NCT06652724

Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This research project stems from the intention to observe possible differences between people with FM and CM as clinical conditions representative of diagnostic clusters of DN of a chronic nature, with the ultimate goal of helping to improve treatments for pain management (Cohen, 2022). The overall goals of the project, in line with the literature review showing a dearth of evidence on mechanisms underlying the onset and maintenance of FM and CM and associated subpopulation (FibroMig), is to identify patterns of psychological and neurofunctional functioning associated with these DN syndromes. In light of the elucidation of such processes that can distinguish these clinical populations, the second general purpose will be to evaluate the efficacy of brief psychodynamic treatments in this area, i.e., to test the efficacy of brief psychodynamic treatment on improvement of pain severity, symptoms of chronic pain pathology, mental pain, psychopathological symptoms (anxiety, depression, etc.), effects on alexithymic functioning and quality of life, in three distinct conditions, FM, CM and comorbidities of FM and CM (FibroMig). Specifically, the project consists of 2 separate studies that aim to: * To observe possible differences in psychosocial variables among three groups of patients: isolated form (without comorbidities) of FM, CM and FM and CM comorbidities (FibroMig), compared with a group of healthy subjects (HC) (study 1) * To evaluate possible differences in the organization of baseline brain functioning (resting-state) between the 3 clinical groups and the healthy control sample (study 1) * To evaluate the effectiveness of dynamic interpersonal psychotherapy (DIT) on the three patient groups (FM, CM and FibroMig) by comparing them with the application of Expressive Writing Therapy (TSE) and a control group (Treatment as usual - TAU) on improvement with respect to pain severity (VAS), symptom severity (FIQR and symptomatology for CM), mental pain (MPQ), psychopathological symptoms related to anxiety and depression (GAD7, HSRD and PHQ6), level of central sensitization (CSI), level of alexithymia (TAS-20) and Quality of Life (SF-12) (Study 2).

Conditions

• Fibromyalgia (FM)
• Chronic Migraine Headache

Interventions

Type	Name	Description
BEHAVIORAL	Dynamic interpersonal therapy (DIT)	Dynamic 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.
BEHAVIORAL	technique of expressive writing (TSE)	The 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.
OTHER	Treatment as Usual (TAU)	The 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.

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

2 sites across 1 country: Italy