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Clinical Trials/NCT02268331
NCT02268331
Completed
Not Applicable

Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children

University of Alberta1 site in 1 country96 target enrollmentOctober 2014
ConditionsAdverse Events

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adverse Events
Sponsor
University of Alberta
Enrollment
96
Locations
1
Primary Endpoint
Adverse event occurring after treatment
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will be utilized in this study for the passive reporting and learning arm.

Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Licensed doctors of chiropractic who provide manual therapy in US or Canada
  • Willing to collect data per protocol for 60 consecutive pediatric (13 years of age and younger) patients

Exclusion Criteria

  • Doctors of chiropractic and patient participation will be limited to those that speak / read English.

Outcomes

Primary Outcomes

Adverse event occurring after treatment

Time Frame: Up to one week after treatment

Study Sites (1)

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