Pain Neuroscience Education, Conditioned Pain Modulation and Emotional Processes in Fibromyalgia

Официальное название

Development of a Pain Neuroscience Education Intervention to Analyze Conditioned Pain Modulation Mechanisms and the Emotional Processes Underlying Centralized Pain in Patients With Fibromyalgia

Обзор

Chronic pain represents a significant public health concern worldwide and is a primary reason why patients seek specialized medical care. Fibromyalgia (FM) is a highly prevalent chronic condition, affecting approximately 2% to 5% of the global population. Its main symptom is widespread, diffuse pain, often accompanied by joint stiffness, persistent fatigue, paresthesia, hyperalgesia, non-restorative sleep, anxiety, cognitive difficulties, and sensory hypersensitivity. Although the exact pathophysiology of FM remains incompletely understood, alterations in central nervous system (CNS) nociceptive processing are believed to play a fundamental role in the development, propagation, and persistence of pain associated with this condition. Increased sensitivity to both painful and non-painful stimuli-known as central sensitization-may result from changes in neural function and activity, which also impact the emotional and affective regulation of pain perception and experience. Pain neuroscience education (PNE) is an emerging therapeutic approach that focuses on helping patients reconceptualize and understand their pain through education about the neurophysiology, neuroanatomy, and neurobiology of pain. This intervention aims to promote patient awareness of the origins of their symptoms, reduce hyperactivity within the nervous system, and modify maladaptive beliefs and attitudes related to their pain experience. PNE seeks to enhance patients' capacity to manage emotional, psychological, and environmental factors that influence pain perception-such as beliefs, cultural background, motivation, and body awareness-in order to improve coping strategies in daily activities. In this study, the investigators aim to analyze the effects of a PNE program on nociceptive processing and emotional-affective modulation in patients with FM. The hypothesis is that the intervention will lead to improvements in markers of nociceptive processing, such as pressure hyperalgesia, conditioned pain modulation (CPM), and temporal summation (TS), all of which are related to descending inhibitory pain pathways. Furthermore, the researchers anticipate enhancements in the emotional and affective mechanisms that underlie centralized pain in this population.

Вмешательства

• Поведенческое Experimental: Pain Neuoescience Education Group
  The experimental group will receive a pain neuroscience education (PNE) intervention delivered through an in-person, didactic educational model in small groups of 5 to 10 patients. PNE sessions will be conducted once per week for 6 weeks, each lasting approximately 45 to 60 minutes, by a physiotherapist with extensive clinical experience and specialized training in PNE. The content of the sessions will be based on models described in previous studies. Patients will receive detailed information o
• Поведенческое Active Comparator: Biomedical Education Group
  The control group will receive two sessions of biomedical education and general guidance on chronic pain and its management, delivered in small groups of 5 to 10 patients with a duration about 45-60 minute. These sessions will also be conducted by the same physiotherapist who delivers the intervention sessions. Both groups will be instructed to continue their usual care and will be encouraged to engage in therapeutic exercise tailored to their physical limitations. All variables will be recorded

Первичные конечные точки

• Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia [Срок оценки: Six weeks]
• Endogenous pain modulation mechanisms_Deep Hyperalgesia [Срок оценки: Six Weeks]
• Endogenous pain modulation mechanisms_ Temporal Summation of pain [Срок оценки: Six Weeks]
• Endogenous pain modulation mechanisms_Conditioned pain modulation [Срок оценки: Six Weeks]

Вторичные конечные точки (12)

• Pain Intensity: Visual Analog Scale [Срок оценки: Baseline and 6 weeks]
• Pain Intensity: Visual Analog Scale [Срок оценки: Baseline and 12 weeks]
• Pain Intensity: Visual Analog Scale [Срок оценки: Baseline and 18 weeks]
• Pressure Pain Threshold [Срок оценки: Baseline and 6 weeks]
• Pressure Pain Threshold [Срок оценки: Baseline and 12 weeks]
• Pressure Pain Threshold [Срок оценки: Baseline and 18 weeks]
• Central Sensitization [Срок оценки: Baseline and 6 weeks]
• Central Sensitization [Срок оценки: Baseline and 12 weeks]
• Central Sensitization [Срок оценки: Baseline and 18 weeks]
• Severity of Fibromyalgia_perceived disability [Срок оценки: Baseline and 6 weeks]
• Severity of Fibromyalgia_perceived disability [Срок оценки: Baseline and 12 weeks]
• Severity of Fibromyalgia_perceived disability [Срок оценки: Baseline and 18 weeks]

Критерии участия

Критерии включения

• Diagnosis of Fibromyalgia in accordance with the American College of Rheumatology criteria for classifying Fibromyalgia (2016 revision) by a rheumatologist of the Public Health System of Andalusia (Spain)

Критерии исключения

• Presence of liver, cardiac, or renal disease.
• Presence of previous inflammatory rheumatic disease or neurological disorders.
• Presence of infectious processes, fever, hypotension, or respiratory alterations.
• Severe physical disability or severe psychiatric illness.
• Previous surgical intervention prior to the study period.
• Presence of associated comorbidities (chemical hypersensitivity syndrome, chronic fatigue syndrome, interstitial cystitis, etc.).
• Receiving any other non-pharmacological therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University of Granada — Granada

Идентификаторы

NCT: NCT07055971 · NEUROPAINFIB_2025 · 2024/CH/01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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