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Logistic Regression and Elastic Net Regularization for the Diagnosis of Fibromyalgia (LEDF)

2019年9月12日 更新者: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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

81

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G2A2
        • Toronto Rehabilitation Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients diagnosed with Fibromyalgia and healthy age-matched controls.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ultrasound Image Texture Variables
大体时间: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.
1 hour
Fibromyalgia Diagnostic Criteria
大体时间: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
Central Sensitization Inventory
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dinesh Kumbhare, MD,PhD、Toronto Rehabilitation Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年9月1日

初级完成 (实际的)

2019年9月6日

研究完成 (实际的)

2019年9月6日

研究注册日期

首次提交

2019年9月11日

首先提交符合 QC 标准的

2019年9月12日

首次发布 (实际的)

2019年9月13日

研究记录更新

最后更新发布 (实际的)

2019年9月17日

上次提交的符合 QC 标准的更新

2019年9月12日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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