QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Diagnostic Reference Test: Trigger point (TrP)
研究概览
简要总结
This study is to create a test that can accurately find and measure the problem areas in muscle and fascia tissue, also known as myofascial pain. The hypothesis is that a combination of imaging findings will be able to detect when myofascial pain is present. The goal is to improve management of myofascial pain by making better tools to find changes in the muscle and fascia tissues for a more personalized treatment. This project was funded by the HEAL initiative (https://heal.nih.gov/).
详细描述
The objective of the R61 phase is to use novel imaging techniques to develop a diagnostic biosignature to objectively and accurately determine the location and severity of abnormal myofascial tissue. A cross-sectional study design approach with 3 groups: plantar fasciitis (n=50), Achilles tendinopathy (n=25), and pain-free controls (n=25) to test Specific Aim: Develop a diagnostic imaging biosignature of myofascial tissue to differentiate individuals with plantar fasciitis from other foot pain without a myofascial component (Achilles tendinopathy) and from matched pain-free controls.
The goal is to develop a diagnostic imaging biosignature that will be able to distinguish between A-MTrP in individuals with plantar fasciitis compared to healthy tissue control (pain-free controls). The biosignature developed in this R61 phase will be screened for clinical utility and considered of interest for further study if it meets the following milestone criteria: area under the receiver operating characteristic curve (ROC AUC) >0.7, sensitivity >60%, and specificity >60%. The ROC analysis will estimate diagnostic performance by comparing differences in biosignatures between tissue where myofascial pain is present vs. tissue where pain is absent.
The proposed sample size of 50 individuals with plantar fasciitis, 25 individuals with Achilles tendinopathy, and 25 matched controls was chosen to provide a confidence interval halfwidth of 0.10 for an AUC of 0.70, assuming 5 muscle measurements for each participant and an overall A-MTrPs prevalence of 0.36 in individuals with plantar fasciitis. Further assuming the 20 biomarkers to be considered in the R61 phase have AUCs uniformly distributed from 0.5 to 0.8, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for plantar fasciitis group:
- •Clinical diagnosis of plantar fasciitis
- •Duration of plantar fasciitis pain greater than or equal to 3 months
- •Severity of plantar fasciitis pain greater than or equal to 3/10
- •Inclusion criteria for Achilles tendinopathy group:
- •Clinical diagnosis of insertional Achilles tendinopathy:
- •Duration of Achilles tendinopathy pain greater than or equal to 3 months
- •Severity of Achilles tendon pain greater than or equal to 3/10
- •Control group:
- •Similar age, sex, and BMI as plantar fasciitis and Achilles tendinopathy groups
排除标准
- •Younger than 18 years of age
- •History of an invasive procedures to the foot and ankle on the side of interest
- •History of lower extremity injections, dry needling, or EPAT/ESWT within past 3 months on the side of interest
- •Contraindications for MRI (e.g. non-MR compatible implanted devices, claustrophobia, inability to remain still comfortably for 1 hour in a supine position, body size too large for MR scanner)
- •Clinically unstable medical or psychiatric issues
- •Pregnant or possibly pregnant
- •Co-morbidities associated with changes in musculoskeletal imaging, including: Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, spondyloarthropathy, gout) endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy) Neuromuscular diseases (e.g., Charcot-Marie-Tooth (CMT) disease) Connective tissue disorder (e.g. Marfan's syndrome, Ehlers-Danlos) Osteoarthritis of the foot or ankle History of foot or ankle fracture Infection of the foot or ankle (e.g., infectious fasciitis, calcaneal osteomyelitis) within the past year Familial hypercholesterolemia Neoplasms involving the foot, Plantar fibromatosis
- •Control group only: Persistent or recurrent leg pain in the past 6 months
- •Plantar fasciitis and Achilles tendinopathy groups only: Other source of heel or foot pain (e.g., tarsal tunnel syndrome, peripheral neuropathy, lumbar radiculopathy, calcaneal stress fracture, Morton's neuroma, fibromyalgia) or co-occurring plantar fasciitis and Achilles tendinopathy (for the Achilles tendinopathy group).
研究组 & 干预措施
Diagnostic imaging
All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
干预措施: Clinical exam (Diagnostic Test)
Diagnostic imaging
All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
干预措施: Ultrasound imaging (Diagnostic Test)
Diagnostic imaging
All participants will have a clinical exam, magnetic resonance imaging, and ultrasound imaging of their foot and ankle.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Diagnostic Reference Test: Trigger point (TrP)
时间窗: Enrollment
Travell and Simons' criteria will be used to identify active muscle trigger points (TrPs) as present or absent. The score will be "Yes" for present and "No" for absent.
Diagnostic Index Test: Imaging biosignature
时间窗: Enrollment
The biosignature will include a combination of ultrasound and/or magnetic resonance imaging measures to capture biomechanical, biochemical, and structural profile of myofascial tissue. Current key candidate imaging biomarkers include: T1p of muscle and fascia, Elastic modulus of the muscle, Shear strain of the plantar fascia, Fat fraction of the muscle, and Thickness of the plantar fascia. The is currently no established scale for this biosignature, which will be developed as part of this study.
次要结局
- Pain Intensity and Interference(Enrollment)
- Movement-evoked pain(Enrollment)
- Physical Function(Enrollment)
- Pain Intensity and Interference(Enrollment)
- Movement-evoked pain(Enrollment)
- Physical Function(Enrollment)
研究者
Ruth Chimenti
Assistant Professor, Physical Therapy and Rehabilitation Science
University of Iowa