Alcala De Henares

Temporomandibular disorders (TMD) are a significant public health concern worldwide, with increasing incidence over the years. Researchers are investigating whether combining manual therapy with vagus nerve stimulation, which involves deep breathing to stimulate a parasympathetic nerve connected to jaw innervation, can better reduce pain, increase jaw movement, and improve quality of life in patients with myogenic TMD compared to manual therapy alone. The study is conducted by a team of physiotherapists who will evaluate these effects in a controlled setting. The study will include 20 participants divided into two groups: an experimental group receiving manual therapy plus vagus nerve stimulation, and a control group receiving manual therapy plus a placebo vagus nerve stimulation. Both groups will undergo four weekly physiotherapy sessions over one month and will be taught exercises to perform at home on non-clinic days. The intervention period lasts two months in total. Participants will be assessed by a physiotherapist who is not involved in treatment and remains blinded to group assignment. Evaluations will occur once a month for three months and include questionnaires measuring chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes focus on changes in patient health status and chronic pain levels after two months of treatment.

Researchers are investigating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess changes in blood sugar control and dependence on prandial insulin over one year. The study follows established criteria for Stage 3 T1D diagnosis and includes participants on standard insulin therapy. Participants will receive either teplizumab or placebo through intravenous infusion. Both treatments are given as a solution for injection. The study spans approximately 84 weeks (18 months) for each participant, with the main treatment period lasting 52 weeks. The trial compares the effects of the two treatments on diabetes management and insulin use over this time. During the study, participants will undergo evaluations of their blood sugar control, including measurements of glycated hemoglobin (HbA1c) and insulin use. For those in European Union countries aged 5 years and older, additional tests will measure insulin production response after a meal. Safety and health will be monitored through regular clinical assessments, lab tests, and antibody screening. The study tracks changes from the beginning through the 52-week treatment period to understand the impact of teplizumab on diabetes progression.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are studying how physical exercise affects patients diagnosed with Major Depressive Disorder (MDD), focusing on the anti-inflammatory, oxidative stress, and brain mechanisms that may explain exercise's antidepressant effects. The trial aims to evaluate the effectiveness of a physical exercise program added to standard antidepressant treatment in real-life conditions, compared to standard treatment alone. This study also seeks to understand how exercise influences cognitive performance, functioning, and well-being in MDD patients, along with the long-term effects one year after the intervention. Participants will be randomly assigned to two groups: one receiving a 12-week physical exercise program alongside their usual antidepressant medication, and a control group receiving only standard antidepressant treatment without changes to their usual physical activity. The exercise program includes daily walking monitored by an activity band with progressive step goals, plus two weekly 60-minute supervised online group sessions combining aerobic and strength exercises using elastic bands and body weight. The exercise sessions progress in intensity, exercise difficulty, and work/rest ratios, supervised by an experienced physical education professional. During the study, participants will be assessed at baseline, 12 weeks after starting the intervention, and one year after randomization. Researchers will measure inflammatory and oxidative stress biomarkers, brain imaging, clinical evaluations, cognitive performance, functioning, and well-being. Physical activity and sleep will be objectively tracked using accelerometers. The study also monitors patient acceptance of the exercise intervention and aims to increase awareness among health practitioners about exercise's antidepressant effects.

Researchers are investigating the mechanical effects of dry needling on the quadriceps muscle. This study focuses on measuring changes in muscle structure and mechanics, using ultrasound to assess muscle activity, and evaluating quadriceps strength and knee joint range. The goal is to understand how dry needling influences these variables in healthy adults. Participants will undergo a procedure where the quadriceps muscle is punctured at the most sensitive point using a dry needling technique guided by ultrasound while lying down. Measurements will be taken before and after one week to observe any changes in muscle thickness. During the study, muscle strength will be tested with dynamometry and knee movement will be checked using a goniometer. Ultrasound imaging will monitor muscle thickness changes, with assessments occurring before and after the treatment. Participants will be involved in the study for at least one week to evaluate these outcomes.

Researchers are evaluating the role of Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) with Mitomycin-C in patients with colon cancer that has spread to the peritoneum. The study focuses on patients undergoing complete surgical removal of these metastases combined with systemic chemotherapy. This Phase IV multicenter trial aims to determine if adding HIPEC with Mitomycin-C improves the time patients remain free from cancer recurrence in the peritoneal cavity, addressing limitations seen in previous studies using a different drug and treatment approach. Participants will be divided into two groups: one receiving complete cytoreductive surgery plus HIPEC with Mitomycin-C for 90 minutes, and the other undergoing surgery alone without HIPEC. The HIPEC procedure uses a dose of 35 mg/m2 Mitomycin-C delivered in a heated solution for 90 minutes with specific dose fractionation at set intervals. Only patients with limited volume peritoneal metastases, complete tumor removal, and colon (not rectal) cancer are included. Systemic chemotherapy is given before and/or after surgery as part of the treatment. During the study, patients will be closely monitored to confirm complete tumor removal and disease extent. Researchers will track peritoneal recurrence-free survival over three years as the primary outcome. Patients undergo assessments to ensure they meet health and surgical risk criteria before enrollment. Safety and disease progression are also regularly evaluated, with informed consent and ongoing follow-up care provided throughout the trial.

Subacromial syndrome is a common cause of shoulder pain with unclear causes and no specific treatment. This research compares two treatment methods: manual therapy using ischemic pressure, joint mobilizations, and myofascial techniques, and low-medium energy radial shock wave therapy. The study is a randomized, single-blind clinical trial involving 88 participants with subacromial syndrome, aiming to find which treatment is more effective for pain relief. Participants will be randomly assigned to one of two groups. One group will receive manual therapy treatments adapted to their condition, including joint mobilization and pressure release on muscle trigger points, over six weeks. The other group will undergo radial shock wave therapy once a week for six weeks, targeting specific points around the shoulder. Both groups will follow a 12-week home-based exercise program after their treatments. Throughout the study, researchers will measure shoulder pain using visual analogue scales during movement, rest, and overnight. They will also assess shoulder function with questionnaires, strength tests using a handheld dynamometer, and range of motion measurements. These assessments will be done before treatment and one year after to evaluate long-term effects.

The aging process causes changes in organs and tissues that can lead to increased frailty and a higher risk of falls among older adults. Falls are a major health concern worldwide, often resulting in hospitalization, immobilization, and fear of falling again, which may cause disability. This research aims to study how stress affects neuromuscular function and postural control, important factors in balance and fall risk, particularly in elderly individuals with varying cognitive and functional abilities. All participants will undergo an initial cognitive and physical assessment, followed by two testing sessions. In the baseline test, participants will view low-arousal images from the International Affective Picture System (IAPS) for three minutes while seated, then perform movements including standing, walking, manipulating bottles, and sitting down. In the experimental test, the same physical tasks are repeated after viewing high-arousal IAPS images for three minutes, with the images continuing during the motor tasks. Throughout the study, researchers will measure pressures on the floor, muscle activity using surface electromyography, movement acceleration, and balance before and after the tests. Additional assessments include heart rate variability, respiratory rate, and feelings of unease after viewing images. These measures will help evaluate how stress influences balance and motor control in both young and older adults, with special focus on older adults' cognitive and functional status.

Researchers are investigating the effectiveness of diathermy compared to dry needling in people with chronic low back pain lasting more than six weeks. This randomized controlled trial aims to see if diathermy can better improve pain intensity in the short term. The study follows guidelines from CONSORT and the Declaration of Helsinki, enrolling adults aged 18 to 65 with chronic nonspecific low back pain. Participants will be randomly assigned to receive two treatment sessions of either diathermy or dry needling. Diathermy uses a device delivering capacitive deep thermotherapy at 500 kHz for 10 minutes on each side of the lower back, combined with massage techniques while lying face down. Dry needling involves inserting 4 cm needles with 12 incisions on the most painful side of the lumbar iliocostalis muscle, followed by one minute of ischemic compression. All patients will also follow a home exercise program. Participants will be assessed at the start of the study and then at 1 week, 1 month, and 3 months after treatment. Researchers will measure changes in pain intensity using a visual analogue scale, along with disability, fear of movement, and catastrophic thinking. Statistical analyses will evaluate differences between groups with confidence intervals. The total study period runs from August 2022 to March 2023.

Researchers are studying how different expectations—positive, neutral, or negative—affect the activation of the Autonomic Nervous System (ANS) and pain relief when using dry needling therapy for patients with nonspecific neck pain. Dry needling is a technique that targets myofascial trigger points and has known effects on both the central and autonomic nervous systems. This study aims to better understand how a patient's expectations influence treatment outcomes and ANS activation. Participants will be randomly assigned to one of three groups where they will receive an individual informative talk designed to induce positive, neutral, or negative expectations. All participants will then undergo dry needling treatment at the most painful point in the upper trapezius muscle. The study will monitor variables such as pain levels using the Analogic Visual Scale and Pressure Pain Threshold before and after treatment, along with measurements of the ANS including skin conductance, skin temperature, heart rate, and breathing rate monitored for 5 minutes before, during, and 20 minutes after the intervention. During the study, participants will be assessed for pain and ANS responses through various measurements. Researchers will record changes in skin conductance twenty minutes after treatment as a primary outcome. The total participation will include baseline assessments, treatment, and follow-up monitoring to evaluate how induced expectations influence both the nervous system and the analgesic effect of dry needling in neck pain patients.