Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2012 |
| End Date: | December 2012 |
| Contact: | Ronald Dvorkin, MD |
| Email: | ronald.dvorkin@chsli.org |
| Phone: | 631-376-4094 |
Will the Use of Osteopathic Manipulative Treatments on Patients With Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale?
PURPOSE The purpose of this research is to determine whether osteopathic manipulative
therapy (OMT) is a useful adjunct in evaluation and treatment of headaches.
PROCEDURES If a practitioner determines that a patient has a significant headache he/she may
order tests. He/ She may give the patient medications to treat the headache.
The investigators will also ask permission to evaluate and treat the headache using
osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation
and treatment will be performed by an emergency medicine resident. Osteopathic evaluation
and OMT is not standard of care for this condition. The investigators also may call the
patient in 7 days to see how they are doing.
The investigators wish to see if emergency medicine physicians can use osteopathic
evaluation and OMT to reliably treat headaches. The results of the examination and treatment
will be recorded, but will not be used to change treatment or to change additional tests.
The investigators wish to see whether in the future they can use OMT in certain cases
instead of or in conjunction with medications. The investigators plan on asking 50 patients
to participate.
therapy (OMT) is a useful adjunct in evaluation and treatment of headaches.
PROCEDURES If a practitioner determines that a patient has a significant headache he/she may
order tests. He/ She may give the patient medications to treat the headache.
The investigators will also ask permission to evaluate and treat the headache using
osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation
and treatment will be performed by an emergency medicine resident. Osteopathic evaluation
and OMT is not standard of care for this condition. The investigators also may call the
patient in 7 days to see how they are doing.
The investigators wish to see if emergency medicine physicians can use osteopathic
evaluation and OMT to reliably treat headaches. The results of the examination and treatment
will be recorded, but will not be used to change treatment or to change additional tests.
The investigators wish to see whether in the future they can use OMT in certain cases
instead of or in conjunction with medications. The investigators plan on asking 50 patients
to participate.
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.
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.
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
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