Clinical Trial: Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for migraine. If the method proves to be effective, it will provide a new non-pharmacological treatment option for migraine. This is especially important since some migraineurs do not tolerate acute and/or prophylactic medicine, due to side effects or contraindications due to comorbidity of other diseases while others do not have effect. Thus, alternative treatment options are warranted. The applied methodology of the study will aim towards the highest possible research standards. This international study is a collaboration between Akershus University Hospital, University of Oslo (UiO), Norway and Macquarie University, Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine. By increasing the methodological quality of the investigators research to a very high level, the investigators see the method to work as a guide to increase the quality of chiropractic research in the future, as previous randomized clinical trials (RCTs) of migraine used methodology showing room for improvement.

Detailed Summary:

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
Sponsor: University Hospital, Akershus

Current Primary Outcome: Number og headache days [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Headache duration [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
  1. 25% reduction in headache duration in hours between active treatment and sham.
  2. 25% reduction in headache duration in hours between active treatment and control group.
• Self reported VAS [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
  1. 25% self-reported improvement on VAS between active treatment and sham.
  2. 25% self-reported improvement on VAS between active treatment and control group.
• Headache index [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
  1. 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
  2. 25% reduction in headache index between active treatment and control group.
• Headache medication [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
  1. 50% reduction in headache medication between active treatment and sham.
  2. 50% reduction in headache medication between active treatment and control group.

Original Secondary Outcome: Same as current

Information By: University Hospital, Akershus

Dates:
Date Received: December 2, 2012
Date Started: February 2013
Date Completion:
Last Updated: December 30, 2015
Last Verified: December 2015