Headache Analysis and Intervention

NCT ID: NCT02887638

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-05-18

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

Conditions

Headache

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

headache

Patients diagnosed (neurologist - anesthesiologist - manual therapist) with tension-type and/or cervicogenic headache. During a first phase the sitting-posture, dura mater profile and pain-profile of the Headache-group will be analyzed. In a second phase, the patients will be sub-classified according to the data-analysis and receive intervention (Individual Profile Analysis +Physical therapy Intervention)

Group Type: EXPERIMENTAL

Individual Profile Analysis (Physical therapy Intervention)

Intervention Type: OTHER

The Individual Profile Analysis consists of the following components:

• Analysis of the sitting-posture profile:

o cervical spine, thoracic spine, lumbar spine and pelvis during a longitudinal provoking task (working at a laptop).

• Analysis of the dural profile before and after the provoking task:

o Determination of the dural sensitivity by the use of the slump-test

• Analysis of the pain profile before and after the provoking task:

• Determination of pressure pain sensitivity by the use of pressure algometry
• Determination of the influence of pain on the quality of life by the use of the HIT-6 questionnaire

asymptomatic controls

Asymptomatic controls, matched for gender and age. During a first phase the sitting-posture, dura mater profile and pain-profile of the control-group will be analyzed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individual Profile Analysis (Physical therapy Intervention)

The Individual Profile Analysis consists of the following components:

• Analysis of the sitting-posture profile:

o cervical spine, thoracic spine, lumbar spine and pelvis during a longitudinal provoking task (working at a laptop).

• Analysis of the dural profile before and after the provoking task:

o Determination of the dural sensitivity by the use of the slump-test

• Analysis of the pain profile before and after the provoking task:

• Determination of pressure pain sensitivity by the use of pressure algometry
• Determination of the influence of pain on the quality of life by the use of the HIT-6 questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

1. Males and females between 20 and 50 years

2. Asymptomatic, no headache-history

Exclusion Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: collaborator

Orbisch Medisch Centrum

UNKNOWN

Sponsor Role: collaborator

Zuyd University of Applied Sciences

OTHER

Sponsor Role: collaborator

Algemeen Ziekenhuis Vesalius

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Marita Granitzer

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Leuven University

Leuven, , Belgium

Zuyd University

Heerlen, , Netherlands

Orbis Medisch Centrum

Sittard, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

PHA-2016

Identifier Type: -

Identifier Source: org_study_id