Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.
Management of Functional Thoracic Outlet Syndrome (TOS - Whiplash) With IncobotulinumtoxinA Injections
調査の概要
詳細な説明
TOS symptoms will typical emerge within 24-48 hours following the accident. The duration will depend on the level of severity of the muscle damage. If the severity is a grade 1 (mild damage to individual muscle fibers), symptoms may last up to 3 weeks. If the severity is a grade 2 (more extensive damage with more muscle fibers involved/no complete rupture), symptoms may last up to 3 months. However, in many cases, due to muscle swelling and consequently compression of the nerve plexus, a persistent reflex spasm of muscle develops.
A potentially effective treatment strategy, in patients presenting TOS associated clinical symptoms in the proper distribution, is to relax the scalene muscles that surround the nerve plexus. Botulinum toxin, such as incobotulinumtoxinA (XEOMIN, Merz herapeutics), have been shown to be effective and safe in relaxing these muscles in conditions like spasticity, blepharospasm and cervical dystonia (Kanovský P, 2009; Benecke R, 2005; Roggenkämper P, 2005). It is hypothesised that a subtype of whiplash defined as functional TOS could be improved with incobotulinumtoxinA injections into the medial scalene muscle. IncobotulinumtoxinA when injected into the medial scalene is expected to induce muscle relaxation which leads to nerve plexus decompression. The effect is anticipated to last approximately 3 months, which is the duration of effect of botulinum toxins type A. A similar effect can be induced using a local anaesthetic, such xylocaine, since it has a similar mechanism of action, but his effect should be short lived.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:David B King, BSc, MD
- 電話番号:902 425 7344
- メール:david.larkspur@gmail.com
研究連絡先のバックアップ
- 名前:Debbie Cavicchi, BA
- 電話番号:902 425 7344
- メール:dking@davidbking.ca
研究場所
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3P 1M3
- Private Office
-
コンタクト:
- David B King, BSc, MD
- 電話番号:902 425 7344
- メール:david.larkspur@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
• Patient must have been diagnosed with a muscle strain to the lateral neck muscles following a car accident and there must be the following clinical signs of TOS: pain in the proper distribution, weakened grip, shoulder elevation on the appropriate side and numbness or tingling in the arm or fingers;
- Patient must have no signs suggesting a radiculopathy that could account for similar symptoms;
- Patient must have a PDQ >70, i.e. in the moderate to very severe disability range;
- Patient must experience symptoms for longer than 3 months;
- Patient must have had the accident leading to whiplash within the last 3 years;
- Patient must be 18 years of age or older;
- Patient must be eligible and agreeable to treatment with BoNT-A;
- Patient must be toxin-naïve for the treatment of the cervical region, or have undergone a six months washout period;
- Patient must be English speaking;
- Patient must be able to provide informed consent.
Exclusion Criteria:
• Patient unable or unwilling to complete the necessary assessment tasks;
- Patient with hypersensitivity to botulinum neurotoxin type A or to any of the excipients, generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), or infection or inflammation at the proposed injection site(s);
- Patient who requires physiotherapy and/or massage therapy;
- Patient for whom concomitant medications are not controlled at study start and/or may require change/adjustment during the study;
- Patient who had surgery which may interfere with the study;
- Women who are pregnant or nursing, or women in age of reproduction not using a contraceptive method;
- Patient in active litigation.
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:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
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 |
|---|---|---|
|
Change from baseline in pain disability as assessed using the PDQ at Week 4.
時間枠:week 4
|
PDQ before and after treatment. Pain Disability Questionnaire (Guides to the Evaluation of Permanent Impairment, Sixth Edition. 0= No pain related impairment 1-70= Mild pain related impairment 71-100=Moderate pain related impairment 101-130= Severe pain related impairment 131-150= Extreme pain related impairment |
week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Shoulder Elevation
時間枠:week 4
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Change from baseline in shoulder elevation as assessed by measurement on photograph (clavicular angle) at Weeks 4, 12 and 16;
|
week 4
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Grip Strength
時間枠:Week 4
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3. Change from baseline in grip strength as assessed using a dynamometer at Weeks 4, 12 and 16;
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Week 4
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Pinch Test
時間枠:WFeek 4
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4. Change from baseline in fine motor test (pinch test) at Weeks 4, 12 and 16;
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WFeek 4
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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
- EMSI-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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