Clinical Research Directory

Multicomponent Exercise and Pain Neuroscience Education in Women With Fibromyalgia

Fibromyalgia is a long-term condition that causes widespread pain, fatigue, sleep difficulties, and limitations in daily activities. Exercise and education about pain may help people manage these symptoms, but more information is needed about programs delivered in community settings. The purpose of this study was to evaluate changes in physical function, pain, quality of life, and other health-related outcomes following a 12-week group program combining multicomponent exercise and pain neuroscience education in adults with fibromyalgia. Participants attended one weekly session that included education about persistent pain and supervised exercises designed to improve strength, endurance, balance, and mobility. Assessments were planned before the program, at week 6, and at week 12. Attendance and responses to exercise were also monitored. The researchers expected improvements in physical function, pain-related symptoms, and quality of life. The study involved one group of participants without a comparison group, so it was designed to explore changes during the program rather than establish whether the intervention caused those changes.

Respiratory Function in Fibromiyalgia Syndrome

Fibromyalgia is a condition that may lead to a decline in respiratory function, as well as impaired oxygen delivery to and utilization by the muscles-factors that contribute to fatigue and reduced exercise capacity. However, this aspect remains insufficiently studied and is not yet clearly understood. In this context, this study aims to compare upper extremity functional exercise capacity, respiratory and peripheral muscle strength, muscle oxygenation, pain, and quality of life in patients with fibromyalgia syndrome against those of healthy individuals.

Art and Mindfulness in Fibromyalgia Rehabilitation at the University Museum

This randomized controlled trial investigates the efficacy of a mindfulness-based rehabilitation program delivered in a non-traditional environment rich in art and beauty (the University Museum, UD'A) compared to a traditional university gym setting (CARES) for patients with fibromyalgia. The main question the study aims to answer is whether conducting mindfulness sessions in a museum setting can better reduce muscle pain (primary objective) and improve body awareness and quality of life (secondary objectives) compared to a standard gym setting. Additionally, the study evaluates autonomic nervous system responses using non-invasive thermal infrared imaging. Furthermore, this protocol incorporates an exploratory home-based maintenance component-utilizing an illustrated educational brochure and a preregistered video of previously learned exercises-during a four-week follow-up period (T1-T2) to assess adherence, feasibility, and the maintenance of therapeutic benefits

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.

Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.

Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation

Fibromyalgia is a syndrome with clinical symptoms that affect multiple systems of the body. Although basic science research and clinical research trials have been carried out, the cause and the mechanism of fibromyalgia are still unknown. The goal of current medical treatment is to relieve symptoms and improve quality of life. Recent clinical and experimental studies have shown that stimulation of the vagus nerve has a potential to help pain syndromes. In this study, we aim to evaluate the effects of using transcutaneous vagus nerve stimulation (tVNS) on treating pain and other symptoms in fibromyalgia patients. We will do this by using the VagaCalm device.

Light Bulb Stimuli to Reduce Chronic Pain

This pilot randomized, double-blind, crossover clinical trial will evaluate the feasibility and preliminary efficacy of chromatic (colored) light exposure for reducing pain severity and pain sensitivity in adults with fibromyalgia or chronic widespread pain and fatigue. Participants will complete daily symptom surveys throughout the study and undergo patient-reported outcome assessments and quantitative sensory testing at multiple timepoints. Participants will be randomized to receive either S-cone stimulating chromatic light or equal-energy white light for 2 hours daily over a 7-day treatment period. Following a 1-week washout, participants will cross over to the alternate condition. Outcomes will examine feasibility, changes in pain severity, pain interference, and measures of pain sensitivity. Total study duration is approximately 35 days.

The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial

This research study aims to investigate whether art and integrative medicine, within a unique setting like a university museum, can offer a new approach to help women suffering from fibromyalgia. Fibromyalgia is a chronic condition causing widespread pain and other symptoms such as fatigue and sleep disturbances. The question this study seeks to answer is: Is an 8-week rehabilitation program, based on mindfulness and body awareness techniques, conducted at the University Museum of the G. d'Annunzio University, effective in reducing pain and improving the quality of life (physical and mental well-being) and coping abilities in female fibromyalgia patients? Participants will be randomly assigned to either receive this program in the museum or to a control group.

Daily Cognitive Failures and Medication Adherence in Fibromyalgia

This study aims to investigate the relationship between everyday cognitive failures and medication adherence in adults with fibromyalgia. Fibromyalgia is a chronic condition associated with widespread pain, fatigue, and cognitive difficulties such as forgetfulness and problems with attention. These difficulties may affect patients' ability to take prescribed medications regularly, but their relationship with medication adherence remains unclear. This single-center, observational, cross-sectional study will include 70 adults aged 18-65 years diagnosed with fibromyalgia who regularly take at least one medication for the condition. Everyday cognitive failures will be assessed using the Cognitive Failures Questionnaire (CFQ), and medication adherence will be assessed using the five-item Medication Adherence Report Scale (MARS-5). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Information on pain severity, medications, and daily medication-taking frequency will also be collected. The study will examine whether greater cognitive failures are associated with lower medication adherence and whether this relationship remains after accounting for anxiety, depressive symptoms, number of regularly used medications, and daily medication-taking frequency. All assessments will be completed during a single visit lasting approximately 12-15 minutes. No experimental treatments, additional laboratory tests, or invasive procedures will be performed.

The Effect of Perception of Improvement in Patients With Fibromyalgia

Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.

PEACE: Comparing Chronic Pain Treatment Options

The purpose of this study is to compare two types of acupuncture with usual care on treating chronic pain. This study has three groups. Two groups will received acupuncture. One group will receive usual standard of care for 12 weeks and then will receive acupuncture. Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Each group will undergo a different method of needle administration.

The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms

The purpose of this study is to evaluate the efficacy of two diets - gluten-free and low-FODMAP diet- in relieving symptoms of fibromyalgia, and study whether these changes could be associated with changes in the gut microbiome (gut bacteria).

Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia

Fibromyalgia (FM) is a chronic pain condition that disproportionately impacts Veterans. Individuals diagnosed with FM patients experience lower self-esteem and positive affect, as well as greater levels of depression, anxiety, negative affect, and pain catastrophizing. Among those experiencing FM, clinical and experimental pain are associated with specific dispositional trait profiles, which are indexed by levels of negative affect and positive affect. Neuroinflammation and inflammation also play a role in FM- related affect and pain. Recent studies that have highlighted neuroinflammation and inflammation as physiological mechanisms associated with changes in dysregulated affect and chronic pain. Veterans with FM can ameliorate dispositional traits-i.e., increasing positive affect and reducing negative affect-by participating in exercise. However, a gap exists regarding how to optimally engage Veterans with FM in an exercise program. Thus, to fully take advantage of all potential therapeutic benefits of exercise for FM, there is a critical need to identify those factors underlying exercise engagement for FM pain management. The purpose for this study is to 1) determine associations of dispositional trait styles, neuroinflammation, and inflammation with pain outcomes in Veterans with FM; and 2) develop and design a Veteran-informed exercise program.

Transcraneal Magnetic Stimulation for Treatment of Non-nociceptive Pain in Chronic Diseases

Background: Chronic non-nociceptive or nociplastic pain and neurological sequelae following stroke are associated with substantial functional impairment and reduced quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique capable of modulating cortical excitability and functional brain networks involved in pain processing and neurological recovery. However, its clinical response may vary according to the underlying phenotype and therapeutic target. Objective: To evaluate the safety, tolerability, and clinical response to rTMS as a complementary therapeutic intervention in patients with chronic non-nociceptive pain, fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID, and post-stroke sequelae, and to explore differences in treatment response across clinical conditions. Methods: A clinical study including baseline assessment, rTMS intervention, post-treatment evaluation, and follow-up was conducted. The protocol consisted of ten treatment sessions administered over two consecutive weeks. For chronic pain, fibromyalgia, ME/CFS, and Long COVID, excitatory stimulation at 10 Hz was delivered over the left primary motor cortex (M1), with 1,000 pulses per session. For post-stroke sequelae, inhibitory stimulation at 1 Hz with 600 pulses was applied according to the predominant clinical deficit. Target localization was performed using neuronavigation when individual magnetic resonance imaging was available and the international 10-20 system when it was not. Clinical outcomes included pain, fatigue, sleep, quality of life, motor function, and language performance, assessed using validated clinical scales.

Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

This study evaluates the effectiveness of wearable biofeedback devices in improving pain, mobility, and rehabilitation outcomes in elderly patients with arthritis and fibromyalgia in Karachi, Pakistan. In a randomized controlled trial involving 120 participants, one group will use biofeedback-integrated devices with guided exercises and virtual consultations, while the control group receives standard physiotherapy. The results will inform the potential of digital health solutions to improve accessibility and outcomes in remote rehabilitation for chronic pain management.

Development of a Cloud Platform for Advanced Diagnostics Based on Clinical and Omics Data.

This study aims to explore how information from different types of biological tests, such as genetic, protein, and fat-related analyses, can help doctors better identify and distinguish patients with systemic autoinflammatory diseases (SAIDs), including undifferentiated or complex forms of these conditions (uSAIDs and SAIDs), as well as fibromyalgia. The goal is to improve diagnosis and help identify the most appropriate treatments and care options for each patient. The study will also develop computer-based tools to identify important biological patterns in patients' medical records and laboratory results. These tools will help doctors interpret each patient's individual case and better understand their condition. Finally, the study will bring together biological test results, clinical information, and the findings from these analyses in a single, comprehensive health record. This record will have an easy-to-use interface designed to support patients' care teams. Its usefulness in everyday clinical practice will then be evaluated.

Effects of Adding Motor Imagery Training to Exercise on Pain, Fibromyalgia Impact, and Kinesiophobia in Women With Fibromyalgia: a Randomized Controlled Trial

Aim: To evaluate the effects of adding motor imagery training to exercise on pain, fibromyalgia impact, and kinesiophobia in women with fibromyalgia, and compare imagery ability and kinesiophobia with healthy volunteers. Methods: In this randomized controlled study, 100 women with fibromyalgia were allocated to exercise alone (n=50) or exercise plus motor imagery training (n=50) for one month. Forty-five healthy volunteers provided baseline comparisons. Outcomes included Visual Analog Scale (VAS) pain and global assessment, Revised Fibromyalgia Impact Questionnaire (FIQR), and Tampa Scale of Kinesiophobia (TSK). Baseline imagery ability was assessed using the Kinesthetic and Visual Imagery Questionnaire-20.

Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain

The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.

Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain

The purpose of the study is to discover the underlying subtypes of chronic musculoskeletal pain (muscle and joint pain) in youth. Specifically, the researchers are looking for different profiles of brain and immune system signals that affect how the body feels pain, and how these pain profiles are shaped by a person's medical history, psychology, and social environment. The goal is to develop more precise treatments for chronic pain in young people. Primary Aim: The investigators want to identify subtypes of childhood-onset chronic pain (pain lasting more than 3 months) that affects the musculoskeletal system. To do this, the study will enroll teens and young adults (ages 14-26 years) who were diagnosed with chronic pain in childhood (before the age of 18) or have a pediatric rheumatic disease or major surgery that places them at risk for developing chronic pain. The researchers will look at participants' childhood medical histories and treatments, their current pain and other symptoms, sensory tests of pain and immune system markers found in their blood. The investigators will use this information to find different clinical and neuroimmune profiles of chronic pain. They will also be able to identify the profiles of those who are at risk for chronic pain (because of a rheumatic disease or past surgery) but never develop long term pain. Secondary Aim: The study will look at how medical history, treatments, and different lifestyle factors (like sleep and physical activity), and psychosocial factors (mood, coping, social support) influence the pain experience in subgroups of chronic pain identified in the primary aim. By understanding specific behavioral and psychosocial risk and protective factors-the researchers hope to better understand why some young people develop long-lasting pain and others do not and also how better treatments can be developed for those who do have chronic pain.

The Role of Interoceptive Sensitivity in Central Sensitization Symptom Severity in Fibromyalgia

In fibromyalgia, the increased central sensitization symptom burden can lead to a disruption in the individual's interoception and difficulties in managing symptoms. Additionally, impaired internal perception can also affect conditions such as pain severity, fatigue, sleep quality, and accompanying depression and anxiety in fibromyalgia patients. With this study, the relationship between central sensitization and interoceptive sensitivity in fibromyalgia will be examined, and the relationship of interoceptive sensitivity with issues such as sleep quality, pain severity, fatigue, anxiety, and depression in fibromyalgia patients will also be investigated.

Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers

This randomized controlled pilot trial will evaluate the feasibility and preliminary effects of an asynchronous microlearning intervention on fibromyalgia knowledge among Primary Health Care workers. Participants will be randomly assigned in a 1:1 ratio to either a control group receiving evidence-based written educational material on fibromyalgia or an experimental group receiving the same written material plus an approximately 5-minute asynchronous educational microlearning video. Participants will have two weeks to review the assigned educational content. Fibromyalgia knowledge will be assessed using the Fibromyalgia Knowledge Questionnaire (FKQ) at baseline, before randomization, and two weeks later. Trial feasibility will be assessed through recruitment, retention, intervention participation, and assessment completion indicators.

Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.

Experiences and Care Pathways Shared on Social Media Regarding 5 Conditions Causing Chronic Pain

Chronic pain is a major symptom shared by several medical conditions. This study focuses on five well-defined chronic diseases : Lyme Borreliosis (LB), Post-Acute COVID-19 Syndrome (PACS or "long COVID"), fibromyalgia, endometriosis, and rheumatoid arthritis. Although all of these conditions are associated with chronic pain, they differ in several important aspects, justifying their choice for a comparison. The overall objective of this study was to describe the symptoms, treatments, and healthcare pathways associated with these five conditions, as reported by patients on social media platforms and online forums. The specific objectives were to compare PTLDS with the four other conditions across the following aspects: (i) Incompatible symptoms reported by patients; (ii) Different components of pain : physical, emotional, and social; (iii) Healthcare pathways; and (iv) Adherence to treatment recommendations.