Dose-response of spinal manipulation for cervicogenic headache: study protocol for a randomized controlled trial.
BACKGROUND
Cervicogenic headache is a prevalent and costly pain condition commonly treated by chiropractors. There is evidence to support the effectiveness for spinal manipulation, but the dose of treatment required to achieve maximal relief remains unknown. The purpose of this paper is to describe the methodology for a randomized controlled trial evaluating the dose-response of spinal manipulation for chronic cervicogenic headache in an adult population.


METHODS
This is a mixed-methods, two-site, prospective, parallel groups, observer-blind, randomized controlled trial conducted at university-affiliated research clinics in the Portland, OR and Minneapolis, MN areas. The primary outcome is patient reported headache frequency. Other outcomes include self-reported headache intensity, disability, quality of life, improvement, neck pain intensity and frequency, satisfaction, medication use, outside care, cervical motion, pain pressure thresholds, health care utilization, health care costs, and lost productivity. Qualitative interviews are also conducted to evaluate patients' expectations of treatment.


CONCLUSIONS
With growing concerns regarding the costs and side effects of commonly used conventional treatments, greater numbers of headache sufferers are seeking other approaches to care. This is the first full-scale randomized controlled trial assessing the dose-response of spinal manipulation therapy on outcomes for cervicogenic headache. The results of this study will provide important evidence for the management of cervicogenic headache in adults.


BACKGROUND
ClinicalTrials.gov (Identifier: NCT01530321).
Center for Spirituality and Healing, The University of Minnesota, 420 Delaware St SE C592, Minneapolis, MN 55455 USA.
Linda
L
Hanson
Center for Outcome Studies, The University of Western States, 2900 NE 132nd Ave, Portland, OR 97230 USA.
Mitchell
M
Haas
Center for Spirituality and Healing, The University of Minnesota, 420 Delaware St SE C592, Minneapolis, MN 55455 USA.
Gert
G
Bronfort
Biostatistics, Clinical and Regulatory Affairs, Illumina, 5200 Illumina Way, San Diego, CA 92122 USA.
Darcy
D
Vavrek
Center for Spirituality and Healing, The University of Minnesota, 420 Delaware St SE C592, Minneapolis, MN 55455 USA ; Children's Hospitals and Clinics of Minnesota, Pain, Palliative Care, and Integrative Medicine, 2525 Chicago Ave, Minneapolis, MN 55404 USA.
Craig
C
Schulz
Center for Spirituality and Healing, The University of Minnesota, 420 Delaware St SE C592, Minneapolis, MN 55455 USA.
Brent
B
Leininger
Center for Spirituality and Healing, The University of Minnesota, 420 Delaware St SE C592, Minneapolis, MN 55455 USA.
Roni
R
Evans
Center for Outcome Studies, The University of Western States, 2900 NE 132nd Ave, Portland, OR 97230 USA.
Leslie
L
Takaki
The Mountain-Whisper-Light Statistics, 1827 23rd Ave East, Seattle, WA 98112 USA.
Moni
M
Neradilek
Cervicogenic headache; Chiropractic; Mixed methods; Randomized controlled trial; Spinal manipulation