Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache (OMTHA)

February 11, 2013 updated by: Michael Seffinger, Western University of Health Sciences

Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial

Participants with chronic or recurrent headache, unrelated to any known pathology or disease, will be randomly assigned to one of four interventions: Osteopathic manipulation of the body other than the head, osteopathic manipulation of the head, osteopathic manipulation of the head and rest of the body, or light touch on the head only but no manipulation. Measurements of heart rate and blood pressure variability, peripheral blood flow, and behavioral changes, such as mood, pain duration, intensity and frequency will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty subjects will be recruited to participate in the study via word of mouth and mass email notification of employees and students at Western University of Health Sciences in Pomona, CA.

Patients will be randomly assigned to 1 of 4 groups for a specific Osteopathic Manipulative Treatment (OMT): Compression of Fourth Ventricle (CV4) only, CV4 and subject appropriate OMT, subject appropriate OMT only (no CV4), and sham (touch only). There will be 8 subjects per OMT group, making it 24 subjects altogether assigned to one of the three OMT groups, and 24 sham subjects.

Power analysis for determination of sample sizes: The investigators have no data on preliminary studies of the effect of OMT on chronic headaches, and there is only one study of the immediate effect on tension type headache patients after CV4, so power analysis is a rough estimate at this point for the one week headache symptom evaluation post OMT. From preliminary studies in this lab, the investigators can expect for 'CV4 only' 80% of participants to have significant still point objective response vs sham treatment which the investigators expect will significantly effect about 10% of the participants. There needs to be at least 16 subjects in each of two groups assessing this outcome measure, so 16 receiving CV4 and 16 sham to detect the 70% difference in still point measure. To detect differences between any OMT and sham, since there are three groups receiving OMT of some type, when the investigators consider how many in each of these three groups vs the sham group, the investigators figured 8 per each OMT group, of which 2 are CV4 (thus 16 get CV4), making it 24 subjects in the combined OMT groups. Therefore, the investigators need 24 sham subjects to make it equal numbers for balanced analysis (OMT vs sham), and to detect differences in the OMT interventions and sham interventions. Considering a possibility of 25%, or 12 subjects, not responding to the follow up survey at one week, the investigators figured recruitment of 60 subjects would ensure the investigators would have enough to make our calculations and be able to determine if there are significant differences between groups.

The investigators have no preliminary studies on the effect of OMT or sham on mood in patient with headaches, so this part of the study is an exploratory assessment and sample size calculations will be able to be performed with the data gathered from this study for subsequent studies.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91766
        • Western University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic or recurrent headaches at least as often as one time per week

Exclusion Criteria:

  • recent head trauma
  • brain disease or pathology
  • seizure disorder
  • using beta or alpha blocker medications
  • allergy to sticky tape used to affix leads to skin

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OMT to the head and rest of body
OMT is the intervention that will be applied to areas of somatic dysfunction as well as to the head using a compression of the fourth ventricle (CV4) technique.
Procedure: Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Other Names:
  • headache; OMT; somatic dysfunction ICD-9 code 739.0
Placebo Comparator: Light touch
Light touch will be applied to the head region for 10 minutes with the patient at rest in the supine position.
Procedure: Light touch
Light touch applied to head region for 10 minutes with patient supine at rest.
Other Names:
  • placebo; sham
Experimental: OMT with CV4 to head
OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest.
Procedure: Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Other Names:
  • headache; OMT; somatic dysfunction ICD-9 code 739.0
Active Comparator: OMT to the body except the head region
OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head.
Procedure: Osteopathic Manipulative Treatment (OMT)
O OMT applied to areas of somatic dysfunction other than the head region.
Other Names:
  • headache; OMT; somatic dysfunction ICD-9 code 739.0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head pain frequency
Time Frame: one week after intervention
seven days after the intervention participants will be called by telephone and asked whether they had their usual headache in the week following the intervention.
one week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head pain intensity
Time Frame: one week
one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.
one week
Head pain duration
Time Frame: one week
one week after the intervention participants will be contacted and asked the duration of the headaches.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University of Health Sciences

Investigators

  • Principal Investigator: Michael A. Seffinger, D.O., Western University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV4OMTHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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