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.
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
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 group | Role | What they receive |
|---|---|---|
| Control | A Control group of students at CFB Borden will be recruited to complete questionnaires. Receives: 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 Receives: Other: Adverse Childhood Events |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted2 Mar 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Jan 2025 (estimated)
Why it stopped: Awaiting Approvals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Canadian Forces Health Services Centre Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Gupta, Canadian Forces Health Services Centre Ottawa
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Adverse Childhood Events and Chronic Pain in the Canadian Forces
- ClinicalTrials.gov ID
- NCT05259878
- Acronym / sponsor ID
- 2020-045
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Awaiting Approvals
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- Canadian Forces Health Services Centre OttawaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Adverse Childhood EventsA Control group of students at CFB Borden will be recruited to complete questionnaires. |
| Patients with chronic pain | – | Other: Adverse Childhood EventsPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Patients with chronic pain and student controls providing consent to complete administered questionnaires
Key exclusion criteria (1 listed)
- patients not willing or unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adverse Childhood Events• 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. | Other | Control, Patients with chronic pain |
Primary outcome
The Adverse Childhood Events (ACE) scale
Time frame: baseline
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.
2 secondary outcomes
Pain, Enjoyment and General Activity Scale (PEG)
Time frame: baseline
The Pain Disability Index (PDI)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.