Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults

NCT04786015 | Active Not Recruiting

• 1 other identifier: 202004
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

In Canada, almost 19% of chiropractic patients are aged over 65 years. Although most of patients ≥65 years seek care for musculoskeletal conditions (such as back, neck and lower limb pain), there is inadequate prospective data on the safety of chiropractic care for these patients and the frequency of potential associated adverse events remains unknown. Our study will investigate changes in symptoms reported by older adults receiving chiropractic care, with a focus on safety.

Conditions

Musculoskeletal Pain; Musculoskeletal Symptoms

Keywords

Older adult; Adverse event; Patient safety

Outcome Measures

Primary Outcomes (1)

• Change in presenting symptoms (e.g., pain, weakness, etc.) following a chiropractic visit measured by active surveillance reporting system questionnaires

  An active surveillance reporting system will be used. The questionnaires have been face-validated and used in previous studies. The active surveillance system consists on 3 questionnaires to be completed by the patients regarding their symptoms (such as pain, stiffness, weakness, etc.). First questionnaire is to be completed before a chiropractic visit. Second questionnaire is to be completed immediately after chiropractic treatment is provided. Third questionnaire is to be completed 2-7 days after the chiropractic visit. Based on the answers provided in each questionnaire, the change in symptom (i.e., if the symptom improved, got worse, or if the patient is experiencing new symptoms) can be tracked and recorded.

  up to 7 days after chiropractic visit

Interventions

Active Surveillance Reporting System OTHER

A system to actively record change in symptoms older adult patients experience following a chiropractic visit.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Canadian community-based chiropractors and their older adult patients who come to their office for chiropractic care.

You may qualify if:

• older adults (≥65 years) seeking chiropractic care

You may not qualify if:

• diagnosed with cognitive decline (e.g. Alzheimer's Disease, dementia), acute infections, unable to read English and no access to email.

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• Parker University: collaborator
• Macquarie University, Australia: collaborator
• Memorial University of Newfoundland: collaborator

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3, Canada

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: March 8, 2021
• Study Start: July 5, 2021
• Primary Completion: October 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CA (1)