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Enrolling by invitation NCT07055971

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

No phase Interventional Fibromyalgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Pain Neuoescience Education Group, Active Comparator: Biomedical Education Group.
Who it may be relevant to
Registry conditions: Fibromyalgia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 o
  • 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

Primary outcome measures

  • Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia [Time frame: Six weeks]
  • Endogenous pain modulation mechanisms_Deep Hyperalgesia [Time frame: Six Weeks]
  • Endogenous pain modulation mechanisms_ Temporal Summation of pain [Time frame: Six Weeks]
  • Endogenous pain modulation mechanisms_Conditioned pain modulation [Time frame: Six Weeks]
Secondary outcome measures (12)
  • Pain Intensity: Visual Analog Scale [Time frame: Baseline and 6 weeks]
  • Pain Intensity: Visual Analog Scale [Time frame: Baseline and 12 weeks]
  • Pain Intensity: Visual Analog Scale [Time frame: Baseline and 18 weeks]
  • Pressure Pain Threshold [Time frame: Baseline and 6 weeks]
  • Pressure Pain Threshold [Time frame: Baseline and 12 weeks]
  • Pressure Pain Threshold [Time frame: Baseline and 18 weeks]
  • Central Sensitization [Time frame: Baseline and 6 weeks]
  • Central Sensitization [Time frame: Baseline and 12 weeks]
  • Central Sensitization [Time frame: Baseline and 18 weeks]
  • Severity of Fibromyalgia_perceived disability [Time frame: Baseline and 6 weeks]
  • Severity of Fibromyalgia_perceived disability [Time frame: Baseline and 12 weeks]
  • Severity of Fibromyalgia_perceived disability [Time frame: Baseline and 18 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • University of Granada — Granada

Identifiers

NCT: NCT07055971 · NEUROPAINFIB_2025 · 2024/CH/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗