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HeadachePRANCT02887638

Headache Analysis and Intervention

A study testing Individual Profile Analysis (Physical therapy Intervention) in people with Headache, run by Hasselt University at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Headache
What is being tested?
Individual Profile Analysis (Physical therapy Intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
5 sitesin 2 countries
Study dates
8 Jan 2018to 18 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • Psychiatric comorbidity
  • Visual or temporo-mandibular dysfunction
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Belgium3 sites

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Leuven University

    Leuven, 3000

Other trials in Belgium

Netherlands2 sites

  • Zuyd University

    Heerlen, 6419

  • Orbis Medisch Centrum

    Sittard, 6130 MB

Other trials in Netherlands

About this study

Official title: 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
Conditions
Headache
Being tested
Individual Profile Analysis (Physical therapy Intervention)
Keywords
posture, sit
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual Profile Analysis (Physical therapy Intervention)Other

    The Individual Profile Analysis consists of the following components:

    • Analysis of the sitting-posture profile:
    • 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:
    • 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
Study groups in NCT02887638
Study groupRoleWhat they receive
headacheExperimentalPatients 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)
Receives: Other: Individual Profile Analysis (Physical therapy Intervention)
asymptomatic controlsNo interventionAsymptomatic 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Sitting-posture-profile

    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)

    Measured: day 1

  2. Pain-Profile

    '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).

    Measured: day 1

  3. Sitting-posture-profile

    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)

    Measured: week 1 up to week 8

Secondary outcomes (2)

  1. Headache-related medication-use, headache intensity, duration and frequency.

    Through the use of a specific diary the secondary outcomes will be evaluated.

    Measured: week -4 up to week 8

  2. Impact of headache on the quality of life.

    The 'Headache Impact Test (HIT-6)' will be used.

    Measured: week -4 up to week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study start8 Jan 2018
  3. Primary completion18 May 2020
  4. Study completion18 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887638
Sponsor's protocol ID
PHA-2016
Acronym
PRA
Status last verified
May 2020
First submitted
19 Aug 2016
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mingels S, Granitzer M, Schmid AB, Dankaerts W. Individual endogenous pain modulation profiles within a multidimensional context of people with cervicogenic headache - A retrospective exploratory study. Musculoskelet Sci Pract. 2023 Oct;67:102855. doi: 10.1016/j.msksp.2023.102855. Epub 2023 Sep 2.

    PubMed 37683308

Questions about this trial

What is this clinical trial studying?

A study testing Individual Profile Analysis (Physical therapy Intervention) in people with Headache, run by Hasselt University at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sitting-posture-profile (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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