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临床试验/NCT02216812
NCT02216812已完成不适用

Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

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

Neal Chung-Jen Chen

Medical Doctor

Massachusetts General Hospital

研究点 (1)

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