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128 active trials for Fibromyalgia

Prognostic Factors for Work Disability in Patients With Chronic Widespread Pain and Fibromyalgia.

Introduction: The association between chronic widespread pain (CWP) and disability is well-established. Although research support large inter-individual differences in functional outcomes, limited studies are available on the socio-economic consequences of offering stratified treatment based on prognostic factors. Identification of predictors of long-term functional outcomes such as work disability as a critical consequence, could assist early and targeted personalised interventions. The primary objective of this cohort study is to identify prognostic factors for the primary endpoint work status (employed and working vs not working) in patients with CWP assessed 3- years from baseline, i.e. at referral for specialist care. Methods and analyses: Data are collected at the diagnostic unit at Department of Rheumatology, Frederiksberg Hospital. The first 1,000 patients >=18 years of age registered in a clinical research database (DANFIB registry) with CWP either "employed and working" or "not working" will be enrolled. Participants must meet the American College of Rheumatology (ACR) 1990 definition of CWP, i.e. pain in all four body quadrants and axially for more than three months and are additionally screened for fulfilment of criteria for FM. Clinical data and patient-reported outcomes are collected at referral (baseline) through clinical assessment and electronic questionnaires. Data on the primary endpoint work status at baseline and 3- years from baseline will be extracted from the Integrated Labour Market Database, Statistics Denmark and the nationwide Danish DREAM database. Prognostic factor analysis will be based on multivariable logistic regression modelling with the dichotomous work status as dependent variable.

Start: January 2018

Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.

Start: July 2021

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

Start: January 2020

Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia

Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin. The study team hypothesize that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.

Start: April 2018

Endogenous Opioid Systems and Symptom Change in Fibromyalgia

This study is designed to study brain mechanisms associated with symptoms and severity of Fibromyalgia. This will be accomplished by relating results from PET scans to self-reported and objective measures of disease severity.

Start: November 2021

Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders

The FIBOBS study is a multi-center, interventional, prospective study carried out within specialized chronic pain structures (CPS) in metropolitan France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome consulting within a CPS. The interaction between these sleep disorders and other symptoms of Fibromyalgia Syndrome will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with Fibromyalgia syndrome are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview algologists in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of Fibromyalgia syndrome. In addition, this study will provide a better understanding of the symptoms of Fibromyalgia syndrome, their impact and how patients feel.

Start: April 2021

Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome

The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.

Start: April 2021

Effects of Blue-enriched White Light Therapy in Patients With Fibromyalgia

Fibromyalgia is a chronic condition with an unclear etiology. The syndrome includes symptoms such as chronic musculoskeletal pain, cognitive dysfunctions, fatigue, sleep disorders, and circadian rhythm disturbances. Fibromyalgia-related pain is associated with a substantial socioeconomic burden including greater health care costs and productivity loss from work. Light therapy can improve sleep quality and sleep architecture, advance sleep phases and reduce pain sensitivity and that the effect of light therapy on mood and cognitive function have been widely supported.This randomized controlled study aims to examine the effects of light therapy on sleep quality, depressive symptoms, psychomotor vigilance performance, and overall symptom severity in patients with fibromyalgia.

Start: May 2020

Quality of Life and the Effects of Tailored Health Coaching in Fibromyalgia Patients

Specific Aims: To identify phenotypes of patients with fibromyalgia according to symptom clusters and to compare differences in quality of life (QOL) among different phenotypes. To examine the effects of technology-assisted and tailored health coaching in comparison to telephone support on health status, QOL, pain catastrophizing, and self-efficacy in patients with fibromyalgia. Methods: For Aims 1, the investigators will conduct a cross-sectional study and enroll 300 patients with fibromyalgia. Symptoms will be assessed using the Numerical Rating Scale, Athens Insomnia Scale, Functional Assessment of Cancer Therapy cognition scale, Beck Depression Index-II, Beck Anxiety Index, and Fatigue Severity Scale. The World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) questionnaire will be used to assess participants' overall QOL. Hierarchical cluster analyses will be used to identify fibromyalgia phenotypes according to pain, physical, and psychological variables. A series of multivariate analysis of variance analyses will be used to compare the differences in WHOQOL-BREF scores among those phenotypes. For Aims 2, the investigators conduct an assessor-blind, parallel-group, randomized controlled trial and enroll 110 participants with fibromyalgia. Participants will be randomized to a health coaching group and a control group. The tailored, interactive health-coaching program will be delivered via mobile applications during a 10-week training period. The control group will receive standard education materials and weekly telephone support. The primary outcomes are the revised Fibromyalgia Impact Questionnaire and WHOQOL-BREF scores; the secondary outcomes are pain catastrophizing score and self-efficacy, which will be examined at baseline, post-training, and the 3th month follow-up. Data will be analyzed according to the intention-to-treat principle. To determine the effectiveness of health coaching on primary and secondary outcomes, differences in outcome variables will be analyzed with mixed-effects linear regression models. The between-group differences at the two posttests examined using a mixed-model will include group x time interaction. The investigators will adjust for the baseline score on the outcome variable and for demographics and comorbidities that differ significantly between the intervention and control groups at baseline.

Start: July 2019

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.

Start: April 2021

Evaluation of the Incidence of Fibromyalgia Syndrome and Its Effect on Quality of Life in Rheumatoid Arthritis

Rheumatoid arthritis is a chronic, autoimmune, systemic inflammatory disease with a prevalence of approximately 1%. With a lifetime development rate of 3.6%, rheumatoid arthritis is seen 1.7% more in women than in men. Although there are no diagnostic criteria for rheumatoid arthritis, ACR / EULAR 2010 classification criteria are frequently used in diagnosis. Symptom duration, number of swollen joints, acute phase reactants and serology are used in these criteria. Fibromyalgia syndrome is characterized by chronic widespread pain, fatigue, exercise disorders and cognitive impairment. Although the prevalence of fibromyalgia syndrome in the general population is between 2-4%, it is one of the most common conditions encountered by rheumatologists. A treat to target strategy is recommended in rheumatoid arthritis disease management. This approach suggests close monitoring of disease activity and treatment change in cases where the goal is not achieved. The prevalence of fibromyalgia in rheumatoid arthritis patients was found to be 5-52% in meta-analyzes due to the heterogeneity of fibromyalgia criteria used in studies. This study, it was aimed to evaluate the effect of secondary fibromyalgia syndrome, which is frequently found in rheumatoid arthritis and characterized by symptoms such as fatigue and widespread pain, on rheumatoid arthritis disease activation and patients' quality of life.

Start: April 2021

Randomized Controlled Trial of CES for Fibromyalgia

Given recent increasing opioid-related deaths and evidence showing against the use of opioids for non-malignant chronic pain, there is growing need for non-narcotic pain management. Fibromyalgia is a difficult to treat chronic pain condition that is often treated with opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans returning from the gulf war and is already a significant burden in senior Veterans who may have suffered with chronic pain for decades already. Many treatment options for fibromyalgia carry intolerable side effects. CES (Cranial Electrical Stimulation) is a FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA system, but sufficient evidence regarding its outcomes and neural mechanisms have not been adequately investigated. An understanding of its neural underpinnings and analgesic effects could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3) development of new techniques to address pain.

Start: March 2020

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Start: September 2020

Fatigue in Primary Sjögren's Syndrome

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Start: January 2021

Efficacy of Sana Treatment in Fibromyalgia

The purpose of this research study is to evaluate the effectiveness of an experimental device called the Sana Pain Reliever Device (Sana Device) on treating pain due to fibromyalgia.

Start: July 2020

Effectiveness of Spinal Manipulation in Fibromyalgia

The aim of this study is to evaluate whether spinal manipulation, which is a potential treatment method for musculoskeletal pain, has an additional contribution in patients with fibromyalgia receiving standard pharmacological treatment.

Start: January 2021

Heat Therapy for Fibromyalgia

The purpose of this study is to see if heat therapy intervention via hot water immersion (i.e., a hot tub) is an effective treatment for patients with Fibromyalgia.

Start: July 2019

Pain Neuroscience Education in Patients With Fibromyalgia

Many patients with fibromyalgia have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia syndrome. This study aimed to explore the effectiveness of pain neuroscience education in patients with fibromyalgia.

Start: September 2019

Study of the Influence of POLD Manual Therapy in Fibromyalgia

This clinical research aims to study the effects of the introduction of POLD manual therapy within the protocol of fibromyalgia

Start: March 2021

taVNS Treatment for Fibromyalgia

In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.

Start: March 2021