Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in Pain, Enjoyment, and General Activity (PEG) score
研究概览
简要总结
The purpose of this research is to develop and test new Magnetic Resonance Imaging (MRI) methods that look at how muscles and tissues under the skin (myofascial tissues) move and respond to pressure. The investigators want to see how these tissues differ between healthy people and people with pain or injury, and how they change after hands-on treatment (Tuina therapy). The results will also be compared to a group that receives standard care without Tuina therapy.
The main questions this study aims to answer are:
- Can MR elastography (MRE) show changes in how the fascia and the layers between muscles move and stretch before and after manual therapy?
- Do changes seen on MRE scans match changes in pain, function, and other symptoms reported by participants?
- Can MRE measurements before treatment help predict which participants are most likely to improve with manual therapy?
In this randomized controlled trial, participants with myofascial pain will be randomly assigned (randomized) to either the Tuina group or the Usual Care group following a home-based care program without manual therapy. All treatments are noninvasive, hands-on techniques commonly used in clinical practice to reduce tissue tightness and improve movement.
Participants will be asked to undergo three MRI scans and to complete questionnaires and other standard clinical assessments about their pain, physical function, and quality of life.
详细描述
This research study is linked to the prior study NCT05604066 (Magnetic Resonance Elastography of Myofascial Pain Syndrome), which developed and validated the MRE techniques and biomarkers used in the current trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Patient Inclusion Criteria:
- •Adult males or females (age ≥ 18 years)
- •A history of chronic low back for at least 3 months. (Measured by patient history and physical exam)
- •A palpable taut band or nodule within the skeletal muscle
- •Hypersensitive tender spot within the taut band
- •Recognition of current pain complaint by pressure on the tender nodule/taut band
- •Painful limit to the full stretch range of motion
排除标准
- •Pregnancy or breastfeeding
- •Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
- •Previous therapy in the area to be treated within 3 months
- •Previous severe back injury (including fracture) or surgery
- •Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
- •Severe osteoarthritis
- •Skin injuries in the area to be treated
- •Known or suspected clinically significant lumbar disc or other structural spinal pathology considered to be the primary cause of the participant's symptoms or makes study participation or manual therapy inappropriate.
- •Have a known history of any condition or factor judged by the investigators to preclude participation in the study or which might hinder adherence
- •Inability to provide consent.
研究组 & 干预措施
Usual Care Only
Participants will receive usual care only for three weeks, no additional manual therapy will be provided.
干预措施: Usual care (Other)
Tuina + Usual Care
Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.
干预措施: Usual care (Other)
Tuina + Usual Care
Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.
干预措施: Tuina treatment (Other)
结局指标
主要结局
Change in Pain, Enjoyment, and General Activity (PEG) score
时间窗: Baseline, 1 day post-intervention, 3 weeks post-intervention
The Pain, Enjoyment, and General Activity (PEG) score is a three-item questionnaire asking individuals to rate their Pain, Enjoyment of life, and General activity on a scale of 0 to 10 over the past week. The PEG score is the average of the three responses, ranging from 0 to 10, with higher scores indicating more severe pain or interference with life
次要结局
未报告次要终点