Predictive Models on Pain and Severity in FM Patients
Development of Predictive Models Based on Artificial Intelligence for the Analysis of the Psychosocial Profile of the Patient With Fibromyalgia on Pain and Severity of the Disease.
1 other identifier
observational
150
1 country
1
Brief Summary
The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objectives the research project intends: to predicting Fibromyalgia severity of patients based on clinical variables; to assess the relevance of social-psycho-demographic variables on the fibromyalgia severity of the patients; to predict the pain suffered by the patients as well as the impact of the fibromyalgia on patient's life; to categorize fibromyalgia group of patients depending on their levels of Fibromyalgia severity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJune 9, 2021
June 1, 2021
5 months
June 2, 2021
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Pain intensity
It will be measured with a visual analog scale (VAS) of 100 millimeters in length. The subject has to indicate the level ofpain he feels, being 0 the absence of pain and 100 the maximum imaginable.
Baseline.
Disease severity.
It will be measured using the Polysymptomatic Distress Scale (PDS) (or Fibromyalgia Severity Scale), composed of the sum of the following two scales: 1. Widespread Pain Index (WPI): Questionnaire in which a total of 19 body areas are represented. The subject has to mark the regions where the pain appears. It represents a measure of the extent of pain, with a maximum score of 19 points. 2. Symptom Severity Scale (SSS): Questionnaire that measures the severity of the symptoms associated with fibromyalgia, such as fatigue, non-restorative sleep, cognitive problems, headaches, abdominal pain or cramps and depression. It represents a measure of somatic and non-somatic symptoms of fibromyalgia, with a maximum score of 12 points.
Baseline.
Referred pain area after suprathreshold pressure stimulation.
A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark).
Baseline.
Secondary Outcomes (4)
Fibromyalgia Impact Quality-of-Life.
Baseline.
Anxiety.
Baseline.
Pain catastrophizing.
Baseline.
Depression.
Baseline.
Eligibility Criteria
Members enrolled in a local fibromyalgia association.
You may qualify if:
- Age between 18 and 65 years.
- Fullfilled the 2010 American Collegue of Rheumathology criteria for fibromyalgia.
- Understanding of spoken and written Spanish.
You may not qualify if:
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
- Neurological pathologies that make evaluations difficult.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 9, 2021
Study Start
June 1, 2021
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
June 9, 2021
Record last verified: 2021-06