KCT0005359已完成未知
Clinical study on efficacy and safety of polydioxanone thread procedure for myofascial pain syndrome in the trapezius muscle: a single center, randomized, double-blinded, case-control trial
The Catholic University of Korea, Incheon St. Mary's Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •(1) Male or female subjects no younger than 20 years and no older than 70 years
- •(2) diagnosed as myofascial pain of the neck and shoulders of at least 3 years duration and need treatment
- •(3) failed or insufficient effects of standard therapy (i.e., physical modality, exercise, medication and trigger point injections)
- •(4) pain scale score of 4 or higher
- •(5) voluntary informed consent signed by the patient after the objectives and methods of the clinical study has been explained.
- •(6) can visit for the close follow up
排除标准
- •(1) patients with a history of allergy or sensitivity to polydioxanone or metal.
- •(2) patients diagnosed as fibromyalgia
- •(3) patients got injection within two months
- •(4) patients diagnosed with cervical radiculopathy, spinal cord disease, severe herniated cervical nucleus pulposus, straight neck syndrome, or cervical sprain
- •(5) patients diagnosed with motor neuron disease, neuromuscular junction disease, or severe musculoskeletal lesions
- •(6) patients who have undergone surgery on the cervical vertebrae and shoulder girdle within a year.
- •(7) patients taking anti-platelet drug
- •(8) patients suffering from severe heart disease, respiratory disease, systemic infection, and inflammatory disease.
- •(9) subjects participated in other clinical trial within 3 months
- •(10) patients who have severe cognitive dysfunction
- •(11) patients diagnosed with major depression disorder
- •(12) patients reluctant to cooperative in evaluation, treatment, and follow-up
- •(13) subjects who are pregnant or breastfeeding
- •(14) subjects who do not want to participate in this trial.
- •(15) subjects thought to be inappropriate to participate.
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