Modeling Post-traumatic Pain and Recovery: The SYMBIOME L... | NCT02711085

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

NCT02711085

Sponsor

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

Status

Completed

Last Update Posted

Aug 12, 2021Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Musculoskeletal Pain
Injuries

Interventions

No intervention

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2020Actual

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 12, 2021Actual

Name	Class
The Canadian Pain Society	OTHER
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention - observational study	Acute trauma

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital		London	Ontario	N6A 4V2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34705736	Derived	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.
34292185	Derived

ID	Term
D059352	Musculoskeletal Pain
D014947	Wounds and Injuries

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D010146	Pain
D009461	Neurologic Manifestations