Trial Outcomes & Findings for Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? (NCT NCT02216812)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

Day 1 (baseline), 6 weeks

Results posted on

2019-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	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	Placebo Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Study STARTED	67	67
Overall Study COMPLETED	57	62
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Placebo Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Overall Study Lost to Follow-up	10	5

Baseline Characteristics

Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks	Total n=134 Participants Total of all reporting groups
Age, Continuous	48 Years STANDARD_DEVIATION 17 • n=5 Participants	50 Years STANDARD_DEVIATION 17 • n=7 Participants	49 Years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	52 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Non-causcasian	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	67 Participants n=5 Participants	67 Participants n=7 Participants	134 Participants n=5 Participants
Dominant extremity injured	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Non-operative treatment	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Carpal tunnel release	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
PROMIS Pain Interference CAT	65 T-score STANDARD_DEVIATION 6.4 • n=5 Participants	61 T-score STANDARD_DEVIATION 7.1 • n=7 Participants	63 T-score STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (baseline), 6 weeks

Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

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.

Outcome measures

Outcome measures
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Distance to Palmar Crease Index Through Small Finger Day 1 (baseline)	6.7 Centimeters Standard Deviation 6.7	7.1 Centimeters Standard Deviation 6.0
Distance to Palmar Crease Index Through Small Finger 6 weeks	2.3 Centimeters Standard Deviation 4.0	2.0 Centimeters Standard Deviation 3.8

SECONDARY outcome

Timeframe: Day 1 (baseline), 6 weeks

Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

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

Outcome measures

Outcome measures
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Active Flexion Index Through Small Finger Day 1 (baseline)	725 Degrees Standard Deviation 159	732 Degrees Standard Deviation 144
Active Flexion Index Through Small Finger 6 weeks	896 Degrees Standard Deviation 108	904 Degrees Standard Deviation 132

SECONDARY outcome

Timeframe: Day 1 (baseline), 6 weeks

Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction

Outcome measures

Outcome measures
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
Thumb Motion Day 1 (baseline)	161 Degrees Standard Deviation 59	155 Degrees Standard Deviation 49
Thumb Motion 6 weeks	229 Degrees Standard Deviation 49	232 Degrees Standard Deviation 46

SECONDARY outcome

Timeframe: Day 1 (baseline), 6 weeks, 6 months

Population: Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.

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.

Outcome measures

Outcome measures
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
PROMIS Upper Extremity - CAT Day 1 (Baseline)	26 T-score Standard Deviation 7.9	27 T-score Standard Deviation 7.5
PROMIS Upper Extremity - CAT 6 weeks	35 T-score Standard Deviation 6.9	36 T-score Standard Deviation 8.4
PROMIS Upper Extremity - CAT 6 months	48 T-score Standard Deviation 8.4	48 T-score Standard Deviation 9.1

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	500 mg Vitamin C n=67 Participants 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	Placebo n=67 Participants Arm will take 1 placebo pill per day for 6 weeks 1 placebo pill for 6 weeks
0-10 Ordinal Pain Score Day 1 (baseline)	3.5 units on a scale Standard Deviation 2.4	3.8 units on a scale Standard Deviation 2.6
0-10 Ordinal Pain Score 6 weeks	1.6 units on a scale Standard Deviation 2.2	1.8 units on a scale Standard Deviation 1.9
0-10 Ordinal Pain Score 6 months	1.4 units on a scale Standard Deviation 2.3	1.7 units on a scale Standard Deviation 2.2

Adverse Events

500 mg Vitamin C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neal Chen

Massachusetts General Hospital

Phone: 617-726-4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place