Clinical trials

This study investigates the modification of connectivity patterns in response to one session of active repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. TMS-evoked potentials (TEPs) will be recorded before and after the rTMS session and will serve as a reflection of cortical connectivity to TMS. Four cortical targets will be stimulated for TMS-EEG assessment: left primary motor cortex, right primary motor cortex, left premotor cortex, and right occipital cortex.

Previous research has demonstrated that repetitive magnetic brain stimulation can be an effective adjunctive treatment for several conditions, including chronic pain. However, current stimulation protocols are typically standardized and do not account for individual variability in brain function. This uniform, one-size-fits-all approach results in only about 40% of patients experiencing meaningful clinical benefit, while the remainder show little to no improvement. To address this limitation, the present study will investigate how magnetic stimulation can be tailored to individuals with chronic pain. By analyzing each participant's brain signals prior to treatment, we aim to personalize stimulation parameters to better match individual neural characteristics and potentially enhance therapeutic outcomes. The design of this study builds directly on the findings of a previous clinical trial.

This study investigates the long-term effects of implementing a passive back-support exoskeleton during manual order-picking work in a real-world warehouse environment. Work-related musculoskeletal disorders, particularly low back pain, are common among logistics workers due to frequent lifting, repetitive movements, and awkward postures. Although laboratory studies suggest that occupational exoskeletons can reduce biomechanical load, evidence from long-term, real-world workplace implementations remains limited. The RELAX project is an 18-month controlled in-field intervention study conducted in two departments of a Danish warehouse. Approximately 90 full-time warehouse workers will participate. Workers in the intervention department will use a passive back-support exoskeleton during manual order-picking tasks, while workers in the control department will continue their work as usual. The primary outcomes include sickness absence, employee turnover, perceived work intensity, and musculoskeletal discomfort. Secondary outcomes include productivity, user acceptance of the exoskeleton, and cost-effectiveness of the intervention. Outcomes will be assessed through company records, repeated questionnaires, and focus-group interviews over the 18-month period. By combining longitudinal quantitative outcomes with qualitative process evaluation, the study aims to determine whether long-term use of a passive back-support exoskeleton can improve worker well-being and reduce work-related musculoskeletal burden without negatively affecting productivity. The results may inform workplace policies and future implementation of occupational exoskeletons in physically demanding industries.

It is well known that itch and pain have many communalities in terms of pathways and molecules involved. Therefore, it is very important to investi-gate different substances that work against both pain and itching. The substances delgocitinib and lidocaine have both been shown to relieve various types of pain. We therefore assume that these creams will be also able to relieve itching. The purpose of this trial experiment is therefore to investigate the effect of delgocitinib, lidocaine and their combination on experimentally induced itching.

This clinical trial aims to compare the effectiveness of an early plyometric exercise approach with traditional heavy, slow resistance training in treating tendinopathies of the Achilles tendon, patellar tendon, and plantar fascia. These conditions, commonly seen in general and rheumatology practices, cause pain, reduced function, and stiffness, often leading to prolonged recovery and incomplete return to full physical activity. The study hypothesizes that introducing plyometric exercises early in rehabilitation will improve jump function after 12 weeks and reduce re-injury rates within 52 weeks compared to traditional methods. The study is a randomized clinical trial including 120 participants aged 18-50 with tendinopathy in one of the targeted areas. Participants must regularly engage in running or jumping sports, have symptoms for at least three months, and meet other inclusion criteria. Exclusion criteria include recent surgery or specific medical conditions. Both groups will perform exercises three times weekly for 12 weeks, tailored to their tendinopathy. The intervention group will add progressive plyometric exercises to the standard strength training performed by the control group. Plyometric training will consist of three levels, with patients self-assessing readiness to progress. The primary outcome is the change in the plyometric quotient, a measure of functional ability, based on a jump test using a force platform at 0 and 12 weeks. Secondary outcomes include dynamic strength, jump height, patient-reported symptoms (via questionnaires), return to sport, training compliance, adverse events, pain thresholds, re-injury rates, and psychological readiness for sports. Assessments will occur at baseline, 12 weeks, and 52 weeks.

The goal of this clinical trial is to learn whether sleep hygiene education can improve sleep quality and reduce pain in adults with migraine and/or chronic lower back pain. Poor sleep is common in people with chronic pain and may worsen symptoms. Improving sleep may help break this cycle. The main questions this study aims to answer are: 1. Does a four-week sleep hygiene education program improve sleep quality? 2. Does improved sleep lead to reduced pain intensity and changes in pain sensitivity? This study does not include a comparison group. Each participant serves as their own comparison by completing the same tests before and after the sleep hygiene program. Participants will: * Attend two study visits lasting 30-60 minutes, one at the beginning and one after four weeks * Complete questionnaires about sleep, pain, mood, and quality of life at both visits * Undergo pain sensitivity testing using light pinprick stimulations on the forearm * Receive individual sleep hygiene education and written materials to use at home for four weeks * Complete a short weekly online check-in about sleep habits and pain * Complete a three-month follow-up questionnaire about sleep habits, sleep quality, and pain

In this study, it will be investigated if the phenomenon of offset analgesia, usually associated with painful heat stimulation, could also be induced using cold painful temperatures.

This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels. A total of 210 participants will be enrolled across three parallel sub-studies: * Type 1 diabetes (n = 76) * Type 2 diabetes (n = 54) * Prediabetes (n = 80) Participants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat). Exploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8. The study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.

Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. This medical treatment needs routine adjustment, but in many cases, this adjustment is not done timely, which results in life treating conditions where the patients need acute hospitalization. Remote health monitoring of HF patients has the potential to ensure timely adjustment. However, only sensors placed inside the blood vessels of the lung, have been shown effective. The disadvantage is that the placement of the sensor requires surgery. This makes the method costly and poses a risk for the patient. The aim of the current project is to develop a small intelligent patch, which can measure the heart's function from the outside of the body. The method will be low-cost, simple to use and will not pose a risk to the patient.

This study aims to explore the effect of burst-taVNS (electric stimulation of the concha cymba) on tonic (capsaicin-induced skin pain) and acute (pressure pain sensitivity) experimental pain and cardioception. Primary outcomes include pain intensity. Secondary outcomes include sensory thresholds, resting heart rate (EKG), pupillary measurements and conditioned pain modulation.

The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. Afterwards, three areas will be selected on each forearm of the subjects. Two areas will be treated with histamine, two with cowhage, and two with vehicle. One application of each substance will be conducted including the contagious itch component. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a VAS scale.

The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. Afterwards, two areas will be selected on each forearm of the subjects. The four areas will be treated with the same vehicle cream for 20 minutes, in order to test the placebo effect. At the end of the cream application, two areas will be randomly treated with histamine while cowhage will be applied on the other two areas. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a Visual Analog Scale.

Previous research has shown the effectiveness of magnetic stimulation of the brain as a supplemental treatment for various conditions, such as depression and chronic pain. However, the application of magnetic stimulation has been standardized across patients without considering individual differences. This one-size-fits-all approach results in only half of the patients benefiting from the treatment, with the other half seeing no improvement in their symptoms. Therefore, a study on individuals with chronic pain will be performed to explore how magnetic stimulation treatments can be tailored to each person. This will involve analysing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.

The experiment consists of three experimental sessions conducted on three consecutive days. In all experimental sessions, the participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. In the first session, we will mark six test areas in your face (three on each side on jaw, cheek, and temple, respectively). Thent a series of measure-ments in each test area will be conducted:measurement of the blood flow in the skin and sensitivity tests to pressure, pinprick and stroke with a brush. In the second session, histamine will be applied in one side of the face. On the other side, cowhage spicules will be applied. After 10 minutes, all the tests will be conducted again. The third session will be identical to the second. However, instead of histamine and spicules, patches containing capsaicin will be applied. In the other side, we will apply patches with placebo (i.e., a non-active patch). After 20 minutes all the tests will be conducted again.

Knee osteoarthritis is a complex condition, and selecting effective non-drug treatments like orthoses or exercise is often difficult and imprecise. This study will follow individuals with early-stage knee osteoarthritis or previous anterior cruciate ligament injury to develop computational models that predict cartilage degeneration and pain over time. The models will integrate data from medical imaging, movement analysis, muscle strength testing, pain assessments, questionnaires, and biomarkers to improve personalized treatment planning.

The goal of this study is to compare two different educational methods for training general practitioners (GPs) in point-of-care ultrasound. The main question it aims to answer is: \- Does the use of ultrasound phantoms and simulators result in superior post-course ultrasound skills compared to traditional training methods involving healthy volunteers? Researchers will compare a group trained with traditional methods (scanning healthy volunteers) to a group trained using ultrasound phantoms and simulators to see if the different training methods result in different levels of ultrasound proficiency. Participants will: * Be 24 general practitioners randomized into two groups of 12. * Receive training in five clinical ultrasound examinations: 1) Aortic abdominal aneurism, 2) gallstones, 3) pleural effusion, 4) hydronephrosis, and 5) free fluid in the abdomen (FAST scan). * Begin with e-learning, followed by two in-person teaching seminars. * Train at their clinics between course days: first on healthy volunteers, then on indicated patients. * Upload scans to an online learning platform and receive feedback from instructors. * Be assessed after 90 days using the validated Objective Structured Assessment of Ultrasound Skills (OSAUS) tool, with blinded evaluators.

Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.

The purpose of this project is to investigate the efficacy of the hip belt squat exercise in pain management and physical function for people with chronic low back pain.

The aim of this project is to determine the effects of performing a motor imagery task on cortical excitability during acute experimental muscle pain (induced by hypertonic saline), acute histaminergic itch (induced by histamine), and non-histaminergic itch stimulation (triggered by Cowhage). We hypothesize that motor imagery will counteract the alterations in cortical excitability observed during experimental muscle pain and both itch models.

In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.

In This experiment, the investigators would like to test following hypotheses regarding the influence of sleep fragmentation on itch: * To investigate similarity and differences between itch and pain by comparing the effect of sleep deprivation in them. * To evaluate the inflammatory state induced by sleep fragmentation via the analysis of C-reactive protein (CRP) levels from blood samples. * To correlate the anxiety and depression scores (evaluated through questionnaires) with itch and pain sensitivity and evaluate how they are affected by sleep fragmentation.

This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.

We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them to a trial, we aim to evaluate the feasibility of our intervention before initiating further trials. The purpose of this non-randomized feasibility study is to test the feasibility and acceptability of this exercise protocol with addition of a corticosteroid injection with no aim of evaluating effects. All participants in this study will receive the following interventions: * An ultrasound-guided corticosteroid injection superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip. * A home exercise program including 3 exercises, scalable to 3 different difficulty levels. * A patient information leaflet containing relevant information on managing lateral hip pain.

In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.