Correlating Heart Rate Variability and Chronic Pain

NCT05283070 | Unknown

• 1 other identifier: 2020-044
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Both sympathetic and parasympathetic nervous systems are involved in regulating pain states and may be disturbed in chronic pain. This disruption of the autonomic nervous system may be measured by variability of the interval between consecutive heart beats

  baseline

Secondary Outcomes (4)

• 2 minute walk test (2MWT)

  baseline

• Elevation & Movement Lift test (EMLi)

  baseline

• Pain, Enjoyment and General Activity Scale (PEG)

  baseline

• The Pain Disability Index (PDI)

  baseline

Study Arms (2)

Control

Volunteers without preexisting chronic pain and/or mental health issues

Other: Questionnaires, physical tests, and heart rate variability measures

Patients with chronic pain

Patients with chronic pain and/or mental health issues

Other: Questionnaires, physical tests, and heart rate variability measures

Interventions

Questionnaires, physical tests, and heart rate variability measures OTHER

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

Control; Patients with chronic pain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of 100 patients with chronic pain and 50 pain-free controls will be asked to complete the research protocol (see sample size calculation below). Our study population will be Canadian Forces members between the ages of 18-60 years old, suffering from chronic pain, seen within the CFO-P. Controls will be recruited from Canadian Forces bases in Ottawa, Borden and/or Petawawa.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Study Sites (1)

Canadian Forces Health Services Centre

Ottawa, Ontario, K1J6L4, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Gaurav Gupta

CONTACT

6139451601; gaurav.gupta@forces.gc.ca

Markus Besemann

CONTACT

6139451601

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 16, 2022
• Study Start: October 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)