The Systematic Merging of Biology, Mental Health and Environment (SYMBIOME) Longitudinal Databanking Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Functional Recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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). -
排除标准
- •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.
结局指标
主要结局
Functional Recovery
时间窗: 1, 2, 3, 6, 12 months
Brief Pain Inventory - Interference Subscale
Recovery change
时间窗: 1, 2, 3, 6, and 12 months
Change in Satisfaction and Recovery Index
次要结局
- Change in Post-traumatic Stress(1, 2, 3, 6, and 12 months)
- Change in Depressive Symptoms(1, 2, 3, 6, and 12 months)
- Change in Work status(1, 2, 3, 6, and 12 months)
- Change in Pain(1, 2, 3, 6, and 12 months)