Multimodal vs Symptom-Specific Treatments for Concussion

(SMART Trial)

Overseen By Astrid Han, Bsc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Developmental delay, Neurological conditions, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

164 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different treatment options for teenagers who have had a concussion and continue to experience symptoms like dizziness, neck pain, headaches, or trouble sleeping. The trial compares a general treatment approach, Generic Concussion Treatment, which combines exercises and relaxation techniques, with more specific treatments targeting each symptom. It aims to determine which methods reduce symptoms faster and more effectively. Teens aged 13-19 who have had a concussion in the last two weeks and are experiencing moderate to severe symptoms might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could improve recovery outcomes for teenagers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments under study for concussion—addressing multiple symptoms, headaches, and dizziness/neck pain—are promising in terms of safety and ease of use.

For the treatment targeting multiple symptoms, studies have found it safe and practical for individuals with post-concussion syndrome. Participants in some studies experienced symptom improvement without serious side effects.

Regarding headache-specific treatments, such as the greater occipital nerve block with Bupivacaine, sources report no safety concerns. Bupivacaine is generally well-tolerated in medical settings.

For treating dizziness and neck pain, studies on cervicovestibular physiotherapy (a combination of neck and balance exercises) suggest it is safe and commonly used in physical therapy. It helps manage symptoms like dizziness and neck pain without significant negative effects.

Overall, these treatments are designed to be safe and have been successfully used in various settings to manage concussion symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for concussion because they offer tailored, symptom-specific approaches that go beyond standard care, which often includes rest and general symptom management. The headache treatment is unique because it uses a peripheral nerve block with 0.5% Bupivacaine, which directly targets headache pain through a novel mechanism of action. The dizziness and neck pain treatment stands out by incorporating cervicovestibular physiotherapy (CV PT), which combines specialized techniques for the cervical spine and vestibular system, providing a more comprehensive approach to rehabilitation. Lastly, the multimodal treatment is distinctive as it integrates multiple therapeutic techniques such as physiotherapy, cognitive-behavioral interventions, and relaxation exercises, addressing a range of concussion symptoms in a holistic manner. These innovative approaches aim to provide more effective and personalized care for concussion patients.

What evidence suggests that this trial's treatments could be effective for concussion?

Research has shown that different treatments can effectively manage post-concussion symptoms. In this trial, participants in the headache treatment arm may receive a peripheral, greater occipital nerve block. Studies have found this treatment significantly reduces symptoms for 77% of patients, with noticeable improvements in headache and dizziness. Alternatively, participants may receive the multimodal treatment protocol, which combines therapies like physical therapy and relaxation techniques. This approach has improved symptoms such as headache and neck pain, with patients showing an average improvement of 9 points on the post-concussion symptom scale. For those in the dizziness and/or neck pain treatment arm, vestibular rehabilitation, a therapy to improve balance and reduce dizziness, has proven beneficial. These findings suggest that each treatment approach in this trial can help reduce post-concussion issues. ^{1 4 6 7 8}

Who Is on the Research Team?

Carolyn Emery, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The SMART Concussion Trial is for young people aged 13-19 who've had a concussion with symptoms like headaches, dizziness, or neck pain lasting over a week but less than three weeks. They must be able to communicate in English and have access to a smartphone or computer. Those with severe brain injuries, certain medical conditions, or an inability to participate in physical activities due to reasons other than the concussion cannot join.

Inclusion Criteria

I've had moderate to severe dizziness, neck pain, headaches, or sleep issues for 1-3 weeks.

If you have memory loss from an injury for less than a day, you cannot participate.

If your Glasgow Coma Scale score is between 13 and 15.

Exclusion Criteria

I currently have active cancer.

Inability to provide informed consent

I do not have uncontrolled rheumatologic, inflammatory, or neurologic disorders, fibromyalgia/chronic fatigue syndrome, coagulopathy, or immunosuppression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive symptom-specific or multimodal treatment for up to 6 weeks, including headache treatment, dizziness/neck pain treatment, or a combination of physiotherapy and cognitive-behavioral interventions.

6 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom changes and quality of life.

6 weeks

2 visits (virtual)

Long-term Follow-up

Participants are monitored for return to unrestricted physical activity and long-term outcomes.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Generic Concussion Treatment
• Symptom-specific Dizziness &/or Neck Pain Treatment
• Symptom-specific Headache Treatment
• Symptom-specific Sleep Disturbance Treatment

Trial Overview This trial tests multiple treatments for concussions in youth. It's looking at how effective different symptom-specific approaches are when started early after injury. The study uses randomized controlled methods meaning participants are randomly assigned to treatment groups without choosing which one they receive.

How Is the Trial Designed?

Group I: Multimodal Treatment Experimental Treatment 1 Intervention

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 II: Headache Treatment Experimental Treatment 2 Interventions

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 III: Dizziness and/or Neck Pain Treatment Experimental Treatment 2 Interventions

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.

Generic Concussion Treatment is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Generic Concussion Treatment for:

• Symptomatic relief for post-concussion syndrome
• Rehabilitation for concussion-related injuries

Approved in Canada as Generic Concussion Treatment for:

• Symptomatic relief for post-concussion syndrome
• Rehabilitation for concussion-related injuries

Approved in European Union as Generic Concussion Treatment for:

• Symptomatic relief for post-concussion syndrome
• Rehabilitation for concussion-related injuries

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Posttraumatic headaches after traumatic brain injury can be effectively managed with treatments similar to those for migraines, and adding physical therapy may enhance recovery.

For dizziness and balance issues caused by vestibular dysfunction, vestibular physical therapy is the primary treatment approach, highlighting the importance of targeted rehabilitation in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Assessment and Management of Neurosensory Deficits After Traumatic Brain Injury in the Polytrauma Veteran. Bhatnagar, S., Anderson, M., Chu, M., et al.[2018]

A comprehensive physical therapy approach, including manual therapy, vestibular rehabilitation, and neuromotor retraining, effectively improved symptoms and function in a 21-year-old male with chronic post-concussion syndrome (PCS) after nearly a year without treatment.

After eight sessions over five weeks, the patient's postural stability and cervical range of motion improved significantly, and his symptom severity score dropped from 20 to 2, indicating substantial recovery except for persistent headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of Neuromotor Retraining to Augment Manual Therapy and Vestibular Rehabilitation in a Patient with Post-Concussion Syndrome: A Case Report. Teare-Ketter, A., LaForme Fiss, A., Ebert, J.[2023]

In a study of 11 individuals with persistent concussion symptoms, neck treatment as part of multidisciplinary care led to sustained improvements in post-concussion symptoms over 6 and 12 months.

While most participants found neck treatment beneficial for their recovery, 7 out of 11 reported recurring headaches, neck pain, or dizziness, indicating that while neck treatment is helpful, some symptoms may persist long-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the neck contribute to persistent symptoms post concussion? Long-term follow up from a prospective descriptive case series. Kennedy, E., Chapple, C., Quinn, D., et al.[2022]

A multidisciplinary approach is essential for effectively managing concussions in children and adolescents, highlighting the importance of Physical Therapists in the recovery process.

Targeted treatments such as vestibular rehabilitation, cervicogenic rehabilitation, and exertional training can help alleviate common concussion symptoms like headache, dizziness, and balance dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Physical Therapy in Concussion Rehabilitation. Brown, L., Camarinos, J.[2020]

A case study of a motor vehicle collision victim showed that osteopathic manipulative treatment (OMT) led to direct and progressive improvement in post-concussion symptoms (PCS), suggesting its potential as an effective adjunct therapy.

This report is the first to explore OMT for PCS management in polytrauma patients within an organized trauma system, highlighting the need for further research to evaluate its efficacy across various injury mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. Baltazar, GA., Kolwitz, C., Petrone, P., et al.[2020]

A new treatment-based profiling model has been proposed to assist physical therapists in managing patients after a concussion, focusing on symptom type, intensity, and movement response.

The model emphasizes three key treatment areas: symptom management, movement system optimization, and performance optimization, which can help therapists make informed decisions tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. Alsalaheen, B., Landel, R., Hunter-Giordano, A., et al.[2020]

Whiplash and concussion can present with similar symptoms, such as neck pain and dizziness, which may lead to misdiagnosis; therefore, integrating guidelines for both conditions could improve patient outcomes.

In a study of three cases, patients showed significant improvement in daily activities and reductions in symptoms after receiving multidisciplinary management that addressed both whiplash and postconcussion syndrome, highlighting the need for comprehensive assessment and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concussion in Combination With Whiplash-Associated Disorder May Be Missed in Primary Care: Key Recommendations for Assessment and Management. Rebbeck, T., Evans, K., Elliott, JM.[2020]

Postconcussion syndrome (PCS) is a complex condition with symptoms that can persist for months or years, and it can be divided into early-phase and late-phase posttraumatic disorders, influenced by various psychosocial factors.

Effective treatment for PCS requires a careful diagnosis of symptoms and comorbid conditions, with a recommended approach that includes managing treatable symptoms and incorporating guided aerobic exercise to aid recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postconcussion syndrome. Dwyer, B., Katz, DI.[2019]

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