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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216812
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Neal Chen, MD||Massachusetts General Hospital|