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

Sponsor
University of Calgary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05446597
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
294
1
4
29
10.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Symptom-specific Headache Treatment
  • Other: Symptom-specific Dizziness &/or Neck Pain Treatment
  • Behavioral: Symptom-specific Sleep Disturbance Treatment
  • Behavioral: Generic Concussion Treatment
Phase 3

Detailed Description

The primary objective of this randomized controlled superiority trial (RCT) is to examine if 6-week symptom-specific (1. headache, 2. Dizziness and neck pain, 3. sleep disturbance) treatments initiated in the acute/sub-acute stages (1-3 weeks) following concussion in 13-19 year old participants recruited acutely (<2 weeks) following concussion are superior to a generic 6-week multifaceted treatment program. We have two primary outcomes: 1. Post-Concussion Symptom Score (PCSS /132) on the SCAT5 at 6-weeks following initiation of treatment (T3) and 2. Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a multi-arm single-blind randomized controlled superiority trial with three trial arms. Following determination of trial inclusion, consenting participants will enter one of three treatment arms based on symptoms of headaches, dizziness/neck pain, and/or sleep disturbance. Patients will then be randomized within the identified trial arm to one of two study groups [symptom-specific intervention vs generic intervention].This is a multi-arm single-blind randomized controlled superiority trial with three trial arms. Following determination of trial inclusion, consenting participants will enter one of three treatment arms based on symptoms of headaches, dizziness/neck pain, and/or sleep disturbance. Patients will then be randomized within the identified trial arm to one of two study groups [symptom-specific intervention vs generic intervention].
Masking:
Single (Outcomes Assessor)
Masking Description:
Study personnel assessing patients will not be involved, or the same personnel, as those staff performing treatment. Personnel performing assessments will not be aware of which arm, or which treatment, participants receive
Primary Purpose:
Treatment
Official Title:
Symptom Management vs Alternative Randomized Treatment of Concussion Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Headache Treatment

Participants in the headache arm will be randomized to receive a peripheral, greater occipital nerve block with 0.5% Bupivacaine or the generic 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 generic treatment portion, will have 6 weeks of scheduled generic treatment sessions.

Procedure: Symptom-specific Headache Treatment
Greater Occipital Nerve Block

Experimental: Dizziness and/or Neck Pain Treatment

Participants will be randomized to receive cervicovestibular physiotherapy (CV PT) or the generic 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.

Other: Symptom-specific Dizziness &/or Neck Pain Treatment
Cervicovestibular Physiotherapy Treatment

Experimental: Sleep Disturbance Treatment

Participants allocated to the sleep disturbance arm will be randomized to receive 6 weekly sessions of cognitive behavioral therapy for insomnia (CBT-I) or to the generic treatment program. CBT-I includes psychoeducation about insomnia, relaxation strategies, instruction on sleep consolidation, stimulus control/sleep hygiene, cognitive restructuring, problem solving/relapse prevention, and mindfulness techniques. The 6 sessions of CBT-I include: (1) introduction; (2) relaxation training; (3) stimulus, sleep consolidation, and medication use; (4) cognitive therapy; (5) sleep hygiene; and (6) mindfulness and relapse prevention. Participants will also receive a link to an online sleep diary, sent via text message, every morning. The sleep diary will ask for bedtimes, wake up times, naps, sleep quality, time spent sleeping, and if there were any interruptions to sleep.

Behavioral: Symptom-specific Sleep Disturbance Treatment
Cognitive Behavioral Therapy for Insomnia

Experimental: Generic, Multi-faceted Treatment

The generic multifaceted 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.

Behavioral: Generic Concussion Treatment
Lite combination of headache advice, general physiotherapy exercises, mindfulness, visualization, and relaxation

Outcome Measures

Primary Outcome Measures

  1. Change in symptoms [Collected at 6 weeks from the start of treatment]

    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)

  2. Return to unrestricted physical activity [Measured until 3 months from the start of treatment]

    Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Secondary Outcome Measures

  1. Change in symptoms on the Buffalo Concussion Treadmill Test [Measured at 6 weeks from the start of treatment]

    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'.

  2. Changes in symptom-specific ratings [Measured at 6 weeks from the start of treatment]

    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)]

  3. Change in quality of life rating [Measured at 6 weeks from the start of treatment]

    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

  4. Change in resilience [Measured at 6 weeks from the start of treatment]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N 1N4

Sponsors and Collaborators

  • University of Calgary
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05446597
Other Study ID Numbers:
  • REB21-1045
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022