Clinical trial NCT05446597: SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial
Official title: Symptom Management vs Alternative Randomized Treatment of Concussion Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Headaches Posttraumatic
Neck Pain
Dizziness
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-07-06
Enrollment: 164
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind randomized controlled superiority trial with three treatment groups. Trial participants will be screened for headache and neck pain/dizziness based on symptom ratings on the Sport Concussion Assessment Tool 5 (SCAT5) Post-Concussion Symptom Scale (PCSS) (rating 0-2 mild, 3-4 moderate, 5-6 severe /6). Patients will be allocated to one of three treatments based on symptom severity:

1. Headache treatment
2. Neck pain / Dizziness treatment
3. Multimodal treatment All participants will receive standard of care education and exercise recommendations based on BCTT and sub-symptom threshold tolerance at baseline
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: Inclusion Criteria:

* 13 - 19 years of age at the start of treatment
* Diagnosed by the study physician with a concussion as per the 5th International Consensus Statement on Concussion in Sport1
* Glasgow Coma Scale 13-15 if recorded
* Loss of consciousness \< 30 minutes if present
* Post-traumatic amnesia \< 24 hours if present
* Diagnosis within 2 weeks of injury
* Moderate-severe symptoms of dizziness, neck pain, headaches, or sleep disturbance at \> one week and \< three weeks post injury reported on the PCSS (3-6 on 0-6 Likert scale for at least one of three symptoms)
* Patients can have a history of migraine or a family history of migraine

Exclusion Criteria:

* Inability to communicate orally and/or in writing in English language
* Significant developmental delay or intellectual disability
* No access to smartphone or computer
* Red flags or other clinical indication suggesting that further medical investigation is warranted (e.g., neurological scan - reflexes, dermatomes, myotomes, long tract signs, CN II-XII, Cerebellar Scan
* Unresolved Benign Paroxysmal Positional Vertigo (BPPV) (Dix-Hallpike and Roll Test)
* Inability to participate in physical activity for a reason other than concussion
* Orthopedic or other injury precluding ability to participate
* Medical history of neurological conditions: seizures (febrile SZ will be allowed), stroke, previous moderate/severe TBI, CNS cancers, SCI
* Psychotic disorder
* Inability to provide informed consent
* History of surgery in the occipital region
* Uncontrolled rheumatologic, inflammatory, or neurologic disorders (eg MS); Fibromyalgia/chronic fatigue syndrome; coagulopathy; immunosuppression
* Active cancer
* Herpes zoster infection in last 6 months
* Pregnancy
* Steroid injection to the greater or lesser occipital nerve infiltration in past 3 months
* Previously enrolled in the trial

Primary outcomes:
measure: Change in symptoms
timeFrame: Collected at 6 weeks from the start of treatment
measure: Return to unrestricted physical activity
timeFrame: Measured until 3 months from the start of treatment
Secondary outcomes:
measure: Change in symptoms on the Buffalo Concussion Treadmill Test
timeFrame: Measured at 6 weeks from the start of treatment
measure: Changes in symptom-specific ratings
timeFrame: Measured at 6 weeks from the start of treatment
measure: Change in quality of life rating
timeFrame: Measured at 6 weeks from the start of treatment
measure: Change in resilience
timeFrame: Measured at 6 weeks from the start of treatment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Carolyn Emery, PhD
role: PRINCIPAL_INVESTIGATOR
References: