An observational study in Fibromyalgia, sponsored by Toronto Rehabilitation Institute. Completed at 1 site in Canada. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by Toronto Rehabilitation Institute · Observational
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.
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.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 81 is below the median of 100 across 282 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Toronto Rehabilitation Institute is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
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Patients diagnosed with Fibromyalgia and healthy age-matched controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who display symptoms and have a history of Fibromyalgia, between 20-65 years of age.
Diagnostic Test: Ultrasound Imaging
Age-matched, healthy controls, between 20-65 years of age who present no signs of chronic pain.
Diagnostic Test: Ultrasound Imaging
B-mode ultrasound pictures of the upper Trapezius were collected from both left and right sides.
Ultrasound Image Texture Variables
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.
Time frame: 1 hour
Fibromyalgia Diagnostic Criteria
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.
Time frame: 10 minutes
Central Sensitization Inventory
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.
Time frame: 10 minutes
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2018 to primary completion in Sep 2019, 12 months.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Toronto Rehabilitation Institute