Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

NCT02216812 | Completed Results DMC

• 1 other identifier: 2014P000561
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Finger Stiffness; Distal Radius Fracture

Keywords

Finger stiffness; Range of motion; Distal radius fracture; Vitamin C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Active Flexion Index Through Small Finger

  Day 1 (baseline), 6 weeks

• Thumb Motion

  Day 1 (baseline), 6 weeks

• PROMIS Upper Extremity - CAT

  Day 1 (baseline), 6 weeks, 6 months

• 0-10 Ordinal Pain Score

  Day 1 (baseline), 6 weeks, 6 months

Study Arms (2)

500 mg vitamin C

EXPERIMENTAL

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

PLACEBO COMPARATOR

Arm will take 1 placebo pill per day for 6 weeks

Drug: 1 placebo pill for 6 weeks

Interventions

500 mg vitamin c, 1 pill per day for 6 weeks DRUG

500 mg vitamin C

1 placebo pill for 6 weeks DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with severe kidney failure, known allergy for vitamin C or pregnancy
• Multiple fractures, except for ulna fractures

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Ascorbic Acid; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Neal Chen
• Organization: Massachusetts General Hospital

nchen1@mgh.harvard.edu

617-726-4700

Study Officials

• Neal Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: August 14, 2019
• Results First Posted: September 17, 2018

Record last verified: 2019-08

Locations

US (1)