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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02711085
Acronym
SYMBIOME
Enrollment
134
Registered
2016-03-17
Start date
2015-12-31
Completion date
2020-12-31
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries, Musculoskeletal Pain

Brief summary

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

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.

Interventions

OTHERNo intervention

No intervention - observational study

Sponsors

The Canadian Pain Society
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligible participants: 1. Will be aged 18 years or older 2. Will be able to speak and understand conversational (grade 6) English 3. Will be free of cognitive impairments that would interfere with ability to follow directions (e.g. diagnosed Alzheimer's Dementia, Down's Syndrome) 4. Will be free of neuromuscular disorder that impairs mobility (e.g. stroke, multiple sclerosis, cerebral palsy, ALS) 5. Will be free of active malignancies for the past 5 years 6. Will be free of systemic inflammatory conditions, including rheumatoid or psoriatic arthritis, scleroderma, or systemic lupus erythematosus 7. Will not have been diagnosed with a concussion over the previous 6 months (including the current injury) 8. Will not have been hospitalized overnight over the previous 6 months (including the current injury) 9. Will not have taken steroid-based medications (either prescribed or self-administered) over the previous 6 months 10. 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.

Design outcomes

Primary

MeasureTime frameDescription
Recovery change1, 2, 3, 6, and 12 monthsChange in Satisfaction and Recovery Index
Functional Recovery1, 2, 3, 6, 12 monthsBrief Pain Inventory - Interference Subscale

Secondary

MeasureTime frameDescription
Change in Work status1, 2, 3, 6, and 12 monthsWork status in relation to pre-injury status
Change in Pain1, 2, 3, 6, and 12 monthsNumeric Rating Scale
Change in Post-traumatic Stress1, 2, 3, 6, and 12 monthsPTSD Checklist
Change in Depressive Symptoms1, 2, 3, 6, and 12 monthsPatient Health Questionnaire - 9

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026