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

NCT02711085 | Completed

• 1 other identifier: 106140
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Work status

  1, 2, 3, 6, and 12 months

• Change in Pain

  1, 2, 3, 6, and 12 months

• Change in Post-traumatic Stress

  1, 2, 3, 6, and 12 months

• Change in Depressive Symptoms

  1, 2, 3, 6, and 12 months

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention - observational study

Acute trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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). -

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Canadian Pain Society: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Related Publications (4)

• 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.

  PMID: 34705736 DERIVED

• 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.

  PMID: 34292185 DERIVED

• 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.

  PMID: 33937906 DERIVED

• 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.

  PMID: 32943021 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Blood Hair Stool

MeSH Terms

Conditions

Musculoskeletal Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: March 17, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 12, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)