Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- BCTQ
研究概览
简要总结
Carpal Tunnel Syndrome (CTS) is the most frequent mononeuropathy. CTS is more frequent in females than in males, it has been associated to work activities, hormone exposure and obesity. Although its primary treatment is conservative, there is strong evidence that patients who retard surgery are more prone to develop worse outcomes. Surgery to treat CTS consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however, more than 20% of patients who undergo surgery have recurrent CTS (RCTS). RCTS is due to a fibrotic process in the site of the surgery. Amniotic membrane (AM) is the inner layer of the placenta which has been used to treat different pathologies. AM transplantation (AMT) has demonstrated to significantly inhibit inflammation and fibrosis. Therefore, the aim of the present study was to determine the effect of AMT in CTS surgery. The present is a randomized, open labeled, controlled clinical study. The investigators included patients with recent diagnosis of CTS and divided into two groups. The experimental group received AMT concomitantly with conventional surgery; whilst, the control group received only the conventional surgery. Clinical status of patients measured with the BCTQ questionaire was the main outcome. Both groups showed similar BCTQ punctuation at the beginning of the study. However, the results of the experimental group were significantly better than those from the control group through time, until the finish of the study. None of the patients presented complications or adverse effects related to the AMT. These results indicate that AMT is a secure and suitable treatment for CTS presenting better clinical outcomes at one-year follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent CTS diagnosis
- •Patients that undergo CTS surgery
- •Patients that accept to participate in the study
- •Patients that sign informed consent
排除标准
- •Patients with recurrent CTS diagnosis;
- •Patients with concomitant hand/arm comorbidities
- •Patients with any systemic disease that comprises muscles and bones
- •Collagenopathies
- •Systemic lupus erythematosus
研究组 & 干预措施
Control
The patients underwent conventional CTS surgery
Experimental
The patients underwent conventional CTS surgery and transplantation of amniotic membrane
干预措施: Amniotic membrane transplantation (Other)
结局指标
主要结局
BCTQ
时间窗: Through study completion, an average one year
The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome. It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
次要结局
未报告次要终点
