View clinical trials related to Fibromyalgia.
Filter by:This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.
Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one patient to another, with great heterogeneity in clinical, physical, social, psychological and therapeutic responses. . A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients; a collective expertise is led by INSERM to help in patient care. Faced with the heterogeneity of FM, several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which suggested four groups, but with methodological limitations, not taking into account the new criteria10 for evaluating FM. Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of the autonomous system. Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN much simpler, faster and less invasive than the technique of ophthalmology or biopsy. Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19, no study has been used to assess the presence of SFN in FM. The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this new non-invasive device, in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age, sex, BMI and by menopausal status for women.
Chronic pain is a major health problem. It causes high economic and social costs around the world and severely impairs the quality of life of those who suffer from it. Chronic pain and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients. This intervention targets mechanisms of action that seem to be common to both disorders. In spite of this, the efficacy of this intervention has not been yet examined in people with both conditions. Therefore, the purpose of the present study is to examine the efficacy of BA compared to usual care among Chilean women with fibromyalgia and mayor depression (N = 90). Women will be randomized to an experimental arm (n = 45) who will receive usual care (UC) for fibromyalgia with comorbid depression plus BA; and a comparison arm, who will receive only UC for fibromyalgia with comorbid depression (n =45). Primary and secondary outcomes will be assessed before, during, and after the intervention, as well as at a three month follow-up. The investigators expect to find that, after treatment, the group receiving BA will experience higher statistical and clinical significant reductions in depressive symptom severity (primary outcome), as well as in their levels of some pain-related variables (namely pain intensity, fibromyalgia impact, pain-related anxiety, catastrophism, and physical health symptoms severity). In addition, the percentage of women in remission from the diagnosis of depression (as well as the percentage of women responding to treatment) will be greater in the experimental arm than in the comparison arm. Also, the percentage of women who show a clinically significant reduction in pain intensity (decreases greater than two units in the pain intensity scale) will be greater in the experimental arm than in the comparison arm. Finally, the investigators hypothesize that the decrease observed in the pain-related variables will be mediated by the decrease observed in depressive symptoms severity. Regarding the outcomes assessed at a three months follow-up, the investigators expect to find that the differences found after treatment between the two arms will be maintained at follow-up. In order to test our hypothesis, Hierarchical Linear Models (HLM) and Cochran-Mantel-Haenszel tests will be performed. The results of these study might contribute to facilitate the integrated treatment of fibromyalgia and depression, and to reduce the burden on the health system due to the lack of effective therapeutic strategies to treat these comorbidity.
The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
The aim of this study is to assess the effectiveness of transcranial direct current stimulation (tDCS) in treating fibromyalgia. Participants will be randomly assigned to one of the two groups: Group I (Intervention group) tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic). Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will receive sham tDCS will be applied using the above described parameters in group I. For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is. The investigator responsible for delivering tDCS had no contact with the patients. All study participants will be followed up by the same evaluation sheet and by an evaluator who are blinded to the type of intervention she /he has received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one month and post 2 months by using wide spread pain index (WPI) & symptoms severity of fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start sessions and after end 10 sessions.
Fibromyalgia is the second most common autoimmune rheumatic diseases with clinical manifestations of widespread pain, fatigue and accompanied cognitive and emotional disturbances. It often associated with sleep disorders and headaches. The cardinal symptom of fibromyalgia is widespread pain. Clinical observations reveal that pain in patients with fibromyalgia could not simply improve by using analgesics only. Patients often use Chinese medicine or acupuncture to help them to ease the pain. The aim of this study is to investigate the efficacy of acupuncture in patients with fibromyalgia. The study adapted a randomized, assessor- and participant-blinded, sham-controlled, and parallel-design approach to investigate whether acupuncture can improve the clinical symptoms and quality of life as well as the mechanism through laboratory biochemistric and image study.
Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP) in taut bands within the affected muscles. Chronic MPS over neck is prevalent and responsible for markedly loss of work-day and a reduction of quality of life. Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood by low-level laser light through an optical fiber inserted in a vein. Researches disclosed that ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen saturation in blood. However, no research studies the effectiveness of ILIB to treat MPS. Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the relative stiffness of structures. For a given material, faster SWV indicates the greater stiffness. To our knowledge, only one research using RTS and SWV to study MPS. To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of RTS and SWV for MPS, we conducted this study.
Fibromyalgia and migraine are diseases with high prevalence in women between the age group of 30-60 years, which seem to share the same pathophysiological mechanism; both originate from neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous system, and are therefore closely related. In addition to the strong relationship with migraine, fibromyalgia can also be associated with sleep disorders, chronic fatigue and psychological disorders. The combination of these factors decreases the quality of life and contributes to increased sedentary this population. It is known that physical exercise promotes positive changes in pain pathophysiological pathway to increase the release of endorphins neuroendógenas, improving the symptoms of fibromyalgia. The objective of this study is to analyze whether the application of an aerobic exercise program may result in the reduction of the frequency, duration and intensity of migraine attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and migraine. Initially, all answer questionnaires assessing quality of life, impact of headache, level of depression and anxiety, sleep quality, physical activity level, and; will be held ergospirometry for research in exercise tolerance. The experimental group will implement the protocol consists of heating, aerobic exercise according to the heart rate established for training by spirometry and slowdown; and the control group will hold the heat on low speed and heart rate will next baseline. Both groups will be followed for 12 weeks, with a frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4 weeks. At the end of the protocol, the groups will have their results were compared and statistically analyzed.
tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover.