Clinical trial NCT00246350: Spinal Manipulation for Treatment of Chronic Headaches
Official title: Dose-Response of Manipulation for Chronic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Headache Disorders
Keywords: Headaches
Spinal manipulation
Massage
chiropractic
Lead sponsor: University of Western States
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Modified Von Korff pain scale for headaches
Secondary outcomes:
measure: Modified Von Korff disability scale for headaches
measure: Number of cervicogenic headaches
measure: general physical and mental health status
measure: patient satisfaction
measure: neck pain
Other outcomes:
Locations:
city: Portland
country: United States
facility: Western States Chiropractic College
state: Oregon
Study officials:
affiliation: University of Western States
name: Mitchell Haas, DC
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jmpt.2004.10.007.
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.
citation: 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: 10.1016/j.jmpt.2009.11.007.
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.
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.