Using Saline for Myofascial Pain Syndromes (USAMPS)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.
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 (Participant, 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
- •Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.
排除标准
- •Patients allergic to lidocaine and/or steroids.
- •Pregnant women.
- •Prisoners.
- •Patients who are cognitively impaired and/or unable to consent for the study.
- •Signs of localized infection or skin breakdown at the injection site.
研究组 & 干预措施
TPI with Normal Saline
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
干预措施: Normal Saline (Drug)
TPI with Lidocaine & Triamcinolone Acetonide
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
干预措施: Lidocaine Hydrochloride (Drug)
TPI with Lidocaine & Triamcinolone Acetonide
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
Pain Intensity
时间窗: 2 weeks
The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
次要结局
- Duration of Pain Relief(16 days)
研究者
Carlos Roldan
Associate Professor of EMS
The University of Texas Health Science Center, Houston