Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

• ClinicalTrials.gov Identifier: NCT02216812
• Recruitment Status: Completed
• First Posted: August 15, 2014
• Results First Posted: September 17, 2018
• Last Update Posted: August 14, 2019
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Neal Chung-Jen Chen, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Finger Stiffness; Distal Radius Fracture	Drug: 500 mg vitamin c, 1 pill per day for 6 weeks; Drug: 1 placebo pill for 6 weeks	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: December 22, 2017
• Actual Study Completion Date: December 22, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Distance to Palmar Crease Index Through Small Finger [ Time Frame: 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.

Secondary Outcome Measures :

1. Active Flexion Index Through Small Finger [ Time Frame: Day 1 (baseline), 6 weeks ]
   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
2. Thumb Motion [ Time Frame: Day 1 (baseline), 6 weeks ]
   Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction
3. PROMIS Upper Extremity - CAT [ Time Frame: Day 1 (baseline), 6 weeks, 6 months ]
   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.
4. 0-10 Ordinal Pain Score [ Time Frame: Day 1 (baseline), 6 weeks, 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Neal Chen, MD; Massachusetts General Hospital

  Study Documents (Full-Text)

Documents provided by Neal Chung-Jen Chen, Massachusetts General Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] February 22, 2017

More Information

• Responsible Party: Neal Chung-Jen Chen, Medical Doctor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02216812
• Other Study ID Numbers: 2014P000561
• First Posted: August 15, 2014
• Results First Posted: September 17, 2018
• Last Update Posted: August 14, 2019
• Last Verified: August 2019

Keywords provided by Neal Chung-Jen Chen, Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Fractures, Bone; Radius Fractures; Wounds and Injuries; Forearm Injuries; Arm Injuries; Ascorbic Acid; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents