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Completed

NCT Number: NCT02887638

Headache 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

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Headache-group:

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

Exclusion criteria

Headache-group:

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

Inclusion criteria

Control-group:

  • Males and females between 20 and 50 years
  • Asymptomatic, no headache-history

Exclusion criteria

Control-group:

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

Treatment and study plan

Individual Profile Analysis (Physical therapy Intervention)

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

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

Registry information

Official study title

Posture-related Headache: Profile Analysis and Intervention

Acronym: PRA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2016
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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