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临床试验/NCT04075357
NCT04075357已完成不适用

Amniotic Membrane Transplantation for Carpal Tunnel Syndrome Treatment: One-year Follow-up

Instituto de Oftalmología Fundación Conde de Valenciana2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

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

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

No Intervention

The patients underwent conventional CTS surgery

Experimental

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

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (2)

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