Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture; Finger Stiffness
• Intervention / Treatment: Drug: 500 mg vitamin c, 1 pill per day for 6 weeks; Drug: 1 placebo pill for 6 weeks

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500 mg vitamin C; Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks	Drug: 500 mg vitamin c, 1 pill per day for 6 weeks
Placebo Comparator: Placebo; Arm will take 1 placebo pill per day for 6 weeks	Drug: 1 placebo pill for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance to Palmar Crease Index Through Small Finger	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.	Day 1 (baseline), 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Flexion Index Through Small Finger	Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints	Day 1 (baseline), 6 weeks
Thumb Motion	Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction	Day 1 (baseline), 6 weeks
PROMIS Upper Extremity - CAT	The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.	Day 1 (baseline), 6 weeks, 6 months
0-10 Ordinal Pain Score	Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.	Day 1 (baseline), 6 weeks, 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): December 22, 2017

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin C; Distal radius fracture; Range of motion; Finger stiffness
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 2014P000561