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BackgroundProvision of information and advice from a physiotherapist is often assumed to be translated into action by a patient with low back pain (LBP). However, this assumption is questionable. The aim of this study is to explore physiotherapy students’ individual experiences with managing persistent low back pain.MethodsThis is a qualitative interview study using individual semi-structured interviews based on a phenomenological approach to explore physiotherapy students’ management of their own low back pain. Participants had to have non-specific low back pain for more than three months. Interviews were audio recorded, transcribed and analysed using thematic text analysis.ResultsTen participants with a median age of 25 years were included. The analysis revealed three themes important for the participants’ management of their own persistent LBP: impact on everyday life, knowledge about LBP and ability to self-manage.ConclusionsSelf-managing persistent low back pain can still be a challenge even when possessing professional knowledge about pain. This indicates that only providing patients with information and advice does not lead to the expected behaviours, but that healthcare professionals need to listen to their patients and tailor advice and strategies to meet physical, psychological and social challenges. BackgroundProvision of information and advice from a physiotherapist is often assumed to be translated into action by a patient with low back pain (LBP). However, this assumption is questionable. The aim of this study is to explore physiotherapy students’ individual experiences with managing persistent low back pain.MethodsThis is a qualitative interview study using individual semi-structured interviews based on a phenomenological approach to explore physiotherapy students’ management of their own low back pain. Participants had to have non-specific low back pain for more than three months. Interviews were audio recorded, transcribed and analysed using thematic text analysis.ResultsTen participants with a median age of 25 years were included. The analysis revealed three themes important for the participants’ management of their own persistent LBP: impact on everyday life, knowledge about LBP and ability to self-manage.ConclusionsSelf-managing persistent low back pain can still be a challenge even when possessing professional knowledge about pain. This indicates that only providing patients with information and advice does not lead to the expected behaviours, but that healthcare professionals need to listen to their patients and tailor advice and strategies to meet physical, psychological and social challenges.

BACKGROUND: Return-to-work processes involve many stakeholders who need to cooperate to best support the person on sick leave. Yet, there is little knowledge of how workers sick listed due to back pain experience navigating between stakeholders. OBJECTIVE: This study aimed to explore how Danish workers on sick leave due to back pain experience navigating between the involved stakeholders, focusing on settings related to social work, health care and workplace. METHODS: Sixteen individual semi-structured interviews were conducted and data analysed using a thematic analysis approach. RESULTS: Analysis resulted in three themes. 1) ‘Meeting the system” where establishing a positive relationship with the social worker was hampered by a negative perception of the job centre. This perception was initiated by the convening letter and accentuated by physical meetings being experienced as a waste of time. 2) In ‘Navigating between systems’ some participants lacked support from professionals to navigate the role as messenger between the job centre and health care system. 3) In ‘The workplace – a familiar arena’ workers experience the workplace as a familiar arena, even if negative decisions were made. Analysis additionally revealed that patients’ return-to-work processes could be divided into two types, namely complex and smooth. CONCLUSION: The initial contact from the job centre seems pivotal for the following return-to-work process. The main challenges experienced by sick listed workers were related to the job centre and to being a messenger between job centre and health care, not to their work place and the decisions made there.

Low back pain (LBP) is the leading cause of disability worldwide. Providing evidence-based practice (EBP) for patients with LBP is more cost-effective compared with non-EBP. To help health care professionals provide EBP, several clinical practice guidelines have been published. However, a relatively poor uptake of the guidelines has been identified across various countries. To enhance future implementation of EBP, the aim of this study was to explore barriers to using LBP guidelines in clinical practice. A qualitative constructivist grounded theory design was employed in order to gain an in-depth understanding of the barriers. Semi-structured interviews (+/− observations) of nine physiotherapists and nine chiropractors from primary care in the Central Denmark Region were conducted. Two key barriers were found to using guidelines in practice: (1) a scepticism due to doubts about validity and applicability of the guidelines, which emerged particularly among physiotherapists; and (2) a deep biomechanical professional identity, due to perceived role, interest, lack of skills, and patient preferences, which emerged particularly among chiropractors. For guidelines to be better implemented in practice, these key barriers must be addressed in a tailored strategy. Furthermore, this study showed a difference in barriers between the two professions. It is important that physiotherapists and chiropractors reflect on what constitutes their core task and professional identity if the implementation of the biopsychosocial model is to be successful.To overcome the barrier of scepticism towards guidelines, the applicability of the guidelines could be improved by elaborating on how the recommendations could be individualised.It is important to incorporate the biopsychosocial model into the programs of educational institutions and provide training to improve those skills in physiotherapists and chiropractors. It is important that physiotherapists and chiropractors reflect on what constitutes their core task and professional identity if the implementation of the biopsychosocial model is to be successful. To overcome the barrier of scepticism towards guidelines, the applicability of the guidelines could be improved by elaborating on how the recommendations could be individualised. It is important to incorporate the biopsychosocial model into the programs of educational institutions and provide training to improve those skills in physiotherapists and chiropractors.

Objective To investigate the effects of a group-based cognitive behavioural intervention for patients with persistent low back pain (LBP) and psychological risk factors referred to secondary care. Design A randomised controlled trial. Setting Silkeborg Regional Hospital, Denmark. Subjects A total of 136 participants with chronic LBP and psychological risk factors. Interventions Participants were randomised to the standard care group, including examination by a rheumatologist and/or a physiotherapist, or the intervention group, including standard care plus a multidisciplinary group-based pain management programme. Main measures Patient-reported outcomes were collected at baseline and after 6 and 12 months. The primary outcome was disability (Roland Morris Disability Questionnaire). Secondary outcomes included low back pain intensity, pain catastrophising, health-related quality of life, and sick leave. Results Among 136 participants, 68 (mean age: 41.7 years (SD 11.8)) were randomised to standard care and 68 (mean age: 46.0 years (SD 10.8)) were randomised to the intervention group. Except for age, baseline characteristics were comparable between groups. 12-month follow-up was completed by 92.6% in the intervention group and 80.9% in the standard care group. Both groups achieved significant improvements on disability, with a reduction of −4.8 points (SD 6.1) in the intervention group compared to −3.7 points (SD 5.2), resulting in an insignificant difference between groups. No significant differences were found in the secondary outcomes. Conclusion A group-based pain management programme was no more effective than standard care for patients with persistent LBP and psychological risk factors.

The concept of pulmonary embolism is evolving. Recent and emerging evidence on the treatment of specific patient populations, its secondary prevention, long-term complications, and the unmet need for rehabilitation has the potential to change clinical practice for the benefit of the patients. This review discusses the recent evidence from clinical trials, observational studies, and guidelines focusing on anticoagulation treatment, rehabilitation, emotional stress, quality of life, and the associated outcomes for patients with pulmonary embolism. Guidelines suggest that the type and duration of treatment with anticoagulation should be based on prevalent risk factors. Recent studies demonstrate that an anticoagulant treatment that is longer than two years may be effective and safe for some patients. The evidence for extended treatment in cancer patients is limited. Careful consideration is particularly necessary for pulmonary embolisms in pregnancy, cancer, and at the end of life. The rehabilitation and prevention of unnecessary deconditioning, emotional distress, and a reduced quality of life is an important, but currently they are unmet priorities for many patients with a pulmonary embolism. Future research could demonstrate optimal anticoagulant therapy durations, follow-ups, and rehabilitation, and effective patient-centered decision making at the end of life. A patient preferences and shared decision making should be incorporated in their routine care when weighing the benefits and risks with primary treatment and secondary prevention.

Background Managing low back pain (LBP) often involves MRI despite the fact that international guidelines do not recommend routine imaging. To allow us to explore the topic and use this knowledge in further research, a reliable method to review the MRI referrals is needed. Consequently, this study aimed to assess the inter-rater reliability of a method evaluating lumbar spine MRI referrals’ appropriateness. Methods Four inexperienced students (chiropractic master’s students) and a senior clinician (chiropractor) were included as independent raters in this inter-rater reliability study. Lumbar spine MRI referrals from primary care on patients (> 18 years) with LBP with or without leg pain were included. The referrals were classified using a modified version of the American College of Radiology (ACR) imaging appropriateness criteria for LBP. Categories of appropriate referrals included; fractures, cancer, previous surgery, candidate for surgery or suspicion of cauda equina. Inappropriate referrals included lacking information on previous non-surgical treatment, no word on non-surgical treatment duration, or “other reasons” for inappropriate referrals. After two rounds of training and consensus sessions, 50 lumbar spine MRI referrals were reviewed independently by the five raters. Inter-rater reliability was quantified using unweighted Kappa statistics, and the observed agreement was calculated with both a pairwise comparison and an overall five-rater comparison. Results Inter-rater reliability was substantial, with a Kappa value for appropriate vs. inappropriate referrals of 0.76 (95% CI: 0.55–0.89). When six and eight subcategories were evaluated, the Kappa values were 0.77 (95% CI: 0.58–0.91) and 0.82 (95% CI: 0.72–0.92), respectively. The overall percentage of agreement for appropriate and inappropriate referrals was 92% and ranged from 88 to 98% for the pairwise comparisons of the five raters’ results. For the six and eight subcategories, the overall agreement was 92 and 88%, respectively, ranging from 88 to 98% and 84–92%, respectively, for the pairwise comparisons. Conclusion The inter-rater reliability of the evaluation of the appropriateness of lumbar spine MRI referrals, according to the modified ACR-appropriateness criteria, was found to range from substantial to almost perfect and can be used for research and quality assurance purposes.

IntroductionTo date, there exists no gold standard conservative treatment for lateral hip pain due to tendinopathy of the gluteus medius and/or minimus tendon (GT), a condition often complicated by pain and disability. Higher loads during everyday activities and exercise seems to be contraindicated with GT. The purpose of this study was to evaluate the feasibility of exercise with low-loads concurrent partial blood flow restriction (LL-BFR) and patient education for patients present GT.MethodsRecruitment took place at three hospitals in the Central Denmark Region. The intervention consisted of daily sessions for 8 weeks with one weekly supervised session. From week three patients exercised with applied partial blood flow restriction by means of a pneumatic cuff around the proximal thigh of the affected leg. Throughout the intervention patients received patient education on their hip condition. Sociodemographic and clinical variables were collected at baseline. The feasibility of LL-BFR was conducted by adherence to the exercise protocol and drop-out rate. Patient reported outcome measures (The Victorian Institute of Sport Assessment-Gluteal Questionnaire, EuroQol - 5 Dimensions-Visual Analogue Scale, Oxford Hip Score, Copenhagen Hip and Groin Outcome Score), maximal voluntary isometric hip abduction-, hip extension, and knee extension strength (Nm/kg) measured using a handheld dynamometer, and functional capacity tests (30 second chair-stand test and a stair-climb test) was conducted as secondary outcomes.ResultsSixteen women with a median (IQR) age of 51 (46–60) years were included. Median (IQR) Body Mass Index was 26.69 (23.59–30.46) kg/m2. Adherence to the total number of training sessions and the LL-BFR was 96.4 and 94.4%, respectively. Two patients dropped out due to (i) illness before initiation of LL-BFR and (ii) pain in the affected leg related to the LL-BFR-exercise. At follow-up both pain levels and patient-reported outcome measures improved. Isometric hip abduction-, hip extension-, and knee extension strength on both legs and functional performance increased. Conclusion: LL-BFR-exercise seems feasible for treatment of GT. At follow-up, a high adherence and low drop-out rate were observed. Further, patients reported clinically relevant reductions in pain, and showed significant increases in isometric hip and knee strength.

Background: Physiotherapists (PTs) have an essential role in the facilitation of patients’ mobilization after lumbar spinal fusion (LSF). The aim of this study is to investigate whether PTs can predict one-year post-surgery outcome based on their first meeting with the patient immediately after LSF. Method: A prospective cohort study with one-year follow-up was conducted. In the first days after surgery, the PTs from hospital wards were asked to predict the patients’ overall LSF outcome one year after surgery. One year after surgery, the patients received a questionnaire including the Oswestry Disability Index (ODI), visual analogue scales (VAS) for leg and back pain, quality of life survey (EQ-5D-3 L), global perceived effect (GPA), and satisfaction with surgery outcome (SSO). Univariate and logistic regression were used to calculate the associations between the prognosis and predictive values. Results: The study included 170 patients. The analyses showed a significant association between the PTs’ prognosis and the primary outcome ODI (p 2 ≤ 0.09). There was no significant association between the PTs’ prognosis and the patients’ SSO (p = .17; R 2 = 0.01). Conclusion: There were significant associations between the PTs’ prognosis and disability, pain, health-related quality of life and global perceived effect one-year post-surgery, although the associations had low predictive values. There was no significant association between the PTs’ prognosis and patients’ SSO after one year. The PTs’ prognosis should not be used as a single component in further rehabilitation planning.

Aim This study aimed to describe and compare general practitioner (GP) attendance patterns in the years surrounding HPV-vaccination among cases suspected to experience adverse events and their matched controls in order to determine if a potential larger change in GP attendance among cases was observed in temporal relation to vaccination. Methods Register-based, matched case-control study. Cases were defined as women referred to specialized hospital settings (HPV-centers) for suspected adverse event between June 1st 2015 and December 31st 2015 (n=1458). Information on referral was obtained from the HPV-centers directly. Each case was matched with five controls on age at vaccination, region, time of first vaccine registration and total number of doses, resulting in a total study population of 8670 girls and women. Negative binomial regression analyses were used (i) to estimate mean yearly GP contacts among cases and controls, and (ii) to further investigate the relative difference in change in GP attendance following vaccination between cases and controls. Results Overall, cases displayed higher GP attendance than controls from five years before vaccination up until five years after. Compared to controls, cases increased their GP attendance more in the years following HPV vaccination, corresponding to a 40% increase in the incidence rate ratios (IRR) from before to after vaccination (ratio-IRR = 1.40 [1.36; 1.44]). The change occurred in close proximity to vaccination, and the pattern was the same independently of the year of vaccination. However, for the later vaccination years cases displayed an additional increase in their GP attendance around time of extensive media attention. Conclusion Girls and women being referred for suspected adverse events after HPV-vaccination changed their GP attendance pattern in close proximity to their first HPV-vaccination and not solely in temporal linkage to the onset of public debate.

Background: A number of papers highlight the extent to which low back pain (LBP) is generally mismanaged, especially regarding overuse of magnetic resonance imaging (MRI). International guidelines do not recommend routine imaging, including MRI, and seek to guide clinicians only to refer for imaging based on specific indications. Despite this, several studies show an increase in the use of MRI among patients with LBP and an imbalance between appropriate versus inappropriate use of MRI for LBP. This study aimed to investigate to what extent referrals from general practice for lumbar MRI complied with clinical guideline recommendations in a Danish setting.Materials and methods: From 2014-2018, all referrals for lumbar MRI were included from general practitioners in the Central Denmark Region for diagnostic imaging at a public regional hospital. A modified version of the American College of Radiology Imaging Appropriateness Criteria for LBP was used to classify referrals as appropriate or inappropriate, based on the unstructured text in the GPs’ referrals. Appropriate referrals included fractures, cancer, symptoms persisting for more than 6 weeks of non-surgical treatment, previous surgery, candidate for surgery or suspicion of cauda equina. Inappropriate referrals were sub-classified as lacking information about previous non-surgical treatment and duration. Results: Of the 3,772 retrieved referrals for MRI of the lumbar spine, 55% were selected and a total of 2,051 referrals were categorised. Approximately one quarter (24.5%) were categorised as appropriate, and 75.5% were deemed inappropriate. 51% of the inappropriate referrals lacked information about previous non-surgical treatment, and 49% had no information about the duration of non-surgical treatment. Apart from minor yearly fluctuations, there was no change in the distribution of appropriate and inappropriate MRI referrals from 2014 to 2018.Conclusion:The majority of lumbar MRI referrals (75.5%) from general practitioners for lumbar MRI did not fulfil the ACR Imaging Appropriateness Criteria for LBP based on the unstructured text of their referrals. There is a need for referrers to include all guideline-relevant information in referrals for imaging. More research is needed to determine whether this is due to patients not fulfilling guideline recommendations or simply the content of the referrals.

Background International guidelines do not recommend routine imaging, including magnetic resonance imaging (MRI), and seek to guide clinicians only to refer for imaging based on specific indications. Despite this, several studies show an increase in the use of MRI among patients with low back pain (LBP) and an imbalance between appropriate versus inappropriate use of MRI for LBP. This study aimed to investigate to what extent referrals from general practice for lumbar MRI complied with clinical guideline recommendations in a Danish setting, contributing to the understanding and approaches to lumbar MRI for all clinicians managing LBP in the primary sector. Materials and methods From 2014 to 2018, all referrals for lumbar MRI were included from general practitioners in the Central Denmark Region for diagnostic imaging at a public regional hospital. A modified version of the American College of Radiology Imaging Appropriateness Criteria for LBP was used to classify referrals as appropriate or inappropriate, based on the unstructured text in the GPs’ referrals. Appropriate referrals included fractures, cancer, symptoms persisting for more than 6 weeks of non-surgical treatment, previous surgery, candidate for surgery or suspicion of cauda equina. Inappropriate referrals were sub-classified as lacking information about previous non-surgical treatment and duration. Results Of the 3772 retrieved referrals for MRI of the lumbar spine, 55% were selected and a total of 2051 referrals were categorised. Approximately one quarter (24.5%) were categorised as appropriate, and 75.5% were deemed inappropriate. 51% of the inappropriate referrals lacked information about previous non-surgical treatment, and 49% had no information about the duration of non-surgical treatment. Apart from minor yearly fluctuations, there was no change in the distribution of appropriate and inappropriate MRI referrals from 2014 to 2018. Conclusion The majority of lumbar MRI referrals (75.5%) from general practitioners for lumbar MRI did not fulfil the ACR Imaging Appropriateness Criteria for LBP based on the unstructured text of their referrals. There is a need for referrers to include all guideline-relevant information in referrals for imaging. More research is needed to determine whether this is due to patients not fulfilling guideline recommendations or simply the content of the referrals.

Background Research is often undertaken using patient-reported outcomes from questionnaires. Achieving a high response rate demands expensive and time-consuming methods like telephone reminders. However, it is unknown whether telephone reminders change outcome estimates or only affect the response rate in research of populations with low back pain (LBP). The aim is to compare baseline characteristics and the change in outcome between patients responding before and after receiving a telephone reminder. Methods This is an ancillary analysis of data from a prospective cohort study employing questionnaires from 812 adults with LBP lasting more than 3 months. Patients not responding to the 52-week questionnaire were sent reminder emails after two and 3 weeks and delivered postal reminders after 4 weeks. Patients still not responding were contacted by telephone, with a maximum of two attempts. Patients were categorised into three groups: 1) patients responding before a telephone reminder was performed; 2) patients responding after the telephone reminder and 3) patients not responding at all. A positive outcome was defined as a 30% improvement on the Roland Morris Disability Questionnaire after 52 weeks. Results A total of 695 patients (85.2%) responded. Of these, 643 patients were classified in Group 1 and 52 patients were classified in Group 2. One hundred seventeen were classified in Group 3. No differences in outcome or baseline characteristics was found. In Group 1, 41.3% had a positive outcome, and in Group 2 48.9% had a positive outcome (P = 0.297). In group 3, non-respondents were younger, more often unemployed, more often smokers, more often reported co-morbidity, and reported higher depression scores than respondents. Conclusions Using a telephone reminder had no consequence on outcome estimates nor were there any differences in baseline characteristics between patients who responded before or after the telephone reminder. Trial registration The initial trial was registered in Clinicaltrials.gov (NCT03058315).

INTRODUCTION: There is an increasing awareness that patients with acute pulmonary embolism (APE) suffer long-term consequences like fatigue, anxiety, and reduced physical capacity. However, we lack knowledge on how patients manage everyday life and physical activity following an APE. The study aimed to explore how patients experience and cope with daily life and physical activity in the first year following an APE.MATERIALS AND METHODS: Semi-structured individual interviews were performed with 16 patients, 6-12 months after a first-time APE event. The methodological framework for the analysis was interpretive description.RESULTS: Most participants had managed to return to their daily routines at the time of the interview, although some struggled more than others. They experienced their daily life and well-being to be negatively affected by fatigue, anxious thoughts and bodily hypervigilance, and were concerned about themselves, their family, friends and life situation. In many cases, they lacked advice from health professionals. Participants used various strategies for re-engaging in everyday life and physical activities, reflecting their physical and mental resources, contextual support, and different life situation. One central theme was the challenge of coming to terms with a more vulnerable identity, and adjusting this identity to established family and work roles.CONCLUSIONS: Most participants had managed to resume their everyday life 6-12 months after the APE event, but were still limited in their daily activities and found it difficult to sustain a sufficient level of physical activity. They described different barriers and facilitators, which should be addressed in future rehabilitation interventions.

Objective: The aim of the study was threefold: Firstly, to investigate the adherence to clinical practice guidelines for low back pain (LBP) among Danish physiotherapists with regard to three key domains: (a) activity, (b) work and (c) psychosocial risk factors. Secondly, to investigate whether adherence differed between physiotherapists working in private clinics (private physiotherapists) and physiotherapists working at public healthcare centres (public physiotherapists). Thirdly, to describe the physiotherapists' treatment modalities for patients with LBP. Methods: A cross-sectional online survey was conducted with 817 physiotherapists working in the Central Denmark Region. Adherence to the guideline domains was assessed using two vignettes. The difference in adherence between the groups was assessed using the Chi-squared test. Treatment modalities were reported using descriptive statistics. Results: A total of 234 physiotherapists responded, hereof 163 private physiotherapists and 71 public physiotherapists (response rate 29%). The proportions of physiotherapists managing the patients strictly in line with the guideline domains were 32% (activity), 16% (work) and 82% (psychosocial risk factors) for Vignette 1 and 6% (activity), 53% (work) and 60% (psychosocial risk factors) for Vignette 2. Public physiotherapists were more likely to manage patients strictly in line with guidelines for assessing the psychosocial risk factors compared to private physiotherapist (Vignette 1: 92% vs. 77% p =.030; Vignette 2:70% vs. 55% p =.035). Regarding the other two domains, there was no significant difference between the two groups in terms of adherence (p >.05). Concerning treatment modalities, the majority of physiotherapists instructed the patients in adopting an exercise program or informed the patients about the benign nature and prognosis of LBP. Conclusion: Overall, the participating Danish physiotherapists strictly adhered to only one out of three key domains. This underlines the importance of bringing focus on implementing the current guidelines' recommendations in clinical practice.

BackgroundPatients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objectives are to examine the effect of GAPE on, respectively, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life.MethodsThe study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery), and at three and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery), and at three, six, and 12 months post-surgery. DiscussionWe hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significantly reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration: www.clinicaltrials.gov (NCT04103970), 24 September 2019

Background Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life. Methods The study is an RCT planned to include 144 patients undergoing LSF at 1–2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery. Discussion We hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration www.clinicaltrials.gov NCT04103970, Registered on 24 September 2019

Background International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient. Objectives The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions. Patients/methods The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention. Results Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again. Conclusions This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.

Introduction Assessment of Motor and Process Skills (AMPS) has been proven to be a suitable measurement tool for assessing performance-based ADL ability; however, its reliability and validity have not been tested on patients with hand-related disorders. Methods Patients referred for outpatient hand rehabilitation were assessed with AMPS, The Canadian Occupational Performance Measure (COPM), dynamometer and goniometer at baseline and after eight weeks of hand therapy. Construct validity and responsiveness of AMPS were assessed by hypothesis testing. Construct validity was assessed by correlating the baseline score of AMPS with the baseline score of the other measurement tools. Responsiveness was assessed by correlating the change scores of each measurement tool with a Global Rating Scale. Results Fifty-one patients were recruited. The construct validity of AMPS indicated that the various measurement tools captured different aspects to functioning from the AMPS, as the correlations between AMPS and the other measurement tools were generally weak to low (r Discussion In a sample of 51 patients, this study found that the construct validity of AMPS seemed to be moderate, while the responsiveness of AMPS seemed to be poor. However, due to the small sample size no conclusions can be made, and should be further assessed in larger studies.

Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated. Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE. Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted. Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations. Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs. Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49). Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.

Background According to clinical guidelines, advice to stay active despite experiencing pain is recommended to patients with non-specific low back pain (LBP). However, not all patients receive guideline-concordant information and advice, and some patients still believe that activity avoidance will help them recover. The purpose was to study whether guideline-concordant beliefs among patients and other explanatory variables were associated with recovery. The main aim was to investigate whether believing staying active despite having pain is associated with a better functional outcome. Methods This was a prospective cohort study involving adults with non-specific LBP referred from general practices to the Spine Centre at Silkeborg Regional Hospital, Denmark. Patients reported on their beliefs about the importance of finding the cause, the importance of diagnostic imaging, perceiving to have received advice to stay active, pain duration, pain intensity, and STarT Back Tool. Agreeing to: ‘An increase in pain is an indication that I should stop what I’m doing until the pain decreases’ adjusted for age, gender, and education level was the primary explanatory analysis. A 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score after 52 weeks was the outcome. Results 816 patients were included and 596 (73.0%) agreed that pain is a warning signal to stop being active. Among patients not considering pain as a warning signal, 80 (43.2%) had a favourable functional improvement of ≥30% on the RMDQ compared to 201 (41.2%) among patients considering pain a warning signal. No difference was found between the two groups (adjusted P = 0.542 and unadjusted P = 0.629). However, STarT Back Tool high-risk patients had a less favourable functional outcome (adjusted P = 0.003 and unadjusted P = 0.002). Chronic pain was associated with less favourable functional outcome (adjusted P Conclusions Holding the single belief that pain is a warning signal to stop being active was not associated with functional outcome. However, patients characterised by having multiple psychological barriers (high-risk according to the STarT Back Tool) had a less favourable functional outcome. Trial registration Registered at ClinicalTrials.gov (registration number: NCT03058315), 20 February 2017.

Introduction Systemic sclerosis is a connective tissue disease associated with significantly impaired hand mobility, which may hamper activities of daily living. The aim of the present study was to investigate the effect on hand mobility and health status of patients with systemic sclerosis of warming up hands with paraffin compared with warming up hands in lukewarm water prior to hand exercises. Methods Patients were allocated to receive either warm-up treatment with water or paraffin prior to hand exercises for a period of six months. Primary outcome was Hand Mobility in Scleroderma (HAMIS), while secondary outcomes included SF-36 and measurements of fingertips to proximal and distal palmar crease. Follow-up assessments were conducted 3, 6 and 12 months post baseline. Results Ninety patients were enrolled in the study and 56 patients completed. No statistically significant differences were observed between groups regarding hand mobility post intervention. Within both groups, hand mobility improved on the HAMIS six months post baseline with −2.6 points (95% CI: −4.4; −0.8) in the paraffin group and −3.3 points (95% CI: −5.2; −1.5) in the water group. Improvements were maintained at 12-month follow-up. Conclusions Our findings suggested that warm-up with paraffin compared to lukewarm water prior to hand exercises in patients with systemic sclerosis had no additional effect on hand mobility. Results may have been affected by the high dropout rate and statistical errors underestimating a possible effect.

The modified International Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) is a widely used patient-reported tool ranging on a scale from 0 to 100. We aimed to translate Pedi-IKDC into Danish and assess its reproducibility and responsiveness in children with knee disorders. The translation complied with the international guidelines. Reproducibility was assessed in 53 children (15 years) responding Pedi-IKDC at baseline and after 3-14 days. For analysis of responsiveness, 94 children (15 years) responded Pedi-IKDC again after 3 months. Test-retest reliability was excellent. Intraclass correlation coefficient was 0.9, standard error of measurement was 4.1 points, and smallest detectable change (SDC) was 11.3 points. Evaluating responsiveness as a large effect was found in children reporting improvement compared with children reporting deterioration. The change score was correlated to the external anchor Global Rating Scale consisting of 15 answers from -7 "A very great deal worse" to +7 "A very great deal better," with a Spearmen's rho of 0.45 (P > 0.001). The minimal clinically important changes was 12.0. In conclusion, excellent test-retest reproducibility was found at group level, but at individual level the SDC was high. The Pedi-IKDC showed adequate responsiveness and is suitable for assessing improvement or deterioration in children with knee disorders.

Background The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE. Methods One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30–60 minutes’ duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients’ physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients’ quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility. Discussion We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of PE patients, and may thereby form the basis of future recommendations in this field. Trial registration ClinicalTrials.gov, NCT02684721. Registered on 20 January 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1939-y) contains supplementary material, which is available to authorized users.

BACKGROUND: Patients receiving lumbar spinal fusion surgery often have persisting postoperative pain negatively affecting their daily life. These patients may be helped by interdisciplinary cognitive-behavioral therapy which is recognized as an effective intervention for improving beneficial pain coping behavior, thereby facilitating the rehabilitation process of patients with chronic pain.

HPV vaccination offers protection against ~70% of cervical cancers, however, serious concerns have been raised about the possible side effects from HPV vaccination. Studies have found no increased risk of neurologic disease, autoimmune disorder, thromboembolic disease, postural orthostatic tachycardia syndrome, or complex regional pain syndrome in HPV-vaccinated persons compared to unvaccinated persons. Affected individuals should undergo a proper clinical examination to ensure a correct diagnosis and treatment, because symptoms might arise due to a somatic, psychiatric or functional disorder.

Study Design. A cost-effectiveness analysis conducted alongside a randomized clinical trial. Objective. To assess the cost-effectiveness of a preoperative cognitive-behavioral therapy (CBT) intervention compared to usual care for patients undergoing lumbar spinal fusion surgery (LSF). Summary of Background Data. The clinical effectiveness of a preoperative CBT intervention for patients undergoing LSF has been investigated in a randomized clinical trial. Economic evaluation is however essential for decision makers to make informed choices regarding allocation of scarce resources. Methods. 90 patients undergoing LSF were randomly allocated to usual care (control group) or usual care plus a preoperative CBT intervention (CBT group). Outcome parameters included quality-adjusted life years (QALY), based on the EQ-5D, and pain-related disability, based on the Oswestry disability index (ODI). Health care use and productivity loss were estimated from national registers. Results. One year after LSF the estimated QALY was significantly better for the CBT group with 0.710 (95% CI 0.670; 0.749) versus 0.636 (95% CI 0.5573; 0.687). For the ODI, the CBT group reported significantly larger disability reductions at 3 months (P =0.003) and 6 months (P =0.047), but not at 1 year (P=0.082).There was no difference in the overall costs of the two groups (-s89 (95% CI-12,080; 11,902)), leading to a 70% probability of the CBT intervention being cost-effective at a willingness-to-pay of s40,000 for one additional QALY. For an additional gain of 15 ODI points the probability was 90% at a threshold of s10,000. These results remained largely unaffected by relevant sensitivity analyses, confirming the robustness of findings. Conclusion. Preoperative CBT appears to be more effective and cost neutral when considering the overall health care sector and labor market perspective, supporting the implementation of preoperative CBT in the course of treatment for LSF surgery in a Danish context.

Study design A randomized clinical trial including 90 patients. Objective To examine the effect of a preoperative cognitive-behavioral intervention (CBT) for patients undergoing lumbar spinal fusion (LSF) surgery. Summary of background data Few published studies have looked at the potential of rehabilitation to improve outcomes after LSF. Rehabilitation programs using CBT are recommended. Furthermore, initiating interventions preoperatively seems beneficial, but only limited data exist in the field of spine surgery. Methods Patients with degenerative disc disease or spondylolisthesis undergoing LSF were randomized to usual care (control group) or preoperative CBT and usual care (CBT group). Primary outcome was change in Oswestry Disability Index from baseline to 1-year follow-up. Secondary outcomes were catastrophizing, fear avoidance belief, work status, and back and leg pain. Results At 1-year follow-up, there was no statistically significant difference between the CBT group and the control group in Oswestry Disability Index score (P = 0.082). However, the CBT group had achieved a significant reduction of -15 points (-26; -4) already at 3 months (between group difference P = 0.003), and this reduction was maintained throughout the year. There were no differences between groups at 1-year follow-up with regard to any of the secondary outcomes. Conclusion Participating in a preoperative CBT intervention in addition to usual care did not produce better outcomes at 1-year follow-up for patients undergoing LSF. Although the reduction in disability was achieved much faster in the CBT group, resulting in a significant difference between groups already 3 months after surgery, it did not translate into a faster return to work. Our findings support the need for further research into the use of targeted rehabilitation interventions among patients with elevated levels of catastrophizing and fear avoidance beliefs. Level of evidence 2.

IntroductionThe modified international Knee Documentation Committee Subjective Knee Form (Pedi-IKDC) is a widely used patient-reported tool applicable for children with knee disorders ranging on a scale from 0-100. We aimed to translate the Pedi-IKDC Subjective Knee Form into Danish, and furthermore to assess its reliability and responsiveness.Material and MethodsThe Pedi-IKDC Subjective Knee Form was translated to Danish according to international guidelines. Reliability was assessed with Bland Altman plots, standard error of measurement (SEM), Minimal Detectable Change (MDC) and the Intra-class Correlation Coefficient (ICC). Responsiveness was assessed by calculating the Standardised Response Mean (SRM) and the correlation between the form and the Global Rating Scale (GRS). Furthermore, area under the receiver operating characteristics (ROC) curve (AUC) was calculated using the external anchor GRS. Reliability and responsiveness were assessed in 50 children (median 15 years) referred to hospital due to different knee disorders. ResultsThe SEM was 4.2 points and the MDC was 11.5 points. The ICC was 0.91 (0.9-1.0). The change score of the Pedi-IKDC Subjective Knee form was correlated to the external anchor GRS with a Spearmen´s Rho of 0.45 (p=0.001). The value of the AUC was 0.7 (0.5, 0.9).ConclusionsAcceptable test-retest agreement was found at group level, but at the individual level the MDC was high. Thus, considerable changes are needed to detect true change at individual level. The form showed adequate responsiveness and is suitable for assessing improvement or deterioration in children with knee disorders.

BACKGROUND: The optimal type of exercise protocol in the physical rehabilitation of non-specific neck pain has not yet been established. Furthermore, the role of fear-avoidance belief in the maintenance of pain and disability has been highlighted. Research indicates that exercise may be a means to reduce fear-avoidance belief, but evidence is scarce.AIM: To compare the effect of two different exercise programs on pain, strength and fear-avoidance belief.DESIGN: Randomized clinical trial.SETTING: A specialized outpatient hospital clinic in Denmark.POPULATION: Twenty-three men and 60 women on sick leave due to non-specific neck pain.METHODS: Participants were randomized to either general physical activity (GPA group) or GPA and additional strength training of the neck and shoulder (SST group). The primary outcome was pain intensity. Secondary outcomes were muscle strength of the neck and shoulder and fear-avoidance belief.RESULTS: Pain was significantly reduced within groups with a median of -1 (IQR: -3 to 0, PCONCLUSION AND REHABILITATION IMPACT: This study indicates that in rehabilitation of subjects severely disabled by non-specific neck pain, there is no additional improvement on pain or muscle strength when neck exercises are given as a home-based program with a minimum of supervision. However, strength training of the painful muscles seems to be effective in decreasing fear-avoidance beliefs.

The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals. The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion. Current Controlled Trials ISRCTN42281022 .

Lumbar decompression surgery (LDS) and total hip arthroplasty (THA) are frequently performed in the elderly population, but very little is known about their subsequent physical capacity and participation in leisure activities. Despite similar demographics and comorbidities, it is questionable whether LDS patients achieve equally high levels of physical capacity and quality of life postoperatively as do THA patients. The aim was to compare the physical activity level, participation in leisure activities and related quality of life 1 year after an LDS and THA procedure.Data from 95 THA patients and 83 LDS patients were gathered from questionnaires on self-reported physical activity level, leisure activities and quality of life.LDS and THA patients reported equally moderate levels of physical activity. The median score was 42.3 METs/day (IQR 37.9; 47.7) for the LDS group and 41.0 METs/day (IQR 38.5; 48.5) for the THA group (p = 0.79). Weekly time consumption for leisure activities in the LDS group was a median of 420 min/week (IQR 210; 660) compared to a median of 480 min/week (IQR 240; 870) in the THA group (p = 0.16). Regarding quality of life, LDS patients reported significantly worse Euroqol Five Dimensions scores with a median value of 0.740 (IQR 0.68; 0.82) compared to THA patients' median of 0.824 (IQR 0.72; 1.0), p0.001.Despite being equally physically active and engaged in leisure activities, LDS patients did not achieve a quality of life comparable to that of THA patients 1 year postoperatively.

Formål: I et kvalitetsudviklingsprojekt at afprøve en screenings- og aktivitetsalgoritme på et dansk intensivafsnit med henblik på at intensivere mobilisering og træning af kritisk syge patienter ud fra den enkelte patients funktionsniveau.Metode: Screenings- og mobiliseringsalgoritmen blev afprøvet i tre måneder. Der blev sideløbende udført en systematisk registrering af alle udførte screeninger og aktiviteter.Resultater: I 60 pct. af screeningerne kunne patienterne ikke godkendes til mobilisering ud fra algoritmens kriterier. Ud fra en tværfaglig vurdering blev hovedparten af patienterne alligevel mobiliseret og trænet. Den udførte mobilisering og træning stemte derimod godt overens med det niveau, der blev fastsat på baggrund af algoritmen.Konklusion: Algoritmens fysiologiske screeningskriterier viste sig ikke anvendelige til vurdering af patienterne i nærværende studie. Algoritmen var derimod anvendelig i forhold til at tilpasse niveauet for mobilisering og træning.Relevans for klinisk praksis: Tidlig mobilisering og træning er mulig at indføre med en simpel algoritme, dog med hensyntagen til individuelle screeningskriterier fra sted til sted, da disse åbenbart ikke er nemme at fastsætte. I fremtiden skal grænseværdierne benyttes som en vejledende risikovurdering forud for tidlig mobilisering og træning i stedet for til konkret screening.

BACKGROUND: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF).METHODS: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records.RESULTS: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention.CONCLUSION: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention.TRIAL REGISTRATION: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

HPV vaccination offers protection against ~70% of cervical cancers, however, serious concerns have been raised about the possible side effects from HPV vaccination. Studies have found no increased risk of neurologic disease, autoimmune disorder, thromboembolic disease, postural orthostatic tachycardia syndrome, or complex regional pain syndrome in HPV-vaccinated persons compared to unvaccinated persons. Affected individuals should undergo a proper clinical examination to ensure a correct diagnosis and treatment, because symptoms might arise due to a somatic, psychiatric or functional disorder.