Spinal Manipulation for Treatment of Chronic Headaches - Full Text View

Sponsor:	Western States Chiropractic College
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	Western States Chiropractic College
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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 Western States Chiropractic College:

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

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

Western States Chiropractic College

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Mitchell Haas, DC

Western States Chiropractic College

More Information

Publications:

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.

Study ID Numbers:	R21 AT002324, R21AT002324
Study First Received:	September 13, 2005
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00246350 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Western States Chiropractic College:

Headaches
Spinal manipulation
Massage
chiropractic

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on November 27, 2009