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SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial

NCT05446597 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-09-11

No results posted yet for this study

Summary

Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion

Conditions

  • Mild Traumatic Brain Injury
  • Headaches Posttraumatic
  • Neck Pain
  • Dizziness

Interventions

PROCEDURE

Symptom-specific Headache Treatment

Greater Occipital Nerve Block

OTHER

Symptom-specific Dizziness &/or Neck Pain Treatment

Cervicovestibular Physiotherapy Treatment

BEHAVIORAL

Multimodal Concussion Treatment

Lite combination of headache advice, general physiotherapy exercises, mindfulness, visualization, and relaxation

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Calgary

    lead OTHER

Principal Investigators

  • Carolyn Emery, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446597 on ClinicalTrials.gov