Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Good Samaritan Hospital Medical Center, New York
Sponsor:
Information provided by (Responsible Party):
Good Samaritan Hospital Medical Center, New York
ClinicalTrials.gov Identifier:
NCT01704625
First received: September 19, 2012
Last updated: October 10, 2012
Last verified: October 2012

September 19, 2012
October 10, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Headache Pain as Measured by a VAS [ Time Frame: Immediately before and after intervention (less than 30 minutes) ] [ Designated as safety issue: No ]
The primary outcome will be the change in pain before and immediately after intervention as measured by a 100 mm visual analog scale (VAS) for pain in patients with headaches that meet the inclusion criteria.
Same as current
Complete list of historical versions of study NCT01704625 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Headache
  • Procedure: Osteopathic Manipulative Treatment
    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.
  • Procedure: Sham Osteopathic Manipulative Treatment
    The sham group will receive 3 sham treatments.
  • Experimental: Osteopathic Manipulative Treatment
    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
    Intervention: Procedure: Osteopathic Manipulative Treatment
  • Sham Comparator: Sham Osteopathic Manipulative Treatment
    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.
    Intervention: Procedure: Sham Osteopathic Manipulative Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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

-

Both
21 Years and older
Yes
Contact: Ronald Dvorkin, MD 631-376-4094 ronald.dvorkin@chsli.org
Contact: Genevieve McGerald, DO 631-376-4094 genevieve.mcgerald@chsli.org
United States
 
NCT01704625
11-013
No
Good Samaritan Hospital Medical Center, New York
Good Samaritan Hospital Medical Center, New York
Not Provided
Principal Investigator: Genevieve McGerald, DO Good Samaritan Hospital Medical Center
Good Samaritan Hospital Medical Center, New York
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP