Clinical Research Directory

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.

Alternative Treatment in Fibromyalgia

The goal of this randomized control trial is to know evaluate the effects of a therapeutic exercise protocol with one programme based in pain neuroscience education as a treatment in fibromyalgia. The main question it aims to answer are: if the treatment is effective on reduction in pain, kinesiophobia, catastrofism, impact of fibromyalgia, in short term (at the final of interventions) and follow-up at 3 months, 6 months and a year after. Participants will be alocated in two diferents groups: experimental and control. The experimental group is going to do therapeutic exercise and pain neuroscience education and the control group is going to do only therapeutic exercise.

Effects of Basic Body Awareness Therapy Added to Aerobic Exercise in Women With Fibromyalgia

This study aims to investigate the effects of Basic Body Awareness Therapy combined with aerobic exercise on inflammatory biomarkers (interleukin-6 and cortisol), cognitive functions, and depression levels in women diagnosed with fibromyalgia syndrome. Participants will be randomly assigned to an intervention group receiving aerobic exercise plus Basic Body Awareness Therapy or a control group receiving aerobic exercise alone. Clinical, biochemical, cognitive, and psychological assessments will be conducted at baseline and after the intervention period. The findings are expected to contribute to evidence-based non-pharmacological rehabilitation approaches for fibromyalgia management.

Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

The goal of this clinical trial is to learn if adding Shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. The main question it aims to answer is: Does Shiatsu therapy help improve the quality of life in children with long-lasting pain? All participants will continue their regular treatment and will also: * Receive a 30-minute Shiatsu session once a week for six weeks * Complete questionnaires about their quality of life and family impact before, during, and after the treatment period The study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at Tel Aviv Sourasky Medical Center.

COMT and IL6 Genotype-Phenotype Associations in Fibromyalgia and Myofascial Pain Syndrome

Fibromyalgia (FM) and myofascial pain syndrome (MPS) are chronic pain conditions that may share some clinical features but differ in the distribution and extent of pain and associated symptoms. The biological factors contributing to these differences remain incompletely understood. This observational study aims to compare the distribution of two pain-related genetic variants, COMT rs4680 and IL6 rs1800795, between individuals with FM and MPS and to investigate their associations with clinical characteristics. Participants will undergo standardized clinical assessment, including measures of symptom burden, physical functioning, and energy/fatigue. In participants with MPS, musculoskeletal ultrasonography will be used as an adjunct to clinical examination to support phenotypic characterization. Genetic analysis will be performed using DNA obtained from peripheral venous blood. COMT rs4680 and IL6 rs1800795 will be genotyped using a TaqMan probe-based real-time polymerase chain reaction method. The study is intended to explore genotype-phenotype associations in two clinically characterized chronic pain conditions. The investigated genetic variants are not being evaluated as diagnostic tests, and no intervention is assigned as part of the study.

Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia

This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Eligible participants are adults aged 18 to 65 years who have had fibromyalgia for at least 1 year and have been receiving pregabalin and/or duloxetine for at least 3 months. Participants will be randomly assigned to receive either FibroThol or placebo, administered as 15 mL three times daily for 4 weeks, while continuing their existing treatment. Follow-up assessments will be performed at baseline, week 2, and week 4 using patient-reported symptom and function measures. The study aims to determine whether this supportive supplement provides additional benefit compared with placebo in patients with persistent symptoms despite standard therapy.

Mechanism Study of Yangyin Roujin Formula in the Treatment of Fibromyalgia Syndrome

This prospective randomized, double-blind, controlled clinical trial is designed to address the current challenges in the clinical management of fibromyalgia (FM). Investigators adopt Yangyin Roujin Formula, an empirical herbal prescription used in routine clinical practice, to evaluate its comprehensive therapeutic efficacy and safety in FM patients, including alleviating physical pain and common concomitant symptoms, improving physical function, and enhancing quality of life. Serum and fecal samples as well as brain MRI scans will be collected at baseline and after 12 weeks of intervention. The underlying mechanisms of this formula will be explored from multiple dimensions, including serology, gut microbiota-metabolome profiling, and central neuroimaging, so as to clarify the therapeutic advantages of Yangyin Roujin Formula for FM treatment.

Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade. Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

Craniovertebral Angle and Fibromyalgia Severity

Forward Head Posture Frequency in Fibromyalgia Patients Assessed by Craniovertebral Angle: Association with Symptom Severity. Forward head posture is more common in patients with fibromyalgia and is a factor that increases symptom severity.

Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)

This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or enhanced usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.

Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. Obesity is considered a major predisposing factor for OSAS. In addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in OSAS patients.

PRL2019 in the Treatment of Juvenile Fibromyalgia

Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease. This study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS. The hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.

Yishen Shujin Decoction for Fibromyalgia Syndrome

This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.

Pain & Reward Neuromodulation of CNS Circuits

This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.

Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome

Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.

A Study Comparing Real and Sham Repetitive Transcranial Magnetic Stimulation in Adults With Fibromyalgia, Assessing Effects on Pain, Fatigue, Sleep, Mood, Quality of Life, Cognition, and Walking Under Usual and Dual-task Conditions

Fibromyalgia is a chronic condition that causes widespread pain and is often accompanied by fatigue, poor sleep, mood symptoms, memory and concentration difficulties, and reduced quality of life. Many adults with fibromyalgia also experience limitations in daily physical functioning. These limitations may include slower or less stable walking, reduced walking endurance, and greater difficulty walking while performing another task at the same time, such as counting or carrying out a mental task. This clinical study is designed to evaluate the effects of repetitive transcranial magnetic stimulation, also called rTMS, in adults with fibromyalgia. rTMS is a non-invasive brain stimulation technique that delivers magnetic pulses through the scalp to influence activity in specific brain areas involved in pain processing, mood regulation, and physical function. The procedure does not require surgery or anesthesia. Participants in this study are randomly assigned to receive either real rTMS or sham rTMS. Sham rTMS is designed to look and feel similar to the real procedure but does not deliver active therapeutic brain stimulation. Comparing real and sham rTMS allows researchers to assess whether any observed improvements are related to the active treatment rather than to expectation or participation in the study. The study evaluates whether real rTMS can improve symptoms and function in adults with fibromyalgia. Outcomes include pain, fatigue, mood, sleep, quality of life, cognition, and walking performance. Walking is assessed during usual walking and during dual-task walking, when participants walk while also performing another task. These assessments are used to better understand how fibromyalgia affects everyday functioning and whether rTMS may help improve both symptoms and objective physical performance. The main hypothesis is that participants who receive real rTMS will show greater improvement than those who receive sham rTMS. It is expected that real rTMS may reduce pain and related symptoms, improve quality of life and cognitive or emotional functioning, and have a favorable effect on walking performance, especially under more demanding dual-task conditions.

Transcutaneous Vagus Nerve Stimulation for Pain and Autonomic Dysfunction in Fibromyalgia (RESET-FMS)

Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mechanism-based interventions. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that enhances parasympathetic activity through stimulation of the auricular branch of the vagus nerve. Preliminary studies suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life in patients with FMS, although available evidence is limited by small sample sizes and heterogeneous methodologies. The RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of tVNS in patients with FMS. Participants will be randomized in a 1:1 ratio to receive either active tVNS or sham stimulation for four consecutive weeks. Stimulation will be administered daily for 30 minutes using the Nurosym™ device applied at the tragus of the external ear. The primary objective is to assess the effect of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values. Exploratory objectives include: * evaluation of autonomic symptoms, fatigue, pain distribution, symptom severity, and sleep quality using validated clinical scales, including the Composite Autonomic Symptom Score (COMPASS-31), Fatigue Severity Scale (FSS), Widespread Pain Index (WPI), Symptom Severity Score (SSS), and Pittsburgh Sleep Quality Index (PSQI) at T4; * assessment of the persistence of treatment effects four weeks after treatment discontinuation (T8); * evaluation of treatment effects during intermediate assessments (T2); * evaluation of the effects of tVNS on non-invasive indices of autonomic nervous system function, including heart rate variability (HRV) and sudomotor function assessed by dynamic sweat test (DST); * analysis of serum biomarkers potentially associated with autonomic dysfunction, neuroinflammation, and cognitive symptoms, including neuropeptide Y (NPY), interleukin-6 (IL-6), and neurofilament light chain (NFL); * comparison of treatment response between patients with and without evidence of small-fiber pathology on skin biopsy; * identification of clinical and biological predictors of response to tVNS. The study is expected to provide clinically relevant evidence regarding the efficacy and safety of tVNS in FMS and to improve the understanding of the relationship between pain modulation, autonomic dysfunction, and peripheral nervous system involvement in this condition. The identification of predictors of treatment response may contribute to the development of more personalized therapeutic strategies for patients with FMS.

AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial

Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

This longitudinal study evaluates the effects of semi-permanent auricular acupuncture on the Autonomic Nervous System (ANS) activity and pressure pain threshold in adult female patients (aged 35-64) diagnosed with Fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria. The study aims to investigate how a 5-week treatment cycle influences cardiac autonomic regulation and pain sensitivity

Aerobic Dance Exercises in Fibromyalgia Syndrome

The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.

Unilateral and Bilateral taVNS in Fibromyalgia

This randomized controlled trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia syndrome (FMS). Participants diagnosed with fibromyalgia were randomly assigned to one of three groups: unilateral taVNS, bilateral taVNS, or a home exercise program. The intervention period lasted two weeks and included ten treatment sessions. Clinical outcomes were assessed using validated scales including the Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Autonomic function was evaluated using heart rate variability (HRV) parameters, and exercise performance was assessed based on repetition capacity. The study aimed to determine whether bilateral stimulation provides additional benefits compared to unilateral stimulation and exercise alone. The findings may contribute to understanding the role of neuromodulation strategies in improving autonomic regulation, symptom severity, and functional performance in individuals with fibromyalgia.

Effectiveness of Pain Science Education in Patients With Fibromyalgia Syndrome Living in Rural Areas.

Fibromyalgia Syndrome (FMS) is a complex chronic pain disorder characterized by widespread pain associated with numerous symptoms. It is more common in women over 50 years of age with low educational and socioeconomic status living in rural areas. Pain Science Education (PSE) is one of the most widely used treatments for chronic pain management. This treatment consists of an educational intervention aimed at reconceptualizing and modifying erroneous cognitions regarding pain in these patients. The objective of this study is to evaluate the effectiveness of PSE in patients with FMS living in rural areas. They will be randomly assigned to one of two treatment groups. The intervention group will receive two adapted in-person sessions (90 minutes per session/week) by a therapist experienced in teaching PSE. The control group will begin the conventional treatment they received before participating in the study. After the end of the study, patients in the control group will be given their intervention group records. The variables measured will include the impact of FMS on daily life, pain sensitivity, central sensitization, pain catastrophizing, fear of movement, anxiety and depression, self-efficacy, and assessment of knowledge and beliefs about PSE. Assessments will be conducted before the intervention, after the second PSE session, and three months later by the same researcher.

Metformin for Fibromyalgia Symptoms (INFORM Trial)

The main purpose of the project is to evaluate the safety and efficacy of low dose metformin for improving symptoms associated with fibromyalgia syndrome (FMS) via modulating neuroinflammatory pathways. The investigators hypothesize that FMS patients in the low-dose metformin conditions will show greater improvement in FMS symptoms than those who are in the placebo group. Further, the investigators hypothesize that metformin will increase phosphorylated AMPK in peripheral immune cells of FMS patients and will decrease the transcription of mTORC1, NLRP3 inflammasome, and nociceptive cytokines interleukin 1beta and interleukin 18.

Slow Breathing and Resistance Exercise in Fibromyalgia

This randomized controlled trial investigates whether slow breathing techniques influence heart rate variability, exercise self-efficacy, and resistance exercise performance in women with fibromyalgia. Participants will be randomly assigned to one of three breathing conditions (slow breathing with visual pacer, slow breathing without pacer, or spontaneous breathing) before performing a biceps curl resistance exercise. The study will examine how breathing patterns interact with psychological variables (anxiety sensitivity, pain catastrophizing, pain hypervigilance, and kinesiophobia) to affect physiological and performance outcomes.