Recruiting

Observational Study

Sponsor:

Canadian Forces Health Services Centre Ottawa

Code:

NCT05283070

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Questionnaires, physical tests, and heart rate variability measures

Study Details

Brief summary:

The Canadian Armed Forces (CAF) has limited data on baseline quality of life measures and objective measures of function, for active serving members with chronic pain. This study aims to collect this data using patient reported outcomes and 2 minute walk test (2MWT) while validating the newly created Elevation Movement Lift Off Test (EMLi) and correlating the data with heart rate variability (HRV) while comparing performance to healthy controls

Conditions

Chronic Pain

Study ID

NCT05283070

Start date

Oct 1, 2021

Status verified date

Jul, 2022

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • for patients male and female between 18 and 60 years old
  • seen within the CFO-P
  • diagnosed with one or more chronic pain condition

Exclusion Criteria:

  • adults who are unable to give their own consent
  • adults with uncontrolled mental health issues For Controls
  • Pacemaker/Cardiac Issues
  • SSRI/Beta Blocker/Anticholinergic medication use in controls
  • Migraine, cold medication, antihistamine, drugs use (ie cannabis <48hours)

Patients/controls will be asked

  • to bring exercise attire including running shoes,
  • not to drink alcohol within 24 hours of testing,
  • not to consume caffeinated products (ie energy drinks or tea/coffee) within 2 hours of the testing,
  • not to eat within 2 hours of testing,
  • not to participate in intense exercise for 24 hours before testing,
  • not to use nicotine products (smoke, vaping, and tobacco) in the 2 hours before testing,
  • not to use plant-based cannabis products 2 hours before testing
  • to use the bathroom before testing.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Volunteers without preexisting chronic pain and/or mental health issues

Patients with chronic pain

Patients with chronic pain and/or mental health issues

Interventions

Questionnaires, physical tests, and heart rate variability measures

The 2MWT will be conducted in an unobstructed hallway with patients being asked to walk at moderate intensity (brisk walk) for the duration of the activity (2 minutes). The amount of distance in metres will be recorded.

The EMLi movement consists of pushing a 2kg weighted ball from the chest level forward, and then raising the ball overhead, before returning it to the starting position (Figure 1). The number of repetitions done at moderate intensity will be recorded after 60 seconds.

HRV and questionnaires previously listed

Primary outcome measure

  • Heart Rate Variability [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Gaurav Gupta

6139451601gaurav.gupta@forces.gc.ca

Markus Besemann

6139451601

Locations

Canadian Forces Health Services Centre

Recruiting

Ottawa, Ontario, Canada, K1J6L4

Contacts

Gaurav Gupta, MD

6139451601gaurav@trunostic.com

More Information

Sponsor

Canadian Forces Health Services Centre Ottawa

Last update posted

Jul 20, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Canadian Forces Health Services Centre Ottawa on 2022-07-20.