Immune-Pineal Axis Function in Chronic Tension-Type Headache
Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
調査の概要
詳細な説明
Tension-type headache can be defined as a constant sensation of pressure or heaviness, and is a highly-prevalent condition in the health services. The objective of the present study is to investigate the function of the immuno-pineal axis in chronic tension headache, focussed on the neuro-immune regulatory dysfunction. In addition, the effect of neuro-stimulation (electroacupuncture) on the function of this axis will also be studied.
This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control.
The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol.
Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. Evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Women,
- Aged between 18 and 60 years old,
- Providing informed consent to participate in the study,
- Literate,
- Clinical diagnosis of Chronic Tension-Type Headache according to the International Headache Society.
Exclusion Criteria:
- Psychiatric or neurologic disorder that unable patient to consent and follow study protocol,
- De-compensated systemic disease,
- Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
- HIV.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
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Eletroacupuncture performed using acupuncture needles.
他の名前：
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偽コンパレータ：Placebo Sham
All patients will receive 10 placebo sham sessions.
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Placebo Sham is performed using electrodes, without electrical stimulation.
Lights and sounds were identical to active treatment.
他の名前：
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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 |
|---|---|---|
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Pain Visual Analogue Scale (VAS)
時間枠：An expected average of 3 months. (At baseline and at the end of each intervention period).
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The intensity of pain was measured by a 10 cm VAS.
The scores range from no pain (zero) to the worst possible pain (10 cm).
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache Impact Test (HIT-6)
時間枠：An expected average of 3 months. (At baseline and at the end of each intervention period).
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This test was developed in 2004, and has equivalent psychometric properties in nine languages, including Portuguese.
It consists of six questions that assess the impact of headache on the ability to work, study, home and in social situations.
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Biomarkers (BDNF nd TNF)
時間枠：An expected average of 3 months. (At baseline and at the end of each intervention period).
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The BDNF and the TNF will be measured by ELISA.
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An expected average of 3 months. (At baseline and at the end of each intervention period).
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協力者と研究者
協力者
捜査官
- スタディチェア：Wolnei Caumo, MD, PhD、Hospital de Clinicas de Porto Alegre
- 主任研究者：Mônica Chassot、Federal University of Health Science of Porto Alegre
- 主任研究者：Francislea C. Sehn、Federal University of Health Science of Porto Alegre
- 主任研究者：Rafael Vercelino、Federal University of Health Science of Porto Alegre
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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