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Completed

NCT Number: NCT02711085

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention - observational study

Primary outcomes

  1. Recovery change

    Time frame: 1, 2, 3, 6, and 12 months

    Change in Satisfaction and Recovery Index

  2. Functional Recovery

    Time frame: 1, 2, 3, 6, 12 months

    Brief Pain Inventory - Interference Subscale

Secondary outcomes

  1. Change in Work status

    Time frame: 1, 2, 3, 6, and 12 months

    Work status in relation to pre-injury status

  2. Change in Pain

    Time frame: 1, 2, 3, 6, and 12 months

    Numeric Rating Scale

  3. Change in Post-traumatic Stress

    Time frame: 1, 2, 3, 6, and 12 months

    PTSD Checklist

  4. Change in Depressive Symptoms

    Time frame: 1, 2, 3, 6, and 12 months

    Patient Health Questionnaire - 9

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Canadian Pain Society

Registry information

Official study title

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

Acronym: SYMBIOME

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2016
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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