Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Is there improvement in Health Related Quality of Life?
研究概览
简要总结
This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.
详细描述
As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL will be used to determine if anterior intramuscular transposition provides patients with positive outcomes. To measure HRQOL 3 specific scales will be administered:
- A generic scale, the Short Form-36
- A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
- A utility scale, the EuroQOL, five dimension questionnaire
These scales are widely reported in the literature, are valid, reliable and easy to fill out. Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which, allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.
Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2 performance tests (grip strength, and a moving 2-point discrimination test) at the following time points:
- 1 week prior to surgery
- 1 day prior to surgery
- 3 months post surgery
- 6 months post surgery
- 12 months post surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging
- •Ability to comprehend English and complete health related quality of life questionnaires
- •Willing to provide informed consent
- •Age > 18 years
- •Not pregnant
排除标准
- •Prior ipsilateral cubital tunnel release
- •Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS)
- •Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand
结局指标
主要结局
Is there improvement in Health Related Quality of Life?
时间窗: 1 week and 1 day pre-op & 3, 6, 12 months post op
HRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)
次要结局
- Which Domains of Health Related Quality of Life Improve?(1 week and 1 day pre-op & 3, 6, 12 months post op)
- Is there improvement in physical performance?(1 week and 1 day pre-op & 3, 6, 12 months post op)