D-cycloserine in the Management of Chronic Low Back Pain
D-Cycloserine in the Management of Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
調査の概要
詳細な説明
Human brain imaging studies indicate that the medial prefrontal cortex activity can predict more than 80% of the variance of chronic back pain intensity. Therefore, the investigators have hypothesized that modulation of brain activity at this site should result in analgesia. D-cycloserine has been shown to potentiate conditioned fear extinction. Based on this the investigators hypothesize that chronic neuropathic pain (back pain with radiculopathy) is partially mediated or potentiated by decreased ability to extinguish the pain memory, which the investigators hypothesize to be mediated through reward/aversion brain circuitry, and specifically through medial prefrontal cortex. They have tested this idea in pre-clinical studies and demonstrated that rats with neuropathic pain show analgesia over the long-term when treated with D-cycloserine. In humans with chronic back pain, the investigators hypothesize that D-cycloserine will enhance extinction of back pain which in turn should result in reduced emotional relevance of the pain, that is reduced suffering. It is quite possible that the overall intensity of the back pain will be unaffected, however, the associated suffering will be significantly attenuated.
This will be a double-blind, randomized, parallel group escalating dose study comparing D-cycloserine twice a day (bid) with placebo bid in patients with chronic low back pain. Subjects meeting inclusion criteria will continue baseline medications and be treated for 12 weeks with study drug: 50 mg bid DCS or matching placebo for the first 4 weeks, then 100mg bid DCS or matching placebo for 4 weeks and finally 200mg bid DCS or matching placebo for 4 weeks. Assessments of efficacy and safety will be undertaken every 2 weeks using standard, validated instruments to evaluate change in pain, function, quality of life and adverse events.
研究の種類
入学 (実際)
段階
- フェーズ2
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 Feinberg School of Medicine
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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:
- Must have a history of low back pain for a minimum of 6 months with or without radiation of pain to leg or buttocks.
- Must be 18 years of age.
- Must have a visual analogue scale (VAS) pain score >50 mm
- Must be in generally stable health
- Must be willing to abstain from drinking alcohol during the course of the study.
- If female, must be post-menopausal for at least one year or practicing an accepted, highly effective method of contraception or abstinence and plan to continue either during the course of the study.
- Must be able and willing to read and understand instructions as well as questionnaires
- Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.
Exclusion Criteria:
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back.
- Involvement in litigation regarding their back pain or have a disability claim or are receiving workman's compensation or seeking either as a result of their low back pain
- Neurologic disorder, including history of seizures
- Major psychiatric disorder during the past 6 months
- Moderate or severe depression as determined by the Beck Depression Inventory or any active suicidal ideation
- Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy
- Significant renal disease or severe renal insufficiency
- History of, or current, substance abuse/dependence including alcohol
- Significantly abnormal laboratory values
- Pregnant or lactating at any time during the course of the study
- Known sensitivity to D-cycloserine
- Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
- In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
- Any change in medication for back pain in the last 30 days.
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：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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プラセボコンパレーター：2
プラセボ
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プラセボ入札
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実験的：1
D-cycloserine 50mg bid/100mg bid/200 mg bid
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D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
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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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Change in Numeric Rating Scale (NRS-11)
時間枠：6 weeks
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Change in NRS score after 6 weeks of treatment as compared to baseline.
The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible.
Thus, a larger negative number indicates positive change and a higher efficacy.
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6 weeks
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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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McGill Pain Questionnaire (MPQ)
時間枠：6 weeks
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Change in MPQ score after 6 weeks of treatment as compared to baseline.
The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible.
A lower score is also indicative of a lower quality of pain.
Thus, a larger negative number indicates positive change and therefore higher efficacy.
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6 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Thomas J Schnitzer, M.D., Ph.D.、Northwestern University
- 主任研究者：Vania Apkarian, Ph.D.、Northwestern University
出版物と役立つリンク
便利なリンク
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
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。
痛みの臨床試験
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Dexa Medica Group完了
プラセボの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない