- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04088747
Logistic Regression and Elastic Net Regularization for the Diagnosis of Fibromyalgia (LEDF)
12 septembre 2019 mis à jour par: Dinesh Kumbhare, Toronto Rehabilitation Institute
Logistic Regression and Elastic Net Regularization for the Diagnosis of Fibromyalgia: A Quantitative Approach Using B-Mode Ultrasound
This study will utilize ultrasound image texture variables to construct an elastic net regularized, logistic regression model to differentiate between healthy and Fibromyalgia patients.
The collected ultrasound data will be from participants who are healthy, and from participants who have Fibromyalgia.
The predicted performance accuracy of the diagnostic model will be validated and this will confirm or deny the hypothesis that differentiation between the two cohorts is possible.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Fibromyalgia (FM) diagnosis remains a challenge for clinicians due to a lack of objective diagnostic tools.
One proposed solution is the use of quantitative ultrasound (US) techniques, such as image texture analysis, which has demonstrated discriminatory capabilities with other chronic pain conditions.
The investigators propose the use of US image texture variables to construct an elastic net regularized, logistic regression model, for differentiating between the trapezius muscle in the healthy and FM patients.
162 Ultrasound videos of the right and left trapezius muscle were acquired from healthy participants and participants with FM.
The videos will then be put through a mutli-step processing pipe including converting them into skeletal muscle regions of interest (ROI).
The ROI's will be then filtered by an algorithm utilizing the complex wavelet structural similarity index (CW-SSIM), which removes ROI's that are too similar to one another.
Eighty-eight texture variables will be extracted from the ROI's, which will be used in nested cross-validation to construct a logistic regression model with and without elastic net regularization.
The generalized performance accuracy of both models will be estimated and confirmed with a final validation on a holdout test set.
Depending on the predicted, generalized performance accuracy it will be validated or not by the final, holdout test set (confirming the model construction is accurate).
These models should then confirm or deny the hypothesis that a regularized logistic regression model built on ultrasound texture features can accurately differentiate between healthy trapezius muscle and that of patients with FM.
Type d'étude
Observationnel
Inscription (Réel)
81
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Ontario
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Toronto, Ontario, Canada, M5G2A2
- Toronto Rehabilitation Institute
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients diagnosed with Fibromyalgia and healthy age-matched controls.
La description
Inclusion Criteria:
- gender independent; chronic widespread pain, fitting the 2016 FM criteria, absence of myofascial pain syndrome trigger points and between the ages of 20 and 65 years (44.3 ± 13.9 years).
- Healthy asymptomatic volunteers who were age matched (n = 17) with no physical complaints or abnormality on physical examination also participated.
Exclusion Criteria:
- Participants were excluded if they demonstrated clinical evidence of another cause for widespread pain, such as polymyositis, dermatomyositis, endocrine disorders, etc. None of the participants had performed any physical exercise during the two to three days prior to entry into the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Fibromyalgia
Patients who display symptoms and have a history of Fibromyalgia, between 20-65 years of age.
|
B-mode ultrasound pictures of the upper Trapezius were collected from both left and right sides.
|
|
Healthy Controls
Age-matched, healthy controls, between 20-65 years of age who present no signs of chronic pain.
|
B-mode ultrasound pictures of the upper Trapezius were collected from both left and right sides.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ultrasound Image Texture Variables
Délai: 1 hour
|
91 statistical image texture variables are extracted from the B mode ultrasound images from both cohorts in order to construct a diagnostic model.
The texture variables will be extracted using MATLAB.
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1 hour
|
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Fibromyalgia Diagnostic Criteria
Délai: 10 minutes
|
This evaluates symptoms related to Fibromyalgia and determines a score to assess the severity.
This score is comprised of the Widespread Pain Index(WPI), which quantifies the regions of pain, and the Symptom Severity Scale(SSS), which measures qualitative aspects of pain such as fatigue and cognitive symptoms.
The WPI scale ranges from 0-19 (0- no areas of body pain, 19- all body regions have pain), whereas the SSS ranges from 0-12 (0-no qualitative aspects of pain, 12-many qualitative aspects of pain).
This criteria was evaluated on each patient to determine which cohort they belong to.
According to the Fibromyalgia Diagnostic Criteria, one is diagnosed with Fibromyalgia if they have a WPI score of 7 or higher, and a SSS score of 5 or higher.
Fibromyalgia is also diagnosed with a score of 3-6 on the WPI score, and a score of 9 or higher on the SSS score.
|
10 minutes
|
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Central Sensitization Inventory
Délai: 10 minutes
|
This is a self reported outcome measure designed to identify patients that experience central sensitization.
It involves 25 questions which include symptomatic experiences.
The subject must answer on a scale of 0(never) to 5(always) corresponding to how often they experience these.
The maximum score is 100 and a score of more than 40 indicates the presence of Central Sensitization.
This criteria was evaluated on each patient to determine which cohort they belong to.
|
10 minutes
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dinesh Kumbhare, MD,PhD, Toronto Rehabilitation Institute
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
- Kumbhare DA, Ahmed S, Behr MG, Noseworthy MD. Quantitative Ultrasound Using Texture Analysis of Myofascial Pain Syndrome in the Trapezius. Crit Rev Biomed Eng. 2018;46(1):1-31. doi: 10.1615/CritRevBiomedEng.2017024947.
- Gittins R, Howard M, Ghodke A, Ives TJ, Chelminski P. The Accuracy of a Fibromyalgia Diagnosis in General Practice. Pain Med. 2018 Mar 1;19(3):491-498. doi: 10.1093/pm/pnx155.
- Schaefer C, Mann R, Masters ET, Cappelleri JC, Daniel SR, Zlateva G, McElroy HJ, Chandran AB, Adams EH, Assaf AR, McNett M, Mease P, Silverman S, Staud R. The Comparative Burden of Chronic Widespread Pain and Fibromyalgia in the United States. Pain Pract. 2016 Jun;16(5):565-79. doi: 10.1111/papr.12302. Epub 2015 May 16.
- Ablin JN, Wolfe F. A Comparative Evaluation of the 2011 and 2016 Criteria for Fibromyalgia. J Rheumatol. 2017 Aug;44(8):1271-1276. doi: 10.3899/jrheum.170095. Epub 2017 Jun 1.
- U.S. Department of Health and Human Services Food and Drug Administration/Centre for Drug Evaluation and Research. Guidance for Industry and FDA Staff Qualification Process for Drug Development Tools. Silver Spring, MD: Author; 2014
- Kravis MM, Munk PL, McCain GA, Vellet AD, Levin MF. MR imaging of muscle and tender points in fibromyalgia. J Magn Reson Imaging. 1993 Jul-Aug;3(4):669-70. doi: 10.1002/jmri.1880030418.
- Meenagh G, Sakellariou G, Iagnocco A, Delle Sedie A, Riente L, Filippucci E, Di Geso L, Grassi W, Bombardieri S, Valesini G, Montecucco C. Ultrasound imaging for the rheumatologist XXXIX. Sonographic assessment of the hip in fibromyalgia patients. Clin Exp Rheumatol. 2012 May-Jun;30(3):319-21. Epub 2012 Jun 26.
- Bendtsen L, Norregaard J, Jensen R, Olesen J. Evidence of qualitatively altered nociception in patients with fibromyalgia. Arthritis Rheum. 1997 Jan;40(1):98-102. doi: 10.1002/art.1780400114.
- MathWorks. Image Processing Toolbox., Release 2018a, The MathWorks Inc.,Natick, Massachusetts, United States
- Sampat MP, Wang Z, Gupta S, Bovik AC, Markey MK. Complex wavelet structural similarity: a new image similarity index. IEEE Trans Image Process. 2009 Nov;18(11):2385-401. doi: 10.1109/TIP.2009.2025923. Epub 2009 Jun 23.
- Behr M, Noseworthy M, Kumbhare D. Feasibility of a Support Vector Machine Classifier for Myofascial Pain Syndrome: Diagnostic Case-Control Study. J Ultrasound Med. 2019 Aug;38(8):2119-2132. doi: 10.1002/jum.14909. Epub 2019 Jan 7.
- Haralick, R. M., & Shanmugam, K. Textural features for image classification. IEEE Transactions on systems, man, and cybernetics. 1973;SMC-3(6):610-621.
- Galloway, M. M. Texture classification using gray level run length. Computer graphics and image processing. 1975;4(2):172-179.
- Zou, H., & Hastie, T. Regularization and variable selection via the elastic net. Journal of the royal statistical society: series B (statistical methodology) 2005;67(2):301-320.
- MathWorks. Statistics and Machine Learning Toolbox., Release 2018a, The MathWorks Inc.,Natick, Massachusetts, United States
- Jalalian A, Mashohor SB, Mahmud HR, Saripan MI, Ramli AR, Karasfi B. Computer-aided detection/diagnosis of breast cancer in mammography and ultrasound: a review. Clin Imaging. 2013 May-Jun;37(3):420-6. doi: 10.1016/j.clinimag.2012.09.024. Epub 2012 Nov 13.
- Virmani, J., Kumar, V., Kalra, N., & Khandelwal, N. Prediction of liver cirrhosis based on multiresolution texture descriptors from B-mode ultrasound. International Journal of Convergence Computing 2013;1(1):19-37.
- Xian, G. M. An identification method of malignant and benign liver tumors from ultrasonography based on GLCM texture features and fuzzy SVM. Expert Systems with Applications 2010;37(10):6737-6741.
- Bishop, C. M. Pattern recognition and machine learning. New York, NY: Springer-Verlag: 2006. p. 205-207.
- Sarle, W. S. Stopped training and other remedies for overfitting. Computing science and statistics, 1996:352-360.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2018
Achèvement primaire (Réel)
6 septembre 2019
Achèvement de l'étude (Réel)
6 septembre 2019
Dates d'inscription aux études
Première soumission
11 septembre 2019
Première soumission répondant aux critères de contrôle qualité
12 septembre 2019
Première publication (Réel)
13 septembre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 septembre 2019
Dernière vérification
1 septembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FibromyalgiaDiagnosis
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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