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

NCT ID: NCT07055971

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-09
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain Neuoescience Education

Group Type: EXPERIMENTAL

Experimental: Pain Neuoescience Education Group

Intervention Type: BEHAVIORAL

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.

Biomedical Education

Group Type: ACTIVE_COMPARATOR

Active Comparator: Biomedical Education Group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Antonio Casas

Principal Investigator, PhD research and teaching staff of the University of Granada

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Casas Barragán, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

University of Granada

Granada, Andalusia, Spain

Countries

Spain

Other Identifiers

2024/CH/01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NEUROPAINFIB_2025

Identifier Type: -

Identifier Source: org_study_id