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

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ClinicalTrials.gov Identifier: NCT02711085
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
The Canadian Pain Society
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Musculoskeletal Pain Injuries Other: No intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Systematic Merging of Biology, Mental Health and Environment (SYMBIOME) Longitudinal Databanking Project
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Acute trauma
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
No intervention - observational study




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Saliva Blood Hair Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 18 or over presenting for issues of pain/limited function arising from acute (<3 weeks) injury affecting the musculoskeletal system that does not require hospital admission or surgery ('minor' injuries).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711085


Contacts
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Contact: David M Walton, PhD 15196612111 ext 80145 dwalton5@uwo.ca
Contact: Melanie Columbus Melanie.Columbus@lhsc.on.ca

Locations
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Canada, Ontario
St. Joseph's Hospital Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Melanie Columbus       Melanie.Columbus@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
The Canadian Pain Society
Canadian Institutes of Health Research (CIHR)

Additional Information:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02711085     History of Changes
Other Study ID Numbers: 106140
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified database will be made available on a cost-recovery basis as data accrue.
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms