The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- visual analog scale (VAS)
研究概览
简要总结
Patients with an myofascial trigger point (MTrP) in their upper trapezius will be divided into three groups: Group A receiving MTrP injection with normal saline (control group), Group B with hypo-osmolar dextrose (5% dextrose), and Group C with hyper-osmolar dextrose (15% dextrose). Clinical outcomes and morphological changes will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection to delineate the therapeutic effects of dextrose injection for an MTrP.
详细描述
This experiment is designed to evaluate the therapeutic effects of dextrose injection on an myofascial trigger point (MTrP). Patients with an MTrP in their upper trapezius will be recruited and be divided into three groups: Group A receiving MTrP injection with normal saline (control group), Group B with hypo-osmolar dextrose (5% dextrose), and Group C with hyper-osmolar dextrose (15% dextrose). Clinical outcomes (visual analog scale, pressure pain threshold, range of motion, neck disability index) will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection. Morphological changes of an MTrP before, and after the injection will also be evaluated by sonography. Through this study, the definite therapeutic effects, and the better osmolality of dextrose injection for the treatment of an MTrP will be delineated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Patients should be 20 years of age or older;
- •. They are able to communicate freely;
- •. Patients have the diagnosis of myofascial pain syndrome (MPS) with a definite myofascial trigger point (MTrP) in the neck base and upper back regions (the upper trapezius muscle). The MTrP is identified based on the following criteria, as recommended by Simons [Simons et al., 1999]:
- •(a). a localized tender spot in a palpable taut band of muscle fibers,
- •(b). recognized pain (as the usual clinical complaint) when the tender spot is compressed,
- •(c). characteristic and consistent referred pain.
- •. Symptoms of MPS should be more than 3 weeks.
排除标准
- •(1). acute or serious medical problems;
- •(2). cognitive impairment or psychiatric disorder;
- •(3). coagulopathy or any other bleeding disorder;
- •(4). taking medication of anticoagulation or antithrombolytics;
- •(5). sensory deficiency over the body part where MTrPs located;
- •(6). serum hepatitis B or acquired immunodeficiency syndrome;
- •(7). malignancy;
- •(8). pregnant or likely to be pregnant.
- •(9). diabetes mellitus
研究组 & 干预措施
Normal saline
Injection of 2 ml normal saline into a myofascial trigger point.
干预措施: normal saline (Other)
hypo-osmolar dextrose solution
Injection of 2 ml 5% dextrose into a myofascial trigger point.
干预措施: Dextrose 5% in water (Drug)
hyper-osmolar dextrose solution
Injection of 2 ml 15% dextrose into a myofascial trigger point.
干预措施: Dextrose 15% in water (Drug)
结局指标
主要结局
visual analog scale (VAS)
时间窗: Change from Baseline visual analog scale at one month after intervention.
To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).
visual analog scale (VAS)
时间窗: Change from Baseline visual analog scale at two weeks after intervention.
To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).
visual analog scale (VAS)
时间窗: Change from Baseline visual analog scale at one hour after intervention.
To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).
visual analog scale (VAS)
时间窗: Change from Baseline visual analog scale at one week after intervention.
To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).
次要结局
- pressure pain threshold (PPT)(Change from Baseline pressure pain threshold at one month after intervention.)
- Range of motion (ROM) of the neck(Change from Baseline range of motion (ROM) of the neck at one month after intervention.)
- neck disability index (NDI)(Change from Baseline neck disability index (NDI) at one month after intervention.)
- pressure pain threshold (PPT)(Change from Baseline pressure pain threshold at one hour after intervention.)
- pressure pain threshold (PPT)(Change from Baseline pressure pain threshold at one week after intervention.)
- pressure pain threshold (PPT)(Change from Baseline pressure pain threshold at two weeks after intervention.)
- Range of motion (ROM) of the neck(Change from Baseline range of motion (ROM) of the neck at one hour after intervention.)
- Range of motion (ROM) of the neck(Change from Baseline range of motion (ROM) of the neck at one week after intervention.)
- Range of motion (ROM) of the neck(Change from Baseline range of motion (ROM) of the neck at two weeks after intervention.)
- neck disability index (NDI)(Change from Baseline neck disability index (NDI) at one hour after intervention.)
- neck disability index (NDI)(Change from Baseline neck disability index (NDI) at one week after intervention.)
- neck disability index (NDI)(Change from Baseline neck disability index (NDI) at two weeks after intervention.)
研究者
Ta-Shen Kuan, MD
associate professor, M.D.
National Cheng-Kung University Hospital