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Headache Analysis and Intervention (PRA)

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ClinicalTrials.gov Identifier: NCT02887638
Recruitment Status : Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : September 2, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Headache Other: Individual Profile Analysis (Physical therapy Intervention)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Posture-related Headache: Profile Analysis and Intervention
Study Start Date : November 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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)
Other: 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
No Intervention: 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.


Outcome Measures

Primary Outcome Measures :
  1. Sitting-posture-profile [ Time Frame: day 1 ]
    Sitting-posture will be measured with a 3D-video analysis (Bonita, ©Vicon Motion Systems Ltd. UK). Markers are placed on specific anatomical reference points on the participant. Afterwards angles (°) will be automatically calculated (Nexus, ©Vicon Motion Systems Ltd. UK)

  2. Dural-profile [ Time Frame: day 1 ]
    Using the 'slump-test' according to Shacklock the maximal knee- extension (°) without neurological complaints will be measured.

  3. Pain-Profile [ Time Frame: day 1 ]
    'Pain Pressure Threshold' will be measured. Through pressure- algometry (a) 'Pressure Pain Detection Threshold' (kPa/cm²) and (b) 'Pressure Pain Tolerance' (sec) will be determined (Somedic Sales AB, Stockholm Sweden).

  4. Sitting-posture-profile [ Time Frame: week 1 up to week 8 ]
    Sitting-posture will be measured with a 3D-video analysis (Bonita, ©Vicon Motion Systems Ltd. UK). Markers are placed on specific anatomical reference points on the participant. Afterwards angles (°) will be automatically calculated (Nexus, ©Vicon Motion Systems Ltd. UK)

  5. Dural-profile [ Time Frame: week 1 up to week 8 ]
    Using the 'slump-test' according to Shacklock the maximal knee-


Secondary Outcome Measures :
  1. Headache-related medication-use, headache intensity, duration and frequency. [ Time Frame: week -4 up to week 8 ]
    Through the use of a specific diary the secondary outcomes will be evaluated.

  2. Impact of headache on the quality of life. [ Time Frame: week -4 up to week 8 ]
    The 'Headache Impact Test (HIT-6)' will be used.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02887638


Contacts
Contact: Marita Granitzer, prof. dr. +32 11 26 93 44 marita.granitzer@uhasselt.be
Contact: Sarah Mingels, ass. +32 11 26 85 09 sarah.mingels@uhasselt.be

Locations
Belgium
Ziekenhuis Oost-Limburg Not yet recruiting
Genk, Belgium, 3600
Contact: Jan Van Zundert, prof.dr.       jan.vanzundert@zol.be   
Jessa Ziekenhuis Not yet recruiting
Hasselt, Belgium, 3500
Contact: Katelijne Peeters, dr.       katelijne.peeters@jessazh.be   
Leuven University Not yet recruiting
Leuven, Belgium, 3000
Contact: Wim Dankaerts, prof.dr.         
Netherlands
Zuyd University Not yet recruiting
Heerlen, Netherlands, 6419
Contact: Ludo Van Etten, prof. dr.       ludo.vanetten@zuyd.nl   
Orbis Medisch Centrum Not yet recruiting
Sittard, Netherlands, 6130 MB
Contact: Veronique Triebels, dr.       vtriebels@orbisconcern.nl   
Sponsors and Collaborators
Hasselt University
Katholieke Universiteit Leuven
Ziekenhuis Oost-Limburg
Jessa Hospital
Orbisch Medisch Centrum
Zuyd University of Applied Sciences
More Information

Responsible Party: prof. dr. Marita Granitzer, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02887638     History of Changes
Other Study ID Numbers: PHA-2016
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms