Spinal Manipulation for Treatment of Chronic Headaches

Headache Disorders Clinical Trial

Official title:

Dose-Response of Manipulation for Chronic Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246350
• Other study ID #: R21AT002324
• Secondary ID: R21AT002324
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 19, 2010
• Start date: September 2004
• Est. completion date: July 2007

Study information

• Verified date: November 2010
• Source: University of Western States
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders

Intervention

Procedure:
• massage
8 light massage treatments and hot pack
• massage
16 light massage treatments and hot packs
• spinal manipulation
8 high velocity, low amplitude spinal manipulation treatments and hot pack
• Spinal manipulation
16 high velocity, low amplitude spinal manipulation treatments and hot pack

Locations

Country	Name	City	State
United States	Western States Chiropractic College	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Western States	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13. doi: 10.1 — View Citation

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. — View Citation

Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9. doi: 10.1186/1746-1340-18-9. — View Citation

Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002. — View Citation

Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48. doi: 10.1016/j.jmpt.2010.05.004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Von Korff pain scale for headaches
Secondary	Modified Von Korff disability scale for headaches
Secondary	Number of cervicogenic headaches
Secondary	general physical and mental health status
Secondary	patient satisfaction
Secondary	neck pain