Spinal Manipulation for Treatment of Chronic Headaches - Full Text View

Sponsor:	University of Western States
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	University of Western States
ClinicalTrials.gov Identifier:	NCT00246350

Purpose

This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.

Condition	Intervention	Phase
Headache Disorders	Procedure: massage Procedure: spinal manipulation Procedure: Spinal manipulation	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose-Response of Manipulation for Chronic Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by University of Western States:

Primary Outcome Measures:

Modified Von Korff pain scale for headaches

Secondary Outcome Measures:

Modified Von Korff disability scale for headaches
Number of cervicogenic headaches
general physical and mental health status
patient satisfaction
neck pain

Enrollment:	80
Study Start Date:	September 2004
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 8 light massage treatments	Procedure: massage 8 light massage treatments and hot pack
Active Comparator: 2 16 light massage treatments	Procedure: massage 16 light massage treatments and hot packs
Experimental: 3 8 spinal manipulation treatments	Procedure: spinal manipulation 8 high velocity, low amplitude spinal manipulation treatments and hot pack
Experimental: 4 16 spinal manipulation treatments	Procedure: Spinal manipulation 16 high velocity, low amplitude spinal manipulation treatments and hot pack

Detailed Description:

Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits.

Participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of cervicogenic headaches

Exclusion Criteria:

Contraindications to spinal manipulation or massage
Use of chiropractic or therapeutic massage care prior to study entry
Use of any prophylactic prescription medication
Involved in any type of lawsuit prior to study entry
Headaches with several different causes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246350

Locations

United States, Oregon
Western States Chiropractic College
Portland, Oregon, United States, 97230

Sponsors and Collaborators

University of Western States

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Mitchell Haas, DC

University of Western States

More Information

Publications:

Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28.

Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13.

Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9.

Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48.

Haas M, Groupp E, Aickin M, Fairweather A, Ganger B, Attwood M, Cummins C, Baffes L. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):547-53.

ClinicalTrials.gov Identifier:	NCT00246350 History of Changes
Other Study ID Numbers:	R21 AT002324, R21AT002324
Study First Received:	September 13, 2005
Last Updated:	November 19, 2010
Health Authority:	United States: Federal Government

Keywords provided by University of Western States:

Headaches
Spinal manipulation
Massage
chiropractic

Additional relevant MeSH terms:

Headache
Headache Disorders
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012