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Found 6 Actively Recruiting clinical trials

M

Actively Recruiting

This research aims to evaluate how well differential target multiplexed DTM spinal cord stimulation works to treat chronic back and leg pain in patients with conditions like Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2. The study will also compare outcomes between patients using paddle or surgical leads and those using percutaneous leads to see if there are differences in effectiveness. Participants will receive spinal cord stimulation using the DTM approach as the main treatment. This device-based therapy will be monitored over time, with evaluations conducted at 1 month, 6 months, and 12 months after implantation. The study will collect detailed information on pain intensity, medication use, functional ability, quality of life, and other factors related to pain and daily living. During the study, participants will undergo assessments including pain ratings using the Visual Analogue Scale, measures of disability, psychological factors, and healthcare use. Data on device parameters, battery consumption, and any technical issues will also be tracked. Safety will be monitored by recording any adverse events throughout the study period. Overall, the study involves regular follow-up visits and evaluations over a year to understand the impact of DTM spinal cord stimulation on chronic pain.

Age: 18Years +All Genders
14 locations
P

Actively Recruiting

This research aims to compare the effects of different pain medication tapering approaches before Spinal Cord Stimulation SCS implantation in patients with Persistent Spinal Pain Syndrome Type 2 PSPS T2, a condition causing ongoing low back and leg pain after spinal surgery. The study evaluates whether standardized tapering, personalized tapering, or no tapering affects disability and other health outcomes over 12 months. Researchers are interested in how these approaches influence pain intensity, quality of life, medication use, psychological health, sleep, and healthcare costs. Participants are randomly assigned to one of three groups usual care without tapering, a standardized pain medication tapering program before SCS implantation, or a personalized tapering program tailored to the patient. Pain medication tapering occurs during a hospital stay prior to the SCS implant. The study involves 195 patients, with 130 receiving tapering protocols and 65 receiving usual care. The trial uses a double-blind design to compare these approaches over one year. Throughout the study, participants are evaluated at baseline and at 1, 3, 6, and 12 months after receiving SCS. Assessments include disability scores as the primary outcome and various secondary measures such as pain intensity, health-related quality of life, participation in daily activities, substance use effects, anxiety and depression levels, medication use, psychological factors, sleep quality, central sensitization symptoms, and healthcare use. This comprehensive monitoring helps determine the impact of tapering strategies on overall patient well-being and resource use.

Age: 18Years +All GendersPhase Not Applicable
3 locations
C

Actively Recruiting

Researchers are evaluating a structured, evidence-based rehabilitation pathway called the R pathway for patients undergoing lumbar surgery due to radicular pain. This multicenter cluster randomized controlled trial compares the R pathway against usual care to see if it can reduce the time it takes for patients to return to work after surgery. The study focuses on patients aged 18 to 65 scheduled for lumbar spinal surgery with radicular pain lasting at least six weeks. The R rehabilitation pathway involves coordinated care guided by a case manager, starting before surgery and continuing up to one year afterward. It includes prehabilitation, perioperative rehabilitation, and postoperative rehabilitation, aiming to reduce fear by minimizing unnecessary activity restrictions, eliminating bracing, and actively encouraging return to work. Hospitals are randomized to either implement the R pathway or continue with their usual variable rehabilitation care, which may include no rehabilitation or various types of therapy. Participants will be monitored from surgery through 15 months postoperatively. Researchers will assess the time to return to work as the primary outcome. Secondary outcomes include disability, percentage of patients returned to work, functional status, back and leg pain, health-related quality of life, work productivity, analgesic use, kinesiophobia, and pain catastrophizing at multiple time points. The study requires written consent and involves follow-up assessments to evaluate recovery and work reintegration.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
16 locations
S

Actively Recruiting

The trial investigates treatment options for adults with inflammatory bowel diseases IBD, including Crohns disease and ulcerative colitis, focusing on patients who were previously treated with an optimized dose of intravenous infliximab. The study aims to compare if switching to weekly subcutaneous infliximab leads to better clinical and biological remission outcomes than the standard bi-weekly subcutaneous administration. It also compares patients willing to switch to subcutaneous treatment with those continuing intravenous therapy. Participants who switch from intravenous infliximab will be randomly assigned to receive either 120 mg of subcutaneous infliximab weekly or every other week. Those not willing to switch will continue their existing intravenous dosing schedule. The study is conducted nationally with multiple centers, involving screening and follow-up visits over one year, with physical exams, clinical scoring, blood and stool analyses, and questionnaires about quality of life and treatment satisfaction. During the study, participants will have four visits with their gastroenterologist throughout one year, where clinical remission scores, lab tests, and medication use are assessed. Those on subcutaneous infliximab will keep a diary of at-home injections and complete satisfaction questionnaires. The primary measurement is the proportion of patients maintaining steroid-free clinical and biological remission without treatment changes at week 52. Researchers will also monitor treatment optimization, discontinuation, relapse timing, and patient experiences.

Age: 18Years +All GendersPhase 4
15 locations
E

Actively Recruiting

Researchers are studying how extracorporeal shock wave therapy ESWT, a non-invasive mechanical treatment, affects postsurgical scars, especially those after abdominoplasty and breast reduction. Scars from deep injuries can cause pain, itching, and aesthetic concerns. The study aims to understand how mechanical forces influence scar healing on a cellular level and to determine the best ESWT treatment settings during different wound healing phases. The study involves applying focused ESWT to scarred areas in three intervention groups, each receiving 10 treatments once a week. Different energy levels, frequencies, and intensities of ESWT will be tested to see how they affect scar tissue and cellular pathways. There will also be control groups that do not receive ESWT. Biopsies from abdominoplasty scars will be collected before and after treatment to examine changes in scar tissue at various healing stages. Participants will undergo several assessments including biopsies and non-invasive scar evaluations measuring color, thickness, elasticity, and patient-reported outcomes. These evaluations take place at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. The study will track changes in molecular markers related to scarring and how they relate to physical scar characteristics. Safety and quality of life will also be monitored throughout the study period.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
4 locations
S

Actively Recruiting

Researchers are collecting detailed data about suicide attempts and suicidal thoughts among people who come to healthcare services in Flanders. The study aims to understand how often these behaviors occur, the methods used, and how many receive proper follow-up care after a suicide attempt. This observational study uses a structured interview tool called the Guideline for Suicide Care and Evaluation LOES to gather comprehensive information. Participants undergo a two-part semi-structured interview administered by trained nurses, psychologists, or psychiatrists. The first part happens soon after admission to a healthcare facility and collects information on emotional state, mental health history, social support, hopelessness, and suicidal behavior. The second part provides a deeper evaluation of risk factors, treatment needs, motivations, planning, and coping strategies related to suicidality. Throughout the study, participants provide demographic, clinical, and psychological information through interviews. Researchers assess suicidal intent, planning, past behavior, substance use risk, and care needs. The study tracks treatment agreements and care pathways after assessment. Data collection occurs at the initial presentation, with no drug or medical treatment being tested. The total participation time varies depending on the individuals healthcare encounters and follow-up.

Age: 12Years +All Genders
33 locations