Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group.
研究概览
简要总结
The goal of this clinical trial is to see if a body test called the NUN biomarker can track changes in chronic low back pain after dry needling and predict who will feel better. This study is for adults with chronic low back pain from muscle pain (Myofacial Pain).
The main questions are:
- Does the biomarker drop when pain improves?
- Can it predict who benefits most?
- Do higher starting levels mean better results with real dry needling?
Investigators will compare real and fake (sham) dry needling using ultrasound, muscle pressure tests, and pain reports before and after treatment.
详细描述
The goal of this clinical trial is to see if a special body measurement biomarker (called the NUN biomarker) can show changes after dry needling treatment and if it can predict who will get the most pain relief. The study focuses on adults with chronic low back pain (cLBP) that also has a muscle pain (myofascial pain, MP) component.
The main questions it aims to answer are:
- Does the NUN biomarker go down after dry needling when muscle pain gets better?
- Can the biomarker predict who will feel better after treatment?
- Do people with higher biomarker levels at the start respond better to dry needling than to a fake (sham) treatment?
Investigators will compare real dry needling to sham dry needling (fake treatment) to see if the biomarker changes more with real treatment and if this matches pain relief.
Participants will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 20-70;
- •Predominantly axial LBP (meeting NIH definition of cLBP with daily pain for at least 3 months) with a MP component as determined by the standardized examination for MP;
- •Average pain score of > 3/10, with low back pain being the primary pain site;
- •CLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs). Constant radicular pain associated with sensory loss is likely a confounder to dry needling treatment success;
- •NO HISTORY of receiving dry needling, to improve the effectiveness of the blind;
- •Demonstration of healthcare seeking at some point for LBP.
排除标准
- •Back surgery within the past six months;
- •Active workers' compensation or litigation claims, since these patients are more likely to have exaggerated pain behavior;
- •New pain treatments within 2 weeks of enrollment;
- •Any clinically unstable systemic illness or condition that is judged to interfere with the trial;
- •Non-ambulatory status;
- •Not able to complete the questionnaire
- •Currently pregnant or have intentions to become pregnant during the study.
研究组 & 干预措施
Dry needling
干预措施: Dry Needling (Device)
Dry needling
干预措施: NUN Biomarker (Other)
Sham Dry Needling
干预措施: Sham Dry Needling (Device)
Sham Dry Needling
干预措施: NUN Biomarker (Other)
结局指标
主要结局
Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group.
时间窗: 1 week after treatment at the 2nd scan session
Relationships between changes in the biomarker and changes in the clinical condition
Correlations between changes in the biomarker and changes in the clinical assessment of myofascial pain: tender points, trigger points, and pressure algometry.
时间窗: 1 week after treatment at the 2nd exam session
relationships between changes in the biomarker and the quantitative measures on the structured clinical exam
Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group.
时间窗: 1 week after treatment at the 2nd scan session
Relationships between changes in the biomarker and changes in the clinical condition
Correlations between changes in the biomarker and changes in the clinical assessment of myofascial pain: tender points, trigger points, and pressure algometry.
时间窗: 1 week after treatment at the 2nd exam session
relationships between changes in the biomarker and the quantitative measures on the structured clinical exam
次要结局
- Average Pain Intensity(3 days after treatment)
- Pain interference(3 days after treatment)
研究者
Ajay Wasan, MD, Msc
Professor
University of Pittsburgh