A new paradigm in the management of scalp pruritus: findings from the SCALP-PR trial.

PURPOSE: The "Impact of scalp pruritus in dermatological consultations in Spain: The SCALP-PR trial" was initiated to address the common yet often insufficiently examined issue of scalp pruritus in dermatology. This condition leads to an uncontrollable urge to scratch, affecting the patients' quality of life and potentially causing scalp damage. This study aimed to explore the prevalence, patient profile, underlying conditios, and therapeutic approaches for scalp pruritus in Spain, and to assess the safety and efficacy profile, as well as the tolerability of a non-pharmacologic treatment. METHODS: From 2021 through 2022, 75 dermatologists enrolled a total of 359 patients in a study on scalp pruritus, approved by the Bellvitge University Hospital Research Ethics Committee, Barcelona, Spain. This evidence-based research combined a meta-analysis with observational study techniques focused on real-world evidence to examine the therapeutic impact on quality of life (QoL). Utilizing the Dermatology Life Quality Index (DLQI) for QoL assessments, the study evaluated the effectiveness of the topical product over 15 days. Data collection was conducted via an eCRF and analyzed with statistical methods to provide reliable insights into the management of scalp pruritus. RESULTS: The prevalence of scalp pruritus in Spain was found to be 6.9%, predominantly among women with a mean age of 52.5 years. The leading causes identified were seborrheic dermatitis and pruritus of undetermined etiology or sensitive scalp. Stress was noted as a key factor, with corticosteroids and hygienic measures being common therapies. The topical product demonstrated significant reductions in pruritus and scratching in more than 90% of patients after 15 days. Improvements were also seen in dermatological quality of life, with 87.1% of patients showing enhancements in DLQI scores. The product was well-received thanksto its cosmetic properties, with high ratings in texture, ease of application, and fragrance. CONCLUSION: The topical product studied is a safe, effective, and cosmetically appealing treatment, improving scalp pruritus in various etiologies for most patients. The results highlight the need for patient-center treatments in dermatology, providing important insights for clinical practice and future research.

Effect of different non-pharmacologic placebo treatments on migraine prevention: a network meta-analysis of randomized controlled trials.

BACKGROUND: Placebo control plays an important role in evaluating the effectiveness of interventions. Specifying differential effects of various placebo controls on migraine prevention would be essential in the explanation of preventive treatment for migraine and the indirect comparison between different prophylactic therapeutics. OBJECTIVES: To access the impact of different non-pharmacologic placebo types on different outcomes in migraine patients. METHODS: We searched PubMed, Cochrane Controlled Register of Trials, Embase, and Web of Science databases from the date of creation to June 19, 2023. Randomized controlled trials of migraine that included sham intervention of acupuncture or cognitive behavioural therapy (CBT) or non-invasive Vagus Nerve Stimulation (nVNS) or repetitive Transcranial Magnetic Stimulation (rTMS) or transcranial Direct Current Stimulation (tDCS) were conducted. The primary outcome was the migraine days, and the secondary outcomes were the number of migraine attacks, headache days, headache frequency, and responder's rate. Placebo effects were assessed using five individual placebos for network meta-analysis, using mean differences to measure the relative effect of pair-wise comparisons between interventions. RESULT: A total of 50 trials with 4880 subjects were included. Twenty-seven trials were evaluated for low risk of bias. The results of indirect comparisons show that sham rTMS and sham tDCS had optimal and similar effects in reducing migraine days; sham acupuncture has the greatest effect on reducing the number of migraine attacks and relieving headache frequency; sham rTMS had a highly significant advantage in reducing headache days compared with the other placebo controls. CONCLUSION: Based on the network meta-analysis results, we found that sham acupuncture had the greatest effect on migraine prophylaxis. The strong placebo effect of sham acupuncture should be considered when assessing the therapeutic effect.

Perspectives and Attitudes of General Practitioners Towards Pharmacological and Non-Pharmacological COPD Management in a Belgian Primary Care Setting: A Qualitative Study.

Background: Chronic obstructive pulmonary disease (COPD) is a complex and heterogeneous condition that requires multidisciplinary management. In Belgium, the treatment of COPD is mainly managed by general practitioners (GPs). Several clinical practice guidelines (CPGs) recommend the use of non-pharmacological treatments, such as pulmonary rehabilitation, and interdisciplinary care for COPD patients. Although considerable research has been devoted to addressing the multitude of reasons for the lack of adherence to these aspects of the CPGs, less attention has been paid to understanding the perspectives and attitudes of GPs that lead to this suboptimal implementation. Purpose: This study aimed to 1) explore Belgian GPs' perceptions regarding COPD management in a primary care setting and 2) collect their views on the importance of pulmonary rehabilitation and interprofessional care in COPD management. Methods: A descriptive study, conducted between August 2014 and May 2015, used interviews from a sample of 30 Flemish GPs. Data were analyzed following the principles of thematic analysis. Results: COPD management was patient-centered, focusing on immediate symptom relief and reducing future risks through pharmacotherapy and proper patient education. Deviations from the CPGs were noted, with only a few GPs performing spirometry themselves. Conditions to prescribe respiratory physiotherapy were not well known. Some GPs remained unconvinced about the (cost-)effectiveness of respiratory physiotherapy despite the fast-expanding scientific evidence. Interprofessional care was limited to GP-respiratory physician (re)-referral and communication. GPs showed a reactive attitude towards interprofessional collaboration for non-pharmacological therapies, which is not in line with the proactive approach recommended in CPGs. Conclusion: GPs managed COPD patients mainly by reducing symptoms with pharmacological therapy. Integrated care regarding non-pharmacological treatments was not well implemented due to the obstacles in interprofessional collaboration. Future care models incorporating personalized care planning could provide a solution to manage COPD's complex healthcare demands.

Airway Mucosal Remodeling: Mechanism of Action and Preclinical Data of Pulsed Electric Fields for Chronic Bronchitis and Mucus Hypersecretion.

Patients living with chronic bronchitis (CB) suffer from physical limitations and poor quality of life. In general, treatment options that directly address the mucus hypersecretion component of CB are quite limited. Chronic airway inflammation and the associated hypersecretion and cough that are pathognomonic for CB generally result from long-term exposure to airway irritants such as tobacco use and other environmental insults. This, in turn, results in an increase in the quantity and change in composition of the airway mucosa as a consequence of altered goblet cells, club cells, and submucosal glands. Pulsed electric fields (PEFs) provide a method for eradicating the cellular constituents of tissue with limited impact on the stromal proteins. Preclinical evidence in porcine airways demonstrated that particular PEF waveforms allowed for salutary remodeling of the epithelial and submucosal airway tissue layers and appeared to foster rapid regeneration and recovery of the tissue. Therefore, a therapeutic opportunity might exist whereby the application of a specific form of PEF may result in a reduction of the cellular secretory constituents of the airway while also reducing airway mucosal inflammation. This review discusses the use of such PEF to address the underlying disease processes in CB including challenges around device design, dosing, and appropriate delivery methods. Further, we outline considerations for the transition to human airways along with a brief examination of the initial work treating CB patients, suggesting that the therapy is well tolerated with limited adverse events.

Advances in the Acute and Preventive Treatment of Pediatric Migraine.

PURPOSE OF REVIEW: Headaches are common in children and adolescents. Treatments for debilitating migraine are often not FDA approved or lack evidence of efficacy for children. This narrative review looks at the evidence for acute and preventative pharmacologic and non-pharmacologic treatment of pediatric migraine, as well as reviewing any recent or ongoing clinical trials. RECENT FINDINGS: Studies have been published on pharmacological treatments for headache, as well as non-pharmacological treatments. Recent findings in pediatric migraine using onabotulinumtoxinA, calcitonin gene related peptide antagonists, interventional procedures, and devices are reviewed. Pharmacologic as well as non-pharmacologic approaches for the prevention and treatment of migraine show safety and efficacy data that is promising. These treatments should be incorporated in a multi-modal approach to the management of pediatric migraine. Continued studies, prospective and randomized, are needed to further assess these newer treatments for migraine in the pediatric setting.

Psycho-Educational and Rehabilitative Intervention to Manage Cancer Cachexia (PRICC) for Advanced Patients and Their Caregivers: Lessons Learned from a Single-Arm Feasibility Trial.

BACKGROUND: Key elements in cancer cachexia (CC) management are personalized and multimodal interventions, but it is hard for some patients to follow programs based on several components. We examined the feasibility of a bimodal intervention, including a psycho-educational component and exercises, to support patients and their caregivers in managing CC; Methods: Prospective mixed-methods pilot study explored feasibility data, changes in patient-reported outcomes, and performance outcomes over time in a convenient sample of 30 consecutive CC patients and their caregivers. RESULTS: Twenty-four dyads consented to participate. Twenty dyads received at least two psycho-educational sessions, so the psycho-educational component was feasible for 83.3% of the sample. Six dyads participated in at least fourteen out of twenty-seven rehabilitation sessions, so the exercise program was feasible for 25.0% of the sample. Six dyads showed compliance greater than 50% for both components of the bimodal intervention. CONCLUSIONS: While we did not meet our primary feasibility endpoint and had mixed acceptability, our experience provides insight into the challenges and lessons learned in implementing a primary palliative care intervention for CC. More robust studies are needed to help clinicians understand the best exercise program for CC patients, to be included in a multimodal intervention.

Patient attitudes and beliefs associated with self-referral to physical therapy for musculoskeletal complaints: a qualitative study.

BACKGROUND: Non-pharmacologic treatments such as physical therapy (PT) are advocated for musculoskeletal pain. Early access to PT through self-referral has been shown to decrease costs and improve outcomes. Although self-referral is permitted in most U.S. states and supported by some health insurance plans, patients' utilization of self-referral remains low. OBJECTIVE: To identify factors, beyond legislative policies and health insurance, associated with patients' decisions to access physical therapy through self-referral or provider-referral. METHODS: We recruited 26 females and 6 males whose employer-sponsored insurance benefits included financial incentives for self-referral to physical therapy. Between August 2017 and March 2018, participants completed semi-structured interviews about their beliefs about physical therapy and reasons for choosing self-referral (15 participants) or provider referral (17 participants) for accessing physical therapy. Grounded theory approach was employed to identify themes in the data. RESULTS: Patients selecting self-referral reported major thematic differences compared to the provider-referral patients including knowledge of the direct access program, attitudes and beliefs about physical therapy and pharmacologic treatment, and prior experiences with physical therapy. Self-referral patients were aware that their plan benefits included reduced cost for self-referral and felt confident in selecting that pathway. They also had negative beliefs about the effectiveness of pharmacological treatments and surgery, and previously had positive direct or indirect experiences with physical therapy. CONCLUSION: Knowledge of the ability to self-refer, attitudes and beliefs about treatment, and prior experience with physical therapy were associated with self-referral to physical therapy. Interventions aimed at improving knowledge and changing attitudes toward self-referral to physical therapy to increase utilization appear warranted.

Effects of remote ischemic conditioning on sleep complaints in Parkinson's disease-rationale, design, and protocol for a randomized controlled study.

Objective: Sleep disturbances are common non-motor symptoms of Parkinson's disease. The symptoms affect the quality of patients' life by impeding normal sleep cycles and causing excessive daytime sleepiness. Remote Ischemic Conditioning (RIC) is a therapy often used for ischemic stroke patients to minimize infarct size and maximize post-stroke neurological function. Animal experiments have shown that RIC plays a protective role for retinal ganglion cells and other critical areas of the brain of Parkinson's disease. However, whether RIC improves excessive daytime sleepiness (EDS) for patients with Parkinson's disease remains to be determined. Methods: This is a single-center, double-blind, and randomized controlled trial, which includes patients with Parkinson's disease with EDS. All recruited patients will be randomly assigned either to the RIC or the control group (i.e., sham-RIC) with 20 patients in each group. Both groups receive RIC or sham-RIC treatment once a day for 28 days within 24 h of enrollment. Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Parkinson Disease Sleep Scale-2 (PDSS-2), Parkinson's Disease Questionnaire39 (PDQ39) score scales, and adverse events, such as inability to tolerate the treatment leading to suspension of the study or objective signs of tissue or neurovascular injury caused by RIC and/or sham-RIC are evaluated at 7, 14, 28, and 90 days after enrollment. Results: The primary goal of this study is to assess the feasibility of the treatments in patients with Parkinson's disease by measuring serious RIC-related adverse events and any reduced incidence of adverse events during the trial and to study potential efficacy, improvement of patients' excessive daytime sleepiness, quality of life-based on ESS, PSQI, PDSS-2, and PDQ39 scores. The secondary goal is to confirm the safety of the treatments. Conclusion: This study is a prospective randomized controlled trial to determine the safety, feasibility, and potential efficacy of RIC for patients with Parkinson's disease associated with EDS.

A Single Dose of Oral Sucrose Is Enough to Control Pain During Venipuncture: A Randomized Controlled Trial.

Sucrose is effective in reducing pain during minor procedures in neonates. We evaluated whether a second dose of sucrose was more effective than a single dose during venipuncture. We performed a randomised, double-blind, controlled trial at the NICU of Padua Hospital (August 2016-October 2017). We randomised 72 preterm infants undergoing venipuncture for routine test to a control group, which received a single standard dose of sucrose 2' before the procedure and a placebo 30″ after the venipuncture, and an experimental group in which they received two doses of 24% sucrose 2' before and 30″ after the venipuncture. No difference in pain perception was found between the groups at 30″, 60″ and 120″. In conclusion, we do not recommend a second dose of sucrose during venipuncture in prematures.

Pain Neuroscience Education and Motor Control Exercises versus Core Stability Exercises on Pain, Disability, and Balance in Women with Chronic Low Back Pain.

Background: Several interventions have been used to relieve chronic low back pain (CLBP). This study aimed to compare the effects of pain neuroscience education (PNE) followed by motor control exercises (MCEs) with core stability training (CST) on pain, disability, and balance in women with CLBP. Methods: Thirty-seven women with CLBP were randomly divided into two groups of PNE/MCE (n = 18, 55.2 ± 2.6 years) or CST (n = 19, 54.6 ± 2.4 years). Eight weeks of PNE/MCE or CST were prescribed for each group, independently. Pain intensity (VAS scale), disability (Roland Morris Disability Questionnaire), unipodal static balance, and dynamic balance (time up and go test) were measured at the beginning and 8 weeks after the intervention. Two-way mixed ANOVA was used to analyze the results with alpha of 5%. Results: After 8 weeks, there was a significant difference in VAS scale between groups (p = 0.024), with both PNE/MCE and CST showing 58% and 42% reductions, respectively. There were no differences for all other variables between groups. Regarding pre- to post-comparisons, both groups showed improvements in all dependent variables (p < 0.001). Conclusion: The treatment with PNE/MCE was more effective in improving pain disability and unipodal static and dynamic balance than treatment with CST. Even so, both treatments were shown to be valid and safe in improving all dependent variables analyzed in women with CLBP.

Hypnosis to manage musculoskeletal and neuropathic chronic pain: A systematic review and meta-analysis.

This systematic review and meta-analysis aims to identify and quantify the current available evidence of hypnosis efficacy to manage pain in patients with chronic musculoskeletal and neuropathic pain. Randomized Control Trials (RCTs) with hypnosis and/or self-hypnosis treatment used to manage musculoskeletal and/or neuropathic chronic pain in adults and assessing pain intensity were included. Reviews, meta-analyses, non-randomized clinical trials, case reports and meeting abstracts were excluded. Five databases, up until May 13th 2021, were used to search for RCTs using hypnosis to manage chronic musculoskeletal and/or neuropathic pain. The protocol is registered on PROSPERO register (CRD42020180298) and no specific funding was received for this review. The risk of bias asessement was conducted according to the revised Cochrane risk of bias tool for randomized control trials (RoB 2.0). Nine eligible RCTs including a total of 530 participants were considered. The main analyses showed a moderate decrease in pain intensity (Hedge's g: -0.42; p = 0.025 after intervention, Hedge's g: -0.37; p = 0.027 after short-term follow-up) and pain interference (Hedge's g: -0.39; p = 0.029) following hypnosis compared to control interventions. A significant moderate to large effect size of hypnosis compared to controls was found for at 8 sessions or more (Hedge's g: -0.555; p = 0.034), compared to a small and not statistically significant effect for fewer than 8 sessions (Hedge's g: -0.299; p = 0.19). These findings suggest that a hypnosis treatment lasting a minimum of 8 sessions could offer an effective complementary approach to manage chronic musculoskeletal and neuropathic pain. Future research is needed to delineate the relevance of hypnosis in practice and its most efficient prescription.

A person-centered framework for designing music-based therapeutic studies in dementia: current barriers and a path forward.

Objectives: Music-based interventions have received growing attention to improve quality of life for people diagnosed with dementia. Results of randomized controlled trials and meta-analytic reviews to date, however, reveal a lack of conclusive evidence for or against the effectiveness of such interventions. Herein, we critically review the basic assumptions and methodological issues ingrained in the cultures of research and care as they relate to evaluating music-based treatments for people with dementia, and propose a shift in the methodology by which music interventions are empirically evaluated.Method: We begin by reviewing existing barriers to achieving clarity on the effectiveness of music interventions, and we highlight methodological and sociocultural constraints that have limited our ability to reach concrete conclusions in research studies to-date. We then consider several key factors that have demonstrated relevance in matching people to specific music-based interventions. Based on these key factors, we developed a person-centered framework integrating elements from precision-medicine methodology to guide intervention studies.Results: Our organizing framework systematically integrates the following factors to inform the design of intervention studies: 1) person-centered goals and desired outcomes; 2) differences among individuals in clinical, cognitive, and historical attributes; and 3) the context of intervention and access to resources.Conclusion: Integration of the proposed framework into empirical investigations of music interventions for people living with dementia will inform precise and tailored interventions that will bring clarity to this growing body of research. Another aim of this framework is to foster a more humane, person-centered approach to our culture of care.

Effectiveness of Manual Therapy and Acupuncture in Tension-Type Headache: A Systematic Review.

Tension-type headache is one of the most prevalent types of headache. The common presentation is a mild-to-moderate dull aching pain around the temporal region, like a tight band around the forehead, neck, shoulder, and sometimes behind eyes. It can occur at any age but most commonly in the adult female population. The exact underlying mechanism is not clear but muscle tension is one of the main causes, which can be due to stress and anxiety. There are several non-pharmacologic treatment options suggested for tension-type headaches, such as cognitive behavioral therapy, relaxation, biofeedback, acupuncture, exercise, manual therapy, and even some home remedies. This systematic review was performed to evaluate the effectiveness of acupuncture and manual therapy in tension-type headaches. The literature search was primarily done on PubMed. Eight articles involving 3846 participants showed evidence that acupuncture and manual therapy can be valuable non-pharmacological treatment options for tension-type headaches. Acupuncture was compared to routine care or sham intervention. Acupuncture was not found to be superior to physiotherapy, exercise, and massage therapy. Randomized controlled trials done in various countries showed manual therapy also significantly decreased headache intensity. Manual therapy has an efficacy that equals prophylactic medication and tricyclic antidepressants in treating tension-type headaches. The available data suggests that both acupuncture and manual therapy have beneficial effects on treating symptoms of tension-type headache. However, further clinical trials looking at long-term benefits and risks are needed.

Influence of multidisciplinary therapeutic approach on fibromyalgia patients.

There is no specific cure for fibromyalgia (FM), but combined non-pharmacologic and pharmacologic treatments may mitigate symptoms and improve quality of life in patients. The aim of the present study was to monitor patient response to several types of therapy, including cognitive-behavioral and occupational therapy, and kinetic therapy, as compared to a control group that was not subjected to any form of therapy. The study included 98 FM patients, all women, out of which 32 received cognitive-behavioral therapy and occupational therapy (CBT+OT), 34 kinetic therapy (KT) and 32 participated as controls. The evaluation protocol comprised two questionnaires developed in order to assess the patient's condition as fully as possible: Fibromyalgia Impact Questionnaire (FIQ) and Fibro Fatigue (FF) scale. At the pre-evaluation there were no significant inter-group differences. At post-evaluation significant differences were observed between the control sample and the group subjected to kinetic therapy (P<0.05). FIQ scores decreased in the CBT+OT group too, but less than that in the KT group. The FF scale registered notable evolutions in time for the group subjected to kinetic therapy. In order to control and improve most of the FM symptoms, besides proper medication, we suggest an interdisciplinary intervention mainly focusing on long-term individualized kinetic therapy. The simultaneous integration of a cognitive-behavioural and occupational therapy intervention could be the element that completes the complex treatment of FM patients.

Management of primary headaches during pregnancy, postpartum, and breastfeeding: A systematic review.

BACKGROUND: Primary headaches (migraine, tension headache, cluster headache, and other trigeminal autonomic cephalgias) are common in pregnancy and postpartum. It is unclear how to best and most safely manage them. OBJECTIVE: We conducted a systematic review (SR) of interventions to prevent or treat primary headaches in women who are pregnant, attempting to become pregnant, postpartum, or breastfeeding. METHODS: We searched Medline, Embase, Cochrane CENTRAL, CINAHL, ClinicalTrials.gov, Cochrane Database of SRs, and Epistemonikos for primary studies of pregnant women with primary headache and existing SRs of harms in pregnant women regardless of indication. No date or language restrictions were applied. We assessed strength of evidence (SoE) using standard methods. RESULTS: We screened 8549 citations for studies and 2788 citations for SRs. Sixteen studies (mostly high risk of bias) comprising 14,185 patients (total) and 26 SRs met the criteria. For prevention, we found no evidence addressing effectiveness. Antiepileptics, venlafaxine, tricyclic antidepressants, benzodiazepines, ß-blockers, prednisolone, and oral magnesium may be associated with fetal/child adverse effects, but calcium channel blockers and antihistamines may not be (1 single-group study and 11 SRs; low-to-moderate SoE). For treatment, combination metoclopramide and diphenhydramine may be more effective than codeine for migraine or tension headache (1 randomized controlled trial; low SoE). Triptans may not be associated with fetal/child adverse effects (8 nonrandomized comparative studies; low SoE). Acetaminophen, prednisolone, indomethacin, ondansetron, antipsychotics, and intravenous magnesium may be associated with fetal/child adverse effects, but low-dose aspirin may not be (indirect evidence; low-to-moderate SoE). We found insufficient evidence regarding non-pharmacologic treatments. CONCLUSIONS: For prevention of primary headache, calcium channel blockers and antihistamines may not be associated with fetal/child adverse effects. For treatment, combination metoclopramide and diphenhydramine may be more effective than codeine. Triptans and low-dose aspirin may not be associated with fetal/child adverse effects. Future research should identify effective and safe interventions in pregnancy and postpartum.

An integrated program of computer-presented and physical cognitive training exercises for children with attention-deficit/hyperactivity disorder.

BACKGROUND: This study integrated an experimental medicine approach and a randomized cross-over clinical trial design following CONSORT recommendations to evaluate a cognitive training (CT) intervention for attention deficit hyperactivity disorder (ADHD). The experimental medicine approach was adopted because of documented pathophysiological heterogeneity within the diagnosis of ADHD. The cross-over design was adopted to provide the intervention for all participants and make maximum use of data. METHODS: Children (n = 93, mean age 7.3 +/- 1.1 years) with or sub-threshold for ADHD were randomly assigned to CT exercises over 15 weeks, before or after 15 weeks of treatment-as-usual (TAU). Fifteen dropped out of the CT/TAU group and 12 out of the TAU/CT group, leaving 66 for cross-over analysis. Seven in the CT/TAU group completed CT before dropping out making 73 available for experimental medicine analyses. Attention, response inhibition, and working memory were assessed before and after CT and TAU. RESULTS: Children were more likely to improve with CT than TAU (27/66 v. 13/66, McNemar p = 0.02). Consistent with the experimental medicine hypotheses, responders improved on all tests of executive function (p = 0.009-0.01) while non-responders improved on none (p = 0.27-0.81). The degree of clinical improvement was predicted by baseline and change scores in focused attention and working memory (p = 0.008). The response rate was higher in inattentive and combined subtypes than hyperactive-impulsive subtype (p = 0.003). CONCLUSIONS: Targeting cognitive dysfunction decreases clinical symptoms in proportion to improvement in cognition. Inattentive and combined subtypes were more likely to respond, consistent with targeted pathology and clinically relevant heterogeneity within ADHD.

Incidence of Free of Charge Physiotherapy in a Danish National Cohort of Stroke, Parkinson's Disease, Multiple Sclerosis and Rheumatoid Arthritis Patients.

BACKGROUND: Denmark is a welfare state with a publically funded healthcare system that includes the right to free of charge physiotherapy (FCP) for patients with chronic or progressive disease who fulfill strict criteria. The aim of this study was to investigate the incidence of referral to FCP in patients with a hospital diagnosis of stroke, multiple sclerosis (MS), Parkinson's disease (PD) and rheumatoid arthritis (RA) between 2007 and 2016. METHODS: The study was register-based and included data from The Danish National Patient Registry and The National Health Service Registry. The study population included the four largest disease groups receiving FCP in Denmark. The incidence of receiving FCP was reported as the cumulated incidence proportion (CIP). RESULTS: The study showed that FCP was mainly initiated within the first 2 years after diagnosis. The 2-year CIP was 8% for stroke patients, 53% for PD patients, 49% for MS patients, and 16% for RA patients. The proportion of patients referred to FCP generally increased over the period of the study due to more patients being referred from medical specialists in primary care. CONCLUSION: This study found substantial differences in the incidence of referral to FCP in a Danish population of stroke, PD, MS and RA patients.

Evaluation of a special concept of physical therapy in spondyloarthritis: German multimodal rheumatologic complex treatment for spondyloarthritis.

OBJECTIVES: Multimodal rheumatologic complex treatment (MRCT) is a specific concept of German inpatient care focusing on physical therapy for patients with rheumatic diseases suffering from exacerbated pain and functional impairment. As physical therapy is a key concept in the treatment of spondyloarthritis (SpA), we conducted a monocentric retrospective analysis of the effects of MRCT on pain and functional status in patients with SpA including patients with axial spondyloarthritis (axSpA), non-radiographic axial spondyloarthritis (nr-axSpA) and psoriatic arthritis with axial involvement (axPsA). METHODS: 134 treatment episodes provided to 100 patients with SpA between 2014 and 2017 were analysed. We evaluated changes in pain intensity, in functional status and in disease activity before and after a treatment episode. In addition, we assessed potential influences of various patient characteristics, the course of the disease and comorbidities. RESULTS: Overall, MRCT resulted in significant amelioration of pain (NRS: p < 0.001), significant improvement of functional capacity (FFbH: p = 0.03; HAQ: p = 0.02; BASFI: p < 0.001) and significant reduction of disease activity (BASDAI p < 0.001; DAS28: p = 0.009). In general, treatment effects on axSpA, nr-axSpA and axPsA were comparable. Different aspects of the disease and its previous course did not have a significant effect on the outcome parameters. Comorbidities (e.g. fibromyalgia) did not significantly influence treatment response. CONCLUSION: MRCT not only decreases pain and improves function but also reduces disease activity in patients with axSpA, nr-axSpA and axPsA irrespective of the course of disease and comorbidities (e.g. fibromyalgia), thus underlining the importance of non-pharmacological and physical treatment in the treatment of SpA.Key Points• Physical treatment is a key component in treating SpA.• Multimodal rheumatologic complex treatment (MRCT) is a specific concept of German inpatient care focusing on physical therapy for patients with rheumatic diseases suffering from exacerbated pain and functional impairment.• MRCT not only decreases pain and improves function but also reduces disease activity in patients with axSpA, nr-axSpA and axPsA irrespective of the course of disease and comorbidities (e.g. fibromyalgia).• MRCT could be a role model of treating SpA by means of physical therapy as its effects are not influenced by therapy, disease duration or comorbidities and as it has no side effects.

Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.

INTRODUCTION: Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. METHODS: This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart). RESULTS: Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) (p = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common. CONCLUSIONS: Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The "sham" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.