跳至主要内容
临床试验/NCT02887638
NCT02887638已完成不适用

Posture-related Headache: Profile Analysis and Intervention

Hasselt University10 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
10
主要终点
Sitting-posture-profile

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Headache-group:
  • History of pericranial surgery
  • Serious pathology (neurological/cardiovascular/endocrine/musculoskeletal)
  • 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:
  • 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

结局指标

主要结局

Sitting-posture-profile

时间窗: week 1 up to week 8

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

时间窗: day 1

'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).

次要结局

  • 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)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Marita Granitzer

prof. dr.

Hasselt University

研究点 (10)

Loading locations...

相似试验