Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786015
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-08-10
Brief Title:
Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults
Sponsor:
Canadian Memorial Chiropractic College
Organization:
Canadian Memorial Chiropractic College
Study Overview
Official Title:
Advancing Patient Safety for Special Populations Active Surveillance Reporting to Identify Adverse Events Following Chiropractic Care in Older Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Canadas population is rapidly aging and the socioeconomic burden associated with these conditions will continue to escalate Indeed older patients 65 years account for 188 of a chiropractors 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 eg 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 conditiondisease 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
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 eg 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 conditiondisease 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None