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Completed

NCT Number: NCT00246350

Spinal Manipulation for Treatment of Chronic Headaches

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.

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Key information

Conditions

Headache Disorders Brain Diseases Central Nervous System Diseases Headache Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Western States Chiropractic College

Portland, Oregon, 97230, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage

Procedure

8 light massage treatments and hot pack

Spinal manipulation

Procedure

8 high velocity, low amplitude spinal manipulation treatments and hot pack

Primary outcomes

  1. Modified Von Korff pain scale for headaches

Secondary outcomes

  1. Modified Von Korff disability scale for headaches

  2. Number of cervicogenic headaches

  3. general physical and mental health status

  4. patient satisfaction

  5. neck pain

Sponsors and collaborators

Lead sponsor

University of Western States

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Dose-Response of Manipulation for Chronic Headache

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 31, 2005
Registry last updated
Nov 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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