Effectiveness of treatment for chronic tension headache by the general practitioner or manual therapist: pilot study for a randomized clinical trial

This study is aimed at the treatment of chronic tension headache (CSSH). This
type of headache is characterised by pain on both sides of the head, mild to
moderate intensity, the pain feels like tension or pressure, and does not
increase on physical activity (such as climbing stairs). The symptoms have been
present on at least 15 days of each month, during a period of at least 3
months. CSSH is associated with limitations in emotional and social
functioning, work disability and frequent use of over-the-counter medication.
In primary care CSSH is treated by the general practitioner or
physiotherapist/manual therapist. About 15% percent of all physiotherapy
referrals by the general practitioner concern neck pain/headache.

There is some evidence for the effectiveness of manual therapy for CSSH, but
there are few high quality randomised trials. There is strong need for a
pragmatic trial in which the effects of manual therapy are compared to those of
usual GP care.

The objective of this pilot study is to test the feasiblity of all procedures
of the RCT. The aim of the final study is to investigate the short term and
long term effects of manual therapy on the frequency of headache and the use of
pain medication compared with usual care by the general practitioner.

The pilot study is designed as a pragmatic randomised clinical trial in two
primary care centres.

After selection and baseline assessment a total of 20 participants with CSSH
will be randomly allocated to manual therapy (n=10) or usual GP care (n=10).
The treatment protocol for manual therapy consists of elements that are
commonly used for CSSH. No more than 9 sessions will be given, consisting of
passive mobilisations of the cervical spine using low and high velocity thrust
technieques, stablising exercises and advice regarding better posture.
Usual care by the GP will be carried out according to the national headache
guidelines issued by the Dutch College of General Practitioners. The total
duration of both interventions is 8 weeks.

The participants are asked to take part in a baseline assessment carried out by
a research assistant. This assessment consists of a patient history, written
questionnaire, algometry, and measurement of mobility of the cervical spine.
The entire baseline assessment will take approximately 45 minutes. All
participnats are asked to keep a diary during the intervention period of 8
weeks, and during 4 weeks preceding the assessment after 26 weeks. Completing
the diary will take about 3 minutes each day. The assessment after 8 and 26
weeks are similar to the baseline assessment (45 minutes).

Both interventions are commonly used treatments for CSSH in primary care.
Half of all participants are treated by the GP. They receive usual care for
headache according to the national GP guidelines. With approximately 3
consultations time investment will be about 30 minutes. The other 10
participants receive manual therapy (no more than 9 sessions of 30 minutes).

The costs of treatment by the GP and maual therapist will be covered by health
insurance.