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Headache Analysis and Intervention (PRA)

H

Hasselt University

Status

Completed

Conditions

Headache

Treatments

Other: Individual Profile Analysis (Physical therapy Intervention)

Study type

Interventional

Funder types

Other

Identifiers

NCT02887638
PHA-2016

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

headache
Experimental group
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)
Treatment:
Other: Individual Profile Analysis (Physical therapy Intervention)
asymptomatic controls
No Intervention group
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.

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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