Spinal Manipulation for Treatment of Chronic Headaches - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 1, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Modified Von Korff pain scale for headaches

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00246350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Number of cervicogenic headaches
general physical and mental health status
patient satisfaction

Descriptive Information

Brief Title ^ICMJE

Spinal Manipulation for Treatment of Chronic Headaches

Official Title ^ICMJE

Dose-Response of Manipulation for Chronic Headache

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Headache Disorders

Intervention ^ICMJE

Procedure: massage
Procedure: spinal manipulation
Procedure: Spinal manipulation

Study Arms / Comparison Groups

Active Comparator: 8 light massage treatments
Active Comparator: 16 light massage treatments
Experimental: 8 spinal manipulation treatments
Experimental: 16 spinal manipulation treatments

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00246350

Responsible Party

Study ID Numbers ^ICMJE

R21 AT002324

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Mitchell Haas, DC

Western States Chiropractic College

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP