Prednisone for CRPS in Distal Radius Fracture

NCT06453447 | Recruiting

• 1 other identifier: H23-02327
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Wrist fractures are the most prevalent adult fracture. Complex regional pain syndrome (CRPS) is a common complication that can occur, leading to permanent disability and is costly to the patient and healthcare system. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies. This study aims to evaluate an anti-inflammatory medication, prednisone, in the early treatment of CRPS. Patients with wrist fractures who undergo surgical treatment will be randomized to receiving placebo vs prednisone for 2 weeks. Clinical assessments in the follow up period will be compared.

Conditions

Complex Regional Pain Syndromes; Distal Radius Fractures

Keywords

wrist fracture; pain; orthopaedic surgery

Outcome Measures

Primary Outcomes (5)

• Proportion of patient recruitment

  Percentage of patients approached for recruitment who consent to study participation

  6 months

• Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting

  Percentage of patients enrolled in the study who report to completing their 14-day course of treatment

  6 months

• Proportion of patients with missing data from secondary and tertiary outcomes

  Percentage of enrolled patients who do not have complete secondary and tertiary outcome measures

  6 months

• Proportion of patient consent withdrawal from the study

  Percentage of patients enrolled in the study who withdraw before completion of the study

  6 months

• Proportion of complete patient follow up at 6 months

  Percentage of enrolled patients who complete all follow up visits

  6 months

Secondary Outcomes (3)

• Resolution of CRPS

  2 weeks, 6 weeks, 3 months, 6 months

• Total opioid consumption

  2 weeks

• Adverse effects

  2 weeks, 6 weeks, 3 months, 6 months

Other Outcomes (6)

• Visual analogue scale (VAS) pain score

  2 weeks, 6 weeks, 3 months, 6 months

• Centre of Epidemiologic Studies Depression (CES-D) score

  2 weeks, 6 weeks, 3 months, 6 months

• Short Form-36 item (SF-36) questionnaire

  2 weeks, 6 weeks, 3 months, 6 months

Study Arms (2)

Prednisone

EXPERIMENTAL

40 mg PO once daily for 14 days starting day of surgery

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

placebo tablet PO once daily for 14 days starting day of surgery

Drug: Placebo

Interventions

Prednisone DRUG

40 mg PO once daily for 14 days starting day of surgery

Prednisone

Placebo DRUG

Placebo tablet (cellulose) PO once daily for 14 days starting day of surgery

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is aged 19 years or older;
• Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;
• The fracture is acute, within 21 days of injury;
• Patient undergoes open reduction internal fixation with volar locking plate;
• Patient is identified as at risk of developing CRPS with 2 or more of the following:
• Pain score on visual analogue scale (VAS) greater than or equal to 5/10 within 1 week of injury and beyond;
• Centre of Epidemiologic Studies Depression (CES-D) score on presentation is greater than or equal to 16;
• Patient identifies as female;
• Patient is identified as developing signs of CRPS based on the Budapest CRPS Criteria;
• Patient provides informed consent.

You may not qualify if:

• Patient has previously fractured ipsilateral wrist;
• Patient has neurovascular injury associated with distal radius fracture;
• Patient has associated extremity or polytrauma injuries that would interfere with rehabilitation and outcome measurements, in the opinion of the investigator;
• Patient has allergy to prednisone or placebo ingredients;
• Patient has contraindication to prednisone or placebo ingredients;
• Patient already takes a glucocorticoid medication;
• Patient has active bacterial, viral, or fungal infection;
• Patient is diagnosed with diabetes;
• Patient is pregnant, planning on becoming pregnant, or breastfeeding;
• Patient is anticipated to have difficulty completing study follow up, in the opinion of the investigator.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Orthopaedic Foundation: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Publications (27)

• Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.

  PMID: 16814787 BACKGROUND

• Moseley GL, Herbert RD, Parsons T, Lucas S, Van Hilten JJ, Marinus J. Intense pain soon after wrist fracture strongly predicts who will develop complex regional pain syndrome: prospective cohort study. J Pain. 2014 Jan;15(1):16-23. doi: 10.1016/j.jpain.2013.08.009. Epub 2013 Nov 19.

  PMID: 24268113 BACKGROUND

• Jo YH, Kim K, Lee BG, Kim JH, Lee CH, Lee KH. Incidence of and Risk Factors for Complex Regional Pain Syndrome Type 1 after Surgery for Distal Radius Fractures: A Population-based Study. Sci Rep. 2019 Mar 19;9(1):4871. doi: 10.1038/s41598-019-41152-x.

  PMID: 30890732 BACKGROUND

• Jellad A, Salah S, Ben Salah Frih Z. Complex regional pain syndrome type I: incidence and risk factors in patients with fracture of the distal radius. Arch Phys Med Rehabil. 2014 Mar;95(3):487-92. doi: 10.1016/j.apmr.2013.09.012. Epub 2013 Sep 29.

  PMID: 24080349 BACKGROUND

• Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29.

  PMID: 28961359 BACKGROUND

• Kowalski C, Ridenour R, McNutt S, Ba D, Liu G, Bible J, Aynardi M, Garner M, Leslie D, Dhawan A. Risk Factors For Prolonged Opioid Use After Spine Surgery. Global Spine J. 2023 Apr;13(3):683-688. doi: 10.1177/21925682211003854. Epub 2021 Apr 15.

  PMID: 33853404 BACKGROUND

• Atalay NS, Ercidogan O, Akkaya N, Sahin F. Prednisolone in complex regional pain syndrome. Pain Physician. 2014 Mar-Apr;17(2):179-85.

  PMID: 24658479 BACKGROUND

• Bianchi C, Rossi S, Turi S, Brambilla A, Felisari G, Mascheri D. Long-term functional outcome measures in corticosteroid-treated complex regional pain syndrome. Eura Medicophys. 2006 Jun;42(2):103-11.

  PMID: 16767061 BACKGROUND

• Winston P. Early Treatment of Acute Complex Regional Pain Syndrome after Fracture or Injury with Prednisone: Why Is There a Failure to Treat? A Case Series. Pain Res Manag. 2016;2016:7019196. doi: 10.1155/2016/7019196. Epub 2016 Apr 30.

  PMID: 27445622 BACKGROUND

• Jamroz A, Berger M, Winston P. Prednisone for Acute Complex Regional Pain Syndrome: A Retrospective Cohort Study. Pain Res Manag. 2020 Feb 25;2020:8182569. doi: 10.1155/2020/8182569. eCollection 2020.

  PMID: 32184912 BACKGROUND

• Desai MJ, Matson AP, Ruch DS, Leversedge FJ, Aldridge JM 3rd, Richard MJ. Perioperative Glucocorticoid Administration Improves Elbow Motion in Terrible Triad Injuries. J Hand Surg Am. 2017 Jan;42(1):41-46. doi: 10.1016/j.jhsa.2016.11.011.

  PMID: 28052827 BACKGROUND

• Dutton LK, Rhee PC. Complex Regional Pain Syndrome and Distal Radius Fracture: Etiology, Diagnosis, and Treatment. Hand Clin. 2021 May;37(2):315-322. doi: 10.1016/j.hcl.2021.02.013.

  PMID: 33892884 BACKGROUND

• Shim H, Rose J, Halle S, Shekane P. Complex regional pain syndrome: a narrative review for the practising clinician. Br J Anaesth. 2019 Aug;123(2):e424-e433. doi: 10.1016/j.bja.2019.03.030. Epub 2019 May 2.

  PMID: 31056241 BACKGROUND

• Li Z, Smith BP, Tuohy C, Smith TL, Andrew Koman L. Complex regional pain syndrome after hand surgery. Hand Clin. 2010 May;26(2):281-9. doi: 10.1016/j.hcl.2009.11.001.

  PMID: 20494753 BACKGROUND

• Jupiter JB, Seiler JG 3rd, Zienowicz R. Sympathetic maintained pain (causalgia) associated with a demonstrable peripheral-nerve lesion. Operative treatment. J Bone Joint Surg Am. 1994 Sep;76(9):1376-84. doi: 10.2106/00004623-199409000-00013.

  PMID: 8077268 BACKGROUND

• 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: 10636366 BACKGROUND

• Zollinger PE, Tuinebreijer WE, Breederveld RS, Kreis RW. Can vitamin C prevent complex regional pain syndrome in patients with wrist fractures? A randomized, controlled, multicenter dose-response study. J Bone Joint Surg Am. 2007 Jul;89(7):1424-31. doi: 10.2106/JBJS.F.01147.

  PMID: 17606778 BACKGROUND

• Ekrol I, Duckworth AD, Ralston SH, Court-Brown CM, McQueen MM. The influence of vitamin C on the outcome of distal radial fractures: a double-blind, randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 3;96(17):1451-9. doi: 10.2106/JBJS.M.00268.

  PMID: 25187584 BACKGROUND

• Kwak SG, Choo YJ, Chang MC. Effectiveness of prednisolone in complex regional pain syndrome treatment: A systematic narrative review. Pain Pract. 2022 Mar;22(3):381-390. doi: 10.1111/papr.13090. Epub 2021 Nov 25.

  PMID: 34779145 BACKGROUND

• Beuschlein F, Else T, Bancos I, Hahner S, Hamidi O, van Hulsteijn L, Husebye ES, Karavitaki N, Prete A, Vaidya A, Yedinak C, Dekkers OM. European Society of Endocrinology and Endocrine Society Joint Clinical Guideline: Diagnosis and therapy of glucocorticoid-induced adrenal insufficiency. Eur J Endocrinol. 2024 May 2;190(5):G25-G51. doi: 10.1093/ejendo/lvae029.

  PMID: 38714321 BACKGROUND

• Henzen C, Suter A, Lerch E, Urbinelli R, Schorno XH, Briner VA. Suppression and recovery of adrenal response after short-term, high-dose glucocorticoid treatment. Lancet. 2000 Feb 12;355(9203):542-5. doi: 10.1016/S0140-6736(99)06290-X.

  PMID: 10683005 BACKGROUND

• Aslan M, Simsek G, Yildirim U. Effects of short-term treatment with systemic prednisone on bone healing: an experimental study in rats. Dent Traumatol. 2005 Aug;21(4):222-5. doi: 10.1111/j.1600-9657.2005.00300.x.

  PMID: 16026529 BACKGROUND

• Prommersberger KJ, Fernandez DL. Nonunion of distal radius fractures. Clin Orthop Relat Res. 2004 Feb;(419):51-6. doi: 10.1097/00003086-200402000-00009.

  PMID: 15021131 BACKGROUND

• Yeoh JC, Pike JM, Slobogean GP, O'Brien PJ, Broekhuyse HM, Lefaivre KA. Role of Depression in Outcomes of Low-Energy Distal Radius Fractures in Patients Older Than 55 Years. J Orthop Trauma. 2016 May;30(5):228-33. doi: 10.1097/BOT.0000000000000514.

  PMID: 27101161 BACKGROUND

• Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.

  PMID: 20493633 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Atkins RM, Duckworth T, Kanis JA. Features of algodystrophy after Colles' fracture. J Bone Joint Surg Br. 1990 Jan;72(1):105-10. doi: 10.1302/0301-620X.72B1.2298766.

  PMID: 2298766 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Wrist Fractures; Pain

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• David Stockton, MD, MASc, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Stockton, MD, MASc, FRCSC

CONTACT

604-875-5809; David.Stockton@vch.ca

Alice (Wei Ting) Wang, MSc, MD

CONTACT

alicew22@student.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Orthopaedic Trauma Surgeon

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)