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

Launched by UNIVERSIDAD DE GRANADA · Jun 27, 2025

Keywords

ClinConnect Summary

This trial from the University of Granada in Spain is testing whether a Pain Neuroscience Education (PNE) program helps people with fibromyalgia (FM) understand their pain and improve how their nervous system handles it. Participants are randomly assigned to receive either the PNE program or an active comparison education program about biomedical topics. Both groups meet in small in-person sessions once a week for 6 weeks and continue their usual care and exercise. The study uses a blinded design, so neither participants nor the people measuring outcomes know which group each person is in.

Eligible participants are adult women (18+) with a fibromyalgia diagnosis confirmed by a rheumatologist in Andalusia, Spain. People with serious liver, heart, or kidney disease, inflammatory or neurological disorders, infections, severe psychiatric illness, recent surgery, or who are in other non-drug therapy programs are excluded. If you participate, you’ll join a small group (5–10 people) for 6 weekly sessions and will have follow-up assessments at about 6, 12, and 18 weeks. Researchers will look at a wide range of outcomes, including pain intensity, sleep quality, fatigue, mood, memory of pain education, and several tests that show how the body and brain process pain. The main focus is on objective measures of pain processing (like sensitivity to pressure, how pain signals are modulated, and how pain summates over time) to see if PNE can improve central pain mechanisms and related emotional factors. Enrollment is expected to include around 46 participants, with results anticipated after the study completes in 2026.

Gender

FEMALE

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.