FibromyalgiaNEUROPAINFIBNCT07055971
Pain Neuroscience Education, Conditioned Pain Modulation and Emotional Processes in Fibromyalgia
A study testing Experimental: Pain Neuoescience Education Group and Active Comparator: Biomedical Education Group in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Experimental: Pain Neuoescience Education Group and Active Comparator: Biomedical Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Experimental: Pain Neuoescience Education Group, Active Comparator: Biomedical Education Group
- Keywords
- Fibromyalgia, Chronic pain, Health Education, Pain Neuroscience Education, Emotional Intellegence, Condioned Pain Modulation, Central Sensitization
- Medical subject headings
- Fibromyalgia, Chronic Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Pain Neuoescience Education GroupBehavioural
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.
Active Comparator: Biomedical Education GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuoescience Education | Experimental | Not described Receives: Behavioral: Experimental: Pain Neuoescience Education Group |
| Biomedical Education | Active comparator | Not described Receives: Behavioral: Active Comparator: Biomedical Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Six Weeks
Secondary outcomes (48)
Pain Intensity: Visual Analog Scale
Change from baseline in pain in the Visual Analog Scale (VAS). Score range between 0-10 cm where 0 is in considerer no pain and 10 is the worst pain
Measured: Baseline and 6 weeks
Pain Intensity: Visual Analog Scale
Change from baseline in pain in the Visual Analog Scale (VAS). Score range between 0-10 cm where 0 is in considerer no pain and 10 is the worst pain
Measured: Baseline and 12 weeks
Pain Intensity: Visual Analog Scale
Change from baseline in pain in the Visual Analog Scale (VAS). Score range between 0-10 cm where 0 is in considerer no pain and 10 is the worst pain
Measured: Baseline and 18 weeks
Pressure Pain Threshold
Change from baseline un pressure pain thresold. A digital pressure algometer will be use to measure the pressure pain thresold bilaterally over the 22 tender points considered by the American College of Rheumatology for Fibromyalgia
Measured: Baseline and 6 weeks
Pressure Pain Threshold
Change from baseline un pressure pain thresold. A digital pressure algometer will be use to measure the pressure pain thresold bilaterally over the 22 tender points considered by the American College of Rheumatology for Fibromyalgia
Measured: Baseline and 12 weeks
Pressure Pain Threshold
Change from baseline un pressure pain thresold. A digital pressure algometer will be use to measure the pressure pain thresold bilaterally over the 22 tender points considered by the American College of Rheumatology for Fibromyalgia
Measured: Baseline and 18 weeks
Central Sensitization
Change from baseline in the Central Sensitization Inventory (CSI). The score ranges from 0 to 100.Higher scores indicate increased frequency and severity of the symptoms
Measured: Baseline and 6 weeks
Central Sensitization
Change from baseline in the Central Sensitization Inventory (CSI). The score ranges from 0 to 100.Higher scores indicate increased frequency and severity of the symptoms
Measured: Baseline and 12 weeks
Central Sensitization
Change from baseline in the Central Sensitization Inventory (CSI). The score ranges from 0 to 100.Higher scores indicate increased frequency and severity of the symptoms
Measured: Baseline and 18 weeks
Severity of Fibromyalgia_perceived disability
Change from baseline in Revised Fibromyalgia Impact Questionnaire (FIQ-R), the score ranges from 0 to 100 . High scores indicate high severity of fibromyalgia symptoms
Measured: Baseline and 6 weeks
Severity of Fibromyalgia_perceived disability
Change from baseline in Revised Fibromyalgia Impact Questionnaire (FIQ-R) , the score ranges from 0 to 100 . High scores indicate high severity of fibromyalgia symptoms
Measured: Baseline and 12 weeks
Severity of Fibromyalgia_perceived disability
Change from baseline in Revised Fibromyalgia Impact Questionnaire (FIQ-R), the score ranges from 0 to 100 . High scores indicate high severity of fibromyalgia symptoms
Measured: Baseline and 18 weeks
Fatigue severity
Change from baseline in the Multidimensional fatigue inventory (MFI) . High scores indicate a greater degree of fatigue
Measured: Baseline and 6 weeks
Fatigue severity
Change from baseline in the Multidimensional fatigue inventory (MFI). High scores indicate a greater degree of fatigue
Measured: Baseline and 12 weeks
Fatigue severity
Change from baseline in the Multidimensional fatigue inventory (MFI). High scores indicate a greater degree of fatigue
Measured: Baseline and 18 weeks
Quality of sleep
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI). The total score varies in a range from 0 to 21 points. Higher scores report poorer sleep quality.
Measured: Baseline and 6 weeks
Quality of sleep
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI). The total score varies in a range from 0 to 21 points. Higher scores report poorer sleep quality.
Measured: Baseline and 12 weeks
Quality of sleep
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI). The total score varies in a range from 0 to 21 points. Higher scores report poorer sleep quality.
Measured: Baseline and 18 weeks
Psychological aspects and common symptoms of anxiety
Change from baseline in the Beck Anxiety Inventory (BAI). Total score range from 0 to 63 points, with high scores indicating a higher degree of anxiety
Measured: Baseline and 6 weeks
Psychological aspects and common symptoms of anxiety
Change from baseline in the Beck Anxiety Inventory (BAI). Total score range from 0 to 63 points, with high scores indicating a higher degree of anxiety
Measured: Baseline and 12 weeks
Psychological aspects and common symptoms of anxiety
Change from baseline in the Beck Anxiety Inventory (BAI). Total score range from 0 to 63 points, with high scores indicating a higher degree of anxiety
Measured: Baseline and 18 weeks
Fear of movement_ Kinesiophobia
Change from baseline in Tampa Scale of Kinesiophobia (TSK). The total score ranges from 11 to 44 points, with higher scores indicating greater levels of kinesiophobia
Measured: Baseline and 6 weeks
Fear of movement_ Kinesiophobia
Change from baseline in Tampa Scale of Kinesiophobia (TSK). The total score ranges from 11 to 44 points, with higher scores indicating greater levels of kinesiophobia
Measured: Baseline and 12 weeks
Fear of movement_ Kinesiophobia
Change from baseline in Tampa Scale of Kinesiophobia (TSK). The total score ranges from 11 to 44 points, with higher scores indicating greater levels of kinesiophobia
Measured: Baseline and 18 weeks
Pain Catastrophizing
Change from baseline in the Pain Catastrophizing Scale (PCS). Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts
Measured: Baseline and 6 weeks
Pain Catastrophizing
Change from baseline in the Pain Catastrophizing Scale (PCS). Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts
Measured: Baseline and 12 weeks
Pain Catastrophizing
Change from baseline in the Pain Catastrophizing Scale (PCS). Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts
Measured: Baseline and 18 weeks
Perceived Emotional Intelligence
Change from baseline in Trait Meta-Mood Scale (TMMS-24) This scale consists of 24 items distributed across 3 subscales that assess emotional attention, emotional clarity, and emotional repair. Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Normal scores are considered to range from 22 to 35 points for the emotional attention dimension, and from 24 to 35 points for the emotional clarity and emotional repair dimensions
Measured: Baseline and 6 weeks
Perceived Emotional Intelligence
Change from baseline in Trait Meta-Mood Scale (TMMS-24) This scale consists of 24 items distributed across 3 subscales that assess emotional attention, emotional clarity, and emotional repair. Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Normal scores are considered to range from 22 to 35 points for the emotional attention dimension, and from 24 to 35 points for the emotional clarity and emotional repair dimensions
Measured: Baseline and 12 weeks
Perceived Emotional Intelligence
Change from baseline in Trait Meta-Mood Scale (TMMS-24) This scale consists of 24 items distributed across 3 subscales that assess emotional attention, emotional clarity, and emotional repair. Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Normal scores are considered to range from 22 to 35 points for the emotional attention dimension, and from 24 to 35 points for the emotional clarity and emotional repair dimensions
Measured: Baseline and 18 weeks
Global Level of Empathy
Change from baseline in the Interpersonal Reactivity Index (IRI). This scale consists of 28 items that assess both the cognitive aspect and the emotional response of the individual when adopting an empathetic attitude. Each item is rated on a Likert scale ranging from 0 (does not describe me well) to 4 (describes me very well)
Measured: Baseline and 6 weeks
Global Level of Empathy
Change from baseline in the Interpersonal Reactivity Index (IRI). This scale consists of 28 items that assess both the cognitive aspect and the emotional response of the individual when adopting an empathetic attitude. Each item is rated on a Likert scale ranging from 0 (does not describe me well) to 4 (describes me very well)
Measured: Baseline and 12 weeks
Global Level of Empathy
Change from baseline in the Interpersonal Reactivity Index (IRI). This scale consists of 28 items that assess both the cognitive aspect and the emotional response of the individual when adopting an empathetic attitude. Each item is rated on a Likert scale ranging from 0 (does not describe me well) to 4 (describes me very well)
Measured: Baseline and 18 weeks
Cognitive and Affective Levels of Empathy
Change from baseline in Cognitive and Affective Empathy Test (TECA) It consists of 33 items distributed across 4 subscales . Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater levels of empathy
Measured: Baseline and 6 weeks
Cognitive and Affective Levels of Empathy
Change from baseline in Cognitive and Affective Empathy Test (TECA) It consists of 33 items distributed across 4 subscales . Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater levels of empathy
Measured: Baseline and 12 weeks
Cognitive and Affective Levels of Empathy
Change from baseline in Cognitive and Affective Empathy Test (TECA) It consists of 33 items distributed across 4 subscales . Each item is rated on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater levels of empathy
Measured: Baseline and 18 weeks
Positive and Negative Affect of Emotions and Feelings
Change from baseline in Positive and Negative Affect Schedule (PANAS). It consists of 20 items distributed across two subscales that assess various emotions and feelings of a positive or negative nature. Each item is rated on a Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 10 to 50 points, with higher scores indicating a greater presence of the specific type of affectTime
Measured: Baseline and 6 weeks
Positive and Negative Affect of Emotions and Feelings
Change from baseline in Positive and Negative Affect Schedule (PANAS). It consists of 20 items distributed across two subscales that assess various emotions and feelings of a positive or negative nature. Each item is rated on a Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 10 to 50 points, with higher scores indicating a greater presence of the specific type of affectTime
Measured: Baseline and 12 weeks
Positive and Negative Affect of Emotions and Feelings
Change from baseline in Positive and Negative Affect Schedule (PANAS). It consists of 20 items distributed across two subscales that assess various emotions and feelings of a positive or negative nature. Each item is rated on a Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 10 to 50 points, with higher scores indicating a greater presence of the specific type of affectTime
Measured: Baseline and 18 weeks
Emotional Well-being
Change from baseline in the Mental Health-5 (MH-5) Scale It consists in a subscale of the Short Form-36 Health Survey, with 5 items related to the area of emotional well-being and assesses the mental health of the participants. Each item is rated on a Likert scale ranging from 1 (always) to 6 (never). Higher scores are associated with better mental health
Measured: Baseline and 6 weeks
Emotional Well-being
Change from baseline in the Mental Health-5 (MH-5) Scale It consists in a subscale of the Short Form-36 Health Survey, with 5 items related to the area of emotional well-being and assesses the mental health of the participants. Each item is rated on a Likert scale ranging from 1 (always) to 6 (never). Higher scores are associated with better mental health
Measured: Baseline and 12 weeks
Emotional Well-being
Change from baseline in the Mental Health-5 (MH-5) Scale It consists in a subscale of the Short Form-36 Health Survey, with 5 items related to the area of emotional well-being and assesses the mental health of the participants. Each item is rated on a Likert scale ranging from 1 (always) to 6 (never). Higher scores are associated with better mental health
Measured: Baseline and 18 weeks
Patients' knowledge levels regarding the neurophysiology of pain
Change from baseline in the Revised Neurophysiology of Pain Questionnaire (R-NPQ). The questionnaire consists of 13 statements about pain (True/False/Don't know), with a total score ranging from 0 to 13 (sum of all correct items).
Measured: Baseline and 6 weeks
Patients' knowledge levels regarding the neurophysiology of pain
Change from baseline in the Revised Neurophysiology of Pain Questionnaire (R-NPQ). The questionnaire consists of 13 statements about pain (True/False/Don't know), with a total score ranging from 0 to 13 (sum of all correct items).
Measured: Baseline and 12 weeks
Patients' knowledge levels regarding the neurophysiology of pain
Change from baseline in the Revised Neurophysiology of Pain Questionnaire (R-NPQ). The questionnaire consists of 13 statements about pain (True/False/Don't know), with a total score ranging from 0 to 13 (sum of all correct items).
Measured: Baseline and 18 weeks
Pain vigilance and awareness
Change from baseline in the 9-item short form of the Pain Vigilance and Awareness Questionnaire (PVAQ-9). Each item is rated on a Likert scale from 0 (never) to 5 (always), with a total score ranging from 0 to 45 points. The optimal cutoff point for identifying women with fibromyalgia who experience poorer daily functioning is set at 24.5 points
Measured: Baseline and 6 weeks
Pain vigilance and awareness
Change from baseline in the 9-item short form of the Pain Vigilance and Awareness Questionnaire (PVAQ-9). Each item is rated on a Likert scale from 0 (never) to 5 (always), with a total score ranging from 0 to 45 points. The optimal cutoff point for identifying women with fibromyalgia who experience poorer daily functioning is set at 24.5 points
Measured: Baseline and 12 weeks
Pain vigilance and awareness
Change from baseline in the 9-item short form of the Pain Vigilance and Awareness Questionnaire (PVAQ-9). Each item is rated on a Likert scale from 0 (never) to 5 (always), with a total score ranging from 0 to 45 points. The optimal cutoff point for identifying women with fibromyalgia who experience poorer daily functioning is set at 24.5 points
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start9 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Casas, Universidad de Granada
- Investigators
- Antonio Casas Barragán, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055971
- Sponsor's protocol ID
- NEUROPAINFIB_2025
- Other IDs
- 2024/CH/01
- Acronym
- NEUROPAINFIB
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07055971
- Acronym / sponsor ID
- NEUROPAINFIB / NEUROPAINFIB_2025
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Chronic pain, Health Education, Pain Neuroscience Education, Emotional Intellegence, Condioned Pain Modulation, Central Sensitization
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuoescience Education | Experimental | Behavioral: Experimental: Pain Neuoescience Education Group |
| Biomedical Education | Active comparator | Behavioral: Active Comparator: Biomedical Education Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Pain Neuoescience Education GroupThe 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. | Behavioural | Pain Neuoescience Education |
| Active Comparator: Biomedical Education GroupThe 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 | Behavioural | Biomedical Education |
Primary outcome
Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia
Time frame: Six weeks
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.
Endogenous pain modulation mechanisms_Deep Hyperalgesia
Time frame: Six Weeks
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.
Endogenous pain modulation mechanisms_ Temporal Summation of pain
Time frame: Six Weeks
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
Endogenous pain modulation mechanisms_Conditioned pain modulation
Time frame: Six Weeks
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.
48 secondary outcomes
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
Fatigue severity
Time frame: Baseline and 6 weeks
Fatigue severity
Time frame: Baseline and 12 weeks
Fatigue severity
Time frame: Baseline and 18 weeks
Quality of sleep
Time frame: Baseline and 6 weeks
Quality of sleep
Time frame: Baseline and 12 weeks
Quality of sleep
Time frame: Baseline and 18 weeks
Psychological aspects and common symptoms of anxiety
Time frame: Baseline and 6 weeks
Psychological aspects and common symptoms of anxiety
Time frame: Baseline and 12 weeks
Psychological aspects and common symptoms of anxiety
Time frame: Baseline and 18 weeks
Fear of movement_ Kinesiophobia
Time frame: Baseline and 6 weeks
Fear of movement_ Kinesiophobia
Time frame: Baseline and 12 weeks
Fear of movement_ Kinesiophobia
Time frame: Baseline and 18 weeks
Pain Catastrophizing
Time frame: Baseline and 6 weeks
Pain Catastrophizing
Time frame: Baseline and 12 weeks
Pain Catastrophizing
Time frame: Baseline and 18 weeks
Perceived Emotional Intelligence
Time frame: Baseline and 6 weeks
Perceived Emotional Intelligence
Time frame: Baseline and 12 weeks
Perceived Emotional Intelligence
Time frame: Baseline and 18 weeks
Global Level of Empathy
Time frame: Baseline and 6 weeks
Global Level of Empathy
Time frame: Baseline and 12 weeks
Global Level of Empathy
Time frame: Baseline and 18 weeks
Cognitive and Affective Levels of Empathy
Time frame: Baseline and 6 weeks
Cognitive and Affective Levels of Empathy
Time frame: Baseline and 12 weeks
Cognitive and Affective Levels of Empathy
Time frame: Baseline and 18 weeks
Positive and Negative Affect of Emotions and Feelings
Time frame: Baseline and 6 weeks
Positive and Negative Affect of Emotions and Feelings
Time frame: Baseline and 12 weeks
Positive and Negative Affect of Emotions and Feelings
Time frame: Baseline and 18 weeks
Emotional Well-being
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Casas Barragán, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Pain Neuoescience Education Group and Active Comparator: Biomedical Education Group in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia (time frame: Six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.