Clinical trial NCT02887638: Headache Analysis and Intervention
Official title: Posture-related Headache: Profile Analysis and Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Keywords: posture, sit
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
name: Orbisch Medisch Centrum
name: Zuyd University of Applied Sciences
name: Algemeen Ziekenhuis Vesalius
First posted: 2016-09-02
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. Current therapies are therefore not as effective and the population of patients with PRH keeps on increasing. The diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. This goal can be achieved through fundamental research with a clinically oriented background. Our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to play an important role in PRH, the first step in the diagnostic process is to analyse postural differences between a PRH- and a control-group. In addition, the role of the dura mater in the headache-process will be examined. Patients with PRH will be classified in homogeneous groups based on these results. In a second phase individual-specific treatment programs will be composed. The general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal problems has been proven to be successful in the past (O'Sullivan \& Dankaerts, non-specific low back pain).

Our study is divided in 2 phases:

* phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls)
* phase 2: interventional phase (clustered headache-groups, based on the results of phase 1


Eligibility criteria: Inclusion Criteria Headache-group:

1. Males and females between 20 and 50 years
2. Confirmed medical diagnosis of tension-type headache, cervicogenic headache or a mixture
3. Headache can be provoked by awkward cervical and/or head postures

Exclusion Criteria Headache-group:

1. Pregnancy
2. History of pericranial surgery
3. Serious pathology (neurological/cardiovascular/endocrine/musculoskeletal)
4. Red flags
5. Physical or manual therapy treatment for headache \< 4 weeks prior the study
6. Excessive (\> 10 days/month for \> 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics
7. Psychiatric comorbidity
8. Visual or temporo-mandibular dysfunction

Inclusion Criteria Control-group:

1. Males and females between 20 and 50 years
2. Asymptomatic, no headache-history

Exclusion Criteria Control-group:

1. Pregnancy
2. History of pericranial surgery
3. Excessive (\> 10 days/month for \> 3 months) use of: ergotamine, NSAID's, opioids, triptans, acetylsalicylic acid and simple analgesics
4. Visual or temporo-mandibular dysfunction

Primary outcomes:
measure: Sitting-posture-profile
timeFrame: day 1
measure: Pain-Profile
timeFrame: day 1
measure: Sitting-posture-profile
timeFrame: week 1 up to week 8
Secondary outcomes:
measure: Headache-related medication-use, headache intensity, duration and frequency.
timeFrame: week -4 up to week 8
measure: Impact of headache on the quality of life.
timeFrame: week -4 up to week 8
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Leuven
country: Belgium
facility: Leuven University
city: Heerlen
country: Netherlands
facility: Zuyd University
city: Sittard
country: Netherlands
facility: Orbis Medisch Centrum
Study officials:
References: