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NCT Number: NCT06652724

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

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.

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Key information

Conditions

Fibromyalgia (FM) Chronic Migraine Headache Chronic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dynamic and Clinical Psychology and Health Studies, Rome, RM, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • medical certification for FM and CM diagnosis for FibroMig group.

Exclusion criteria

  • 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;
  • history of other rheumatological disorders besides fibromyalgia for FM and FibroMig;
  • For the healthy control group: no diagnosis of FM or CM; no severe psychiatric disorders/cognitive impairment; no or low levels of depression; no history of rheumatological and/or neurological disorders.

Treatment and study plan

Dynamic interpersonal therapy (DIT)

Behavioral

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.

technique of expressive writing (TSE)

Behavioral

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.

Treatment as usual (TAU)

Other

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.

Primary outcomes

  1. severity of pain

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    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.

  2. severity of symptoms

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    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.

  3. mental pain

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    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.

  4. level of central sensitization

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    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.

  5. psychopathological symptoms related to anxiety and depression

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    Psychopathological symptoms related to anxiety and depression will be detected using:

    Generalized Anxiety Disorder (GAD-7; Spitzer et al., 2006): for assessing the presence and severity of anxiety symptomatology according to DSM-IV diagnostic criteria Hamilton Depression Rating Scale (HDRS; Hamilton, 1960): for assessing the presence and severity of depressive symptomatology Patient Health Questionnaire (PHQ-9; Kroenke 2001): for assessing the presence and severity of depressive symptomatology according to the DSM-IV diagnostic criteria

  6. alexithymia level

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    To assess the level of alexithymia, the Toronto Alexithymia Scale (TAS-20; Bagby et al., 1994) will be used: this is a self-administered questionnaire consisting of 20 questions that measures difficulty in identifying and describing emotions.

  7. quality of life

    Time frame: An initial survey at the time of enrollment (T0) then one immediately after the end of the planned interventions (T1, after 4 months of the first one) and finally a survey at 6 months of the end of the intervention (T2).

    To measure quality of life, the SF-12 - Quality of Life Assessment (SF-12; Apolone et al., 2001) will be used: this is a generic health survey developed that produces two measures for assessing self-perceived physical and mental health.

Secondary outcomes

  1. traumatic experiences

    Time frame: baseline, pre-intervention

    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

  2. highly sensitivity

    Time frame: baseline, pre-intervention

    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.

  3. personality traits

    Time frame: baseline, pre-intervention

    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).

  4. defensive functioning

    Time frame: baseline, pre-intervention

    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).

  5. psychopathological symptoms

    Time frame: baseline, pre-intervention

    The Symptom Checklist-90-Revised (SCL-90-R; Derogatis, 1994) will be used to measure psychopathological symptoms: it assesses psychopathological risk dimensions on 9 dimensions: Somatization, Obsessive-Compulsive Dimension, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism; it also provides a Global Symptom Score (GSI).

  6. reflective function

    Time frame: baseline, pre-intervention

    The Reflective Functioning Questionnaire (RFQ; Fonagy, 2016) will be used to measure reflective function: this is a self-administered questionnaire to assess the ability to think about oneself and others regarding mental states. It provides for two scales, "certainty" indicating hypermentalization, that is, being over-informed about one's own mental states and those of others; and the "uncertainty" scale indicating hypomentalization, that is, showing a total lack of knowledge about mental states and relying on concrete thinking.

  7. attachment style

    Time frame: baseline, pre-intervention

    To measure attachment style, the Relationship Questionnaire (RQ; Bartholomew & Horowitz, 1991) will be used: it assesses attachment style-that is, attitudes and behaviors that contribute to the formation of a specific bond between two people

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Galli, Professor

CONTACT

[email protected]

3355492778 ext. +39

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Azienda Policlinico Umberto I
  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • University of Pavia
  • University of Turin, Italy

Registry information

Acronym: FIBROMIG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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