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

NCT ID: NCT05446597

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2025-04-30

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Headache Treatment

Participants in the headache arm will be randomized to receive a peripheral, greater occipital nerve block with 0.5% Bupivacaine or the multimodal treatment protocol. Participants will complete a daily headache diary over the 6-week treatment period, following a link on their mobile device. Patients receiving a nerve block will have weekly over-the-phone or virtual check-ins by the study team to evaluate for any side effects, pain, as needed medications, and study compliance. These patients will be given supplemental HA education as needed. Participants receiving the block will be offered a second block at 6 weeks if they meet the following criteria: a. no side effects with the first block, b. participant received relief from the first block and prefers a second, and c. headache is still occurring at least once per week. Participants randomized to the multimodal treatment portion, will have up to 6 weeks of scheduled multimodal treatment sessions.

Group Type: EXPERIMENTAL

Symptom-specific Headache Treatment

Intervention Type: PROCEDURE

Greater Occipital Nerve Block

Multimodal Concussion Treatment

Intervention Type: BEHAVIORAL

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

Dizziness and/or Neck Pain Treatment

Participants will be randomized to receive cervicovestibular physiotherapy (CV PT) or the multimodal treatment program. The CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings for six weeks. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, and dynamic balance.

Group Type: EXPERIMENTAL

Symptom-specific Dizziness &/or Neck Pain Treatment

Intervention Type: OTHER

Cervicovestibular Physiotherapy Treatment

Multimodal Concussion Treatment

Intervention Type: BEHAVIORAL

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

Multimodal Treatment

The multimodal treatment consists of 6 treatment sessions that will combine basic physiotherapy exercises to address dizziness and balance problems, training in deep breathing, progressive muscle relaxation, visualization to address headache, sleep hygiene education to address insomnia, and cognitive-behavioral intervention and gratitude exercises to promote coping and resilience. The treatment is designed to be implemented by a variety of clinical health care professionals.

Group Type: EXPERIMENTAL

Multimodal Concussion Treatment

Intervention Type: BEHAVIORAL

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

Interventions

Symptom-specific Headache Treatment

Greater Occipital Nerve Block

Intervention Type: PROCEDURE

Symptom-specific Dizziness &/or Neck Pain Treatment

Cervicovestibular Physiotherapy Treatment

Intervention Type: OTHER

Multimodal Concussion Treatment

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn Emery, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Heather Godfrey, MNNP, BSc, BN

Role: CONTACT

heather.godfrey@ahs.ca

4039552797

Astrid Han, Bsc

Role: CONTACT

astrid.han@ucalgary.ca

4036712852

Facility Contacts

Heather Godfrey, BSc, BN

Role: primary

4039552797

Lisa Marie Langevin, PhD

Role: backup

4039557254

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

REB21-1045

Identifier Type: -

Identifier Source: org_study_id