Patient-reported Adverse Events From Osteopathic Manipulative Treatment

NCT ID: NCT02386085

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-08-31

Brief Summary

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?

Conditions

Osteopathic Manipulative Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Osteopathic manipulative treatment (OMT)

All participants will have received OMT to be eligible and will be followed for 1 week after treatment.

Osteopathic manipulative treatment (OMT)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Osteopathy

OTHER

Sponsor Role: collaborator

A.T. Still Research Institute

OTHER_GOV

Sponsor Role: collaborator

DO-Touch.NET

UNKNOWN

Sponsor Role: collaborator

A.T. Still University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane C Johnson, MA

Role: PRINCIPAL_INVESTIGATOR

A.T. Still University of Health Sciences

Brian F Degenhardt, DO

Role: PRINCIPAL_INVESTIGATOR

A.T. Still University of Health Sciences

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OMT Adverse Events Study

Identifier Type: -

Identifier Source: org_study_id