Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Distance to Palmar Crease Index Through Small Finger
研究概览
简要总结
The reported prevalence of disproportionate pain and disability among patients recovering from a fracture of the distal radius varies widely. Literature reports numbers between 1% and 37%, perhaps in part because it is poorly defined, known by so many different names, subjective, and unverifiable.
The investigators are interested in the effect of vitamin C after distal radius fractures on objective measurement of finger motion, patient reported outcome measures, and pain intensity, instead of the previously used, subjective and imprecise criteria for complex regional pain syndrome.
Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius fracture will be asked to participate in this clinical trial. Patient will be randomly assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as regarded by the treating physician at follow-up or for 6 weeks.
The investigators hypothesize no difference in finger stiffness at 6 weeks measured by distance to palmar crease of the index through little finger between patients taking vitamin C or placebo after a distal radius fracture. Additionally, the investigators assess finger stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper extremity function and pain score both measured at six months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All adult (age 18 or greater) patients presenting to the Hand and Orthopaedic Trauma Services of the Massachusetts General Hospital (MGH) within two weeks of a fracture of the distal radius, either operatively or nonoperatively treated
排除标准
- •Patients with severe kidney failure, known allergy for vitamin C or pregnancy
- •Multiple fractures, except for ulna fractures
研究组 & 干预措施
500 mg vitamin C
Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks
干预措施: 500 mg vitamin c, 1 pill per day for 6 weeks (Drug)
Placebo
Arm will take 1 placebo pill per day for 6 weeks
干预措施: 1 placebo pill for 6 weeks (Drug)
结局指标
主要结局
Distance to Palmar Crease Index Through Small Finger
时间窗: Day 1 (baseline), 6 weeks
To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.
次要结局
- Thumb Motion(Day 1 (baseline), 6 weeks)
- 0-10 Ordinal Pain Score(Day 1 (baseline), 6 weeks, 6 months)
- PROMIS Upper Extremity - CAT(Day 1 (baseline), 6 weeks, 6 months)
- Active Flexion Index Through Small Finger(Day 1 (baseline), 6 weeks)
研究者
Neal Chung-Jen Chen
Medical Doctor
Massachusetts General Hospital
