Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04786015 |
Other study ID # |
202004 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 5, 2021 |
Est. completion date |
July 2025 |
Study information
Verified date |
May 2024 |
Source |
Canadian Memorial Chiropractic College |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.