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Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

Primary Purpose

Finger Stiffness, Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
500 mg vitamin c, 1 pill per day for 6 weeks
1 placebo pill for 6 weeks
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Finger Stiffness focused on measuring Finger stiffness, Range of motion, Distal radius fracture, Vitamin C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

500 mg vitamin C

Placebo

Arm Description

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

Arm will take 1 placebo pill per day for 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
August 12, 2014
Last Updated
August 13, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02216812
Brief Title
Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?
Official Title
Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Stiffness, Distal Radius Fracture
Keywords
Finger stiffness, Range of motion, Distal radius fracture, Vitamin C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
500 mg vitamin C
Arm Type
Experimental
Arm Description
Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm will take 1 placebo pill per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
500 mg vitamin c, 1 pill per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
1 placebo pill for 6 weeks
Primary Outcome Measure Information:
Title
Distance to Palmar Crease Index Through Small Finger
Description
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.
Time Frame
Day 1 (baseline), 6 weeks
Secondary Outcome Measure Information:
Title
Active Flexion Index Through Small Finger
Description
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
Time Frame
Day 1 (baseline), 6 weeks
Title
Thumb Motion
Description
Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction
Time Frame
Day 1 (baseline), 6 weeks
Title
PROMIS Upper Extremity - CAT
Description
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.
Time Frame
Day 1 (baseline), 6 weeks, 6 months
Title
0-10 Ordinal Pain Score
Description
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.
Time Frame
Day 1 (baseline), 6 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

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