Spinal Manipulation for Treatment of Chronic Headaches

November 19, 2010 updated by: University of Western States

Dose-Response of Manipulation for Chronic Headache

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
8 light massage treatments
Procedure: massage
8 light massage treatments and hot pack
Procedure: massage
16 light massage treatments and hot packs
Active Comparator: 2
16 light massage treatments
Procedure: massage
8 light massage treatments and hot pack
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Modified Von Korff pain scale for headaches

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western States

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Mitchell Haas, DC, University of Western States

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

November 22, 2010

Last Update Submitted That Met QC Criteria

November 19, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT002324 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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