Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

NCT ID: NCT02216812

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-12-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

500 mg vitamin C

Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Placebo

Arm will take 1 placebo pill per day for 6 weeks

Group Type: PLACEBO_COMPARATOR

1 placebo pill for 6 weeks

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

1 placebo pill for 6 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neal Chung-Jen Chen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P000561

Identifier Type: -

Identifier Source: org_study_id