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

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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Injuries
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery change	Change in Satisfaction and Recovery Index	1, 2, 3, 6, and 12 months
Functional Recovery	Brief Pain Inventory - Interference Subscale	1, 2, 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Work status	Work status in relation to pre-injury status	1, 2, 3, 6, and 12 months
Change in Pain	Numeric Rating Scale	1, 2, 3, 6, and 12 months
Change in Post-traumatic Stress	PTSD Checklist	1, 2, 3, 6, and 12 months
Change in Depressive Symptoms	Patient Health Questionnaire - 9	1, 2, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); The Canadian Pain Society

Publications and helpful links

General Publications

• Modarresi S, MacDermid JC, Suh N, Elliott JM, Walton DM. How Is the Probability of Reporting Various Levels of Pain 12 Months After Noncatastrophic Injuries Associated with the Level of Peritraumatic Distress? Clin Orthop Relat Res. 2022 Feb 1;480(2):226-234. doi: 10.1097/CORR.0000000000002024.
• Lee JY, Fakhereddin M, MacDermid JC, Elliott JM, Schabrun SM, Walton DM. An Exploration of Blood MarkerxEnvironment Interaction Effects on Pain Severity and Interference Scores in People With Acute Musculoskeletal Trauma. Clin J Pain. 2021 Oct 1;37(10):747-758. doi: 10.1097/AJP.0000000000000961.
• Ghodrati M, Walton DM, MacDermid JC. Exploring the Domains of Gender as Measured by a New Gender, Pain and Expectations Scale. Womens Health Rep (New Rochelle). 2021 Apr 9;2(1):87-96. doi: 10.1089/whr.2020.0109. eCollection 2021.
• Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: 106140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified database will be made available on a cost-recovery basis as data accrue.