Patient-reported Adverse Events From Osteopathic Manipulative Treatment

NCT02386085 | Completed

• 1 other identifier: OMT Adverse Events Study
• Study Type: observational
• Target: 1,303
• Locations: 0 countries
• Sites: N/A

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

Conditions

Osteopathic Manipulative Treatment

Keywords

Osteopathic Manipulative Medicine; Osteopathic Manipulation; adverse effects; side effects; undesirable effects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Osteopathic manipulative treatment (OMT) 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.

Osteopathic manipulative treatment (OMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• received osteopathic manipulative treatment at one of participating clinics

You may not qualify if:

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

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead
• American Academy of Osteopathy: collaborator
• A.T. Still Research Institute: collaborator
• DO-Touch.NET: collaborator

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jane C Johnson, MA

  A.T. Still University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Brian F Degenhardt, DO

  A.T. Still University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 11, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 25, 2019

Record last verified: 2019-04