Migraine is Associated With Altered Mechanical Pain Sensitivity. This Study Investigates Mechanical Pain Sensitivity, Headache Burden, and Quality of Life in Episodic and Chronic Migraine, Comparing Pressure Algometry and Algopeg® and Assessing Mechanosensitivity of Peripheral Nerves. (MechSens_Migra)
Mechanical Pain Sensitivity, Headache Burden, and Quality of Life in Episodic and Chronic Migraine - A Cross-Sectional Study
Migraine is one of the most prevalent neurological disorders and is associated with a substantial individual and societal burden. In chronic migraine, central and peripheral sensitization mechanisms are considered key pathophysiological factors and may manifest, among other features, as altered mechanical pain sensitivity.
Quantitative assessment of mechanical pain sensitivity using pressure algometry is an established method; however, it is partly dependent on examiner technique and measurement protocols. The Algopeg® represents a standardized instrument for assessing mechanical pain sensitivity and may serve as a practical complement or alternative to classical pressure algometry. To date, evidence regarding the use of the Algopeg® in migraine populations remains limited.
In addition to increased mechanosensitivity in trigeminal and extra-trigeminal regions, peripheral nerve structures, such as branches of the greater occipital nerve and the supraorbital nerve, may show sensitivity to mechanical stimuli during neurodynamic testing or palpation. This may have clinical relevance, as these regions are often targeted in symptomatic and prophylactic treatments.
The aim of this study is to systematically investigate mechanical pain sensitivity, headache-related outcomes, and quality of life in patients with episodic and chronic migraine. Furthermore, the study aims to compare pressure algometry and Algopeg® measurements and to explore the clinical relevance of mechanosensitivity in specific peripheral nerve regions using a standardized assessment protocol.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Bernhard Taxer, PhD
- 電話番号：+436508108217
- メール：b.taxer@crcs.at
研究場所
-
-
-
Salzburg、オーストリア、5020
- Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation
-
コンタクト：
- Bernhard Taxer, PhD
- 電話番号：+436508108217
- メール：b.taxer@crcs.at
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Female and male sex
- Age 18-65 years
- Diagnosis of episodic or chronic migraine according to ICHD-3 criteria (beta version)
- Stable medication regimen (if applicable) for at least 4 weeks prior to inclusion
- Ability to understand study procedures and provide written informed consent
Exclusion Criteria:
- Other primary or secondary headache disorders
- Severe neurological, psychiatric, or systemic diseases
- Pregnancy or breastfeeding
- Participation in another (interventional) study within the last 3 months
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pressure Pain Algometry and neurodynamic testing for mechanical hypersensitivity
時間枠：Regarding the observational character of the study the participants are screened in one session expecting a total time frame of 15 minutes on day 1.
|
Pressure pain algometry, a psychophysic approach used in quantitatitve sensory testing, is a tool, that can be used to evaluate mechanosensitivity of affected muscles (pressure pain threshold - measured in kg).
We use the classical tool out of QST and compare it with the Algopeg® tool, a calibrated clothespin, not used in regular clinical work so far.
The tool is applied on the index finger for 10 seconds measuring the resulting painful feeling on a numeric rating scale (NRS 0-10).
Neurodynamic testing includes movement maneuvers to assess the mechanosensitivity of the soft tissue of peripheral nerves, explicitly greater occipital nerve and the supraorbital nerve (V1).
Here the outcome mainly relies on the feedback of the participants.
|
Regarding the observational character of the study the participants are screened in one session expecting a total time frame of 15 minutes on day 1.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Stefan Leis, PD Dr.med.、Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。