Lier

Researchers are evaluating the effectiveness of differential target multiplexed spinal cord stimulation (DTM SCS) for treating chronic back and leg pain, specifically in patients with Failed Back Surgery Syndrome (FBSS) and Persistent Spinal Pain Syndrome Type 2. The study will also analyze differences in outcomes between patients using paddle/surgical leads versus those using percutaneous leads. Participants will receive spinal cord stimulation using the differential target multiplexed stimulation device. The study is observational and includes patients suitable for DTM SCS treatment as determined by their physician. There are no separate treatment groups described, but subgroup analysis will compare different lead types. Participants will be assessed for overall pain intensity using the Visual Analogue Scale (VAS) at baseline, then at 1 month, 6 months, and 12 months after the DTM stimulation. The study involves regular visits to monitor pain levels and treatment outcomes. Participants must comply with the study protocol, including attending scheduled visits and following instructions.

This research aims to evaluate the impact of different pain medication tapering approaches before Spinal Cord Stimulation (SCS) implantation in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2). PSPS T2 involves persistent low back pain despite prior spinal surgery. The study's main goal is to compare disability outcomes 12 months after SCS in patients who undergo either a standardized pain medication tapering program, a personalized tapering program, or no tapering before SCS implantation. Additional health aspects such as pain intensity, quality of life, substance use effects, mental health, medication use, sleep, and healthcare costs will also be assessed. Participants will be randomly assigned to one of three groups: a standardized pain medication tapering program, a personalized tapering program, or no tapering before receiving SCS. The tapering interventions occur during a hospital stay before implantation. Usual care with respect to SCS implantation is provided to all participants. The study is a multicenter randomized controlled trial involving a total of 195 patients, with 130 receiving tapering programs and 65 receiving no tapering. Throughout the study, data will be collected at the start and at 1, 3, 6, and 12 months after SCS implantation. Researchers will measure changes in disability, pain intensity, quality of life, participation, substance use impact, anxiety, depression, medication use, psychological factors, sleep, central sensitization, and healthcare expenditures. This comprehensive monitoring helps understand the effects of tapering pain medication on long-term outcomes of SCS treatment in PSPS T2 patients.

Researchers are evaluating a structured rehabilitation pathway called the R³ pathway for patients undergoing lumbar surgery due to radicular pain, such as lumbar radiculopathy and radicular low back pain. This multicenter cluster randomized controlled trial compares the R³ pathway to usual care, aiming to see if this approach can reduce the time it takes for patients to return to work after surgery. The study focuses on a person-centered rehabilitation that supports patients through pre-, peri-, and postoperative phases while promoting early activity and work resumption. The R³ rehabilitation pathway involves a case manager guiding patients from before surgery up to one year after surgery. It includes prehabilitation, perioperative care, and postoperative rehabilitation emphasizing minimal activity restrictions, eliminating the use of braces, and active encouragement to resume work early. Hospitals participating in the trial are randomly assigned to either implement this pathway or continue with their usual care methods. The pathway specifically targets fear reduction and structured support to improve recovery. Participants will be monitored from surgery through 15 months postoperatively, with the main outcome being the time it takes to return to work. This involves regular assessments throughout the year following surgery to evaluate recovery progress and work reintegration. The study includes ongoing follow-up to understand the impact of the rehabilitation pathway compared to standard care on patient outcomes related to work and recovery.

This research aims to evaluate the effectiveness, safety, and tolerability of atogepant, a medicine approved for preventing migraine, when used to treat migraine attacks quickly. The study focuses on adults aged 18 to 75 years who have a history of moderate to severe migraine attacks. It includes a double-blind phase where neither participants nor doctors know who receives atogepant or placebo, followed by an open-label phase where everyone receives atogepant. The study is conducted at about 160 sites worldwide with around 1300 participants. Participants will receive both atogepant and placebo in a random sequence to treat qualifying migraine attacks during the double-blind phase. After treating four migraine attacks this way, participants will enter an open-label phase lasting until week 24, during which they will receive atogepant for any additional migraine attacks. Treatments are given as oral tablets. Throughout the study, participants will attend regular hospital or clinic visits and telephone check-ins. They will complete electronic diaries with questionnaires about their migraines and treatment effects. Medical assessments, blood tests, and monitoring for side effects will be conducted. The main outcome measured is the percentage of participants who experience freedom from pain two hours after taking the study medication for their first treated migraine attack, observed over about 16 weeks.

Researchers are evaluating the use of subcutaneous infliximab in adults with inflammatory bowel diseases (IBD) such as Crohn's disease, ulcerative colitis, and IBD type unclassified. This study focuses on patients who were previously treated with an optimized dose of intravenous infliximab and are currently in steroid-free clinical and biological remission. The trial aims to determine whether a weekly dose of subcutaneous infliximab leads to better outcomes compared to the standard bi-weekly dosing in these patients. Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomly assigned to receive either weekly or bi-weekly subcutaneous injections. A comparison group of patients who prefer to continue their optimized intravenous infliximab treatment will also be observed. The study will follow patients for one year, with assessments at weeks 0, 8, 24, and 52, though timing may vary based on individual intravenous dosing schedules. During the study, participants will undergo physical exams, blood and stool tests, and complete questionnaires about their health-related quality of life. Those switching to subcutaneous infliximab will also keep a diary of their home injections and answer questions about their experience. The main outcome measured is the proportion of patients who maintain steroid-free clinical and biological remission at week 52 without needing treatment changes. Safety and treatment satisfaction will also be monitored throughout the year.

Scars can result from physical trauma, surgical incisions, burns, and acne, with deep skin injuries sometimes causing problematic scars like hypertrophic or keloid scars. These scars may cause pain, itching, functional issues, and aesthetic concerns, impacting quality of life. Researchers aim to better understand how mechanical forces applied through extracorporeal shock wave therapy (ESWT) influence scar healing, especially after surgeries such as abdominoplasty and breast reduction, since the best treatment approach and mechanism behind ESWT's benefits remain unclear. In this study, patients who have postsurgical scars from abdominoplasty will receive focused ESWT treatments. The therapy will be applied once a week for 10 weeks in three different intervention groups, varying energy levels and timing during scar formation phases. A control group without ESWT will also be studied to compare effects. ESWT is a non-invasive, outpatient treatment aimed at activating cellular pathways involved in scar healing by controlled mechanical loading. Participants will undergo biopsies before and after treatment to analyze cellular and molecular changes in scars, including markers like myofibroblasts, macrophages, collagen types, and signaling proteins. Physical scar characteristics such as redness, thickness, pliability, pain, and overall quality of life will be assessed through objective and subjective measurements. This comprehensive approach will help link cellular changes with clinical scar improvements and guide future scar management therapies.

Researchers are collecting data in Flanders on how often suicide attempts and suicidal thoughts occur across various healthcare settings like hospitals, psychiatric centers, crisis teams, and general practitioners. The study aims to understand the methods used in suicidal behavior and see how many people receive proper aftercare following a suicide attempt. It uses a detailed tool called the Guideline for Suicide Care and Evaluation (LOES) to gather comprehensive information about individuals with suicidal thoughts or behaviors. The study includes a two-part semi-structured interview conducted by trained healthcare professionals such as nurses, psychologists, and psychiatrists. The first part happens shortly after admission to a healthcare facility following a suicide attempt or suicidal thoughts and collects demographic data, history, social support, hopelessness levels, and current suicidal ideation. The second part explores psychological factors more deeply, including motives, personal and interpersonal problems, and current thoughts of self-harm or suicide. Participants undergo detailed assessments on the first day covering demographics, clinical details, suicidal behavior methods, emotional state, suicidal intent and planning, past self-harm, social support, mental health history, substance use, coping strategies, and care needs. The study tracks participants’ openness to help and care pathways to formulate well-supported risk assessments. This comprehensive evaluation helps understand suicidal processes and needs in the Flanders region.