Modeling Post-traumatic Pain and Recovery: The SYMBIOME Longitudinal Cohort Study

Study Overview
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Brief Summary
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This study will explore the contribution of stress-system activity to pain and functional disability in the acute stage of traumatic musculoskeletal injury, and to the maintenance of symptoms after 3, 6 and 12 months post-injury.

Detailed Description
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Purpose: The purpose of this protocol is to establish a longitudinal database of data collected from people having experienced an acute traumatic injury to their musculoskeletal system. This includes injuries commonly considered 'non-catastrophic' or 'minor' soft tissue injuries such as whiplash, low back injuries, sports or slip and fall-type injuries that result in sprain/strain of muscle, tendon, ligament or other such soft tissues. Uncomplicated bony fractures (those that are managed through casting only, non-surgical) will also comprise this cohort. The data will include biological specimens, psychological and cognitive profiles, and social/environmental indicators. This protocol represents the start of the SYStematic Merging of Biology, Mental health and Environment (SYMBIOME) project from the emerging Solving Traumatic pain and disability through Advanced Research Translation (START) research group centred at Western. Over time, this database will allow rich exploration of complex interactions between biology, psychology and environment as they relate to the resolution of traumatic pain and disability, or similarly the persistence thereof. Additional research ethics board (REB) applications will be submitted as those projects are ready to be formally conducted.

Official Title
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The Systematic Merging of Biology, Mental Health and Environment (SYMBIOME) Longitudinal Databanking Project

Conditions
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Musculoskeletal Pain, Injuries

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants: Will be aged 18 years or older Will be able to speak and understand conversational (grade 6) English Will be free of cognitive impairments that would interfere with ability to follow directions (e.g. diagnosed Alzheimer's Dementia, Down's Syndrome) Will be free of neuromuscular disorder that impairs mobility (e.g. stroke, multiple sclerosis, cerebral palsy, ALS) Will be free of active malignancies for the past 5 years Will be free of systemic inflammatory conditions, including rheumatoid or psoriatic arthritis, scleroderma, or systemic lupus erythematosus Will not have been diagnosed with a concussion over the previous 6 months (including the current injury) Will not have been hospitalized overnight over the previous 6 months (including the current injury) Will not have taken steroid-based medications (either prescribed or self-administered) over the previous 6 months Will not have required surgical correction/relocation as a result of the trauma (e.g. open reduction/internal fixation of a fracture). - Exclusion Criteria: Those who are under the influence of drugs or alcohol, or are otherwise not able to provide appropriate informed consent at the time of contact and those with no fixed address will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute trauma<br>Those within the first 3 weeks of a non-catastrophic injury affecting the musculoskeletal system, including but not limited to whiplash or other road-traffic collisions, sports injuries, work-related injuries, sprains, strains, slips and falls and non-displaced fractures that don't require surgical correction. | Other: No intervention<br>* No intervention - observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery change | Change in Satisfaction and Recovery Index | 1, 2, 3, 6, and 12 months | 
| Functional Recovery | Brief Pain Inventory - Interference Subscale | 1, 2, 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Work status | Work status in relation to pre-injury status | 1, 2, 3, 6, and 12 months | 
| Change in Pain | Numeric Rating Scale | 1, 2, 3, 6, and 12 months | 
| Change in Post-traumatic Stress | PTSD Checklist | 1, 2, 3, 6, and 12 months | 
| Change in Depressive Symptoms | Patient Health Questionnaire - 9 | 1, 2, 3, 6, and 12 months |