Spinal Manipulation for Treatment of Chronic Headaches

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Western States
ClinicalTrials.gov Identifier:
NCT00246350
First received: September 13, 2005
Last updated: November 19, 2010
Last verified: November 2010
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mitchell Haas, DC University of Western States
  More Information

Publications:
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 October 01, 2014