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

Primary Purpose

Headache, Cephalgia, Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment (OMT)
Light touch
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring headache, migraine, cephalgia, osteopathic manipulative treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Experimental

Active Comparator

Arm Label

OMT to the head and rest of body

Light touch

OMT with CV4 to head

OMT to the body except the head region

Arm Description

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.

Light touch will be applied to the head region for 10 minutes with the patient at rest in the supine position.

OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest.

OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head.

Outcomes

Primary Outcome Measures

Head pain frequency
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.

Secondary Outcome Measures

Head pain intensity
one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.
Head pain duration
one week after the intervention participants will be contacted and asked the duration of the headaches.

Full Information

First Posted
April 4, 2011
Last Updated
February 11, 2013
Sponsor
Western University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01332864
Brief Title
Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache
Acronym
OMTHA
Official Title
Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Cephalgia, Migraine
Keywords
headache, migraine, cephalgia, osteopathic manipulative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT to the head and rest of body
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Light touch
Arm Type
Placebo Comparator
Arm Description
Light touch will be applied to the head region for 10 minutes with the patient at rest in the supine position.
Arm Title
OMT with CV4 to head
Arm Type
Experimental
Arm Description
OMT is the intervention using the CV4 technique to the head region for 10 minutes with patient at rest.
Arm Title
OMT to the body except the head region
Arm Type
Active Comparator
Arm Description
OMT is the intervention that will be applied to areas of somatic dysfunction in any region except the head.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment (OMT)
Other Intervention Name(s)
headache; OMT; somatic dysfunction ICD-9 code 739.0
Intervention Description
O OMT applied to areas of somatic dysfunction other than the head region.
Intervention Type
Procedure
Intervention Name(s)
Light touch
Other Intervention Name(s)
placebo; sham
Intervention Description
Light touch applied to head region for 10 minutes with patient supine at rest.
Primary Outcome Measure Information:
Title
Head pain frequency
Description
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.
Time Frame
one week after intervention
Secondary Outcome Measure Information:
Title
Head pain intensity
Description
one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.
Time Frame
one week
Title
Head pain duration
Description
one week after the intervention participants will be contacted and asked the duration of the headaches.
Time Frame
one week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Seffinger, D.O.
Organizational Affiliation
Western University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University of Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.westernu.edu
Description
Western University web site

Learn more about this trial

Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache

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