Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine? A Randomized Controlled Clinical Trial

Migraine is characterized by a unilateral pulsating moderate/severe headache which is aggravated by routine physical activity, and is accompanied by photo- and/or phonophobia, nausea and sometimes vomiting. Migraine exists in two forms, migraine without aura (MO) and migraine with aura (MA). Aura is reversible neurological disturbances of the vision, sensory and/or speech, which occur prior to the headache. The aura symptoms show intra-individual variations. The origin of migraine pain is still debated, since the origin of painful impulses in the trigeminal nerve is still uncertain. Some argues for central and other argues for peripheral mechanisms. Extracranial pain sensitive structures include skin, muscles, arteries, periosteum and joints. The skin is sensitive to all usual forms of pain stimuli, while especially temporal and neck muscles may be sources for pain and tenderness in migraine. Similarly is the frontal supraorbital, superficial temporal, posterior and occipital arteries sensitive to pain. It has been hypothesize that CSMT might relieve migraine due to stimulation of different mechanoreceptors in the neck such as the zygapophyseal joints, intervertebral discs and neck muscles. Numerous studies of manipulations have been conducted, but all had one or more methodological shortcomings, i.e. failure to specify diagnostic criteria, inadequate or no randomization procedure, lack of control, lack of patient blinding, lack of specified primary and secondary end points and shortcomings of statistical evaluation of the results. A few RCTs suggest that CSMT using diversified technique is an effective therapy for migraine. The diversified technique is used by 91% of chiropractors, and include a collections of procedures, hence the name diversified. It focuses on inter-segmental pretension (soft tissue tension) prior to the delivery of high velocity low amplitude (HVLA) adjustment. The Gonstead method is used by 59% of chiropractors and is also based on HVLA, but a major difference is the minimal usage of rotation in all adjustments in contrast to the diversified technique. The Gonstead method is considered safe, since severe adverse reactions have not been encountered. No studies have previously investigated the efficacy of the Gonstead method for migraine, although research in other CSMT modalities has been recommended.

Study hypothesis CSMT using the Gonstead method reduces days with migraine by at least 25% as compared to placebo (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low amplitude) and no intervention (control group).

The RCT is single blinded, placebo-controlled trial of CSMT using the Gonstead method vs. sham manipulation and control group. If the treatment shows to be effective, the participants whom receive sham manipulation or control will be offered true intervention after the follow-up period and free of charge. This study will follow the recommendations set by the clinical trial guidelines from the IHS, while the methodological quality control will in general follow previous suggested criteria and the CONSORT statements.

Patients will be recruited through Akershus University Hospital, Norway as well as through media advertising in Akershus and Oslo County. The diagnoses are set by a chiropractor and a neurologist with experience in headache. In accordance with good clinical practice, all patients will receive written and oral information about the project and will be informed about the harms and benefits as well as adverse reaction of the intervention. A total of 90 participants need to be recruited to the clinical trial.

The clinical trials consist of three stages: Run-in, intervention (treatment) and follow-up.