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OpenTrials
Completed

NCT Number: NCT02268331

Comparison of Active vs. Passive Surveillance to Collect Adverse Events

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CARE

Edmonton, Alberta, T5K 0L4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Surveillance

Other

Passive Surveillance

Other

Primary outcomes

  1. Adverse event occurring after treatment

    Time frame: Up to one week after treatment

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2014
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.