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

Musculoskeletal Pain Clinical Trial

— SYMBIOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711085
• Other study ID #: 106140
• Status: Completed
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Injuries
• Musculoskeletal Pain

Intervention

Other:
• No intervention
No intervention - observational study

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), The Canadian Pain Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery change	Change in Satisfaction and Recovery Index	1, 2, 3, 6, and 12 months
Primary	Functional Recovery	Brief Pain Inventory - Interference Subscale	1, 2, 3, 6, 12 months
Secondary	Change in Work status	Work status in relation to pre-injury status	1, 2, 3, 6, and 12 months
Secondary	Change in Pain	Numeric Rating Scale	1, 2, 3, 6, and 12 months
Secondary	Change in Post-traumatic Stress	PTSD Checklist	1, 2, 3, 6, and 12 months
Secondary	Change in Depressive Symptoms	Patient Health Questionnaire - 9	1, 2, 3, 6, and 12 months