Effect of Osteopathic Manipulative Treatment for Patients With Chronic Headache

NCT01332864 | Completed Phase 4

• 1 other identifier: CV4OMTHA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Cephalgia; Migraine

Keywords

headache; migraine; cephalgia; osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  one week after intervention

Secondary Outcomes (2)

• Head pain intensity

  one week

• Head pain duration

  one week

Study Arms (4)

OMT to the head and rest of body

ACTIVE COMPARATOR

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)

Light touch

PLACEBO COMPARATOR

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

Procedure: Light touch

OMT with CV4 to head

EXPERIMENTAL

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

Procedure: Osteopathic Manipulative Treatment (OMT)

OMT to the body except the head region

ACTIVE COMPARATOR

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

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

O OMT applied to areas of somatic dysfunction other than the head region.

Also known as: headache; OMT; somatic dysfunction ICD-9 code 739.0

OMT to the body except the head region; OMT to the head and rest of body; OMT with CV4 to head

Light touch PROCEDURE

Light touch applied to head region for 10 minutes with patient supine at rest.

Also known as: placebo; sham

Light touch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

Related Links

• Western University web site

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Manipulation, Osteopathic; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Michael A. Seffinger, D.O.

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor and Chair of Dept. of NMM/OMM

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 11, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

US (1)