Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

The Role of Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures: a Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842395
• Other study ID #: UDMS-Orthopedics-5-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: jaber ibrahim, MD PHD
• Phone: 944411241
• Email: drjaberhibrahim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complex Regional Pain Syndrome type 1 is a pain syndrome that develops after a trauma, surgery, or idiopathically. The incidence after distal radius varies significantly in the literature. There are known contributing factors, such as the female sex but no effective treatment or prophylactic method. This study aims to investigate vitamin C's efficacy in preventing CRPS type 1 following distal radius fractures, as the literature states that it might play a role in prophylaxis.

Description:

Complex regional pain syndrome is the most challenging complication to overcome following distal radius fractures. The precise etiology still needs to be fully understood. It is thought that ways of prevention could be the most effective way of managing this dilemma, as no effective treatment is yet to be found.

One of the ways of prevention is vitamin C supplementation, as it is thought that the toxic oxygen radicals play a significant role in the inflammatory process that ultimately manifests as CRPS. Vitamin C, as an antioxidant, could play a role in stopping this process.

The theoretical background of this research is that CRPS commonly occurs following distal radius fractures, and vitamin C supplementation could play a role in prophylaxis. To assess that, the investigator is conducting a randomized controlled trial.

The trial is designed as a multicenter, randomized, controlled study. Two hospitals in Syria, Damascus, participated in this study using the same experimental design.

Adults (18 years or above) with distal radius fractures who will be seen in the emergency department of each hospital will be asked to participate in this study. Patients will be asked to start the trial medication on the day of the fracture following the suitable treatment method chosen by the orthopedics consultant in each hospital. Capsules had to be taken once daily for 90 days. Patients will be allocated randomly to receive either a placebo or 1g of vitamin C daily.

The study's endpoint will be defined as the presence of CRPS at any moment up to one year after the fracture. All participants and physicians will be unaware of the treatment allocation.

The diagnosis will be built upon the Budapest criteria, which will be checked in every follow-up for one year.

Patients will be seen after two weeks, four weeks (or when the cast was removed), six weeks, 12 weeks, six months, and 12 months. The protocol will not compromise the adequate fracture treatment, either conservative or operative, by closed reduction and percutaneous pinning. If necessary, patients will be seen more often and at other times than planned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• participants who were injured with distal radius fractures and classified using the AO classification as A1, A2, A3, B1, and C1.

Exclusion Criteria:

• Multiple trauma patients.

• patients who have neurovascular injuries.

• Patients with fractures are classified using the AO classification as B2, B3, C2, and C3.

• Patients who are eligible for open reduction internal fixation of their fractures.

• Patients with chronic or acute renal failure.

• Patients who already take multi-vitamin supplementation or vitamin C supplementation.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Prophylaxis
• Radius Fractures
• Wrist Fractures

Intervention

Drug:
• Vitamin C
Participants with distal radius fractures will take vitamin C supplementation with a daily dose of 1g orally for three months.
• Placebo
Participants with distal radius fractures will take daily Placebo orally for three months.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (23)

Abdullah M, Jamil RT, Attia FN. Vitamin C (Ascorbic Acid). 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499877/ — View Citation

Beerthuizen A, Stronks DL, Van't Spijker A, Yaksh A, Hanraets BM, Klein J, Huygen FJPM. Demographic and medical parameters in the development of complex regional pain syndrome type 1 (CRPS1): prospective study on 596 patients with a fracture. Pain. 2012 Jun;153(6):1187-1192. doi: 10.1016/j.pain.2012.01.026. Epub 2012 Mar 3. — View Citation

Besse JL, Gadeyne S, Galand-Desme S, Lerat JL, Moyen B. Effect of vitamin C on prevention of complex regional pain syndrome type I in foot and ankle surgery. Foot Ankle Surg. 2009;15(4):179-82. doi: 10.1016/j.fas.2009.02.002. Epub 2009 Apr 5. — View Citation

Bruehl S, Harden RN, Galer BS, Saltz S, Backonja M, Stanton-Hicks M. Complex regional pain syndrome: are there distinct subtypes and sequential stages of the syndrome? Pain. 2002 Jan;95(1-2):119-24. doi: 10.1016/s0304-3959(01)00387-6. — View Citation

Bushnell BD, Bynum DK. Malunion of the distal radius. J Am Acad Orthop Surg. 2007 Jan;15(1):27-40. doi: 10.5435/00124635-200701000-00004. — View Citation

Colles A. On the Fracture of the Carpal Extremity of the Radius. Edinb Med Surg J. 1814 Apr 1;10(38):182-186. No abstract available. — View Citation

Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. doi: 10.1093/oxfordjournals.epirev.a036281. No abstract available. — View Citation

Goris RJ, Dongen LM, Winters HA. Are toxic oxygen radicals involved in the pathogenesis of reflex sympathetic dystrophy? Free Radic Res Commun. 1987;3(1-5):13-8. doi: 10.3109/10715768709069764. — View Citation

Ilyas AM, Jupiter JB. Distal radius fractures--classification of treatment and indications for surgery. Orthop Clin North Am. 2007 Apr;38(2):167-73, v. doi: 10.1016/j.ocl.2007.01.002. — View Citation

Mathews AL, Chung KC. Management of complications of distal radius fractures. Hand Clin. 2015 May;31(2):205-15. doi: 10.1016/j.hcl.2014.12.002. Epub 2015 Feb 28. — View Citation

McKay SD, MacDermid JC, Roth JH, Richards RS. Assessment of complications of distal radius fractures and development of a complication checklist. J Hand Surg Am. 2001 Sep;26(5):916-22. doi: 10.1053/jhsu.2001.26662. — View Citation

Muller ME, Nazarian S, Koch PP. Classification AO des fractures. springer; 1987.

Oaklander AL, Rissmiller JG, Gelman LB, Zheng L, Chang Y, Gott R. Evidence of focal small-fiber axonal degeneration in complex regional pain syndrome-I (reflex sympathetic dystrophy). Pain. 2006 Feb;120(3):235-243. doi: 10.1016/j.pain.2005.09.036. Epub 2006 Jan 19. — View Citation

Owen RA, Melton LJ 3rd, Johnson KA, Ilstrup DM, Riggs BL. Incidence of Colles' fracture in a North American community. Am J Public Health. 1982 Jun;72(6):605-7. doi: 10.2105/ajph.72.6.605. — View Citation

Perez MRSG, Zuurmond AWW, Bezemer DP, Kuik JD, van Loenen CA, de Lange JJ, Zuidhof JA. The treatment of complex regional pain syndrome type I with free radical scavengers: a randomized controlled study. Pain. 2003 Apr;102(3):297-307. doi: 10.1016/S0304-3959(02)00414-1. — View Citation

Pogue DJ, Viegas SF, Patterson RM, Peterson PD, Jenkins DK, Sweo TD, Hokanson JA. Effects of distal radius fracture malunion on wrist joint mechanics. J Hand Surg Am. 1990 Sep;15(5):721-7. doi: 10.1016/0363-5023(90)90143-f. — View Citation

Puchalski P, Zyluk A. Complex regional pain syndrome type 1 after fractures of the distal radius: a prospective study of the role of psychological factors. J Hand Surg Br. 2005 Dec;30(6):574-80. doi: 10.1016/j.jhsb.2005.06.023. Epub 2005 Aug 29. — View Citation

Sandroni P, Benrud-Larson LM, McClelland RL, Low PA. Complex regional pain syndrome type I: incidence and prevalence in Olmsted county, a population-based study. Pain. 2003 May;103(1-2):199-207. doi: 10.1016/s0304-3959(03)00065-4. — View Citation

van der Laan L, Kapitein PJ, Oyen WJ, Verhofstad AA, Hendriks T, Goris RJ. A novel animal model to evaluate oxygen derived free radical damage in soft tissue. Free Radic Res. 1997 Apr;26(4):363-72. doi: 10.3109/10715769709097816. — View Citation

Zollinger PE, Tuinebreijer WE, Kreis RW, Breederveld RS. Effect of vitamin C on frequency of reflex sympathetic dystrophy in wrist fractures: a randomised trial. Lancet. 1999 Dec 11;354(9195):2025-8. doi: 10.1016/S0140-6736(99)03059-7. — View Citation

Zyluk A, Puchalski P. Complex regional pain syndrome of the upper limb: a review. Neurol Neurochir Pol. 2014;48(3):200-5. doi: 10.1016/j.pjnns.2014.05.007. Epub 2014 Jun 6. — View Citation

Zyluk A, Puchalski P. Treatment of early complex regional pain syndrome type 1 by a combination of mannitol and dexamethasone. J Hand Surg Eur Vol. 2008 Apr;33(2):130-6. doi: 10.1177/1753193408087034. — View Citation

Zyluk A. [Chronic, refractory algodystrophy]. Chir Narzadow Ruchu Ortop Pol. 2006;71(6):439-46. Polish. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked 2 weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked four weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked six weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked eight weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked twelve weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked sixteen weeks after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked six months after definitive treatment.
Primary	The positivity of BUDAPEST CRITERIA for diagnosis of CRPS.	BUDAPEST CRITERIA will be checked for the diagnosis of CRPS type 1.	checked twelve months after definitive treatment.