Headache Analysis and Intervention (PRA)

May 18, 2020 updated by: prof. dr. Marita Granitzer, Hasselt University

Posture-related Headache: Profile Analysis and Intervention

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Leuven, Belgium, 3000
        • Leuven University
  • Netherlands
      • Heerlen, Netherlands, 6419
        • Zuyd University
      • Sittard, Netherlands, 6130 MB
        • Orbis Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 1
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).
day 1
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)
week 1 up to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week -4 up to week 8
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.
week -4 up to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

KU Leuven
Jessa Hospital
Ziekenhuis Oost-Limburg
Algemeen Ziekenhuis Vesalius
Zuyd University of Applied Sciences
Orbisch Medisch Centrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

May 18, 2020

Study Completion (Actual)

May 18, 2020

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHA-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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