FibromyalgiaPNENCT05084300
Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia
A study testing Pain Neuroscience Education in people with Fibromyalgia and Executive Function, run by Instituto Neurociencia Del Dolor at 2 sites in 2 countries.
Trial summary
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Executive Function, Neuroscience
- What is being tested?
- Pain Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Apr 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) Be female
- (2) Age between 40-60 years.
- (3) Sign the consent form.
- (4) Diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
- (5) Mini Mental State Examination Score greater than or equal to 26 points
- (6) Schooling of at least 12 years (basic primary and secondary).
- (7) Have Spanish as their native language
- (8) Internet access
Who cannot join
- (1) Pregnant woman
- (2) Illiterate
- (3) Inflammatory rheumatic disease
- (4) Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Colombia1 site
Centro de Artritis y Osteoporosis
Barranquilla, Atlántico, 080020
Mexico1 site
Instituto Transdisciplinario de Rehabilitación (ITR)
Puebla City, Puebla, 72410
About this study
Official title: Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia.
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for FM. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality.
Many studies have shown cognitive impairment in FM patients compared to control groups, and FM patients mainly show problems with working memory processes and / or in their attentional and executive domains, as well as in speed of speech. processing (BD Dick, Verrier, Harker, \& Rashiq, 2008; Glass, 2009; Tesio et al., 2015; Williams, Clauw, \& Glass, 2011).
Read more
Many patients with FM have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia. This study aimed to explore the effectiveness of pain neuroscience education in patients with FM.
Therefore, this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM.
Read the detailed description
The design of the present study will be a parallel-group randomized controlled trial that will be performed between september 2021 and march 2022.
Total = 62 patients. Experimental: PNE (31), Control: Usal care (31). Experimental: In individualized sessions to 31 patients, a health professional will explain the neurological mechanisms that are behind the perception of pain, fatigue and illness from the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to change patien´s behaviour thanks to neuroplasticity.
There will be 10 sessions of 35 minutes, 2 times per week.
Each week the contents of the class and other complementary materials will be sent to the patients.
He outcomes will be assessed at baseline (t1) and one week after intervention (t2). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
- Conditions
- Fibromyalgia, Executive Function, Neuroscience
- Being tested
- Pain Neuroscience Education, Usual care
- Keywords
- Pain, Neurophysiology, Education
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Also called Pain Neurophysiology Education
A total of 10 PNE sessions (Neuroscience pain education) will be carried out, two each week in addition medical treatment similar to control group (Usual care). The NPE sessions will be conducted by an experienced NPE certified physical therapist in 35 minute face-to-face group sessions. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
Usual careOther
The control group (Usual care) is treated with usual treatment, managment or medication for fibromyalgia, anxiolytics, antidepressants, analgesics. Depending on the medical needs and criteria of patients´s primary care physician.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education | Experimental | Pain neuroscience education in addition medical treatment. Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. Receives: Other: Pain Neuroscience Education; Other: Usual care |
| Usual care | Other | The control group is treated with usual medication for fibromyalgia, anxiolytics, antidepressants, analgesics, ... Depending on the medical needs and criteria of patients´s primary care physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale-Pain (EVA)
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Wisconsin card sorting test (WCST)
The WCST measures cognitive processes such as administrative control, characterization, perseveration, executive function, conceptualization, abstract thinking and reasoning, and it is mainly linked to frontal lobe .
Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range <20 to >80) will be reported. Higher values indicate better outcome.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Simon task
A cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Visual-spatial working memory span measured by Corsi Block-Tapping task
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
Measured: at baseline and through intervention's completion, 5 weeks.
Secondary outcomes (5)
Change in Stroop Color-word Task
In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Central Sensitization Inventory Score (CSI)
Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine.
The Central Sensitization Inventory (CSI) consists of two parts:
Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression.
The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Pain Catastrophizing Scale (PCS)
The PCS is measured with a self-administered questionnaire. The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Tampa Scale for Kinesiophobia (TSK-11)
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Measured: at baseline and through intervention's completion, 5 weeks.
Change in Beck Depression Inventory Score
Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.
It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.
Measured: at baseline and through intervention's completion, 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start15 Apr 2023
- Primary completion15 Jun 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Costa, Instituto Transdisciplinario de Rehabilitación (ITR), Puebla, México, Centro Mexicano Universitario de Ciencias y Humanidades (CMUCH), Puebla, México, Centro de Artritis y Osteoporosis, Barranquilla, Colombia
- Responsible party
- Sponsor
- Investigators
- Pedro J Lopez, PhD, Study director, Doctorado en Neurociencia Cognitiva Aplicada, Universidad de la Costa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084300
- Sponsor's protocol ID
- INeurocienciaDolor0001
- Acronym
- PNE
- Status last verified
- Nov 2026
- First submitted
- 18 Mar 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morales-Osorio MA, Ramirez-Velez R, Mejia-Mejia J, Martinez-Martinez LA, Roman F, Lopez-Perez PJ, Ordonez-Mora LT. Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial. Contemp Clin Trials. 2024 Dec;147:107731. doi: 10.1016/j.cct.2024.107731. Epub 2024 Oct 31.
PubMed 39486209
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Pain Neuroscience Education Program in the Executive Functions and Pain Intensity in Patients With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT05084300
- Acronym / sponsor ID
- PNE / INeurocienciaDolor0001
- Conditions
- Fibromyalgia, Executive Function, Neuroscience
- Keywords
- Pain, Neurophysiology, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- Universidad de la Costa, Instituto Transdisciplinario de Rehabilitación (ITR), Puebla, México, Centro Mexicano Universitario de Ciencias y Humanidades (CMUCH), Puebla, México, Centro de Artritis y Osteoporosis, Barranquilla, Colombia
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 19 Oct 2021 (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.
Fibromyalgia (FM) is a chronic, complex and disabling clinical entity that has an average global prevalence of 2.7%. It occurs mainly in women in a 3: 1 ratio. It is characterized by persistent generalized pain, fatigue, unrefreshing sleep, cognitive dysfunction and numerous systemic symptoms such as dizziness, migraine, digestive alterations or sensory intolerances. At present there is no pharmacological treatment with specific indication for FM. Usually, non-curative treatments are recommended that alleviate the symptoms of the patients and improve their quality of life and functionality.
Many studies have shown cognitive impairment in FM patients compared to control groups, and FM patients mainly show problems with working memory processes and / or in their attentional and executive domains, as well as in speed of speech. processing (BD Dick, Verrier, Harker, \& Rashiq, 2008; Glass, 2009; Tesio et al., 2015; Williams, Clauw, \& Glass, 2011).
Many patients with FM have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia. This study aimed to explore the effectiveness of pain neuroscience education in patients with FM.
Therefore, this research aims to analyze the effectiveness of the neuroscience education program on pain in executive functions and the intensity of pain in patients with FM.
Detailed description
The design of the present study will be a parallel-group randomized controlled trial that will be performed between september 2021 and march 2022.
Total = 62 patients. Experimental: PNE (31), Control: Usal care (31). Experimental: In individualized sessions to 31 patients, a health professional will explain the neurological mechanisms that are behind the perception of pain, fatigue and illness from the recent knowledge in neuroscience about brain and pain, as well as the brain's ability to change patien´s behaviour thanks to neuroplasticity.
There will be 10 sessions of 35 minutes, 2 times per week.
Each week the contents of the class and other complementary materials will be sent to the patients.
He outcomes will be assessed at baseline (t1) and one week after intervention (t2). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education | Experimental | Other: Pain Neuroscience Education, Other: Usual carePain neuroscience education in addition medical treatment. Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. |
| Usual care | Other | Other: Usual careThe control group is treated with usual medication for fibromyalgia, anxiolytics, antidepressants, analgesics, ... Depending on the medical needs and criteria of patients´s primary care physician. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- (1) Be female
- (2) Age between 40-60 years.
- (3) Sign the consent form.
- (4) Diagnosis of fibromyalgia, according to the American College of Rheumatology criteria;
- (5) Mini Mental State Examination Score greater than or equal to 26 points
Key exclusion criteria (4 listed)
- (1) Pregnant woman
- (2) Illiterate
- (3) Inflammatory rheumatic disease
- (4) Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.
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 |
|---|---|---|
| Pain Neuroscience EducationAlso: Pain Neurophysiology EducationA total of 10 PNE sessions (Neuroscience pain education) will be carried out, two each week in addition medical treatment similar to control group (Usual care). The NPE sessions will be conducted by an experienced NPE certified physical therapist in 35 minute face-to-face group sessions. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain. | Other | Pain Neuroscience Education |
| Usual careThe control group (Usual care) is treated with usual treatment, managment or medication for fibromyalgia, anxiolytics, antidepressants, analgesics. Depending on the medical needs and criteria of patients´s primary care physician. | Other | Pain Neuroscience Education, Usual care |
Primary outcome
Change in Visual Analog Scale-Pain (EVA)
Time frame: at baseline and through intervention's completion, 5 weeks.
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Change in Wisconsin card sorting test (WCST)
Time frame: at baseline and through intervention's completion, 5 weeks.
The WCST measures cognitive processes such as administrative control, characterization, perseveration, executive function, conceptualization, abstract thinking and reasoning, and it is mainly linked to frontal lobe . Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range <20 to >80) will be reported. Higher values indicate better outcome.
Change in Simon task
Time frame: at baseline and through intervention's completion, 5 weeks.
A cognitive task, assessing control processes under speeded conditions, measured by response time and accuracy rate. shorter response time and higher accuracy rate indicate better performance.
Change in Visual-spatial working memory span measured by Corsi Block-Tapping task
Time frame: at baseline and through intervention's completion, 5 weeks.
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
5 secondary outcomes
Change in Stroop Color-word Task
Time frame: at baseline and through intervention's completion, 5 weeks.
Change in Central Sensitization Inventory Score (CSI)
Time frame: at baseline and through intervention's completion, 5 weeks.
Change in Pain Catastrophizing Scale (PCS)
Time frame: at baseline and through intervention's completion, 5 weeks.
Change in Tampa Scale for Kinesiophobia (TSK-11)
Time frame: at baseline and through intervention's completion, 5 weeks.
Change in Beck Depression Inventory Score
Time frame: at baseline and through intervention's completion, 5 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 39486209Morales-Osorio MA, Ramirez-Velez R, Mejia-Mejia J, Martinez-Martinez LA, Roman F, Lopez-Perez PJ, Ordonez-Mora LT. Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial. Contemp Clin Trials. 2024 Dec;147:107731. doi: 10.1016/j.cct.2024.107731. Epub 2024 Oct 31.
- 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. This study is not recruiting at the moment.
Pedro J Lopez, PhD study director
Doctorado en Neurociencia Cognitiva Aplicada, Universidad de la Costa
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education in people with Fibromyalgia and Executive Function, run by Instituto Neurociencia Del Dolor at 2 sites in 2 countries.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia, Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Visual Analog Scale-Pain (EVA) (time frame: at baseline and through intervention's completion, 5 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?
On the ClinicalTrials.gov record for NCT05084300, which also lists 1 linked publication.
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 4 Nov 2026.