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Headache Analysis and Intervention (PRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02887638
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
KU Leuven
Ziekenhuis Oost-Limburg
Jessa Hospital
Orbisch Medisch Centrum
Zuyd University of Applied Sciences
Algemeen Ziekenhuis Vesalius
Information provided by (Responsible Party):
prof. dr. Marita Granitzer, Hasselt University

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 Phase
Headache Other: Individual Profile Analysis (Physical therapy Intervention) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Posture-related Headache: Profile Analysis and Intervention
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : May 18, 2020
Actual Study Completion Date : May 18, 2020

Resource links provided by the National Library of Medicine


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.



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. 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).

  3. 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)


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.



Information from the National Library of Medicine

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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

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


Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Leuven University
Leuven, Belgium, 3000
Netherlands
Zuyd University
Heerlen, Netherlands, 6419
Orbis Medisch Centrum
Sittard, Netherlands, 6130 MB
Sponsors and Collaborators
Hasselt University
KU Leuven
Ziekenhuis Oost-Limburg
Jessa Hospital
Orbisch Medisch Centrum
Zuyd University of Applied Sciences
Algemeen Ziekenhuis Vesalius
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Responsible Party: prof. dr. Marita Granitzer, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02887638    
Other Study ID Numbers: PHA-2016
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof. dr. Marita Granitzer, Hasselt University:
posture, sit
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations