Headache Analysis and Intervention

Headache Clinical Trial

— PRA  

Official title:

Posture-related Headache: Profile Analysis and Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887638
• Other study ID #: PHA-2016
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Leuven University	Leuven
Netherlands	Zuyd University	Heerlen
Netherlands	Orbis Medisch Centrum	Sittard

Sponsors (7)

Lead Sponsor	Collaborator
Hasselt University	Algemeen Ziekenhuis Vesalius, Jessa Hospital, KU Leuven, Orbisch Medisch Centrum, Ziekenhuis Oost-Limburg, Zuyd University of Applied Sciences

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Headache-related medication-use, headache intensity, duration and frequency.	Through the use of a specific diary the secondary outcomes will be evaluated.	week -4 up to week 8
Secondary	Impact of headache on the quality of life.	The 'Headache Impact Test (HIT-6)' will be used.	week -4 up to week 8