Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Static two points discrimination (S2PD)
研究概览
简要总结
Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.
详细描述
Patients over the age of 20 with an acute traumatic isolated digital nerve injury to any of the fingers and not in the thumb will be investigated for inclusion in the study. After informed written consent a sealed envelope randomisation will allocate patients to treatment with either surgical exposure and epineural suture or non-operative treatment in a cast. Due to the nature of treatment arms the allocation will not be blinded. Clinical follow-up and investigation of primary and secondary outcomes will be conducted at 3 weeks, 3 months, 6 months and 1 year after inclusion.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or
- •Patient age => 20 years on day of injury.
- •Injury location on volar aspect of finger.
- •Acute sensory dysfunction in suspected digital nerve injury area.
排除标准
- •Digital nerve injury ot the thumb
- •Digital nerve injury in the palm of the hand (i e proximal to the finger base)
- •Patient does not speak or read the Swedish language.
- •Abusive drug or alcohol use
- •Dementia.
- •Injury mor than 7 days at dianosis AND/OR operative treatment cannot be offered within 10 days from injury.
- •Neurologic disease.
- •Ongoing infektion in the injured finger.
- •concomittant tendoninjury or fracture in injured or adjacent finger.
- •Injury mechanism is of blunt or crush charachter
结局指标
主要结局
Static two points discrimination (S2PD)
时间窗: one year after injury
a static two points discrimination test performed by an occupational therapist of the injured finger
次要结局
- Semmes-Weinstein monofilament test(3 and 6 months and 1 year)
- Mini Sollerman test(3 and 6 months and 1 year)
- Quick-DASH(3 and 6 months and 1 year)
- Pain catastrophising scale, (PCS)(at inclusion)
- Wait for surgery(3 weeks)
- Active range of motion(3 and 6 months and 1 year)
- Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger(3 and 6 months and 1 year)
- Grip strength(3 and 6 months and 1 year)
- HQ-8(3 and 6 months and 1 year)
- Anxiety and depression(at inclusion)
- Neuropathic pain(3 and 6 months and 1 year)
- Sick leave time(1 year)
- Time in operating theatre(day of surgery)
研究者
Cecilia Mellstrand Navarro
MD PhD Ass prof
Karolinska Institutet