Brain Imaging of Lidoderm for Chronic Back Pain
調査の概要
詳細な説明
Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (measured with fMRI). As a next step, we conducted a double blind clinical trial where the drug was tested against placebo to determine whether the effects on CBP were mediated by a pharmacological mechanism. For this we obtained psychophysical measurements of pain and measures of brain activity using fMRI. Two scans after treatment (6 hour and 2 weeks after treatment) were conducted to observe the effects of short term and long term use.
Brain activity was measured by the non-invasive method of functional imaging (fMRI), which enables examination of cortical blood flow during pain rating. These brain scans were acquired in chronic back pain patients while they rated their ongoing chronic pain using a finger span device. In a control task, each patient also rated the changes in the length of a bar n a screen (a visual control task). Anatomical scans were also acquired.
The general design of the study was that CBP subjects were assesses with fmri for brain responses for ongoing pain at three time points. The initial (baseline) scan occurred after a minimum of 48 hour period during which the patients refrained from taking analgesic medication. The patients were next scanned at 6 hours after treatment and again after 2 weeks of continuous treatment. Subjects were randomised to placebo or Lidoderm (both Lidoderm and placebo patches were supplied by Endo Pharmaceuticals).
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern University
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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:
- Male or Female 18 years or older of age
- Pain in the location of the lower back
- Pain duration for a minimum of 6 months on a continuous basis
- Pain intensity of at least 3 out of 10 on most days of the week over the past six months
- Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).
- Right handedness
Exclusion Criteria:
- Applying for or currently receiving workers' compensation or disability status.
- Back pain secondary to spinal cord injury
- Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
- Diabetes mellitus
- Back pain secondary to tumors.
- Standard MRI criteria re: claustrophobia, metal objects etc.
- Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease
- Pregnant and/or lactating women
- Left handedness
- Active cancer
- Other serious painful condition (e.g., arthritis)
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：lidocaine
5% lidoderm patch
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5% lidoderm patch
他の名前：
|
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プラセボコンパレーター：control
placebo patch
|
プラセボ
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 |
|---|---|---|
|
Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable".
時間枠：2 weeks
|
the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch. A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful. |
2 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Apkar V. Apkarian, PhD、Northwestern University
出版物と役立つリンク
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STU00022968
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