The Bio-Psycho-Social markers on Fibromyalgia Syndrome

Project location: Italy, Rome
Project start date: May 2017 - Project end date: April 2019
Project number: 2017-018
Beneficiary: Fondazione Isal

Fibromyalgia syndrome is a poorly understood chronic pain condition affecting 1-3% of the world population. Beside the persistent and widespread pain, fibromyalgia is characterised by several other disabling symptoms which deeply worsen the quality of life of the patients. A full understanding of the pathological mechanisms underlying fibromyalgia is lacking today even if it is clear that a complex interplay of physiological, psychological and socio-relational factors is at play.
An adequate understanding of such a complex condition cannot but take in account the complexity of the disease by looking at the biological, psychological and socio-cultural features of it; furthermore, the way in which these aspects appear and are mutually influencing is crucial in order to approach fibromyalgic syndrome.
The context, the motivations and the objectives of ISAL Foundation's project are outlined in details below.
Chronic pain is more and more recognized as a real disease, leading to severe disability and social alienation. In the UE, its prevalence is between the 16% and 46% that means that about 80 milions of Europeans suffer from chronic pain. Women experience more severe and longer pain syndromes than men because of diverse biological features and a different neurological sensitivity to pain. Despite this incidence, female pain is underestimated by clinicians.
Fibromyalgia (FM) is one of most severe and disabling female chronic pain syndromes. Fibromyalgic sufferers' quality of life is deeply impaired and no ultimate treatment are available today for FM.
In fibromyalgia, a complex interplay of physiological, psychological and socio-cultural factors mutually reinforcing is particularly evident and this gives way to a vicious circle of suffering. The lack of an integrated approach considering the multi-faceted nature of fibromyalgia leads to an inappropriate understanding of the condition and therefore, to scarce treatment outcomes. A second crucial consequence is the stigmatization of these patients who often feel an underestimation of their suffering.

A multi-specialist research will analyse fibromyalgia from different perspectives namely the biomedical, psychological and anthropological one. Moreover, the study will frame the predisposing factors of FM as well as the aspects that make the symptomatology worse in a multi-level perspective.

The project will be developed in Italy , specifically in Rome. It will be carried on by a specialized team that under the supervision of Prof. William Raffaeli, ISAL Foundation's President, will be composed by one rheumatologist (afferent to the Clinic for the Diagnosis and Therapy of FM of the Unit of Rheumatology of the Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Referent: Prof. Giudo Valesini), one biotechnologist (afferent to the Institute San Raffaele Pisana, Rome), one psychologist (afferent to ISAL Foundation ) and two anthropologists (one afferent to ISAL Foundation, the other one afferent to the UMR 7367 Dynamyques Européenes of the University of Strasbourg).

The crucial goal of the project is a multi-level analysis that highlights the several factors influencing the development and the maintenance of fibromyalgic syndrome, obtained through the cooperation of biologists, psychologists and anthropologists.
The tools employed for the analysis are aimed at identifying biological, psychological and anthropological markers for fibromyalgia which could be useful in the future for the prevention, the diagnosis, the care and the rehabilitation of FM patients.
ISAL Foundation's project is the first attempt to put together a biological, psychological and anthropological analysis of fibromyalgic syndrome by providing a full scenario of the way in which several factors are involved and related between them.
The project aims at identifying biological markers in order to propose laboratory diagnostic kits to use in clinical practices. Specifically, peripheral opioid receptors are conceived as innovative molecular markers in this regard. Moreover, from a simple blood sample the attention will be focused on gender differences by analysing also specific epigenetic status, biomolecular structures and neuro-hormonal release. At the same time, psychological and anthropological markers will be studied, in order to clustery diverse patients profiles and characterizations to transform these latter as useful elements to develop new prevention, care and rehabilitation processes in FM.

The first phase is the analysis of the subjects' blood samples: in particular, the expression and function of opioid receptors on the surface of circulating lymphocytes will be studied, considering them as biological diagnostic markers of FM. Cellular and molecular methods and techniques will be employed to find specific biological information for each patient, considering the sex differences.

The psychologists will investigate then the existence of specific FM patients' profiles on the basis of their illness representation. Here, it might be useful to determine whether a non-adaptive illness representation is associated with specific psychological, clinical, biological variables and therefore represents a "psycho-marker" able to legitimize specific clinical attention and to guide customized clinical approach.

Finally, anthropologists will analyse the symbolic elaboration processes of the disease and will identify the elements that occur more frequently in the illness narratives in order to evaluate them as anthropological markers in fibromyalgic syndrome.

The project, which received a grant from the Nando and Elsa Peretti Foundation, will produce two operational outcomes capable of intervening on the attitudes of health professionals and on the prevention's strategies addressed at the
woman's health:
1) the clinic outcome aims to produce an early biological diagnostic Kit for FM and then a standardized and personalized multidisciplinary and multidimensional approach based on intimate experience of the disease. The data that will emerge from the anthropological and psychological analysis will increase the understanding of the syndrome, and will be useful in order to develop supportive and concretes actions for improving treatment and rehabilitation's programs with FM
2) the social outcome aims to provide new tools for the public health prevention and sensitization campaigns. The innovative nature of the project lies in its multidisciplinary nature. Despite in the scientific literature the importance of a multidisciplinary approach in fibromyalgia syndrome is underlined, only a few studies have been able so far to actually integrate various knowledge for approaching this disease.

The project will last for 24 months.
After the clinical protocol will be written and the final approval from ethical committees will be obtained, the research will begin. During the first 10 months, FM patients will be enlisted and the control group will be enrolled. The day of the first clinical visit the blood sample will be taken and used for molecular analysis. Sample collection and analysis will begin.

Psychological questionnaires and ethnographic interviews will be submitted to the study populations starting from the third month and the data will be analysed during the second year; at the end of the research the results will be disseminated.

Fibromyalgia is a poorly understood chronic pain condition affecting 1-3% of the world population causing a low quality of life. In this condition, biological, psychological and socio-cultural factors are deeply intertwined and mutually reinforcing giving way to a vicious circle hard to tackle in the clinic. ISAL Foundation's project will present a multi-specialist analysis of fibromyalgia from different perspectives by framing the predisposing factors of FM and the aspects that make the symptomatology worse.



think global, act local
you are here: Home  > Projects:  Medical research or Europe  (or Both)  > 2017-018  > Project Description