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| Sponsored by: |
Stichting Achmea Slachtoffer en Samenleving |
| Information provided by: | Stichting Achmea Slachtoffer en Samenleving |
| ClinicalTrials.gov Identifier: | NCT00296868 |
Purpose
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.
| Condition | Intervention | Phase |
|
RSD (Reflex Sympathetic Dystrophy) Algodystrophy CRPS Type I |
Drug: ascorbic acid (vitamin C) versus placebo |
Phase IV |
| MedlinePlus related topics: | Complex Regional Pain Syndrome Fractures |
| ChemIDplus related topics: | Ascorbic acid |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2005 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |||||
| Rode Kruis Ziekenhuis, Vondellaan 13 | |||||
| Beverwijk, Netherlands, 1942 LE | |||||
| Stichting Achmea Slachtoffer en Samenleving |
| Principal Investigator: | Paul E Zollinger, MD | department of orthopedic surgery, Ziekenhuis Rivierenland, Pres Kennedylaan 1, 4002 WP Tiel, the Netherlands |
More Information
homepage of department of orthopaedics of Ziekenhuis Rivierenland, Tiel, the Netherlands
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| Study ID Numbers: | SRvB/2001-290/JV |
| First Received: | February 24, 2006 |
| Last Updated: | February 24, 2006 |
| ClinicalTrials.gov Identifier: | NCT00296868 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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