NCT05259878

Brief Summary

There is data to suggest that early childhood physical, emotional and sexual trauma could contribute to the development of chronic pain later in life, but this has not been studied in the Canadian Forces. The investigator will examine the relationship between adverse childhood events (ACE) and patient reported pain and function conducted within the CAF

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

February 12, 2022

Last Update Submit

August 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Adverse Childhood Events (ACE) scale

    A validated 10-item binary questionnaire ("yes" or "no") that retrospectively measures domains of physical, emotional, and sexual abuse in the first 18 years of life. Scores range from 0 to 10 with higher scores indicating more adverse experiences during patients' childhood.

    baseline

Secondary Outcomes (2)

  • Pain, Enjoyment and General Activity Scale (PEG)

    baseline

  • The Pain Disability Index (PDI)

    baseline

Study Arms (2)

Control

A Control group of students at CFB Borden will be recruited to complete questionnaires.

Other: Adverse Childhood Events

Patients with chronic pain

Patients are active service members, ranging from the age of 18-60 years old, referred primarily from the National Capital Region, CFB Petawawa, CFB Kingston, and CFB Trenton for consultation and management

Other: Adverse Childhood Events

Interventions

• The Adverse Childhood Events (ACE) scale is a validated 10-item binary questionnaire ("yes" or "no") that retrospectively measures domains of physical, emotional, and sexual abuse in the first 18 years of life. Scores range from 0 to 10 with higher scores indicating more adverse experiences during patients' childhood.

ControlPatients with chronic pain

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Physical Medicine and Rehabilitation clinic within the Canadian Forces Health Services Centre Ottawa services about 500 patients with complex chronic pain issues per year. Patients are active service members, ranging from the age of 18-60 years old, referred primarily from the National Capital Region, CFB Petawawa, CFB Kingston, and CFB Trenton for consultation and management. A Control group of students at CFB Borden will be recruited to complete questionnaires

You may qualify if:

  • Patients with chronic pain and student controls providing consent to complete administered questionnaires

You may not qualify if:

  • patients not willing or unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canadian Forces Health Services Centre

Ottawa, Ontario, K1J6L4, Canada

Location

Canadian Forces Health Services-

Ottawa, Ontario, K1K0T2, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2022

First Posted

March 2, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

January 31, 2025

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations