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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 mg vitamin C | Experimental | Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks |
|
| Placebo | Placebo Comparator | Arm will take 1 placebo pill per day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mg vitamin c, 1 pill per day for 6 weeks | Drug |
| ||
| 1 placebo pill for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (baseline), 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 (baseline), 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Chen, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys. | Posted | Mean | Standard Deviation | Centimeters | Day 1 (baseline), 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal Chen | Massachusetts General Hospital | 617-726-4700 | nchen1@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2017 | Jun 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
| 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 |
| Day 1 (baseline), 6 weeks |
| 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. | Day 1 (baseline), 6 weeks, 6 months |
| 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. | Day 1 (baseline), 6 weeks, 6 months |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Dominant extremity injured | The number of participants whose injured arm is the same side as that of their dominant hand (i.e., the hand with which they write or perform fine motor skills). | Count of Participants | Participants |
|
| Non-operative treatment | Count of Participants | Participants |
|
| Carpal tunnel release | Count of Participants | Participants |
|
| PROMIS Pain Interference CAT | The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring the amount pain interferes in the subjects' activities. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T scores above 50 represents more of the measured variable than the average. Investigators measured this at enrollment. | Mean | Standard Deviation | T-score |
|
Arm will take 1 placebo pill per day for 6 weeks
1 placebo pill for 6 weeks
|
|
|
| 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 | Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys. | Posted | Mean | Standard Deviation | Degrees | Day 1 (baseline), 6 weeks |
|
|
|
| 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 | Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys. | Posted | Mean | Standard Deviation | Degrees | Day 1 (baseline), 6 weeks |
|
|
|
| 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. | Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys. | Posted | Mean | Standard Deviation | T-score | Day 1 (baseline), 6 weeks, 6 months |
|
|
|
| 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. | Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up | Posted | Mean | Standard Deviation | units on a scale | Day 1 (baseline), 6 weeks, 6 months |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Placebo | Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks | 0 | 67 | 0 | 67 | 0 | 67 |
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| 6 weeks |
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| 6 weeks |
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| 6 weeks |
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| 6 months |
|
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| 6 weeks |
|
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| 6 months |
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