Patient-reported Adverse Events From Osteopathic Manipulative Treatment

Currently, there is a significant deficiency in evidence regarding the safety of osteopathic manipulative treatments (OMT). To address this deficit, this study is designed to systematically evaluate the incidence and severity of OMT adverse events and examine the relationship of these adverse events to the technique(s) used and the body region(s) treated. The study is being conducted at the clinics of participating members of DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic manual medicine research. Eligible patients who receive OMT at one of the participating clinics will be asked to complete either a paper or online survey regarding any adverse events they experience within 1, 3, and 7 days following their treatment. Information regarding their diagnoses, which osteopathic techniques were used in their OMT, and which body regions were treated will be obtained from participant medical records. This data will be used to answer the following research questions:

1. What is the incidence of adverse events from osteopathic manipulative treatment?
2. What types of adverse events occur following osteopathic manipulative treatment?
3. Are there individual osteopathic techniques in particular body regions that have higher incidences of adverse events than other techniques or body regions?
4. Is the incidence of adverse events higher for some patient conditions than others?

Study Overview

• Status: Completed
• Conditions: Osteopathic Manipulative Treatment
• Intervention / Treatment: Procedure: Osteopathic manipulative treatment (OMT)

• Study Type: Observational
• Enrollment (Actual): 1303

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is patients who receive osteopathic manipulative treatment from a licensed practitioner for any reason.

Description

Inclusion Criteria:

• received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria:

• unable to communicate in English, Spanish, French, German, or Portuguese

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Osteopathic manipulative treatment (OMT); All participants will have received OMT to be eligible and will be followed for 1 week after treatment.	Procedure: Osteopathic manipulative treatment (OMT); OMT will be provided as part of the patient's health care, prior to enrollment in the study. All participants would have received the same intervention (OMT) if they had not enrolled in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of adverse events related to osteopathic manipulative treatment (OMT)	Data from surveys completed 24 hours, 72 hours, and 1 week after receiving OMT will be used to determine the severity, duration, and onset of symptoms/complaints experienced by participants. The 24- and 72-hour surveys assess the patient-reported severity, duration, and location of potential adverse events, as well as the existence and severity of these symptoms within the week prior to treatment and the participant's assessment of whether the symptom/complaint was related to the OMT they received. The 1-week survey will follow-up on symptoms/complaints reported on the 72-hour survey and whether participants have sought follow-up or urgent care, visited the emergency room, or been hospitalized during the week following OMT.	Within 1 week after receiving OMT

Collaborators and Investigators

• Sponsor: A.T. Still University of Health Sciences
• Collaborators: American Academy of Osteopathy; A.T. Still Research Institute; DO-Touch.NET
• Investigators: Principal Investigator: Jane C Johnson, MA, A.T. Still University of Health Sciences; Principal Investigator: Brian F Degenhardt, DO, A.T. Still University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (ESTIMATE): March 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Osteopathic Manipulation; adverse effects; side effects; Osteopathic Manipulative Medicine; undesirable effects
• Other Study ID Numbers: OMT Adverse Events Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED