NCT05842395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

April 24, 2023

Last Update Submit

March 17, 2026

Conditions

Distal Radius FractureVitamine cProphylaxis

Keywords

distal radius fracturesvitamine cprophylaxis

Outcome Measures

Primary Outcomes (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Participants with distal radius fractures taking vitamin c supplementation.

EXPERIMENTAL

Participants who give informed consent and successfully pass the eligibility criteria will take 1g of oral vitamin C daily for three months.

Drug: Vitamin C

Participants with distal radius fractures taking a placebo.

PLACEBO COMPARATOR

Participants who give informed consent and successfully pass the eligibility criteria will take a placebo daily for three months.

Drug: Placebo

Interventions

Vitamin CDRUG

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

Participants with distal radius fractures taking vitamin c supplementation.
PlaceboDRUG

Participants with distal radius fractures will take daily Placebo orally for three months.

Participants with distal radius fractures taking a placebo.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (23)

  • 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.

    PMID: 2229966BACKGROUND

  • 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.

    PMID: 12749974BACKGROUND

  • 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.

    PMID: 22386473BACKGROUND

  • 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.

    PMID: 19840748BACKGROUND

  • 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.

    PMID: 9167941BACKGROUND

  • 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.

    PMID: 3902494BACKGROUND

  • 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.

    PMID: 7072880BACKGROUND

  • 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.

    PMID: 30329360BACKGROUND

  • 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.

    PMID: 17560399BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 11561246BACKGROUND

  • 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.

    PMID: 17213380BACKGROUND

  • 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.

    PMID: 25934197BACKGROUND

  • 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.

    PMID: 24981185BACKGROUND

  • 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.

    PMID: 3508426BACKGROUND

  • 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.

    PMID: 16427737BACKGROUND

  • 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.

    PMID: 11790474BACKGROUND

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

    PMID: 17585487BACKGROUND

  • 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.

    PMID: 16126313BACKGROUND

  • 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.

    PMID: 12670672BACKGROUND

  • 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.

    PMID: 18443050BACKGROUND

  • 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.

    PMID: 10636366BACKGROUND

  • Abdullah M, Jamil RT, Attia FN. Vitamin C (Ascorbic Acid). 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK499877/

    PMID: 29763052BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • jaber ibrahim, MD PHD

    Damascus university - faculty of medicine - department of surgery

    STUDY CHAIR

  • hakam alasaad, MD

    Damascus university - faculty of medicine - department of surgery

    STUDY DIRECTOR

  • doried Diri, MD

    Damascus university - faculty of medicine - department of surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All participants and the consultants making definite treatment decisions and the researcher assistant collecting participants' data will be unaware of allocation until the completion of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

June 15, 2023

Primary Completion

May 30, 2024

Study Completion

March 15, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)