paradigm. Subsequently, the Pain Catastrophizing Scale was introduced and patients were instructed to reference the conditioning pain while answering. Ratings of movement-evoked pain and consumption of morphine equivalents were obtained during postoperative days 2–5. Pain was reevaluated at six months postoperatively.Z = 1.0, P = 0.3) or level of catastrophizing . In the acute postoperative phase, situational pain catastrophizing predicted movement-evoked pain, independently of anxiety and depression  whereas conditioned pain modulation predicted morphine consumption .Patients reporting persistent pain at six months follow-up (n = 15) were not significantly different from pain-free patients (n = 16) concerning preoperative conditioned pain modulation response (Preoperative conditioned pain modulation and situational pain catastrophizing were not associated with the development of persistent postoperative pain following funnel chest repair. Secondary outcome analyses indicated that conditioned pain modulation predicted morphine consumption and situational pain catastrophizing predicted movement-evoked pain intensity in the acute postoperative phase. These findings may have important implications for developing strategies to treat or prevent acute postoperative pain in selected patients. Pain may be predicted and the malfunctioning pain inhibition mechanism as tested with CPM may be treated with suitable drugs augmenting descending inhibition. Pain is an expected part of surgical recovery but effective pain management remains challenging dispositional catastrophizing , which probably measures different pain experiences than situational catastrophizing  Endogenous pain modulation has been experimentally investigated in humans via conditioned pain modulation (CPM) paradigms, during which central inhibition of a painful stimulus is induced by applying a second painful conditioning stimulus to a remote body region  To the best of our knowledge, no studies have yet combined preoperative assessment of CPM with measurements of cognitive and emotional processes in the prediction of postoperative pain. Such a study would add to our understanding of the causes underlying individual differences in pain and potentially enable identification of patients at high risk of developing persistent postoperative pain. In turn this may have important implications for developing multimodal pharmacological or psychological intervention strategies to treat or prevent postoperative pain in the future. We hypothesized that patients with a preoperative deficient endogenous pain inhibition capacity, expressed by less efficient CPM and/or high levels of situational pain-related catastrophic thinking, were more susceptible to postoperative pain and pain persistency.The current study was a prospective observational cohort study designed to investigate whether preoperative assessment of endogenous pain inhibition capacity can predict the course of postoperative pain in a consecutive cohort of patients undergoing surgical correction of funnel chest (pectus excavatum). Funnel chest is the most common congenital deformity of the anterior chest wall and the male/female ratio is approximately 6/1 for patients undergoing surgical correction of funnel chest at our institution. The deformity is primarily treated to achieve anatomical correction and thus avoid cosmetic and psychological inconveniences for the patient. Patients undergoing surgical funnel chest repair are generally healthy pain-free opioid naïve adolescents. However, they are at high risk of experiencing moderate to severe acute postoperative pain.A schematic illustration of the study protocol is depicted in The Regional Committee on Biomedical Research Ethics (M-20110064) and the Danish Data Protection Agency (J. no.: 2011–41–6061) approved the study. The study was registered in the clinicaltrials.gov database  and was conducted in accordance with the Declaration of Helsinki. Patients admitted to surgery received written information explaining the purpose of the study along with the appointment for surgery. Upon arrival at the department, the principal investigator (K.G.) restated the study purpose verbally to eligible patients. All participating patients provided written informed consent. Of note, the 15–17-year-old patients received special information adapted to their age and abilities, both in language and in content. To further aid decision-making, parents, next of kin, caretakers, or guardians who had parental rights and responsibilities of underage patients, received separate information in writing and also participated in the conversation about the study purpose and possible participation of the young. The Ethics Committee granted special dispensation for the underage patients to provide written informed consent autonomously.Patients were recruited consecutively from the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark, during a pre-determined one-year period (May 2011 to May 2012). Patients were prospectively enrolled according to the following inclusion criteria: (1) elective minimally invasive surgical correction of funnel chest (pectus excavatum); and (2) age ≥15 years. Exclusion criteria were: (1) previous thoracic surgical interventions; (2) presence of diseases affecting the central and/or peripheral nervous system; (3) presence of chronic pain conditions; (4) inability to speak and/or understand Danish; (5) inability to understand and participate in the experimental pain session; (6) presence of psychiatric disorders; (7) history of frostbite in the non-dominant upper limb; (8) presence of sores or cuts on non-dominant upper limb; (9) presence of cardiovascular disease; (10) history of fainting and/or seizures; (11) presence of fractures of the non-dominant upper limb; or (12) presence of Reynaud's phenomenon. Secondary exclusions included: (1) insensitivity to experimental cold pressor pain; (2) lack of epidural catheter placement; or (3) re-operation.et al. was used to explain the reporting of pain intensity and unpleasantness using an 11-point numerical rating scale (NRS), where 0 =  no pain/unpleasantness and 10 =  worst pain/unpleasantness imaginable TM Brush-05, Somedic AB, Hörby, Sweden) and mechanical dynamic hyperalgesia using a single von Frey monofilament  as previously described by Stubhaug et al.All preoperative assessments were conducted by the principle investigator (K.G.), the day before scheduled surgery in a quiet room with a constant temperature of approximately 20–22°Celsius. Initially, patients were informed briefly about the purpose of the study, excluding any information about examination of CPM and the focus on pain catastrophizing, and asked to read and sign a consent form. Patients were then asked to fill in the Spielberger's State-Trait Anxiety Inventory (STAI) and Beck's Depression Inventory (BDI). Subsequently, a standardized written statement based on instructions published by Price Mechanical Pressure Pain Threshold – the Test Stimulus. Pressure algometry was performed at the patients' quadriceps muscle (rectus femoris) 10 cm above the patella on the same side as the dominant hand. A handheld digital pressure algometer with a probe size of 1 cm2 was used . The pressure was gradually increased with a rate of 30 kPa per second. Patients were instructed to press a button when the feeling of pressure changed into a sensation of pain. This in turn froze the assessment parameter, i.e., the pressure measured in kPa at the pressure pain threshold on the algometer's display and the value was instantaneously stored it in the internal memory of the apparatus. The algometer was calibrated between patients using a manufacturer-supplied weight equal to 100 kPa.Cold Pressor Test – the Conditioning Stimulus. Patients were asked to place their non-dominant hand in a stirred ice water bath (1±1°Celsius) in a still position with their fingers spread for as long as possible. A cut-off time of 120 seconds was set for safety reasons. The CPM effect was evaluated by comparing the baseline pressure pain threshold with the pressure pain threshold following the cold pressor test. In order to control for individual variation in baseline measures, the proportion of difference in pressure pain thresholds from baseline was used rather than the raw difference, and expressed in percentages. This approach results in negative CPM scores for pain facilitation and positive CPM scores for pain inhibition. In other words a positive CPM score was considered indicative of effective endogenous pain modulation The tendency to engage in pain catastrophizing was assessed by means of the Danish version of the Pain Catastrophizing Scale (PCS) Pain catastrophizing shares variance with negative affect constructs such as depression and anxiety. It is thus important to statistically control for depressive symptoms and level of anxiety when investigating relations between pain catastrophizing and pain-related outcomes  Anxiety was measured with the Danish version of the state part of the Spielberger's State-Trait Anxiety Inventory (STAI) for adults Depression was assessed with the Danish version of Beck's Depression Inventory (second edition) (BDI) consisting of 21 items assessing psychological and physiological aspects of depression over the preceding two weeks The primary outcome measure was the presence of persistent postoperative pain at six months, and the potentially predictive role of CPM on such pain. Persistent pain was assessed according to responses to the Brief Pain Inventory – Short Form (BPI) Postoperative movement-evoked pain was self-reported by patients in a study-specific pain diary based on NRSs. It is recommended to use NRSs in adult clinical trials −1 day−1Data on postoperative opioid use following epidural analgesia , independent of route or mode of administration was extracted from the electronic medical records or pain diaries if the patient was discharged before postoperative day 5. Missing data on morphine consumption on postoperative days 4 and 5 were acceptably imputed using the fixed daily morphine dose prescribed at discharge. Doses of opioid other than morphine were converted to morphine equivalents using standard equianalgesic dose conversion ratios  and calculated as mg kget al. It has been suggested that using pain scores and analgesic requirements as isolated variables may prevent identification of the total benefit provided by the analgesic regimen. Hence, an integrated analgesic assessment score was calculated as described by Silverman −1) and cisatracurium (0.1–0.15 mg kg−1).All patients followed a standardized anesthesia regimen. Prior to the induction of general anesthesia, an epidural catheter placed at the thoracic levels 4–6. With the patient sitting in an upright position, using local anesthesia and a paramedian approach, the catheter was placed using a hanging drop technique. The epidural block was activated and tested with an injection of 0.5% bupivacaine with simultaneous intravenous infusion of a 6% hydroxyethyl starch. General anesthesia was initiated with intravenous injection of fentanyl (0.05–0.1 mg), propofol . The standardized analgesic regimen combined epidural analgesia, and non-opioid and opioid analgesics as described below. This regimen has previously been linked to enhanced recovery in fast-track surgery Epidural Analgesia−1 for the first 24 hours and with 0.25% bupivacaine for the next 24 hours. Maximum epidural infusion rate was set at 10 ml h−1. Epidural analgesia was discontinued and the epidural catheter was removed at 9:00 on postoperative day 2 in all patients.The preoperative epidural blockade was reactivated during surgery or upon arrival in the Post Anesthesia Care Unit at the discretion of the attending anesthetist and subsequently provided continuously for an additional 48 hours. Epidural analgesia was provided with continuous infusion of 0.25% bupivacaine + morphine, 50 µg mlNon-opioid Analgesia−1) and ibuprofen (1200 mg day−1) from the day of surgery.Non-opioid analgesic treatment was initiated in all patients with acetaminophen .Rescue AnalgesiaIntermittent epidural bolus injections were given if the patient was uncomfortable due to pain . If the patient required additional boluses within the hour, the continuous basal infusion was either increased or the epidural catheter was retracted to optimize the spread of injected solutions and avoid fluctuations in the level of analgesia. Additionally, bolus intravenous injections of 2 mg of morphine followed by an upward titration in 1–2 mg increments were available as rescue analgesia throughout hospitalization.The size of the study population was based on a conservative estimate for a predetermined 1-year study period. We wanted to avoid overlooking an actual difference in CPM effect between pain-free patients and patients developing persistent postoperative pain at six months. Power calculation was based on results from previous studies showing that 14% of patients undergoing similar chest wall surgery developed persistent postoperative pain at six months P values less than 0.05 were considered statistically significant unless stated otherwise. Categorical variables are presented as numbers (percentages); continuous variables with a normal distribution are described with mean ± standard deviation; whereas non-normally distributed data is described with median [interquartile range], unless stated otherwise. Non-normally distributed data was attempted log-transformed to normality.Stata/IC 12.1 for Mac (64-bit Intel)  was used for all statistical analyses. Two-tailed t test was used to test the null hypothesis that conditioning cold pressor pain had no effect on the response to pressure algometry. Spearman's rank correlation coefficients (ρ) were calculated as measures of dependence between preoperative, perioperative, and postoperative study variables including predictors, potential confounders and outcomes. Considering the small sample sizes and obviously skewed data, the Wilcoxon-Mann-Whitney rank sum test was used for primary analyses to compare the distributions of CPM responses, S-PCS, BDI, and STAI scores in pain-free patients and patients reporting persistent postoperative pain at six months.A paired S-PCS]). Hence, for each of the three mentioned multiple regressions (i-iii), log[S-PCS] was entered in Model 1; CPM response in Model 2; and log[S-PCS], STAI score, and BDI score in Model 3.For analyses of secondary outcomes, we performed three separate ordinary least squares (OLS) linear regressions of (i) movement-evoked pain; (ii) morphine consumption; and (iii) the integrated analgesic assessment score on each of the continuous covariates: conditioned pain modulation (CPM) and situational pain catastrophizing (S-PCS). State anxiety and depression were solely chosen to control the effect of pain catastrophizing on postoperative pain-related outcome measures. Following initial residual analyses it was found appropriate to log-transform the S-PCS score , and leverage versus squared residuals. If the leverage versus squared residuals plot revealed an observation with high leverage and large residuals, we performed regressions with and without this outlier to assess its potential impact. Additionally, we conducted robust regressions in which influential observations were automatically dropped, , and those with large absolute residuals were down-weighted. Model validation did not suggest severe assumption violation and the conclusions were broadly similar regardless of using model-based or robust standard errors.In order to interpret and visualize the regression models, we calculated adjusted means (predictive margins) with 95% confidence intervals (95% CI) of the patient's postoperative movement-evoked pain intensity given different log-transformed values of preoperative situational pain catastrophizing and of postoperative morphine consumption given different values of preoperative CPM.We included 51 patients  in the experimental protocol . Preopert = −4.0, P = 0.0003) (P = 0.04) and the integrated analgesic assessment score . We found no evidence of associations between measures of postoperative pain intensity and analgesic consumption. In other words, patients reporting postoperative pain of high intensity do not necessarily consume more morphine, and vice versa.There was a 17% increase in the mean pressure pain thresholds before and after cold pressor test  . Change Thirty-one patients (74%) responded to our questionnaire assessment at six months after surgery . Of thesZ = 0.99, P = 0.3).The median CPM response in patients reporting pain at six months after surgery was 1.2% ; in pain-free patients it was 9.0% . Accordingly, there was no significant difference between the two groups .The distributions of S-PCS scores were not significantly different for patients reporting pain at six months after surgery and pain-free patients, with median S-PCS scores of 11  and 15 , respectively  would yield predicted means at 4.8  and 6.0 , respectively. Similarly, a CPM response of e.g. 25% would yield a predicted mean postoperative morphine consumption of 1.0  mg kg−1 day−1 using the simple regression model in which patients' morphine consumption was uniquely predicted from their preoperative CPM response  consumed more morphine than patients with efficient CPM (positive CPM scores), and vice versa.Contrary to some previous studies et al. showing that pain catastrophizing in response to experimental heat pain accounted significantly for the variance in cesarean section pain Our findings extend previous observations To date, very few studies have assessed the CPM effect as predictor of analgesic efficacy and results diverge Preoperative CPM and situational pain catastrophizing were not predictive of the proposed integrated analgesic assessment score. One possible explanation for this may be attributed to our co-administration of several analgesics. Despite the use of a standardized analgesic regimen, we cannot rule out that the administration of several analgesics may have resulted in differential synergistic effects across patients. Another explanation for this observation may be based on evidence that a combined endpoint may cause problems if the predictor effect is in opposite directions for different outcomes included in the composite endpoint Some of the limitations of the present study have implications for the generalizability of findings. Although we used a highly standardized surgical procedure and protocols for anesthesia and analgesia in a homogenous study population, inevitable differences in anesthesia, analgesia and surgically induced tissue injury and inflammation may have affected postoperative pain perception differently across patients. However, we found no evidence of significant associations between measures related to the anesthesia, analgesia, and complexity of surgery and study outcomes. Furthermore, patients in this study were primarily pain-free male adolescents who were not suffering from chronic pain before undergoing surgery. The applicability of the present findings to patients suffering from pain-related conditions thus remains uncertain. We acknowledge that our results are based on a small sample and that results need to be confirmed and replicated in larger studies. However, the homogeneous patient sample free from the usual bias related to pain, social and economical parameters, the uniform surgical procedure and the fact that all patients were operated on by the same surgeon and investigated by the same investigator strengthen our findings.In conclusion, preoperative CPM scores and levels of pain catastrophizing in response to experimental pain were not predictive of persistent postoperative pain development. Analyses of secondary pain-related outcomes, however, indicated that reduced pain-inhibition may contribute to enhanced clinical postoperative pain and morphine consumption. If replicated and confirmed in larger samples, this may potentially enable clinicians to tailor individualized analgesic drug administration and thus hypothetically improve postoperative pain management in future patients.


With quantitative sensory testing (QST) we recently found no differences in sensory function of the foot soles between groups of torture victims with or without exposure to falanga (beatings under the feet). Compared to matched controls the torture victims had hyperalgesia to deep mechano-nociceptive stimuli and hypoesthesia to non-noxious cutaneous stimuli. The purpose of the present paper was to extend the group analysis into individual sensory profiles of victims’ feet to explore possible relations between external violence (torture), reported pain, sensory symptoms and QST data to help clarify the underlying mechanisms..We employed interviews and assessments of the pain and sensory symptoms and QST by investigators blinded to whether the patients, 32 male torture victims from the Middle East, had (n=15), or had not (n=17) been exposed to falanga. Pain intensity, area and stimulus dependence were used to characterize the pain. QST included thresholds for touch, cold, warmth, cold-pain, heat-pain, deep pressure pain and wind-up to cutaneous noxious stimuli. An ethnically matched control group was available.The normality criterion, from our control group data, was set as the mean +/− 1.28SD, thus including 80% of all values.QST data were transformed into three categories in relation to our normality range; hypoesthesia, normoesthesia or hyperesthesia/hyperalgesiaMost patients, irrespective of having been exposed to falanga or not, reported severe pain when walking. This was often associated with hyperalgesia to deep mechanical pressure. Hypoesthesia to mechanical stimuli co-occurred with numbness, burning and with deep mechanical hyperalgesia more often than not, but otherwise, a hypoesthesia to cutaneous sensory modalities did not co-occur systematically to falanga, pain or sensory symptoms.In torture victims, there seem to be overriding mechanisms, manifested by hyperalgesia to pressure pain, which is usually considered a sign of centralization. In addition there was cutaneous hypoesthesia, but since there was no obvious correlation to the localization of trauma, these findings may indicate centrally evoked disturbances in sensory transmission, that is, central inhibition. We interpret these findings as a sign of changes in central sensory processing as the unifying pathological mechanism of chronic pain in these persons. Many victims of torture, even after extended time periods, experience pain in the feet when walking. The use of falanga (beatings on the soles of the feet) is a torture method which deliberately aims at inflicting intense pain in the feet and lower legs,2. It isIn previous studies we have confirmed and extended the clinical evidence of chronic foot pain and disability in falanga victims with chronic pain in the feet,6. ChronWhen examining torture victims with quantitative sensory testing (QST), we recently and remarkably found no obvious differences in sensory function of the foot soles between groups of torture victims with or without exposure to falanga. This waThe primary objective of the present paper was to extend the group analysis of the QST data from our previous study into indThe patients recruited were torture victims who had been granted asylum in Denmark. They were all referred to our centre from their general practitioner, because of their long-term sequelae from various types of torture that they had been subjected to several years earlier in their homeland. The patients were screened by an assessment team , supported by an interpreter, with reference to the centre’s admission criteria: 1) torture victim with asylum in Denmark; 2) physical, psychological and social needs; 3) no overt psychosis; 4) no drug or alcohol abuse; and 5) available treatment capacity.The inclusion criteria for this study were tortured male patients originating from the Middle East and speaking Arabic or Farsi . Seventy-nine consecutively referred patients were identified via the electronic patient records , diabetes (n=3), not mentally fit (n=2), opioid medication (n=2), spinal fracture (n=1), arteriosclerosis in the legs (n=1), hydrocephalus (n=1), not been tortured but referred for having been secondarily traumatized (n=3), other problems and were referred for treatment elsewhere (n=7). Clinical symptoms and signs, including the typical temporal and anatomical progression of sensory symptoms of peripheral neuropathy were always sought for during the clinical history–taking and examination.The remaining 52 patients were invited to participate in the study. At individual meetings the examiner (KP) informed them about the purpose and methods used in the study; seventeen persons turned down the offer at this stage. If the patient agreed to participate an informed consent form was signed and dates for the assessments arranged. Three persons started but dropped out during the test sessions. Thus 32 patients participated in all three sessions. All were offered compensation for travel expenses. Arabic or Farsi interpreters assisted at all sessions. The project was carefully introduced to the three interpreters involved, all of whom had long experience in interpreting for torture victims.It was possible to recruit 14 ethnically and age matched men from the Middle East community in Copenhagen to form a control group, going through exactly the same QST methods as for the patients. They had a mean age of 37 years (range 21–55), had no chronic pain conditions, and were integrated and active in the Danish society. They had lived in Denmark for an average of 15.8 years (range 7–26) and all spoke Danish.The examiner (KP) and a research assistant were blinded with regard to patient history, diagnosis and whether falanga torture had occurred or not. Breaking of the blinding took place only after the completion of all examinations and data analyses of the individual patients.All examinations were scheduled to 3x2 hour sessions within a two-week period and took place in a quiet room (stable temperature of 22–24°C) in the research department at our centre. For details of the procedures and measurement techniques, we refer the reader to our previous paper.To our knowledge only few studies have examined the arch of the foot sole with respect to normal QST values, and the available data are mostly found from the dorsum of the foot,14. AccoThe patients were asked about pain in the foot soles at rest and when walking and the findings were registered on a 3-point Likert scale  to deteThe patients shaded in the locations of their pain on a special foot chart . The shSelf-reported current pain intensity was assessed on a visual analogue scale , with rst and 4th stimulus. A 5-minute pause followed. Thereafter, to produce a more intense stimulation, 10 consecutive stimuli were applied at the rate of 1.0 Hz. The patient rated their pain after the 1st and 10th stimulus. If the VAS difference between the 1st and last stimulus was positive, a temporal summation (wind-up) had occurred.For a detailed description of the techniques used to measure the different modalities, see our previous study. BrieflyDynamic mechanical allodynia is a painful or unpleasant sensation evoked by a cutaneous mechanical stimulus which does not normally evoke pain. To examine this phenomenon we used light strokes with a soft brush . Three consecutive strokes over a 60 mm long distance in the arch of both foot soles were applied with the brush, and theSome of the QST stimuli that may evoke a transient unpleasant sensation or pain were applied as a pre-test in another area far from the feet  to familiarize the patients with the procedures. It was emphasized that the QST test was not an endurance test and should not evoke pain; the patients should press the stop button or indicate to the examiner at the absolute first instance of pain detection. In this way the patient was in control at all times.We chose to analyse the data from the right and left feet separately, since they may share common analysis mechanisms in the central nervous system, even if separate. The mean, SD, 95%CI, median, and range were calculated for all eight QST variables. The data were analyzed using the Statistical Package for Social Sciences (SPSS) version 18, Software for Windows .Each participant was informed verbally about the study and was also given an information kit containing a comprehensive written description translated into their respective languages. They also received translated guidelines concerning participation in medical research issued by the Danish Ethical Committee. The assessments comply with the Helsinki II Declaration and the All 32 patients reported pain in many parts of the body. When asked about their one most painful region, neck, shoulder and low-back pain were the most common complaints, and only two patients who had been exposed to falanga reported their pain as being most severe in the feet. Data of reported pain and sensory symptoms for all individuals are presented separately in TablesSince the results from measuring sensory modalities with QST have varying denominations, we have chosen to transform the data into three categories in relation to our matched controls: hypoesthesia, normoesthesia and hyperesthesia/hyperalgesia Tables and4. TSince torture victims often present with walking difficulties, we chose to sort our patients according to how intense the reported pain in their feet was when walking  the occurrence of deep hyperalgesia, 2) pain when walking and 3) type of foot pain, more clearly illustrates that this change of sensory transmission was as common after generalized torture as after falanga Tables. FurtherFrom the present analysis it appears that little discriminates pain mechanisms in torture victims who have been exposed to trauma from torture on different parts of the body. Rather, it seems as if there are important overriding mechanisms, manifested by the hyperalgesia to pressure pain in the QST analysis, which is usually considered a sign of centralization and is aRegarding torture victims, our findings are on one hand similar to those of Olsen et al., who fouRegarding the use of QST in medico-legal matters, such practice is not applicable, since the size of the effects of non-organic factors on the QST method is currently unresolved. On the The high side-to-side correlations of all QST parameters predict that short-term test-retest reliability within the same day should be high. However, formal determination of test-retest reliability over different time ranges of 1 day, 1 month or 1 year are not available.The patients were refugees with residence permits in Denmark and had been referred by their general practitioner to our specialized clinic, making our sample highly selected, and thus it may not be representative of all torture victims.With our traumatized patients, it was unfortunately not possible to collect exact information on the extent of torture. Attempts to retrieve such information may produce intense anxiety and flash backs. Moreover, all patients had been subjected to various forms of torture, increasing the risk of brain injuries, which m, motor deficits, typical for severe polyneuropathies, were never found among the included patients. Furthermore, the combination often seen in our patients, cutaneous hypoesthesia, normal nociceptive transmission and deep mechanical hyperalgesia, is not typical for peripheral neuropathies but has been reported without signs of nerve injury in, for example, chronic regional pain syndrome . However it is difficult to completely exclude the possibility of nerve injury here.Since many of these patients have been imprisoned for long time periods, it is important to distinguish the present findings from those elicited by peripheral neuropathy, whether from toxic, nutritional or infectious causes. However, the victims were carefully examined for such comorbidities during the medical assessment (see Methods) and secondlyFor patients with neuropathic pain, some of the QST procedures may be briefly painful, for example the Wind-up test. In our study design, we have considered this problem, and as is obvious from our methods, the patients were always in control. In fact, we only had to discontinue one of the sensory examination sessions due to pain.In conclusion, by comparing QST data from the foot soles of 32 torture victims in chronic pain to ethnically matched healthy persons, we found hyperalgesia to deep mechanical pressure in combination with cutaneous hypoesthesia to non-nociceptive modalities to be a common sensory disturbance. We interpret these findings as a sign of changes in central sensory processing which may be the unifying pathological mechanism of chronic pain in these persons.The authors declare that they have no competing interests.KP has been active in all aspects of the study: conception, design, acquisition of data (main responsibility), analysis and interpretation of data, writing of the manuscript and final approval. ALP contributed to the conception, design, analysis, and interpretation of data (main responsibility), writing of manuscript and final approval. BHS had main responsibility for the conception and design of the study, contributed to the interpretation of data and participated in writing of manuscript and final approval.KP, PT, MSc, has long experience of treating victims of torture since more than twenty years at our centre. This research is intended to become part of her PhD - thesis. ALP, PT, PhD, is a Senior Researcher in pain and rehabilitation research at our centre and has extensive experience of multidisciplinary pain rehabilitation. BHS, MD, DMSc, Professor of Rehabilitation at the University of Southern Denmark, is a pain management physician and was till recently Director General of our centre.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-698X/12/40/prepub


Objective: Post-traumatic stiff hand is common a condition which causes pain and disability, the paraffin wax bath and joint mobilizations have the key role in its rehabilitation. We conducted the present study to determine the efficacy of paraffin wax bath with mobilization techniques compared with joint mobilization alone.Methodology: This single blind randomized control trial was conducted on 71 patients in department of physical therapy and rehabilitation, Riphah International University Islamabad, and patients with post-traumatic stiff hand after distal upper extremity fractures, were included. The patients were randomized into two groups: the joint mobilization techniques with paraffin wax bath were included in group A, and joint mobilization techniques without paraffin wax bath in group B. The study variables were pain score on visual analogue scale (VAS) 0/10, thumb function score (TFS) and passive range of motion (PROM) of wrist flexion, extension, radial and ulnar deviation, and were compared at baseline and at completion on plan-of-care after six weeks.Results: Seventy one patients with post-traumatic stiff hand were enrolled and placed randomly into two groups. The baseline characteristics were similar in both groups. Six week after intervention, patients in group A had more improvement in pain score (p=0.001), TFS (p=0.003), and PROM of wrist flexion (p=0.002), extension (p=0.003), radial deviation (p=0.013), and ulnar deviation (p=.004), as compared to group B. However, in group B the improvement was less in pain score (p=0.104), TFS (p=0.520), and PROM of wrist flexion (p=0.193), extension (p=0.1081), radial deviation (p=0.051), and ulnar deviation (p=.168), as compared to group A.Conclusion: Paraffin wax bath with joint mobilization techniques are more effective than mobilization techniques without paraffin wax bath in the rehabilitation of post traumatic stiff hand.  The physical therapy plan of care is based on physical examination, includes evaluation of PROM, muscle strength, edema, gross sensation, bone healing, and adhesions. The common goals of physical therapy management of post-traumatic stiff hand are to manage pain, increase PROM, and muscle strength.2The post-traumatic stiff hand commonly occurs in post traumatic upper extremity (UE) fractures, and is clinically complex problem. It generally results in common symptoms of edema, immobility and pain. The post-traumatic stiff hand generally leads to disuse of hand function, due to restricted range of motion and loss of muscle strength. The physical therapists rehabilitate the patients with post-traumatic stiff hand by joint mobilization techniques, stretching and strengthening exercises.3The improvement in joint PROM is the key component of physical therapy management, due to musculotendinous tightness. The joint mobilization techniques are used to improve joint PROM, by producing passive glides with distraction between the articular surfaces of hand joints to manage pain, break adhesions, and improve joint PROM. The grade I and II are used to manage pain and grade-III for improvement in joint PROM.4 Both hands and feet are most common segments to be treated with paraffin wax bath in physical therapy. Paraffin Wax bath treatment followed by active hand exercise resulted in significant improvements of range of motion.5The paraffin wax bath is commonly used as effective remedy to improve circulation and promotes relaxation.This study is a randomized clinical trial on 71 patients, with the mean age of 39.5 years with minimum age 21 years and maximum 52 years conducted, in department of physical therapy and rehabilitation, Riphah International University Islamabad. This interventional study was conducted from November, 2010 to September, 2012. The inclusion criteria were age range from 20-60 years, pain, loss of PROM, with history of trauma and distal upper extremity fractures. The patient with age less than two years and more than 60 years with any non-traumatic cause of fractures were considered as exclusion criteria. The study variables were measured and documented at the baseline including, age, gender, dominant hand, hand involved, prior level of activity, pain intensity score, Thumb function score, and PROM of wrist flexion, extension, radial and ulnar deviation . The PROThirty six patients were placed randomly in group A, and treated with joint mobilization techniques and paraffin wax bath, and 35 patients were included in group B and were treated with joint mobilization techniques alone. All the patients of both the groups were treated 4 days per week for 6 weeks. The paraffin wax bath was applied for 20 minutes prior to every physical therapy session and followed by joint mobilization techniques including glides of the articular surfaces in sitting position at 8-12 glides at every joint of the hand and wrist. The joint mobilization grade-I and grade-II were used for pain management and relaxation, while grade-III for improvement in the PROM of hand and wrist. The study variables were also calculated at the completion of six weeks physical therapy treatment program.Statistical analysis was done by SPSS version-20 and the paired t-test was applied at 95% level of significance to calculate the p values for pain intensity score on VAS 0/10, TFS and PROM of wrist flexion, extension, radial and ulnar deviation .Seventy one patients with post-traumatic stiff hand were enrolled and placed randomly into two groups. The baseline characteristics were similar in both groups. Six week after intervention, patients in group A had more improvement in pain score (p=0.001), TFS (p=0.003), and PROM of wrist flexion (p=0.002), extension (p=0.003), radial deviation (p=0.013), and ulnar deviation (p=.004), as compared to group B. However, in group B the improvement was less in pain score (p=0.104), TFS (p=0.520), and PROM of wrist flexion (p=0.193), extension (p=0.1081), radial deviation (p=0.051), and ulnar deviation (p=.168), as compared to group A. In our study, the base line measurements of study variables were matched with measurements after six weeks of physical therapy intervention, including joint mobilization with paraffin wax bath in group A and in group B alone. The patients in group A showed significant improvement in pain score, TFS, and PROM of wrist flexion, extension, radial and ulnar deviation, as compare to group B.6Dellhag and colleagues conducted a clinical trial on 52 patients of rheumatoid arthritis and all were randomly placed into four groups, including exercise and wax bath, exercise only, wax bath only, and controls. All the patients were treated three times a week for four weeks. The group of patients treated with paraffin wax bath and followed by active exercises showed significant improvement as compared to the other groups treated with other techniques.7Ayling and Marks carried out a systematic review on efficacy of paraffin wax bath for rheumatoid arthritic hand and critically examined whether paraffin wax is efficacious for this condition in light of this information. They found 4 randomized control trials, and 3 out of 4 reported that after 3-4 weeks of management, paraffin wax applications were accompanied by significant improvements in rheumatoid arthritic hand function when followed by exercise.8Sandqvist and team conducted a clinical trial to determine the effect of paraffin wax bath combined with exercise, on one hand of 17 patients with scleroderma, while the other hand was treated with exercise only. They concluded that paraffin wax bath combined with exercise improved mobility, decrease stiffness, and increase elasticity.9Valdes and Marik worked on a systematic review on the physical therapy management of osteoarthrtic hand, and they searched and evaluated evidence on multiple hand physical therapy interventions, including splinting, joint protection technique instruction, paraffin wax bath, exercises, and provision of a home exercise program. They concluded that literature supports the effectiveness of paraffin wax bath, joint protection instructions, and orthotic support for improvement in hand grip strength and function.10Glasgow and team conducted a systematic review on mobilizing the stiff hand: combining theory and evidence to improve clinical outcomes. The purpose was to evaluate the available evidence on stiff hand. They concluded that mobilization exercise and splinting can prevent contractures in stiff hand.11Sultana and colleagues carried out a systematic review on the role of mobilization after tendon transplant to evaluate the evidence on the role of mobilization after tendon transplant for the improvement of PROM pain at the wrist. They concluded on the basis of available studies of joint mobilization techniques, which are effective for pain management and improve function.We conclude that paraffin wax bath combined with joint mobilization techniques are more effective in the physical therapy rehabilitation of post-traumatic stiff hand as compared to joint mobilization techniques alone.


Patient-rated outcome measures (PROMs) are an important part of clinical decision-making in rehabilitation of patients with shoulder pain. The Disabilities of Arm, Shoulder and Hand (DASH) questionnaire was designed to measure physical disability and symptoms in patients with musculoskeletal disorders of the upper extremity and is one the most commonly used outcome measures for patients with shoulder pain. The purpose of this study was to investigate the reliability and validity of the Norwegian version of the DASH in patients with shoulder impingement syndrome.Sixty-three patients diagnosed with shoulder impingement syndrome at an orthopaedic outpatient clinic were included in the study. Internal consistency of the DASH was evaluated by the Cronbach’s alpha and item-to-total correlations. Test-retest reliability was analyzed by the intraclass correlation coefficient (ICC) and limits of agreement (LoA) according to the Bland Altman method. Standard error of measurement (SEM) and minimally detectable change (MDC) were calculated for the total DASH score. Construct validity was evaluated by testing six a priori hypotheses for the Pearson’s correlation coefficient between the DASH and the Shoulder Pain and Disability Index (SPADI), the 36-item Short Form Health Survey (SF-36) and a Numeric Pain Rating Scale (NPRS).Reliability: Cronbach’s alpha of the DASH was 0.93 and item-to-total correlations ranged from 0.36 to 0.81. ICC was 0.89. The 95 percent LoA was calculated to be between -11.9 and 14.1. SEM was 4.7 and MDC 13.1. Construct validity: Eighty-three percent of the a priori hypotheses of correlation were confirmed. The DASH showed a high positive correlation of 0.75 with the SPADI, a negative moderate correlation of -0.48 to -0.62 with physical functioning, bodily pain and physical component summary of the SF-36 and a moderate positive correlation of 0.58 with the NPRS. DASH correlated higher with the physical component summary than with the mental component summary of the SF-36.The Norwegian version of the DASH is a reliable and valid outcome measure for patients with shoulder impingement syndrome. Patient-rated outcome measures (PROMs) are an important part of clinical decision making in rehabilitation of patients with shoulder pain. A number of PROMs are available,2, of whShoulder impingement syndrome is the most common clinical diagnosis for patients with shoulder pain,9 and caMeasurement properties of an outcome measure are related to the population and context in which it is used. Before a translated outcome measure can be used with confidence in clinical or research settings, the measurement properties of the translated version need to be determined. The meaThe patients were recruited from an outpatient clinic from December 2007 to October 2010. We included adult patients with the primary diagnosis of shoulder impingement syndrome (M75.4 in the ICD-10). The patients were diagnosed by an orthopaedic surgeon and screened for inclusion in the study by a physiotherapist. The impingement diagnosis was based on reported symptoms and clinical findings such as anterior-lateral shoulder pain worsening during elevation of the arm and overhead activities, normal or close to normal passive range of motion of the shoulder and positive impingement sign.Patients were excluded from the study if they had generalized pain, symptoms of cervical spine disease, had undergone surgery in the affected shoulder within the last six months or were unable to understand written and spoken Norwegian. In addition, patients were excluded if they had been diagnosed with any rheumatologic illness, chronic systemic disease or cardiac disease.The DASH was developed by the Institute for Work and Health and the American Academy of Orthopaedic Surgeons (AAOS)-5. It waThe SPADI was designed to measure pain and disability in patients with shoulder disorders. A NorweThe 36 item Short Form Health Survey is a generic PROM developed to assess eight health domains: physicaThe patients were asked to rate their pain on average over the last week prior to assessment using an 11-point Numeric Pain Rating Scale from 0 (no pain) - 10 (worst possible pain). The NPREach patient was scheduled for two visits approximately one week apart. At the first visit the patients filled out the DASH, SPADI, SF-36 and Numeric Pain Rating Scale. Descriptive data such as age, sex, symptom duration and employment status were also collected. At the second visit the patients filled out the DASH and SPADI and they were asked if the shoulder condition had changed since the first visit. The patients did not receive any treatment between the first and the second visit. The study protocol was approved by the Regional committees for medical and health research ethics (REC South East), and was carried out in accordance with the Helsinki Declaration. We obtained written informed consent from all the participants at inclusion.QualityMetric Health Outcomes Scoring Software 3.0  was used to manage missing SF-36 data and to calculate the SF-36 scores. PAWS Statistics 18.0 for Windows  and the Stata/IC 11.2 for Mac  were used for the other analysis. Floor and ceiling effects were evaluated using histograms, and were considered to be present if more than 15% of the respondents achieved the lowest or highest possible score, respectively. P-value95) and MDC (MDC95) was calculated by multiplying by the z-score of 1.96. LoA was calculated according to the Bland-Altman method 12.9) years, were included in the study. The mean duration of symptoms was 46.6 (SD 72.3) months, ranging from 2 to 420 months. Descriptive characteristics of the patients are shown in Table 95 was 8.3. The MDC was 6.7 and MDC95 was 13.1. The 95% LoA was calculated to be between -11.9 and 14.1, and 4 out of 59 (6.8%) were outside the LoA  observations exceeded the limits of agreement. The mean difference between DASH test and retest was 1.1 (95% CI -0.65 to 2.82) and showed no systematic change. There was no apparent tendency for the mean difference to vary systematically with the average score.95 was 8.3 and the MDC95 was 13.1. These results correspond well with the measurement error values reported for the original English version with a SEM of 4.6 points and a MDC95 of 12.8 points[95 is that if a patient has a measured DASH score of for example 50 points at an initial test, the clinician can be 95 percent confident that the patient’s true score lies somewhere between 42 and 58 DASH points. The MDC95 of 13.1 indicates that the clinician can be 95 percent confident that a change has occured if the measured DASH score at retest has changed more than 13.1 points.The SEM was 4.7 points, SEM8 points. The intA distinction between MDC and minimally important change (MIC) is useful when interpreting change scores in PROMs. The MDCOur results of construct validity agree with previous studies. The expWe had hypothesized a moderate and negative correlation with the Social Functioning domain of the SF-36, because the DASH is also meant to measure components of the social dimension: family care, occupational and socializing with friends and relatives. A moderate correlation with the Social Functioning of SF-36 has been reported in several other languages versions with correlation coefficients ranging from -0.53 to -0.64,36,47-49The DASH questionnaire measures whether the respondent has the capacity to do an activity, regardless of how it is performed. It is scored from 0 (best) to 100 (worst). A mean DASH score of 10 have been reported for the general population of the United States. A mean The DASH was designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper extremity. The results in this study are limited to patients with the primary diagnosis of shoulder impingement syndrome and can not be generalized to other disorders of the upper extremity. Another limitation of this study is that we did not evaluate responsiveness, which has been defined as the ability of a questionnaire to detect change over time in the construct to be measured. ResponsThis study demonstrated excellent test-retest reliability, good internal consistency and established error values for the Norwegian language version of the DASH. Furthermore, this study provided evidence supporting the DASH as a valid measure of physical disability and symptoms in patients with shoulder impingement syndrome.The authors declare that they have no competing interests.IS and BH obtained funding for the study. All authors participated in planning and design of the study. IS and BH collected and analyzed the data. BH drafted the manuscript. All authors contributed to interpretation of the study results and participated in revisions of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/15/78/prepub


Study Design/Objective. A single-centre, prospective, non-comparative study of 25 patients to evaluate the performance and safety of the Memory Metal Minimal Access Cage (MAC) in Lumbar Interbody Fusion. Summary of Background Data. Interbody fusion cages in general are designed to withstand high axial loads and in the meantime to allow ingrowth of new bone for bony fusion. In many cages the contact area with the endplate is rather large leaving a relatively small contact area for the bone graft with the adjacent host bone. MAC is constructed from the memory metal Nitinol and builds on the concept of sufficient axial support in combination with a large contact area of the graft facilitating bony ingrowth and ease in minimal access implantation due to its high deformability. Methods. Twenty five subjects with a primary diagnosis of disabling back and radicular leg pain from a single level degenerative lumbar disc underwent an interbody fusion using MAC and pedicle screws. Clinical performance was evaluated prospectively over 2 years using the Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36) and pain visual analogue scale (VAS) scores. The interbody fusion status was assessed using conventional radiographs and CT scan. Safety of the device was studied by registration of intra- and post-operative adverse effects. Results. Clinical performance improved significantly (P < .0018), CT scan confirmed solid fusion in all 25 patients at two year follow-up. In two patients migration of the cage occurred, which was resolved uneventfully by placing a larger size at the subsequent revision. Conclusions. We conclude that the Memory Metal Minimal Access Cage (MAC) resulted in 100% solid fusions in 2 years and proved to be safe, although two patients required revision surgery in order to achieve solid fusion. Chronic low back pain is an insidious problem. Individuals suffer from prolonged discomfort, anxiety, and disability. Low back pain has been shown as the leading cause of man-hours lost to disease or injury. Degeneration of the intervertebral disc is the most common cause of low back pain .Conservative treatment for low back pain may include rest, heat, physical therapy, medication, bracing, and education. Most individuals will find relief given conservative treatments. However, for those with significant continuing specific symptoms, surgical intervention may be appropriate. One of the interventions is posterior lumbar interbody fusion (PLIF). The goal of spinal fusion is to obtain a solid arthrodesis. There is a wide range of fusion rates (56–95%) reported after PLIF with varying techniques –14.The PLIF procedure was introduced independently by Jaslow  and ClowIn order to eventually achieve a solid interbody fusion a bone substitute has to be applied to the disc space. Without a mechanical support, these grafts tend to collapse, displace, or extrude –22. For The Memory Metal Minimal Access Cage (MAC) builds on the concept of sufficient axial support in combination with a large contact area of the graft facilitating bony ingrowth and ease in minimal access implantation due to its high deformability. The MAC cage is a horseshoe-shaped implant. It confers the ability for fast and solid fusion due to the large contact area. The MAC cage is constructed from the memory metal nitinol . This deThe purpose of this pilot study was to evaluate the performance and safety of this new interbody fusion device in a relatively small group of patients.Twenty-five consecutive patients  with a diagnosis of a symptomatic single level degenerative lumbar disc consented to participate in the study, following Research Ethics Committee approval. The average age of the patients was 41.3 (range 23.8–71.4) Inclusion criteria required all patients aged 18 years and over, with disabling back and/or refractory radicular pain who have had at least six weeks of conservative management, with moderate-to-severe degenerative changes in one or two lumbar disc levels based on MRI performed not more than three months prior to study entry. In addition, discography had been provocative for patients back pain. Exclusion criteria ruled out patients with more than two abnormal lumbar disc levels, evidence of infection in the disc or spine, spinal tumor(s), who are immunocompromised, pregnant, and/or have a condition which would compromised their participation and followup in this study. Conservative treatment mostly entailed a combination of appropriate analgesics, physical therapy, and epidural and/or facet injections.The Memory Metal Minimal Access Cage has a horseshoe shape and comprises a material strip of 1.08 mm thickness for the small sizes, and 1.25 mm for the medium and large sizes. All cages have diamond-shaped holes for bone through growth, spikes on the top and bottom edges for stability, and a wedged profile. The diamond-shaped hole design aspect of the MAC is in line with surgical titanium mesh for similar product appearance, and seats on the bony outer cortical rim of the vertebral body.The cages are made of nitinol, a shape memory alloy, which enables the surgeon to un-curve the strip completely, put it into an inserter, and insert it into the disc space while pushing it out of the inserter. The flat strip will henceforth curve into the original horseshoe shape . All surPatients were evaluated preoperatively at 1, 3, 6, 12, and 24 month after surgery. Evaluation at each interval included physical and neurological examination, concomitant medication, additional surgical procedures, subject completed questionnaires , and Visual Analogue Scale for Pain. Any adverse events and complications were recorded in the case report forms.Routine lateral and AP radiographs were obtained at each timer interval. Routine radiographs were used to evaluate the total intervertebral height and subsidence. The CT scan at two years followup was used to establish fusion. The total intervertebral height (TIH) of two fused vertebral bodies was measured as distance between the mid-point of upper end plate of cranial vertebral body and the mid-point of lower end plate of caudal vertebral body on digital radiographs with built-in software (PACS viewer). The degree of subsidence (ΔTIH) was reflected by the difference between the immediate postoperative and follow-up TIH . With thComplications were divided into device-related and non-device-related complications. Non-device-related complications were listed as major and minor.t tests.For statistical analysis, comparisons between pre- and postoperative scores were made using paired The primary radiological objective was fusion rate. Fusion success was achieved in 25 (100%) of 25 patients. There was a solid bony fusion on CT at 2 years postoperative. The disc space height was restored to normal as part of the operative procedure. Disc height in the cage levels was increased from an average of 7.6 mm before surgery to an average of 12.4 mm after surgery losing 0.0 mm during healing in 2 years of followup.All 25 patients completed the 24 months of follow-up without any major adverse event. The clinical parameters are summarized Figures P < .0001).The clinical outcome was the ODI score at 24 months posttreatment compared to baseline. The mean ODI score preoperative was 38.32 ± 10.64. This significantly improved to 8.4 ± 9.49 at 24 months postoperative (P < .0001) and mental (MCM) 60.54 ± 24.22 improved to 91.36 ± 12.76 (P < .0001). Pain assessment (both leg and back) by Visual Analogue Scale (VAS) was also performed. Both leg and back pain improved significantly (P < .0001). The Short-Form 36 health questionnaire (SF-36) data assessed both physical and mental components. Physical (PCM) 36.15 ± 18.93 improved to 84.25 ± 22.29 . The average level of leg pain was reduced by more than 50% after operation . This reduction further improved over the 24 months after operation (0.73 ± 1.31 at 24 month after operation). A similar reduction in back pain was also revealed. With both ODI and SF-36 results, improvement in condition continued throughout the 24 months after operation. Pain results indicated a rapid improvement after operation, which was maintained during the 24 months after operation.The Oswestry Disability Index mean score preoperatively was 38.32 ± 10.64. This significantly improved to 8.4 ± 9.49 at 24 months postoperative. Significant improvement in both physical and emotional components in the SF-36 questionnaires mean scores was also observed, with increases from baseline results of 36.15 ± 18.93 and 60.54 ± 24.22 to 84.25 ± 22.29 and 91.36 ± 12.76 at 24 months, respectively (A study of 60 patients with posterior lumbar interbody fusion combined with instrumented posterolateral fusion reported by Freeman et al. . CompariThe device-related adverse event recorded in this study was two undersized cages, resulting in migration.The migration problem lies within the operation technique.The dural penetrations all developed during decompression in patients who were previously operated on, not during cage insertion, and were repaired at surgery, not requiring reoperation, not causing neurologic injury, and not affecting the hospital course.The Memory Metal Minimal Access Cage performed very well radiographically and clinically. There was a 100 percent interbody fusion at 2 years on CT, no subsidence and significant improvement of clinically important outcomes, although two patients required revision surgery in order to achieve solid fusion.