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Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

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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:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 15, 2014
Results First Submitted Date  ICMJE June 29, 2018
Results First Posted Date  ICMJE September 17, 2018
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
Distance to Palmar Crease Index Through Small Finger [ Time Frame: 6 weeks ]
To establish the distance to palmar crease, we aske 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2014)
  • Active Flexion Index Through Small Finger [ Time Frame: 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
  • Thumb Motion [ Time Frame: 6 weeks ]
    Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar and radial abduction
  • Patient Reported Outcome Measurement System Upper Extremity - Computer Adaptive Testing Score [ Time Frame: 6 months ]
  • 0-10 Ordinal Pain Score [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 13, 2014)
Factors associated with distance to palmar crease index through small finger [ Time Frame: 6 weeks ]
 
Descriptive Information
Brief Title  ICMJE Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?
Official Title  ICMJE Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Finger Stiffness
  • Distal Radius Fracture
Intervention  ICMJE
  • Drug: 500 mg vitamin c, 1 pill per day for 6 weeks
  • Drug: 1 placebo pill for 6 weeks
Study Arms  ICMJE
  • Experimental: 500 mg vitamin C
    Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks
    Intervention: 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
    Intervention: Drug: 1 placebo pill for 6 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2018)
134
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2014)
126
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02216812
Other Study ID Numbers  ICMJE 2014P000561
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neal Chung-Jen Chen, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neal Chen, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP