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

NCT07055971 | Enrolling By Invitation

• 2 other identifiers: NEUROPAINFIB_20252024/CH/01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Fibromyalgia; Chronic pain; Health Education; Pain Neuroscience Education; Emotional Intellegence; Condioned Pain Modulation; Central Sensitization

Outcome Measures

Primary Outcomes (4)

• Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia

  Change from baseline in pressure pain hyperalgesia. Pressure pain thresholds (PPTs) will be assessed at the right trapezius and gastrocnemius muscles using a digital algometer. Force will be increased at a rate of 1 kg/s until the participant reports pain. Three measurements will be taken at each site to calculate the mean value.

  Six weeks

• Endogenous pain modulation mechanisms_Deep Hyperalgesia

  Change from baseline in deep hyperalgesia. To quantify the level of deep hyperalgesia, the pressure occlusion threshold will be calculated. An occlusion cuff on the left arm will be inflated at 20 mmHg/s until the subject reports pain. After 30 seconds, pain is rated on a verbal numerical rating scale (VNSR) from 0 to 10 to obtain the VNRS1 value. The cuff pressure is then adjusted until the subject reports level 3 pain on the VNRS, obtaining the VNRS3 value.

  Six Weeks

• Endogenous pain modulation mechanisms_ Temporal Summation of pain

  Change from baseline in the temporal summation (TS) variable of pain, or endogenous pain facilitation. Will be assessed two minutes after the last quantified Pressure pain thresholds (PPT) at both levels (shoulder and calf). Participants will receive 10 pressure pulses perceived as painful, starting at the previously determined mean PPT intensity. Pressure will be increased at a rate of approximately 2 kg/s for each pulse, with 1-second rest intervals between pulses. For each pulse, the pressure will be maintained for 1 second before being released. After the first, fifth, and tenth pulse, participants will be asked to verbally rate their pain on a verbal numerical rating scale (VNRS). The TS measurement variable will be defined as the difference between the VNRS score after the tenth pulse and that after the first pulse

  Six Weeks

• Endogenous pain modulation mechanisms_Conditioned pain modulation

  change from baseline in Conditioned pain modulation (CPM) or endogenous pain inhibition. To assess CPM, the sequence previously described for the temporal summation of pain will be repeated while a so-called 'heterotopic noxious conditioning stimulus' is applied to the patient. This painful stimulus will consist of placing an occlusion cuff on the left arm. The cuff will be inflated to the pressure previously determined to correspond to a verbal numerical rating scale (VNRS) score of 3, representing a moderate pain intensity stimulus. The CPM measurement variable will be defined as the difference between the initial VNRS score before inflating the cuff and the initial VNRS score during cuff occlusion.

  Six Weeks

Secondary Outcomes (48)

• Pain Intensity: Visual Analog Scale

  Baseline and 6 weeks

• Pain Intensity: Visual Analog Scale

  Baseline and 12 weeks

• Pain Intensity: Visual Analog Scale

  Baseline and 18 weeks

• Pressure Pain Threshold

  Baseline and 6 weeks

• Pressure Pain Threshold

  Baseline and 12 weeks

Study Arms (2)

Pain Neuoescience Education

EXPERIMENTAL

Behavioral: Experimental: Pain Neuoescience Education Group

Biomedical Education

ACTIVE COMPARATOR

Behavioral: Active Comparator: Biomedical Education Group

Interventions

Experimental: Pain Neuoescience Education Group 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.

Pain Neuoescience Education

Active Comparator: Biomedical Education Group 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

Biomedical Education

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, Andalusia, 18071, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Health Education

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Antonio Casas Barragán, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD research and teaching staff of the University of Granada

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 9, 2025
• Study Start: April 9, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)