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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Seffinger, Western University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01332864
First received: April 4, 2011
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Headache
Cephalgia
Migraine
Procedure: Osteopathic Manipulative Treatment (OMT)
Procedure: Light touch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiological and Behavioral Effects of Osteopathic Manipulative Treatment on Patients With Chronic Headache: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Western University of Health Sciences:

Primary Outcome Measures:
  • Head pain frequency [ Time Frame: one week after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: one week ] [ Designated as safety issue: No ]
    one week after intervention participants will be contacted and asked to rate the intensity of their headaches after the intervention.

  • Head pain duration [ Time Frame: one week ] [ Designated as safety issue: No ]
    one week after the intervention participants will be contacted and asked the duration of the headaches.


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: headache; OMT; somatic dysfunction ICD-9 code 739.0

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332864

Locations
United States, California
Western University of Health Sciences
Pomona, California, United States, 91766
Sponsors and Collaborators
Western University of Health Sciences
Investigators
Principal Investigator: Michael A. Seffinger, D.O. Western University of Health Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Seffinger, Principal Investigator, Associate Professor and Chair of Dept. of NMM/OMM, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT01332864     History of Changes
Other Study ID Numbers: CV4OMTHA
Study First Received: April 4, 2011
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Western University of Health Sciences:
headache
migraine
cephalgia
osteopathic manipulative treatment

Additional relevant MeSH terms:
Headache
Migraine Disorders
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014