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NCT07055971: NEUROPAINFIB

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

ENROLLING BY INVITATION NA Last updated 9 July 2025
What this trial tests

NA trial testing Experimental: Pain Neuoescience Education Group in Fibromyalgia in 46 participants. Enrolling by invitation.

Timeline
9 April 2025
Primary endpoint
30 September 2025
30 September 2026

Quick facts

Lead sponsorUniversidad de Granada
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment46
Start date9 April 2025
Primary completion30 September 2025
Estimated completion30 September 2026
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universidad de Granada — full company profile →

Who can join

18 and older, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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