Modeling Post-traumatic Pain and Recovery: The SYMBIOME Longitudinal Cohort Study
- Conditions
- Musculoskeletal PainInjuries
- Interventions
- Other: No intervention
- Registration Number
- NCT02711085
- Lead Sponsor
- Lawson Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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). -
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute trauma No intervention 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.
- Primary Outcome Measures
Name Time Method Functional Recovery 1, 2, 3, 6, 12 months Brief Pain Inventory - Interference Subscale
Recovery change 1, 2, 3, 6, and 12 months Change in Satisfaction and Recovery Index
- Secondary Outcome Measures
Name Time Method Change in Post-traumatic Stress 1, 2, 3, 6, and 12 months PTSD Checklist
Change in Depressive Symptoms 1, 2, 3, 6, and 12 months Patient Health Questionnaire - 9
Change in Work status 1, 2, 3, 6, and 12 months Work status in relation to pre-injury status
Change in Pain 1, 2, 3, 6, and 12 months Numeric Rating Scale
Trial Locations
- Locations (1)
St. Joseph's Hospital
🇨🇦London, Ontario, Canada