AzTrials
AzTrials

Chronic PainNCT05259878

Adverse Childhood Events Chronic Pain

An observational study of Chronic Pain, run by Canadian Forces Health Services Centre Ottawa at 2 sites in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Adverse Childhood Events
How many people
193 participants
Where
2 sitesCanada
Study dates
1 Jan 2021to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • patients not willing or unable to provide consent

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Canadian Forces Health Services Centre

    Ottawa, Ontario, K1J6L4

  • Canadian Forces Health Services-

    Ottawa, Ontario, K1K0T2

Other trials in Canada

About this study

Official title: Examining the Relationship Between Adverse Childhood Events and Chronic Pain in the Canadian Forces

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

Read the detailed description

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 investigators will examine the relationship between adverse childhood events (ACE) and patient reported pain and function conducted within the CAF. Investigators therefore hypothesize that ACE scores will be independently associated with variation in physical limitations, pain intensity when compared with a control group that has no chronic pain.

Procedure Investigators will collect data on pain conditions, potential risk factors, and function using standard patient reported outcome measures. This data includes information about the patient occupation, pain conditions and impact on life, exercise levels, mood, childhood experiences, views on their condition and requests for care support.

Risks and risk mitigation Participation in this study is voluntary and therefore patients and controls could choose not to fill out surveys. They will also be made aware that they can withdraw consent at any time without having any effect on access to future medical care.

Investigators do not foresee significant associated risks but our consent form will also provide information on support resources should distress ensue. Patients' confidentiality/anonymity will be protected through multiple strategies.

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.

As the standard intake, patients will generally complete the patient reported outcome measures listed below. At that time, they will be made aware of the study by a member of the research team not involved in their care. The information handout included in Appendix H will be provided and posted in the clinic. Control patients without chronic pain, will be recruited by word of mouth and through the information handout.

Patient data compiled includes demographics consisting of age, gender, trade, pain conditions and comorbidities. Each patient will undergo a standard in-clinic assessment, which includes standard, validated patient reported outcome measures including body pain diagram, numeric pain scale (PEG), pain disability index (PDI), adverse childhood events (ACE), mood (PHQ-9), perceived injustice (IEQ) and exercise (IPAQ).

All questionnaires can be administered in English or French. Please see Appendix A.

Investigators have included various standardized and adapted versions of other questionnaires which will allow control for known confounders. Control participants will not fill out the litigation status form.

Investigators will complete an analysis of this data to determine the relationship between adverse childhood events and patient reported pain and functional status. A priori power analysis indicates that a sample of 136 patients would provide 90% statistical power, with α set at 0.05, to detect a medium effect size (f2 = 0.15) for a regression with five predictors if ACEs would account for 5% of the variability in physical function, and our complete model would account for 15% of the overall variability. To account for 5% incomplete responses, investigators will enroll 143 patients and 75 controls.

Conditions
Chronic Pain
Being tested
Adverse Childhood Events
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adverse Childhood EventsOther

    • 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.
Study groups in NCT05259878
Study groupRoleWhat they receive
ControlA Control group of students at CFB Borden will be recruited to complete questionnaires.
Receives: Other: Adverse Childhood Events
Patients with chronic painPatients 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
Receives: Other: Adverse Childhood Events

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline

Secondary outcomes (2)
  1. Pain, Enjoyment and General Activity Scale (PEG)

    a 3-question scale with scores from 0-10 looking to describe the change (if any) in activity limitations, symptoms, emotions and overall quality of life, related to the pain condition. Higher scores indicate poorer pain and function

    Measured: baseline

  2. The Pain Disability Index (PDI)

    to investigate the magnitude of self-reported pain-related disability, independent from region of pain or pain-related diagnosis. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Jan 2025 (estimated)

Why it stopped: Awaiting Approvals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
193 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259878
Sponsor's protocol ID
2020-045
Status last verified
Aug 2023
First submitted
12 Feb 2022
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by Canadian Forces Health Services Centre Ottawa at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Adverse Childhood Events (ACE) scale (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in