Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia
NCT05084300, Not applicable, Completed, Instituto Neurociencia Del Dolor
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness Pain Neuroscience Education In The Executive Functions In Patients With Fibromyalgia | ClinicalTrials.gov |
| NCT number | NCT05084300 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 62 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Instituto Neurociencia Del Dolor | ClinicalTrials.gov |
| Conditions | Fibromyalgia, Executive Function, Neuroscience | ClinicalTrials.gov |
| Interventions | Pain Neuroscience Education, Usual care | ClinicalTrials.gov |
| First posted | 2021-10-19 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Visual Analog Scale-Pain (EVA) | 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. | ClinicalTrials.gov |
| Primary | Change in Wisconsin card sorting test (WCST) | 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. | ClinicalTrials.gov |
| Primary | Change in Simon task | 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. | ClinicalTrials.gov |
| Primary | Change in Visual-spatial working memory span measured by Corsi Block-Tapping task | 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. | ClinicalTrials.gov |
| Secondary | Change in Stroop Color-word Task | at baseline and through intervention's completion, 5 weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in Central Sensitization Inventory Score (CSI) | at baseline and through intervention's completion, 5 weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in Pain Catastrophizing Scale (PCS) | at baseline and through intervention's completion, 5 weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in Tampa Scale for Kinesiophobia (TSK-11) | at baseline and through intervention's completion, 5 weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in Beck Depression Inventory Score | at baseline and through intervention's completion, 5 weeks. | 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. | ClinicalTrials.gov |
| Other | Change in Fibromyalgia Impact Questionnaire (FIQ) | at baseline and through intervention's completion, 5 weeks. | The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. A validated self-reported questionnaire developed for FM (scores range from 0 to 100, average FM patients score about 50 and severely affected patients score \>70) wich measures multidimensional function/health-related quality of life. | ClinicalTrials.gov |
| Other | Minimental State Examination Folstein | at baseline and through intervention's completion, 5 weeks. | Mini-Cognitive Lobo est (MEC). To assess the cognitive status before inclusion in the study, the spanish version of Folstein's Minimental State Examination is used. Adapted and validated by Lobo in Spain in 1979. It is a brief cognitive test that consists of the evaluation of the most important cognitive areas (orientation, concentration, calculation, memory, language and construction) with a global maximum score of 35 (30-35 = normal, 24-29 = borderline, \<24 in people over 65). The MEC has widely shown its reliability, validity and discriminative power, with a specificity of 75.1% and a sensitivity of 89.8%. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39486209 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Corsi Block-Tapping Test | Primary outcome | ConductCognition |
| Simon Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)