NCT07712458尚未招募不适用
Magnetic Resonance Elastography Assessment Of Chronic Low Back Pain Before And After A Manual Therapy Intervention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in SII-derived mobility index
研究概览
简要总结
The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adult males or females (age ≥ 18 years)
- •Report chronic low back pain (≥3 months) (measured by patient history and clinical evaluation)
- •Pain intensity reported at baseline must be ≥4 on the pain VAS scale
- •Presence of myofascial pain features in the lumbar region (e.g., localized tenderness and/or trigger points identified by a qualified clinician/therapist)
- •Able to lie in supine and prone positions for study procedures
- •Be able to participate fully in all aspects of the study
- •Have understood and signed study informed consent
排除标准
- •Pregnancy or breastfeeding
- •Patients with the inability to stay in a prone and supine position for the required procedure durations (e.g., ≥30 minutes at a time)
- •Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
- •Previous lumbar spine surgery or history of severe lumbar injury (e.g., fracture) that, in the investigation team's judgment, would interfere with participation or safety
- •Patients with known bleeding disorders or current therapeutic anticoagulation that would increase risk of bruising/bleeding with massage
- •Patients with skin conditions affecting the treatment area (e.g., rash, open wound, active dermatitis) or known allergy to any materials used during treatment (e.g., gels/cleaners), if applicable
- •Receipt of a new pain treatment within 3 days of the study visit (e.g., injection, ablation, spinal manipulation, massage/manual therapy) that could confound pre/post measures
- •Use of short-acting opioid analgesics or sedating medications within 24 hours of the study visit
- •Have an implanted device in or near the treatment area that could interfere with safe application of external pressure
- •Have used an investigational drug within 30 days of study enrollment
- •History of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- •Clinically significant unstable neurologic or systemic illness that would preclude safe participation, as judged by the investigation team.
- •Surgical intervention for pain within 1 month prior to enrollment
- •Active infection, wound, or other external trauma to the areas to be treated
- •Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
- •Inability to provide consent
研究组 & 干预措施
Expert Manipulative Massage Automation (EMMA)
Experimental
Subjects will receive one massage therapy session utilizing the EMMA system
干预措施: EMMA (Expert Manipulative Massage Automation) (Device)
结局指标
主要结局
Change in SII-derived mobility index
时间窗: Baseline, 30 minutes post-intervention
次要结局
- Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score(Baseline, 30 minutes post-intervention)
- Change in Spinal Range of Motion (ROM)(Baseline, 30 minutes post-intervention)
研究者
研究点 (1)
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