Effectiveness of manual therapy compared to usual care by the general practitioner for migraine: a pilot study

The reason for research into the effectiveness of a manual therapy (MT)
treatment of migraine is that there is evidence that manual therapy treatment
might be effective for patients with migraine. The conducted studies into the
effectiveness of MT in migraine show a positive effect. Allthough there are
several limitations to these studies: the number of studies is small, the
sample sizes are small and the inclusion criteria are not according to the IHS
classification. A well-designed pragmatic RCT is needed in order to evaluate
the effectiveness of this intervention.
The present research protocol involves a pilot study: a study to explore the
feasibility of a trial on the effectiveness of MT treatment in migraine. An
important reason for the implementation of this pilot study is that the rate of
inflow of intended participants into the trial is uncertain.
First of all this is related to the inclusion criteria: in the protocol are new
and already well-known participants with migraine included if they have at
least 2 migraine attacks and suffer from their migraine at least 3 days per
month. The annual prevalence of migraine is estimated to be 10-12%, that of
chronic migraines (> 15 days per month) is estimated at 2%. However, it is not
known what is the prevalence of migraine patients who meet the inclusion
criteria as applied in our protocol. We estimate that 100-120 participants per
average general practice will be located. If we include 5 general
practitioners, we would be able to recruit 10 participants in 2 months time.
This expectation is based in part on a previous performed feasibility study on
the treatment of chronic tension-type headache with a one-year prevalence of
2-5%. In this study 20 participants were succesfully randomized in 5 months
time.
Another reason is that in the aforementioned feasibility study participants
with chronic tension-type headaches showed a strong preference for the MT
intervention. Therefore, they could not be randomized . A pilot study can
provide insight if this preference also applies to participants with migraine.
In addition, it is possible to evaluate the procedures concerning measurements
and interventions. This will increase the chance to complete the full trial
successfully. In the pilot study we evaluate the logistics of the research,
the recruitment of potential participants and the feasibility of the research
and treatment protocols

Objective of the pilot study is to examine whether a pragmatic randomised trial
on the effectiveness of manual therapy compared to general practice care in
migraine is feasible.
For this purpose we use the following questions.
* Is it possible to include 10 participants in 2 months time in 5 general
practices?
* How many participants have a strong preference for one of the interventions:
manual therapy or usual care GP?
* Are the baseline and follow up measurements by the research assistant
feasible?
* Is the implementation of the treatment protocol for the manual therapist,
doctor and participant feasible

Design study
Feasibility- study

Both interventions (manual therapy, general practice care) are regular applied
treatments. The manual therapist uses common techniques (mobilizations, pain
relieving techniques, muscle training, posture corrections) which may cause
mild side effects of short duration. In the literature these side effects are
described as stiffness and increase of neck pain immediately after the
treatment. The GP follows the NHG standard "headache" in their treatment. Side
effects of prescribed medication may occur. Because the treatments in our pilot
study are part of daily routine treatment of the MT and general practitioner,
we are of the opinion that there is no extra risk for the participants
involved.