About this trial
Pain is one of the most important manifestations of the disease state and significantly affects people\'s quality of life. According to the International Association for the Study of Pain (IASP), pain is not only a sensory experience related to the activation of the somato-sensory nervous system, but also an emotional experience, resulting from the cortical and emotional processing of nociceptive signals. This means that perceived pain is the result of a complex interaction between physical sensations and emotional responses.
Pain is classified according to two main criteria: duration and pathophysiological mechanism. In terms of duration, pain can be transient, acute, chronic, or persistent. In terms of pathophysiology, pain can be nociceptive, inflammatory, neuropathic, or nociplastic. The latter, in particular, is characterized by altered nociceptive function, without obvious peripheral damage, and is seen in conditions such as fibromyalgia and chronic migraine.
Chronic pain affects a significant proportion of the population, with estimated prevalence rates between 11% and 40%. According to the US Centers for Disease Control and Prevention, about 20.4 percent of adults suffer from chronic pain. This type of pain is more common in women, people of advanced age, and people with low socioeconomic status. In addition to its physical effects, chronic pain has a major psychological impact, increasing the risk of depression, anxiety, and social isolation. Socially and economically, the costs associated with the treatment and management of chronic pain are high.
Nociplastic pain (DN) refers to a chronic pain state that is not related to visible tissue damage or overt neuropathy, but in which there are alterations in the function of pain sensory pathways. The concept of central sensitization (CS), introduced in the 1990s, describes the amplification of pain signals at the level of the central nervous system, leading to increased sensitivity to pain (hyperalgesia) or pain in response to normally non-painful stimuli (allodynia). This central sensitization has been observed in conditions such as fibromyalgia and chronic migraine.
Fibromyalgia (FM) is a syndrome characterized by widespread musculoskeletal pain associated with fatigue, sleep disturbances, and cognitive deficits. The prevalence of FM is higher among women and tends to be associated with a high level of psychological distress, with anxiety symptoms and depression very common among patients. Although the precise cause of fibromyalgia is still unclear, studies suggest that central sensitization plays a central role in its etiology. Patients with fibromyalgia also have high levels of alexithymia, or the difficulty of identifying and describing emotions, and personality disorders such as avoidant or obsessive-compulsive.
Migraine (CM) affects about 15 percent of the world\'s population and is characterized by severe headache attacks, often associated with nausea, vomiting, and hypersensitivity to light and sound. Chronic migraine occurs when symptoms occur for at least 15 days per month. Several genetic and environmental factors contribute to the development of migraine, and there is growing evidence indicating a bidirectional relationship between migraine and depression. Anxiety and depression are also risk factors for migraine chronification.
The comorbidity between fibromyalgia and chronic migraine has been the subject of numerous studies. About 45%-80% of patients with fibromyalgia also have migraine, while 20%-36% of patients with migraine also have fibromyalgia. This high incidence of comorbidity suggests that there are common pathophysiological mechanisms between the two conditions, probably related to central sensitization and alterations in nociceptive pain pathways. Recent studies have confirmed that patients with both conditions (FibroMig) may have specific psychological and neurofunctional patterns that distinguish them from those with only one of the two diseases.
This study aims to explore the differences between people with fibromyalgia and chronic migraine, with the goal of identifying distinctive psychological and neurofunctional patterns that could help improve treatments for chronic pain management. An innovative aspect of the project is the identification of the FibroMig sub-population, namely those who suffer from both conditions. These patients might exhibit unique neurophysiological and psychological mechanisms that could be used to develop more targeted treatment strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
minimum age of 18 years;
at least 5 years of education;
FM diagnosis according to the criteria reported by Wolfe (2016) for the FM group;
CM diagnosis according to Olesen (2018) for the CM group;
Disqualifiers
severe psychiatric disorders and/or cognitive impairment;
difficulty understanding/expressing in Italian;
history of other disorders characterized by chronic pain for FM and CM;
history of other neurological disorders besides migraine for CM and FibroMig;
Trial design
Parallel
Treatments tested in this trial
Dynamic interpersonal therapy (DIT)
BehavioralDynamic interpersonal therapy (DIT) is a dynamically oriented brief psychotherapeutic intervention based on attachment and mentalization theory that views symptoms of depression and anxiety as responses to interpersonal difficulties. This intervention helps patients to understand the connection between their symptoms and their relationships by identifying a core, non-conscious, repetitive pattern of relating. Previous studies have shown positive results: significant reductions have been observed for the variables somatic symptom severity, depression, anxiety, and general psychiatric symptoms. It consists of 16 sessions (one per week) for a total of 4 months.
technique of expressive writing (TSE)
BehavioralThe expressive writing technique created by Pennebaker has shown beneficial health effects in different contexts since, through writing, it is possible to mentally reorganize a difficult event, allowing the mind to find meaning to what has happened or is happening. This technique can be a resource that can promote activation from the ability to recognize, express, and process the unspoken emotional, psychological, and relational, helping to achieve emotional and physiological feedback. Although the application of expressive writing in patients with fibromyalgia is an under-explored area of investigation in the international literature, several studies have shown its effectiveness in some chronic syndromes. It consists of 8 meetings (one every fortnight) for a total of 4 months.
Treatment as Usual (TAU)
Other interventionThe usual treatment involves two contacts by a rheumatologist/neurologist (depending on the clinical condition of the patient) during a four-month period, lasting about 10-15 minutes each, in which patients will be followed up medically. This treatment represents the active control group, planned to monitor specific aspects of the psychotherapeutic intervention, which aims to equate a good standard of primary care.
Treatment groups
Trial outcomes
Primary outcomes
severity of pain
To assess the severity of pain, the Visual analogue scales (VAS; Kane, 2005) will be used: it allows pain intensity to be assessed by a ten-point scale with two perpendicular ends: the first end (zero) means no pain, and the second end (ten) means the worst pain.
severity of symptoms
To assess symptom severity, the Revised Fibromyalgia Impact Questionnaire (FIQR, Benneet et al., 2009; Salaffi et al., 2013) will be used: it detects the functioning of the person with fibromyalgia by assessing the impairment of functioning and quality of life given by fibromyalgia symptoms.
mental pain
To measure mental pain, the Mental Pain Questionnaire (MPQ; Svicher et al., 2019) will be used: it investigates ten aspects of mental pain identified through the literature, namely: presence of mental pain, feeling of helplessness and hopelessness, duration of pain, irreversibility of pain, and intolerance to suffering.
level of central sensitization
To measure the level of central sensitization, the Central Sensitivity Inventory (CSI; Chiarotto et al., 2018) will be used: it was developed to assess some psychological symptoms referable to the central sensitivity syndrome. The CSI is intended as a supportive tool to help the clinician identify the presence of the syndrome at the stage of diagnosis that focuses on the person\'s psychological and emotional experience.
Secondary outcomes
traumatic experiences
Traumatic events experienced will be measured with the Traumatic Experiences Checklist (TEC; Nijenhuis et al., 2002): the instrument surveys 29 types of trauma and other potentially overwhelming events: loss of significant others, life-threatening illness or assault, family foster care experience, emotional neglect, emotional abuse, physical abuse, sexual harassment, and sexual trauma
highly sensitivity
To assess highly sensitivity, Highly Sensitive Person Scale (HSP-12 (HSP-12; Aron \& Aron, 1997; Lionetti et al., 2018) will be used: investigates the theoretical framework of Sensory Processing Sensitivity, which refers to the innate personal predisposition to wider stimulus processing. In other words, a highly sensitive person is predisposed to perceive external (e.g., auditory, visual) and internal (such as emotions and bodily sensations) sensory stimuli as amplified. The questionnaire specifically assesses the number of details the person is able to perceive from the environment, the intensity with which he or she perceives them, and the threshold of activation.
personality traits
To measure personality traits, the Personality Inventory for DSM-5(PID-5 Short form; Thimm et al., 2016) will be used: it assesses five personality traits, including negative affect, detachment, antagonism, disinhibition, and psychoticism (i.e., the presence of unconventional, strange, eccentric thoughts and behaviors that are not recognized by the home culture).
defensive functioning
To measure defensive functioning, the Defense Mechanism Rating Scales (DMRS-SR-30; Di Giuseppe et al., 2020) will be used: it is an instrument based on the identification of 30 psychological defensive strategies. The DMRS defines each defense mechanism, describes its psychological function, and classifies them into three levels based on functioning (mature, immature, and neurotic).
Sponsors and contacts
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University of Roma La Sapienza
Lead sponsor
University of Pavia
Collaborator
Azienda Policlinico Umberto I
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
University of Turin, Italy
Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Collaborator