Dose–response of spinal manipulation for cervicogenic headache: study protocol for a randomized controlled trial

Abstract

BackgroundCervicogenic 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/DesignThis 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.DiscussionWith 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.Trial registrationClinicalTrials.gov (Identifier: NCT01530321)

Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial

“…This study was a two-site, prospective, open-label randomized controlled trial conducted in greater Portland, Oregon and Minneapolis, Minnesota metropolitan regions. The trial protocol has been published elsewhere [20]. We randomized 256 participants with chronic CGH, half at each site, to 1 of 4 dose levels of SMT (Fig.…”

“…The protocol [20] includes an exhaustive list of exclusion criteria summarized here. Participants were ineligible if they had contraindications to spinal manipulation [23,27], complicating conditions possibly related to clinical outcomes, or other confounding factors.…”

“…Time-controlled treatment visits of 10 minutes were delivered to approximate chiropractic practice [28]. During the first 5 minutes, the treating chiropractors conducted a brief history and recorded adverse events as defined in our protocol [20]. A hot pack was applied to relax spine musculature.…”

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“…Over half of the world's population experiences headaches within their lifetime, making headaches a significant burden on society [1]. Millions of days and billions of dollars are lost each year in the workplace due to sick days or missed work from headaches [1]. Cervicogenic headaches (CEH) are secondary headaches related to a cervical disorder or neck pain [2].…”