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
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Greater Occipital Nerve Block
Cervicovestibular Physiotherapy Treatment
Lite combination of headache advice, general physiotherapy exercises, mindfulness, visualization, and relaxation
University of Calgary
Calgary, Alberta, Canada
RECRUITINGChange in symptoms
Change from baseline in symptom burden, measured by the Post-Concussion Symptom Score (PCSS /132) on the SCAT5 (Sport Concussion Assessment Tool - 5th Edition) at 6 weeks following initiation of treatment. Options for scores are: none (0), mild (1), moderate (2), or severe (3) in 22 symptom categories, for a total score of 0 (no symptoms) to 132 (severe symptoms in all categories)
Time frame: Collected at 6 weeks from the start of treatment
Return to unrestricted physical activity
Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)
Time frame: Measured until 3 months from the start of treatment
Change in symptoms on the Buffalo Concussion Treadmill Test
Change in overall symptoms \[visual analogue scale (VAS) 0-10\] from rest prior to the Buffalo Concussion Treadmill Test (BCTT) to age-predicted 80% maximum heart rate on the BCTT at 6-weeks. 0 indicates 'Feeling Good' up to 10 'Worst I have ever felt'.
Time frame: Measured at 6 weeks from the start of treatment
Changes in symptom-specific ratings
Symptom-specific PCSS \[Post-Concussion Symptom Score (PCSS /132)\] ratings of headache, dizziness/neck pain, and sleep disturbance \[0-6 Likert scale; from no symptoms (0), to moderate (3), to severe (6)\]
Time frame: Measured at 6 weeks from the start of treatment
Change in quality of life rating
Pediatric Quality of Life Inventory V4.0 (PedsQL) at 6-weeks. Likert scale: never a problem (0) to sometimes (2) to almost always (4). Total symptom scores from 0/94 up to 94/94. Higher scores indicate poorer quality of life
Time frame: Measured at 6 weeks from the start of treatment
Change in resilience
Resilience at 6-weeks using the short, 10-item Connor-Davidson Resilience Scale (CD-RISC). Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time) for a score range of 0-40. A higher score indicates higher resilience
Time frame: Measured at 6 weeks from the start of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.