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Clinical Trials/NCT06306183
NCT06306183RecruitingNot Applicable

Vitamin C for Acute Musculoskeletal Pain in Emergency Department Patients: A Triple-Blind Randomized Control Trial (VICAMED)

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal4 sites in 1 country204 target enrollmentStarted: September 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
204
Locations
4
Primary Endpoint
Time-weighted sum of the pain-intensity difference (SPID)

Study Overview

Brief Summary

Musculoskeletal (MSK) injuries such as sprains, strains, bruises, and fractures are among the most common reasons people visit the emergency department. These injuries often cause significant pain in the first few days, making it difficult to move, work, or sleep. Usual pain medications like ibuprofen or acetaminophen can help, but they are not safe or effective for everyone. Some people cannot take them because of heart, kidney, stomach, or liver problems. Others still experience strong pain despite treatment. Because of these limits, some patients receive opioids, which can cause side effects and carry a risk of dependence. Safer and more accessible options are needed.

Vitamin C is widely known for supporting the immune system, but research suggests it may also help reduce pain and inflammation. Studies in surgical patients have shown that vitamin C can lower pain levels, reduce the need for opioids, and support healing. These effects may be linked to its antioxidant properties and its role in tissue repair. However, no study has tested whether vitamin C can help people with recent MSK injuries treated in the emergency department.

The VICAMED study aims to answer this question. Adults arriving with an MSK injury that occurred within the past 48 hours can participate if they have at least moderate pain. Participants are randomly assigned to receive either vitamin C or a placebo. The first dose is given in the emergency department, followed by twice daily capsules for three days. Pain is measured using a simple 0-100 scale, recorded in an electronic or paper diary. A follow-up on day six helps the research team understand each participant's recovery, medication use, and overall experience.

Vitamin C is inexpensive, widely available, and very safe at the doses used in this study. If it proves effective, it could offer a simple, low risk option to help patients manage pain after an MSK injury and reduce the need for opioids in emergency care.

Detailed Description

Background:

Acute musculoskeletal (MSK) injuries are a major cause of emergency department (ED) visits and frequently result in moderate to severe pain during the first days following presentation. First-line analgesics such as NSAIDs and acetaminophen have important contraindications and safety limitations, particularly in older adults and patients with comorbidities, underscoring the need for safe, accessible, opioid-sparing alternatives. Preclinical studies and postoperative trials suggest that vitamin C (ascorbic acid) may provide analgesic and anti-inflammatory effects through reduction of oxidative stress, protection of neural tissues, and enhanced collagen synthesis. Meta-analyses have reported reductions in postoperative opioid consumption, pain intensity, and inflammatory markers. However, no randomized controlled trial has evaluated vitamin C for acute traumatic MSK pain in the ED.

Objective:

The primary objective is to determine whether a single 900 mg oral dose of vitamin C reduces pain intensity one hour after administration compared with placebo in adults presenting with acute MSK injuries. The main secondary objective is to assess whether 900 mg of vitamin C taken twice daily for three days reduces the time-weighted sum of pain-intensity difference (SPID) over 72 hours.

Methods:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years old
  • Presenting to the ED with acute MSK pain of ≤ 48 hours duration at triage
  • Verbal numerical rating scale pain intensity at triage of ≥ 4 on a 0-10 scale
  • Triaged to the ambulatory section of the ED
  • Able to communicate in French or English

Exclusion Criteria

  • Usage of Vit C supplements in the last week
  • Active cancer
  • Treated with opioids for any pain within 24 hours prior to recruitment
  • Treatment for chronic pain
  • Unable to fill out a pain intensity diary or unavailable for follow-up
  • Allergy to milk (lactose in the placebo) or Vit C
  • Treated with cyclosporine or warfarin
  • Pre-existing oxalate nephropathy, liver cirrhosis or hemochromatosis
  • Hospitalized after clinician evaluation

Arms & Interventions

Placebo

Placebo Comparator

Placebo taken orally twice a day

Intervention: Placebo (Other)

Vitamin C

Experimental

900 mg vitamin C taken orally twice a day

Intervention: Vitamin C (Dietary Supplement)

Outcomes

Primary Outcomes

Time-weighted sum of the pain-intensity difference (SPID)

Time Frame: Three days

The primary outcome is the time-weighted sum of the pain-intensity difference (SPID) over the three-day treatment period on a 0-100 visual analog scale (VAS), where 0 is no pain and 100 the worst pain imaginable. The SPID accounts for both the magnitude of the pain change and its duration, producing a single value that reflects the patient's overall experience.

Secondary Outcomes

  • Difference in pain intensity(Three days)
  • Consumption of as-needed pain medication(Three days)
  • Time for significant pain relief(Six days)
  • Time to pain-free(Six days)
  • Percentage of days with adequate relief(Six days)
  • New analgesic prescriptions(Three days)
  • Adverse events(Three days)
  • Quality of life improvement at six days(Six days)
  • Quantity of Healthcare visits(Six days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Raoul Daoust

Dr Emergency Medicine, Professor, Clinician Researcher

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Study Sites (4)

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