NCT05446597

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

Symptom Management vs Alternative Randomized Treatment of Concussion Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary objective of this RCT is to examine if up to 6-weeks of symptom-specific (1. headache, 2. dizziness and/or neck pain) treatment initiated in the acute/sub-acute stages following concussion in 13-19 year-old participants recruited acutely (within 2 weeks) following concussion are superior to up to 6 weeks of a multimodal, non-symptom specific treatment program. Treatment will cease once participants are cleared to return to unrestricted physical activity by a sports medicine physician, and will therefore last up to 6 weeks. We have two primary outcomes: 1. Post-Concussion Total Symptom Score (PCSS /132) on the SCAT5 following treatment of up to six sessions 2. Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-10
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2022-07-06
• Last updated: 2023-09-11

Locations

1 site across 1 country: Canada