NCT07055971

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	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 on the neurophysiology and neurobiology of chronic pain and its relationship to fibromyalgia (FM). Pre-prepared PowerPoint presentations will be used to deliver the material in an accessible and engaging manner, employing images, metaphors, anecdotes, and stories to facilitate understanding. All variables will be recorded at baseline (prior to the intervention), at 6 weeks (end of the intervention), at 12 weeks and at 18 weeks.
BEHAVIORAL	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 at baseline (prior to the intervention), at 6 weeks (end of the intervention), at 12 weeks and at 18 weeks

Timeline

• Start date: 2025-04-09
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Spain