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

NCT ID: NCT04786015

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2025-07-31

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.

Detailed Description

Rationale: Musculoskeletal conditions are more common and more severe in older adults than in younger adults and have a negative effect on their overall health-related quality-of-life by decreasing mobility, reducing social participation and causing substantial difficulties with activities of daily living. Canada's population is rapidly aging and the socioeconomic burden associated with these conditions will continue to escalate. Indeed, older patients (≥65 years) account for 18.8% of a chiropractor's case load. Given the high proportion of older adults as chiropractic patients, research on the safety of chiropractic care for this population is critical. Previous studies have reported adverse events (AEs) following specific chiropractic techniques or as secondary outcome measures in older adults; however, there has been no attempt to prospectively capture changes in symptoms (and specifically AEs).

Purpose: To: 1) calculate the frequency of AEs reported by older adults following chiropractic care with an active surveillance reporting system; and 2) explore patient and provider factors related to changes in symptom (e.g., new, worsening, improving) following chiropractic care.

More specifically, this study will use active surveillance reporting system to track the change in symptoms experienced by older adult patients after a chiropractic visit, in comparison to before. These symptoms can be pain, stiffness, fatigue, weakness, dizziness, nausea, etc. As active surveillances track the change in all symptoms experienced by all patients in a participating clinic, no specific condition/disease is being studied, but how the symptoms experienced by older adults seeking chiropractic care for a musculoskeletal condition (such as low back, neck, hip, should pain) change.

Conditions

Musculoskeletal Pain; Musculoskeletal Symptoms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Active Surveillance Reporting System

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• older adults (≥65 years) seeking chiropractic care

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parker University

OTHER

Sponsor Role: collaborator

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: collaborator

Canadian Memorial Chiropractic College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Canadian Memorial Chiropractic College

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

202004

Identifier Type: -

Identifier Source: org_study_id