Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652724
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Relieving Chronic Pain Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Relieving Chronic Pain Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBROMIG
Brief Summary:
Pain is one of the most important manifestations of the disease state and significantly affects people39s 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 204 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 worldamp39s 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
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 204 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 worldamp39s 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None