Manual therapy for migraine

Background: People with migraine experience high disability with consequences for social life and work productivity. The effectiveness of pharmacological prophylactic management of migraine is limited, leading to a demand for alternative non-pharmacological treatment options. We started a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine.
Methods: Eligible participants will be recruited in primary care using the International Classification of Headache Disorders III criteria for migraine of the International Headache Society. Participants will be randomized to either multimodal manual therapy treatment or usual care provided by the GP. GPs will be asked to treat the usual care group according to the Dutch GP guideline for headache. The multimodal MT intervention will include manual pressure techniques, neck muscle-strength exercises, and mobilization of the cervical spine.
The trial will consist of a 12 weeks treatment period and follow-up measurements at 12, 26 and 52 weeks. The primary outcome measure is the number of migraine days, per four weeks, assessed with a headache diary. Secondary outcome measures are the number of migraine attacks, medication use, disability due to headache, headache intensity, number of participants reporting a 50% migraine reduction, measurement of cervical pressure pain thresholds, presence of allodynia, endurance of cervical flexor muscles, days of absence of work and global perceived effect.
Parallel to the RCT we will conduct a prospective cohort study with migraine patients with a strong preference for MT treatment who do not want to be randomized. They will be treated with MT; treatment and measurements will be identical to the treatment procedure and measurements used in the RCT.
A pilot study showed that the treatment protocols and measurements are feasible.
Discussion: The results of the trial will provide evidence for the effectiveness of an MT intervention as a non-pharmacological treatment option for people with migraine.

We hypothesize that, in patients with frequent migraine combined with neck pain, manual therapy can reduce the frequency of migraine days, compared to usual care by the general practitioner for the prophylactic treatment of migraine.

Baseline, follow-up at 3, 6 and 12 months

Intervention Manual therapy treatment
A multimodal manual therapy treatment aiming to restore cervical function will be applied. The treatment will include applying manual pressure techniques on myofascial trigger points of the trapezius muscle and upper cervical/suboccipital musculature to decrease neck pain intensity and cervical muscle tenderness. Neck muscle strength will be trained by giving low load craniocervical muscle exercises and correcting sitting and standing posture. The spinal mobilizations that will be applied are low and high-velocity techniques of the cervical and thoracic spine. No high-velocity techniques will be applied to the upper cervical region (C0-3) because of the small risk of serious adverse events.
The treatment protocol provides recommendations for techniques that can be used; the treating manual therapist decides which techniques will be applied, depending on the characteristics of the participant. The MT intervention will consist of a maximum of 9 sessions of 30 minutes during the 12 weeks treatment period.
Control group (usual care):
Participants assigned to the usual care group will be treated by their GP. The GP will treat participants based on the recommendations of the practice guideline for headache of the Dutch College of General Practitioners (care as usual). Apart from lifestyle advice and reassurance, the GP will prescribe acute medication and may prescibe or alter prophylactic medication. The practice guideline recommends the GP to evaluate the treatment in consecutive appointments discussing medication use and the effect the medication has on the migraine.