The objective of our randomized controlled trial (RCT) is to assess the effectiveness of a multimodal manual therapy treatment compared to usual care for the prophylactic treatment of migraine.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the number of migraine days, administrated
by the participant in a headache diary during the four weeks prior to the
follow-up assessments (Tfelt-Hansen 2012). A migraine day is defined as a day
with migraine characteristics according to the IHS classification ICDH III for
longer than four hours, or a headache that resolves with the intake of triptans
or ergotamine within two hours of intake.
Secondary outcome
All of the secondary outcome measures will be assessed at 12, 26 and 52 weeks
follow-up assessments.
The secondary outcome measures are:
1. Number of migraine attacks per four weeks, administrated in a headache diary
during the four weeks before follow-up measurements (Tfelt-Hansen 2012).
Migraine attacks will be considered as separate attacks if 48 hours without
headache is reported in the headache diary between migraine days.
2. Pain intensity of migraine, assessed on an 11 point numerical rating scale
(0 = no pain, 10 = most severe pain) (Williamson 2005).
3. Neck pain intensity, assessed on an 11 point numerical rating scale (0 =
no pain, 10 = most severe pain).
4. Medication use in number of doses per 4 weeks of simple analgesics (e.g.,
paracetamol), NSAIDs, acute migraine medication (triptans and ergotamines) or
prophylactic medication. Change of medication will be administrated and
reported.
5. Responder rate will be measured by the number of migraine days before vs.
after treatment, dichotomized into *50% reduction or not (Tfelt-Hansen 2012).
6. Disability, assessed by the HIT-6 questionnaire. The HIT-6 consists of 6
questions measuring pain intensity, social functioning, role functioning,
vitality, cognitive functioning and psychological distress on a 5 point ordinal
rating scale (never, to always). Internal consistency is considered high
(Cronbach's alpha 0.82 to 0.90), and test-retest reliability is fair (ICC 0.77)
(Yang 2011). The Dutch version of the HIT-6 questionnaire has shown to be a
valid and reliable tool to measure the impact of migraine (Martin 2004).
7. The endurance of the neck flexor muscles will be scored as the number of
seconds the participant can raise his head from the table when lying in supine
position as described by Harris et al. (2005).
8. Cutaneous allodynia (CA) will be evaluated with the 12 item allodynia
symptom checklist (ASC-12). This questionnaire consists of 12 questions about
cutaneous hypersensitivity in the cervical cephalic region. The participant can
score yes, no, or not applicable (Jakubowski 2005). Allodynia symptoms and
score on CA severity are defined in the following categories: none (0-2), mild
(3-5), moderate (6-8) and severe (9 or higher) (Lipton 2008).
9. We will perform algometry, by measuring pressure pain thresholds (PPT) with
a Wagner FDK algometer at the upper trapezius muscle (at the midpoint between
C7 spinosus and the acromion), the suboccipital muscles and the anterior tibial
muscle. The PPT measurement will be repeated three times at each point, and a
mean score will be calculated.
10. Participants will be asked to report global perceived effect on a 7 point
rating scale (0 = much worse to 6 = much better). Disability due to attacks
will be assessed on a 5 point rating scale (0 = no disability and no medication
to 4 = fully disabled even with medication). Also, use of healthcare resources
and absence of work will be reported.
11. Adverse events will be administrated for both treatments.
Background summary
Migraine is one of the most common neurological disorders worldwide, with an
annual prevalence of 15%. The individual patient experiences the impact of
migraine due to psychosocial problems and during work (Steiner 2014). In the
Netherlands, the direct medical costs of migraine and the indirect costs due to
absence from work and loss of productivity are estimated at more than 4 billion
euros per year (Linde 2012).
The prophylactic management of migraine generally consists of pharmacological
treatment (Diener 2015). In Dutch primary care, people with migraine are
diagnosed and treated according to the guideline for headache of the Dutch
College of General Practitioners (Dekker 2014). The general practitioner (GP)
provides lifestyle advice and, if necessary, medication. Depending on the
frequency of attacks, the recommended treatment consists of acute medication
for a single attack or prophylactic medication when the migraine attacks occur
two times a month or more.
Prophylactic medication (e.g., propranolol, topiramate or amitriptyline)
reduces migraine attacks by 50% in 50% of the patients (Mulleners 2010).
However, taking this medication has some disadvantages. Daily intake of
prophylactic medication can cause side effects, such as fatigue and dizziness,
which induce some patients to refuse this medication (Dekker 2013). This has
led to a growing demand for non-pharmacological prophylactic treatments to
reduce the frequency of migraine (Coppola 2016).
One of these alternatives is manual therapy (MT). MT is a specialization within
physiotherapy that focuses mainly on spine-related complaints.
MT is a specialization within physiotherapy that focuses mainly on
spine-related complaints. In migraine, MT aims to achieve central inhibition of
nociception at the level of the caudal nucleus of the trigeminal nerve by using
cervical mobilization and pain-reducing techniques of the cervical structures.
That manual therapeutic treatment can be effective for patients with migraine
has been described in previous studies. However, these studies show several
methodological shortcomings such as too small sample sizes, lack of blinding
and unclear randomisation procedure (Tuchin 2000, Posadzky 2011). Therefore, a
methodologically well-designed research is necessary to evaluate the
effectiveness of this intervention.
Study objective
The objective of our randomized controlled trial (RCT) is to assess the
effectiveness of a multimodal manual therapy treatment compared to usual care
for the prophylactic treatment of migraine.
Study design
This study is a single blinded, multicentre, pragmatic clinical trial, with two
parallel groups assessing the potential superiority of a multimodal MT
treatment over usual care by the GP. We will include a four weeks run-in period
to provide accurate migraine frequency data prior to enrolment. The treatment
will last 12 weeks with follow-up measurements at 12, 26 and 52 weeks (Figure
1). The study adheres to the guidelines of the International Headache Society
(IHS) for controlled trials in migraine regarding inclusion criteria, outcome
measurements and statistical analysis (Tfelt-Hansen 2012).
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.
We assessed the feasibility of the study by performing a pilot study between
October 2014 to March 2016.
The design and protocol of the pilot study have been approved by the medical
ethics committee of VUmc Amsterdam (approved June 22, 2015, registration number
2015.177 NL52933.029.15). The RCT will be registered in the Dutch Trial
Register.
Participants will be recruited by the 40 participating general practitioners
(GPs) working in an urban area of Hoofddorp, The Netherlands. Participants will
be given usual care by their own GP.
All measurements will take place at health care center Floriande. Manual
therapy will be provided at health care center Floriande or Overbos.
Intervention
Intervention
The total treatment duration in both groups is 12 weeks.
The manual therapy consists of a maximum of 9 treatments (30 minutes) during a
period of 12 weeks with pain-reducing techniques for the high cervical
musculature (stretching), muscle strengthening exercises for the deep neck
flexor muscles and mobilization of the cervical and thoracic spine.
The GP will treat participants as usual, based on the recommendations of the
practice guideline for headache of the Dutch College of General Practitioners
[8]. Apart from lifestyle advice and reassurance, the GP will provide or change
acute medication and may provide or alter prophylactic medication. The GP will
evaluate the treatment in consecutive appointments.
Study burden and risks
Both interventions (manual therapy, usual care by the GP) are regularly applied
treatments. The manual therapist uses conventional techniques (mobilisations,
pain-reducing techniques, muscle training, posture instructions) of which only
minor short-term adverse reactions in the literature have been described such
as stiffness and increase of neck pain immediately after treatment.
For the usual care, the GP acts according to the guideline for headache of the
Dutch College of General Practitioners. Medication for migraine is widely used.
The possible side effects are described in the product information of the given
medication.
Because the treatments in this study are part of daily routine treatment of the
MT and GP, our opinion is that there is no extra risk for the participants
involved.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
Migraine according to the IHS classification ICHD III (2013): repeated attacks
of moderate to intense headache, usually unilateral, throbbing headache with
nausea and/or vomiting, duration of the headache attack between 4 and 72 hours,
two or more attacks per month. Increasing with physical activity such as
climbing stairs. Photofobia or phonofobia.
Tensiontype headache (TTH) ICHD III (2013) that can be distinguished by the
participant.
Migraine with aura symptoms such as neck pain and additional presence of vision
changes , tingling or
numbness in lips, face, or hand (onesided), one-sided muscle weakness, or
impaired speech.
Migraine more than 1 year present and participants who are stable on
prophylactic medication.
Age: between 18 years 65 years
Participant is able to fill in questionnaires (understand Dutch language)
Exclusion criteria
Exclusion criteria are suspected malignancy, pregnancy, cerebrovascular
disease, degenerative central nervous system diseases, medication-overuse
headache, a current diagnosis of depression or other severe psychiatric
disease, rheumatoid arthritis, serious or systemic infection, fever, or change
in medication for migraine within three months before the study, and having
received MT treatment for migraine up to three months prior to the start of the
study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66480.029.18 |
| OMON | NL-OMON24113 |