Multimodal Imaging Biomarkers for Investigating Fascia, Muscle and Vasculature in Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Ultrasound Doppler
研究概览
简要总结
Myofascial pain syndrome (MPS) is highly prevalent in the community. It is primarily diagnosed using patient self reports and physical examination, which lack reliability, sensitivity and specificity and does not provide insights into the abnormal biological and physiological processes in soft tissues. While a number of treatment methods are available to patients, there are currently no criteria to determine which treatments might be best for each patient's unique myofascial pain phenotype. To improve evidence-based management of myofascial pain, there is a critical need to develop quantitative measures that advance the understanding of the physiological processes in the underlying the soft tissues across the clinical continuum of MPS. The objective of this project is to develop a quantitative biomarker informed by the current understanding of underlying tissue-level mechanisms at the level of the "myofascial unit" (muscle, nerve, fascia, vasculature, lymphatics) that are likely to be involved in MPS.
详细描述
Definition of proposed composite multimodal biomarker-The investigators propose to develop a quantitative tissue-level classifier based on quantitative metrics (features) derived from ultrasound elastography, Doppler, bioimpedance spectroscopy and high-density electromyography, as an indicator of the normal biological process in myofascial tissues, and pathogenic process in active and latent phases of myofascial pain.
Overall approach and scientific rigor: In Aim 1, the investigators will develop methods to generate reproducible metrics (features) from the raw tissue-level measures and determine the minimum detectable change in these features in a pilot study. In Aim 2, the investigators will conduct a longitudinal observational study with two groups of subjects (control and myofascial pain). The investigators will develop a classification algorithm that optimally differentiates between active and latent phase of myofascial pain and normal myofascial tissue.
Study population and anatomical site. The chosen pain condition is chronic neck and shoulder pain. The investigators will recruit two groups of subjects: Group 1: Chronic myofascial pain as determined by baseline clinical examination using Travell and Simon's criteria7 and Group 2: pain free controls. The investigators will focus on two standardized anatomical locations (Figure 4). This will enable imaging the medial upper trapezius and the infraspinatus muscles, which are common locations for MTrPs55 as well as the levator scapulae. These three muscles have quite different morphology and fasciae45. The levator is a fusiform muscle with well-defined fascia that includes the muscle while the trapezius has thinner fascia from where perimysium septae cross the muscle belly. The infraspinatus has multiple fascial layers on its surface and has clear segmental linkages to the C5-6 segment56 Eligibility criteria: The investigators will recruit adults 18-65 years of age. Exclusion criteria: (1) diagnosis of fibromyalgia, chronic fatigue syndrome or chronic Lyme disease; (2) Diagnosis of cervical radiculopathy, neuropathy, or neuritis; (3) History of head, neck, cervical spine, or shoulder girdle surgery; (4) Atypical facial neuralgia; (5) New medication or change in medication in past 6 weeks; (6) Current throat or ear infection.
Masking and Matching: This is a single-blind longitudinal observational study. The team performing the data collection and analysis will not know the group allocation of the subjects and will be blinded to the results of the clinical evaluations. The two groups will be age and gender matched using a paired recruitment strategy57. The investigators will identify a pool of eligible control subjects with no history of pain and divide them into gender and age brackets (18-30; 31-50; and >50). For each Group 1 subject recruited in a bracket, the investigators will recruit a matched Group 2 subject from the pool.
Sex as a biological variable: Myofascial pain is widely prevalent in the community and affects both men and women. Trapezius myalgia is more prevalent in women58. The investigators will utilize age and gender-matched groups, and will test the classifier performance for both the pooled population as well as separately by gender to identify any gender-specific differences in the biomarker measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age 18 and older
排除标准
- •Diagnosis of fibromyalgia, chronic fatigue syndrome or chronic Lyme disease confirmed by physical exam
- •Diagnosis of cervical radiculopathy, neuropathy or neuriitis
- •History of head, neck, or shoulder girdle surgery
- •Atypical facial neuralgia
- •New medication or change in medication in past 6 months
- •Current throat or ear infection
研究组 & 干预措施
Active myofascial pain syndrome
Subjects that experience spontaneous pain
干预措施: Ultrasound imaging (Diagnostic Test)
Active myofascial pain syndrome
Subjects that experience spontaneous pain
干预措施: Bioimpedance spectroscopy (Diagnostic Test)
Active myofascial pain syndrome
Subjects that experience spontaneous pain
干预措施: Electromyography (Diagnostic Test)
Active myofascial pain syndrome
Subjects that experience spontaneous pain
干预措施: Physical examination (Diagnostic Test)
Latent myofascial pain syndrome
Subjects that elicit pain only when palpated and disturbed.
干预措施: Ultrasound imaging (Diagnostic Test)
Latent myofascial pain syndrome
Subjects that elicit pain only when palpated and disturbed.
干预措施: Bioimpedance spectroscopy (Diagnostic Test)
Latent myofascial pain syndrome
Subjects that elicit pain only when palpated and disturbed.
干预措施: Electromyography (Diagnostic Test)
Latent myofascial pain syndrome
Subjects that elicit pain only when palpated and disturbed.
干预措施: Physical examination (Diagnostic Test)
Subjects without pain
No symptoms of chronic pain.
干预措施: Ultrasound imaging (Diagnostic Test)
Subjects without pain
No symptoms of chronic pain.
干预措施: Bioimpedance spectroscopy (Diagnostic Test)
Subjects without pain
No symptoms of chronic pain.
干预措施: Electromyography (Diagnostic Test)
Subjects without pain
No symptoms of chronic pain.
干预措施: Physical examination (Diagnostic Test)
结局指标
主要结局
Ultrasound Doppler
时间窗: Baseline, month 3
Ultrasound Doppler estimates the flow velocity in blood vessels. We will extract end-diastolic velocity as the outcome measure.
Bioimpedance spectroscopy
时间窗: Baseline, month 3
Bioimpedance spectroscopy involves sending a small current into tissue at different frequencies and estimating the resistance and reactance. It can be used to measure fluid content in the extracellular space.
High density electromyography
时间窗: Baseline, month 3
High density electromyography involves the placement of a 64-channel electrode array on the skin surface and measuring the electrical activity of muscles. It can be used to measure motor unit excitability. We will extract the Force/EMG ratio as the outcome measure.
Ultrasound shear wave elastography
时间窗: Baseline, month 3
Shear wave elastography utilizes the radiation force of ultrasound to induce shear waves in tissue and measure the propagation speed. It provides information about the mechanical properties of tissue. We will extract the shear anisotropy ratio as the outcome measure.
次要结局
- Pressure pain threshold(Baseline, month 3)
- Cervical and shoulder range of motion(Baseline, month 3)
- NIH HEAL Common data elements for adult chronic pain(Baseline, month 3)
- Ecological Momentary Assessment(Month 1-3)
- Windup ratio(Baseline, month 3)
研究者
Siddhartha Sikdar
Professor
George Mason University
