Distal Radius Fracture, Finger Stiffness
Conditions
Keywords
Finger stiffness, Range of motion, Distal radius fracture, Vitamin C
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.
Interventions
DRUG500 mg vitamin c, 1 pill per day for 6 weeks
DRUG1 placebo pill for 6 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance to Palmar Crease Index Through Small Finger | 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
| Measure | Time frame | Description |
|---|---|---|
| Active Flexion Index Through Small Finger | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 500 mg Vitamin C Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks
500 mg vitamin c, 1 pill per day for 6 weeks | 67 |
| Placebo Arm will take 1 placebo pill per day for 6 weeks
1 placebo pill for 6 weeks | 67 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 5 |
Baseline characteristics
| Characteristic | Placebo | Total | 500 mg Vitamin C |
|---|---|---|---|
| Age, Continuous | 50 Years STANDARD_DEVIATION 17 | 49 Years STANDARD_DEVIATION 17 | 48 Years STANDARD_DEVIATION 17 |
| Carpal tunnel release | 9 Participants | 13 Participants | 4 Participants |
| Dominant extremity injured | 32 Participants | 64 Participants | 32 Participants |
| Non-operative treatment | 41 Participants | 83 Participants | 42 Participants |
| PROMIS Pain Interference CAT | 61 T-score STANDARD_DEVIATION 7.1 | 63 T-score STANDARD_DEVIATION 7 | 65 T-score STANDARD_DEVIATION 6.4 |
| Race/Ethnicity, Customized Non-causcasian | 4 Participants | 17 Participants | 13 Participants |
| Region of Enrollment United States | 67 Participants | 134 Participants | 67 Participants |
| Sex: Female, Male Female | 52 Participants | 99 Participants | 47 Participants |
| Sex: Female, Male Male | 15 Participants | 35 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
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.
Time frame: Day 1 (baseline), 6 weeks
Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 500 mg Vitamin C | Distance to Palmar Crease Index Through Small Finger | Day 1 (baseline) | 6.7 Centimeters | Standard Deviation 6.7 |
| 500 mg Vitamin C | Distance to Palmar Crease Index Through Small Finger | 6 weeks | 2.3 Centimeters | Standard Deviation 4 |
| Placebo | Distance to Palmar Crease Index Through Small Finger | Day 1 (baseline) | 7.1 Centimeters | Standard Deviation 6 |
| Placebo | Distance to Palmar Crease Index Through Small Finger | 6 weeks | 2.0 Centimeters | Standard Deviation 3.8 |
Comparison: We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.p-value: 0.63Regression, Linear
Secondary
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.
Time frame: Day 1 (baseline), 6 weeks, 6 months
Population: Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 500 mg Vitamin C | 0-10 Ordinal Pain Score | Day 1 (baseline) | 3.5 units on a scale | Standard Deviation 2.4 |
| 500 mg Vitamin C | 0-10 Ordinal Pain Score | 6 weeks | 1.6 units on a scale | Standard Deviation 2.2 |
| 500 mg Vitamin C | 0-10 Ordinal Pain Score | 6 months | 1.4 units on a scale | Standard Deviation 2.3 |
| Placebo | 0-10 Ordinal Pain Score | Day 1 (baseline) | 3.8 units on a scale | Standard Deviation 2.6 |
| Placebo | 0-10 Ordinal Pain Score | 6 weeks | 1.8 units on a scale | Standard Deviation 1.9 |
| Placebo | 0-10 Ordinal Pain Score | 6 months | 1.7 units on a scale | Standard Deviation 2.2 |
Secondary
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
Time frame: Day 1 (baseline), 6 weeks
Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 500 mg Vitamin C | Active Flexion Index Through Small Finger | Day 1 (baseline) | 725 Degrees | Standard Deviation 159 |
| 500 mg Vitamin C | Active Flexion Index Through Small Finger | 6 weeks | 896 Degrees | Standard Deviation 108 |
| Placebo | Active Flexion Index Through Small Finger | Day 1 (baseline) | 732 Degrees | Standard Deviation 144 |
| Placebo | Active Flexion Index Through Small Finger | 6 weeks | 904 Degrees | Standard Deviation 132 |
Secondary
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.
Time frame: Day 1 (baseline), 6 weeks, 6 months
Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 500 mg Vitamin C | PROMIS Upper Extremity - CAT | 6 weeks | 35 T-score | Standard Deviation 6.9 |
| 500 mg Vitamin C | PROMIS Upper Extremity - CAT | 6 months | 48 T-score | Standard Deviation 8.4 |
| 500 mg Vitamin C | PROMIS Upper Extremity - CAT | Day 1 (Baseline) | 26 T-score | Standard Deviation 7.9 |
| Placebo | PROMIS Upper Extremity - CAT | Day 1 (Baseline) | 27 T-score | Standard Deviation 7.5 |
| Placebo | PROMIS Upper Extremity - CAT | 6 weeks | 36 T-score | Standard Deviation 8.4 |
| Placebo | PROMIS Upper Extremity - CAT | 6 months | 48 T-score | Standard Deviation 9.1 |
Secondary
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
Time frame: Day 1 (baseline), 6 weeks
Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 500 mg Vitamin C | Thumb Motion | Day 1 (baseline) | 161 Degrees | Standard Deviation 59 |
| 500 mg Vitamin C | Thumb Motion | 6 weeks | 229 Degrees | Standard Deviation 49 |
| Placebo | Thumb Motion | 6 weeks | 232 Degrees | Standard Deviation 46 |
| Placebo | Thumb Motion | Day 1 (baseline) | 155 Degrees | Standard Deviation 49 |