CRPS Type I Clinical Trial
Official title:
Prophylactic Administration of Vitamin C in Wrist Fractures; a Randomized Placebo Controlled Multicentre Dose-Finding Study of the Incidence of Complex Regional Pain Syndrome
Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in literature from 2 - 37%. The female sex is involved three times as much as the male sex. There is one study in literature which describes a prophylactic effect of vitamin C after wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and to replicate these earlier findings.
The trial was designed as a multicentre, randomized, controlled study. Three hospitals in
the Netherlands participated in this study, using the same experimental design.
Adults (18 years or above) with a wrist fracture who were seen in the emergency department
of each hospital were asked to participate in this study. Patients were asked to start the
trial medication on the day of the fracture. Two capsules had to be taken once daily for 50
days. Patients were allocated randomly to receive either placebo or a dosage of 200, 500 or
1500 mg of vitamin C daily.
The endpoint of the study was defined as the presence of CRPS at any moment, in the period
up to one year after the fracture. All participants and physicians were unaware of the
treatment allocation.
Patients were seen after 1 week, 4 or 5 weeks (or when the cast was removed), 6 or 7 weeks,
12 weeks, and 26 weeks. After one year patients were interviewed by telephone or received an
inquiry letter with a postage-paid envelope for their reply. The normal fracture treatment,
either conservative or operative, was not compromised by the protocol, and if necessary
patients were seen more often and/or at other times than planned.
Complex regional pain syndrome was diagnosed when four of the following five symptoms were
present throughout an area larger than the wrist, including the area distal to the wrist
(hand and fingers), and if they occurred or increased after activity: unexplained diffuse
pain, which is not in normal relation to the fracture; difference in skin color relative to
the other arm; diffuse edema; difference in skin temperature relative to the other arm;
limited active range of motion, unrelated to the stage of fracture treatment. If CRPS was
diagnosed, the end point of the study was reached and the protocol was terminated to enable
treatment for CRPS.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05371938 -
Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up
|
N/A |