Surgical Thoracic Outlet Decompression Versus Conservative Approach for Patients With Neurogenic Thoracic Outlet Syndrome, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Disability of the Arm, Shoulder and Hand (DASH) score
研究概览
简要总结
This study will determine the value of TOD (first rib resection with partial scalenectomy and neurolysis) on functionality and quality of life for patients with neurogenic thoracic outlet syndrome. This will be done by randomizing patients into surgery or conservative therapy (physiotherapy and pain relief).
详细描述
Background:
Neurogenic thoracic outlet syndrome (NTOS) is a condition caused by compression and irritation of the brachial plexus serving the upper extremity. NTOS most frequently occurs in relatively young, active and otherwise healthy individuals and can have a tremendous impact on work, social and personal life. The diagnosis and therapy of NTOS still remains disputed. This is partly because diagnosis is largely clinical and subjective in nature, with no definitive (diagnostic) imaging or diagnostic studies available. As a result, disparities in the definition have produced different opinions regarding diagnostic standards for TOS. Furthermore, given the controversy surrounding the definition and diagnosis of TOS, conflict exists regarding the optimal treatment approach for this condition.
Studies in the last years, have shed light on some of the controversies in diagnosing and treating NTOS. Many patients that benefit from thoracic outlet decompression (TOD) do not fit the historical diagnostic criteria. Those patients (up to 90%) with disputed NTOS have shown improvement of symptoms and functionality after TOD surgery.
Recently, several studies have been published about outcome after TOD surgery for NTOS. These large, multicenter studies show a very low complication rate, ranging from 0-2%, with an extremely low risk of nerve injury.
These studies however report on heterogenous populations, diagnosed without any internationally validated diagnostic criteria. They hint beneficial results for TOD in NTOS patients, however the level of evidence they provide is low. Critics have wondered if the improvements - reported in these trials - are attributed to surgery, or are merely due to coincidence, selection bias, conservative treatment or time (rest).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High suspicion of NTOS with high level of impairment.
- •The decision to refer a patient with NTOS for surgery is placed at the sole authority of the TOS multidisciplinary workgroup. Members of this workgroup are 2 dedicated vascular surgeons, 2 neurologists, 1 orthopedic surgeon, 3 physiotherapists, 2 radiologists, 3 anesthesiologists.
- •This decision is based on the reporting standards published by Illig et al. in
- •If a patient fits the criteria postulated in the reporting standards and if there is consensus within the multidisciplinary team, only then patients are referred for TOD.
- •Fit for surgery, at the discretion of the treating vascular surgeon and anesthesiologist.
- •Signed informed consent form.
- •18 years of age or older
- •Dutch or English speaking patients
排除标准
- •Unfit for surgery, at the discretion of the treating vascular surgeon and anesthesiologist.
- •Younger than 18 years of age
- •Patients that do not speak Dutch or English.
- •Patients with a history of TOD
- •Patients that did not receive previous conservative physiotherapy for this condition
结局指标
主要结局
Change in Disability of the Arm, Shoulder and Hand (DASH) score
时间窗: Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion
This questionnaire is validated for neurogenic thoracic outlet syndrome and was developed by the American Academy of Traumatology. It includes 30 questions related to symptoms of daily activities and social and psychological functions. Scores range from asymptomatic (0) to totally invalid (100).
次要结局
- Change in Visual Analogue Scale (VAS) for Pain(Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion)
- Change in Short Form 12 (SF-12) questionnaire score(Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion)
- Chance in Cervical-Brachial Symptoms (CBSQ) Questionnaire score(Change in this outcome will be measured at 0, 3, 6, 12, 24, 36 and 60 months after inclusion)
研究者
Joep Teijink
Professor in vascular surgery
Catharina Ziekenhuis Eindhoven