Skip to main content
OpenTrials
Completed

NCT Number: NCT03412097

(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation

To increase patient safety culture in spinal manipulation therapy (SMT) this study will assess the ability to implement an active surveillance reporting system for a chiropractic teaching clinic and determining preliminary incidence of adverse events (AE) following SMT performed by the chiropractic interns. Adverse events defined for the primary outcome of this study is any new or worsening symptom following a chiropractic encounter.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient Safety Manipulation, Spinal

Sex eligibility

All sexes

Study type

Observational

About this study

Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data on patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients at the Parker University Wellness Clinic
  • Agreed to participate

Exclusion criteria

  • none

Treatment and study plan

Active Surveillance

Other

Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.

Primary outcomes

  1. Number of Patient Encounters That Report a New or Worsening Symptom

    Time frame: Up to 7 days post treatment - Day 0-7

    An adverse advent is any unfavorable sign, symptom or disease temporarily associated with the treatment, whether or not caused by the treatment, specifically any worsened or new symptom reported by the patient up to one week after care.

Sponsors and collaborators

Lead sponsor

Parker University

Other

Collaborators

  • Canadian Memorial Chiropractic College
  • University of Alberta
  • University of Texas at Tyler

Registry information

Official study title

Assessing New or Worsening Symptoms (Aka Adverse Events for This Study) After Chiropractic Care at a Chiropractic Teaching Clinic: An Active Surveillance Pilot Study

Acronym: MIST1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2018
Registry last updated
Mar 4, 2024

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.

Related clinical trials

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