N/A
N=134
Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?
Finger Stiffness · Distal Radius Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02216812 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Distance to Palmar Crease Index Through Small Finger — 6.7; 7.1; 2.3; 2.0 Centimeters — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 500 mg vitamin c, 1 pill per day for 6 weeks (Drug); 1 placebo pill for 6 weeks (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance to Palmar Crease Index Through Small Finger |
6.7; 7.1; 2.3; 2.0 | 0.63 |
| SECONDARY Active Flexion Index Through Small Finger |
725; 732; 896; 904 | — |
| SECONDARY Thumb Motion |
161; 155; 229; 232 | — |
| SECONDARY PROMIS Upper Extremity - CAT |
26; 27; 35; 36; 48; 48 | — |
| SECONDARY 0-10 Ordinal Pain Score |
3.5; 3.8; 1.6; 1.8; 1.4; 1.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Patients with severe kidney failure, known allergy for vitamin C or pregnancy
- Multiple fractures, except for ulna fractures
Data sourced from ClinicalTrials.gov (NCT02216812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.