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Headache Analysis and Intervention (PRA)

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Individual Profile Analysis (Physical therapy Intervention)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Headache focused on measuring posture, sit

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis
  • Leuven University
  • Zuyd University
  • Orbis Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

headache

asymptomatic controls

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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)
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).
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)

Secondary Outcome Measures

Headache-related medication-use, headache intensity, duration and frequency.
Through the use of a specific diary the secondary outcomes will be evaluated.
Impact of headache on the quality of life.
The 'Headache Impact Test (HIT-6)' will be used.

Full Information

First Posted
August 19, 2016
Last Updated
May 18, 2020
Sponsor
Hasselt University
Collaborators
KU Leuven, Ziekenhuis Oost-Limburg, Jessa Hospital, Orbisch Medisch Centrum, Zuyd University of Applied Sciences, Algemeen Ziekenhuis Vesalius
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1. Study Identification

Unique Protocol Identification Number
NCT02887638
Brief Title
Headache Analysis and Intervention
Acronym
PRA
Official Title
Posture-related Headache: Profile Analysis and Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
KU Leuven, Ziekenhuis Oost-Limburg, Jessa Hospital, Orbisch Medisch Centrum, Zuyd University of Applied Sciences, Algemeen Ziekenhuis Vesalius

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
posture, sit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
headache
Arm Type
Experimental
Arm Description
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)
Arm Title
asymptomatic controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Profile Analysis (Physical therapy Intervention)
Intervention Description
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 Outcome Measure Information:
Title
Sitting-posture-profile
Description
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)
Time Frame
day 1
Title
Pain-Profile
Description
'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).
Time Frame
day 1
Title
Sitting-posture-profile
Description
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)
Time Frame
week 1 up to week 8
Secondary Outcome Measure Information:
Title
Headache-related medication-use, headache intensity, duration and frequency.
Description
Through the use of a specific diary the secondary outcomes will be evaluated.
Time Frame
week -4 up to week 8
Title
Impact of headache on the quality of life.
Description
The 'Headache Impact Test (HIT-6)' will be used.
Time Frame
week -4 up to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Leuven University
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Zuyd University
City
Heerlen
ZIP/Postal Code
6419
Country
Netherlands
Facility Name
Orbis Medisch Centrum
City
Sittard
ZIP/Postal Code
6130 MB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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