NCT02887638

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.4 years

First QC Date

August 19, 2016

Last Update Submit

May 18, 2020

Conditions

Headache

Keywords

posture, sit

Outcome Measures

Primary Outcomes (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)

    day 1

  • 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).

    day 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)

    week 1 up to week 8

Secondary Outcomes (2)

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

    week -4 up to week 8

  • Impact of headache on the quality of life.

    week -4 up to week 8

Study Arms (2)

headache

EXPERIMENTAL

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)

asymptomatic controls

NO INTERVENTION

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.

Interventions

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

headache

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Leuven University

Leuven, 3000, Belgium

Location

Zuyd University

Heerlen, 6419, Netherlands

Location

Orbis Medisch Centrum

Sittard, 6130 MB, Netherlands

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

August 19, 2016

First Posted

September 2, 2016

Study Start

January 8, 2018

Primary Completion

May 18, 2020

Study Completion

May 18, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

NL(2)BE(3)