跳至主要内容
临床试验/NCT01961011
NCT01961011Unknown不适用

Simultaneous Bilateral Versus Unilateral Carpal Tunnel Release: A Prospective Comparison of Early Pain and Limitations in Activities of Daily Living

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Change in QuickDASH score

研究概览

简要总结

Carpal tunnel release is a well accepted treatment for median nerve compression at the wrist. With a prevalence of 50 per 1000, it is the most common compressive neuropathy. With a number of anatomic as well as systemic factors playing a role in the development of carpal tunnel syndrome, it is not surprising that there is a high incidence of bilaterality with this disease. Padua et al. reported that 87% of 266 consecutive cases had signs and symptoms of carpal tunnel syndrome in their contralateral hand.

In patients who have bilateral carpal tunnel syndrome that has not responded to conservative treatment, surgical release is indicated. In such cases, a decision must be made whether to offer bilateral simultaneous surgical release or to stage the two affected hands to allow time to recover from each.

The purpose of this study is to determine the differences in short term disability between having bilateral vs unilateral carpal tunnel release. With better understanding of the way in which patients are impaired, better recommendations may be made on which patients to indicate for simultaneous bilateral procedures and who would benefit from staging procedures, allowing the patient to recover from one hand prior to proceeding to surgery on the other hand.

详细描述

Carpal tunnel syndrome is the most common compressive neuropathy, occurring in 0.1 to 3% of the population. The incidence is reported to be higher in certain at risk populations. 87% of individuals exhibit bilateral symptoms. In patients who fail conservative treatment, surgery is indicated. To date, it is not know whether patients benefit from undergoing simultaneous or consecutive carpal tunnel release. Some patients express concern that having both hands operated on may make it impossible to perform necessary activities of daily living in the early postoperative period. Other patients express concern that having two surgeries increases their out of pocket cost, their total disability time, and lengthens the amount of time to resolution of preoperative symptoms. One previous study has attempted to characterize the differences in the effect on activities of daily living of these two treatment paradigms. This study was limited by the fact that there was no comparison group to the study cohort.

Cohort #1: Patients undergoing simultaneous bilateral carpal tunnel release. Inclusion criteria includes any adult patient indicated for bilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, any protected patient population, and the lack of assistance at home during the early postoperative period.

Cohort #2: Patients undergoing unilateral carpal tunnel release. Inclusion criteria include any adult patient indicated for unilateral carpal tunnel release. Exclusion criteria include age less than 18, pregnancy, and any protected patient population.

Once a patient has been identified in the clinic the consent process will begin. Consent will be administered by a member of the research team. Being part of this investigation will not change the standard treatment of carpal tunnel syndrome in any way. After surgery, patients will go home and be asked to fill out the Quick DASH, Levine-Katz Severity Score, WHO HPQ, and SF-6D on pre-operatively and at their first post-operative visit. They will also fill out an activities of daily living log that asks the patient to rate on a scale from 1 to 5 how much difficulty he or she has with each task on the list. The patient will return their ADL log to their physician on their first postoperative visit. A final postoperative visit will occur at 1 month. The investigational questionnaires will be filled out one last time at that visit. No long term follow up is required. Patients will be contacted on their first post-operative day to ensure receipt of the daily log, the day prior to the first post operative visit as a reminder to bring the log into clinic, and on the day before their last post-operative visit thanking them for participation in the study. During their final phone call patients will be asked what factors contributed to their decision to proceed or not proceed with undergoing bilateral carpal tunnel release.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in QuickDASH score

时间窗: 10 days, 30 days

The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

次要结局

  • World Health Organization Health and Performance Questionnaire(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Osei

Assistant Professor of Orthopedic Surgery

Washington University School of Medicine

研究点 (1)

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