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128 active trials for Fibromyalgia

Repetitive Transcranial Magnetic Stimulation of Relief of Fibromyalgia Pain

There are currently several points concerning rTMS for pain relief that have a huge impact in the practical application of rTMS in clinical practice, but which have not been approached by previous studies. Also, an even more important issue is the frequency of the sessions in each treatment protocol. The idea of performing stimulation in chronic pain patients on a consecutive daily basis for long-term treatments seem unrealistic and potentially costly. However, it has been reported in animals, healthy subjects and FM patients that the analgesic effects of rTMS can outlast the stimulation session for several minutes and even days. This has led to the proposal that pain treatment with rTMS could be performed in consecutive daily induction sessions, followed by spaced (weekly, fortnightly and even monthly) maintenance sessions. This approach is similar to what is performed routinely in patients with major depression treated by rTMS to the dorsolateral prefrontal cortex, and has successfully been tested in FM patients in a single- center study. Should this approach prove effective in larger prospective multicentric studies, rTMS could enter the armamentarium of non-invasive, non- pharmacological, low-adverse event therapeutic options to relieve fibromyalgia- related pain and associate symptoms. Hence, our aim is to conduct a multicentric international clinical trial on the influence of rTMS in the control of pain in a consecutive adaptive trial design where real rTMS of two different doses (1500 vs 3000 pulses per session) will be studied. Stimulations will be performed in a clinical practice-friendly approach, where daily maintenance sessions will be followed by weekly, and fortnightly stimulation sessions. There have been very scarce adaptive trials in the pain and non-invasive stimulation fields. This methodological approach allows for the use of lower number of patients in consecutive trials and, among other qualities, it allows for the imputation of data from the first trial into the second one, thus decreasing the duration of the studies and the number of participants.

Start: April 2019

Psychobiological Mechanisms Underlying Chronic Pain

Pain is a powerful motivator of behavior and it is more than the perception of nociceptive input. It is a complex experience that comprises different components: sensory discriminative, emotional-motivational and cognitive components. In chronic pain, a negative hedonic shift has been proposed that is characterized by disproportionally increased emotional-motivational compared to sensory-discriminative pain components. Such a negative hedonic shift is mirrored in a high comorbidity of chronic pain with affective disorders like depression and anxiety. However, the neurobiological mechanisms underlying such a negative hedonic shift i remain elusive. Animal work suggests an involvement of neuroinflammation, caused by chronic pain, which in turn is related to impaired release of the neurotransmitter dopamine. In line with this observation, impaired dopamine functioning has been described in chronic pain. Importantly, dopamine acts also as a neuromodulator, regulating functional connectivity between brain regions. Therefore, dysfunctional dopamine in chronic pain, possibly caused by neuroinflammation, might lead to altered functional connectivity. Correspondingly, altered functional connectivity in fronto-striatal brain networks has been shown to be predictive of transition from subacute to chronic pain. The aim of this study is to investigate the psychobiological mechanisms underlying the negative hedonic shift in chronic pain with a focus on the causal role of neuroinflammation (substudy 1) and the role of dopamine (substudy 2) in functional connectivity of fronto-striatal brain networks and their relation to heightened emotional-motivational pain processing.

Start: January 2021

Veteran Ear Acupuncture Pilot Project

Veterans who have responded well to Battlefield Acupuncture (BFA), a form of auricular acupuncture, in routine clinical practice will be invited to receive education to insert the needles themselves at home. A 3D-printed wearable prosthetic will also be explored as a means to facilitate needle placement. Primary end-points will include whether adverse events occur over a six-month period and whether the aforementioned prosthesis significantly facilitates needle placement in terms of subjective ease of administration.

Start: February 2020

Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.

Start: March 2020

FIbromyalgia anD GenetIcs Subgroups (FIDGIS)

Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses. Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain. Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS. The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.

Start: November 2020

Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Start: December 2018

Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia

This work is part of a broader research with women with fibromyalgia. The aim of this study is to establish the effectiveness of implementation intentions to manage the preference for avoiding pain and fatigue and stop walking exercise, versus to maintain the approximate behavior (walking), taking into account high and low pain catastrophizing conditions.

Start: November 2020

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.

Start: November 2016

Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging, thus a whole body Photobiomodulation (PBM) therapy program is proposed as an effective option.

Start: January 2021

Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain

The proposed research is a two-group randomized controlled trial (RCT) of pain rehabilitation virtual reality (PRVR) aimed at measuring changes in physical function and fear for adolescents with chronic musculoskeletal pain when compared to Standard Physiotherapy Rehabilitation (SPR). Both groups include standard physiotherapy treatment including functional goal setting and progressive exercise with half of the treatment session delivered virtually in the PRVR arm. The RCT aims are as follows: To evaluate physical function outcomes between PRVR and SPR. To evaluate pain-related fear as a potential mechanism of change in physical function. To characterize feasibility of a future hybrid effectiveness-dissemination trial of PRVR in routine physiotherapy practice.

Start: April 2021

Explosive Synchronization of Brain Network Activity in Chronic Pain

This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).

Start: November 2020

Kinesio Taping and Inhibitory Treatment Techniques

Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS). Study Design: A single-blind randomized controlled trial was conducted on patients with FMS. Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving kinesio taping and inhibitory treatment techniques, or to a control group for exercises and electrical stimulation therapy.

Start: August 2016

Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome

Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program for lower thoracic and cervical spine. Study Design: A single-blind randomized controlled trial was conducted on patients with fibromyalgia syndrome (FMS). Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving manipulative and massage therapy, or to a control group for exercise program.

Start: August 2016

Sleep and Pain Interventions in Women With Fibromyalgia

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

Start: February 2019

Retrospective Study of Psychoattitudinal Patterns in Patients With Fibromyalgia Receiving Antalgic Therapy

Fibromyalgia (FM) is a widespread and invalidating disease that requires a multidisciplinary approach. Particularly, the psychiatric component seems to influence the algological management of these patients. Since January 2018, the HADS, SF-36, IMSA, TCI psycho-attitudinal questionnaires have been introduced in the Pain Therapy unit of Policlinico Sant'Orsola-Malpighi in an attempt to improve the care of patients diagnosed with FM. The aim of the study is to identify, through retrospective evaluation of TCI tests and its subdomains, compiled by patients with FM diagnosis, Pain Avoidance and Pain Persistance personality patterns, indicated in the literature. Anxiety and Depression incidence is also observed through retrospective evaluation of HADS tests. Patients in the Antalgic Therapy Outpatient Clinic diagnosed with FM, aged ?18 years, who have completed selfadministered psychoattitudinal tests from January 2018 to January 2019 were considered. The data were collected in aggregate and extrapolated anonymously.

Start: January 2018

An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's

The study aims is to test the efficacy of an emotional regulation procedure for fibromyalgia patients using Information and Communications Technologies (ICTs). This procedure is based in a task that implies exposition to emotional words. The principal hypothesis is that exposition will improve the clinical symptomatology because the procedure restore an adequate emotional regulation.

Start: October 2019

ESKETamine for FIBromyalgia Treatment

Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments. One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

Start: October 2020

Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia

The aim of this prospective, randomized study is to explore the effectiveness of Bowen Therapy in pain management for patients with fibromyalgia. In Hong Kong, Bowen Therapy is a non-invasive technique and one of the treatment modalities adopted by Occupational Therapists. Bowen Therapy uses specific sequences of gentle cross-fibre moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body's healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Bowen Therapy is widely recognized and utilized worldwide for acute and chronic health conditions from new-born to the elderly, both mobilized and bed-ridden patients with no documented evidence to show it has caused any harm or adverse effects. There are two study groups in this study and patients will be randomized and allocated to either one. One group (Control group) will continue receiving conventional treatment; while another group (Bowen group) will receive 8 sessions of Bowen therapy. The investigators hypothesize that Bowen Therapy is superior to the conventional pain treatment for patients with fibromyalgia.

Start: October 2020

Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Start: October 2020

Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng

Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?

Start: October 2020