Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
RecruitingNot applicableNCT06652724
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 p…
Study details
- Official title
- Relieving Chronic Pain: Psychosomatic Mechanisms and Psychological Interventions in Fibromyalgia and Chronic Headache
- Conditions
- Fibromyalgia (FM)
- Chronic Migraine Headache
- Interventions
- Behavioral: Dynamic interpersonal therapy (DIT)
- Behavioral: technique of expressive writing (TSE)
- Other: Treatment as Usual (TAU)
- Sponsor
- University of Roma La Sapienza
- Collaborators
- University of Pavia; Azienda Policlinico Umberto I; IRCCS National Neurological Institute "C. Mondino" Foundation; University of Turin, Italy; I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Start date
- 2024-09-17
- Primary completion
- 2025-09-30
- Sex
- Female
- Age range
- from 18 Years to 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06652724