Suspended

Will the Use of Osteopathic Manipulative Treatments on Patients With Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale?

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What is being tested

Osteopathic Manipulative Treatment

+ Sham Osteopathic Manipulative Treatment

Procedure
Who is being recruted

Neurologic Manifestations+2

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorGood Samaritan Hospital Medical Center, New York
Study ContactRonald Dvorkin, MDMore contacts
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

Will the Use of Osteopathic Manipulative Treatments on Patients with Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale? PROTOCOL Patients will be triaged to the appropriate part of the Emergency Department in the usual fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint is headache the provider will determine if they are a candidate for the study utilizing exclusion criteria for the study TABLE 1. ___ Table 1. Exclusion Criteria for the Study Temperature 100.4 or greater Healthcare provider suspects meningitis, brain abscess, encephalitis Altered mental status History of trauma Cyclic vomiting Abdominal migraines Analgesic medication taken prior to treatment within an hour Providing physician suspects intracranial hemorrhage Focal deficits or other neurological abnormalities that lead providing physician to suspect a pathologic process in which osteopathic treatment would not be safe for the patient Providing physician feels osteopathic treatment would not be safe for the patient If patients have none of the above criteria, they may be selected for the study by the Providing Physician. The provider will ask the patient to rate their initial pain by drawing a vertical line on the 100 mm visual analog scale (VAS) on the Physician Provider Data Form. The provider will then alert an osteopathic emergency medicine resident to enroll the patient into the study. The resident will then obtain informed consent from the patient and will then take an envelope containing a piece of paper stating whether the patient is to receive the actual osteopathic treatment or if the patient will receive placebo/sham treatment. Treatment will be performed by osteopathic emergency medicine residents. Each resident has undergone training in Osteopathic Manipulative Techniques (OMT) in their respective medical schools and has fulfilled the requirements for competency in these techniques for graduation. The osteopathic treatment group will have performed on them 3 standardized osteopathic manipulative treatments. These treatments are muscle energy to the occipital area; muscle energy to the paraspinal muscles bilaterally and facilitated positional release without axial compression. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT.For example, if the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. The sham group will receive 3 sham treatments. The patient consent form and information as to whether or not the patient received osteopathic manipulative treatment will be kept in a locked file. The information will be transferred to a password-protected computer file. After the standardized treatment or sham treatment is performed, the resident will leave the patient and the providing physician will then ask the patient to draw a vertical line on the VAS to again rate their pain. The providing physician will then place the data form into the envelope that also contains the information about whether the patient received the osteopathic treatment vs. the sham treatment, without seeing the actual information. Data will then be analyzed and kept in a password-protected file.

Principal SponsorGood Samaritan Hospital Medical Center, New York
Study ContactRonald Dvorkin, MDMore contacts
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadachePain

Criteria

Inclusion Criteria: Patients will be triaged to the appropriate part of the Emergency Department in the usual fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint is headache the provider will determine if they are a candidate for the study utilizing exclusion criteria for the study - Exclusion Criteria: Exclusion Criteria for the Study Temperature 100.4 or greater Healthcare provider suspects meningitis, brain abscess, encephalitis Altered mental status History of trauma Cyclic vomiting Abdominal migraines Analgesic medication taken prior to treatment within an hour Providing physician suspects intracranial hemorrhage Focal deficits or other neurological abnormalities that lead providing physician to suspect a pathologic process in which osteopathic treatment would not be safe for the patient Providing physician feels osteopathic treatment would not be safe for the patient -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The osteopathic treatment group will have performed on them 3 standardized osteopathic manipulative treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT

Group II

Sham
The sham group will receive 3 sham treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Good Samaritan Hospital Medical Center

West Islip, United StatesOpen Good Samaritan Hospital Medical Center in Google Maps
SuspendedOne Study Center