Manual Therapy Dosage Factorial Study
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.
Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.
All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.
Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).
Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.
調査の概要
研究の種類
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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Ontario
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Hamilton、Ontario、カナダ、L8S 1C7
- McMaster 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:
- acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
- pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
- pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
- must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.
Exclusion Criteria:
- arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
- conditions that make the provision of neck exercise unsafe
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：階乗代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：A
Zero treatment/3 weeks
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アクティブコンパレータ：B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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アクティブコンパレータ：L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
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Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement.
Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
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介入なし：E
Zero treatment/6 weeks
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介入なし：I
Zero treatment/12 weeks
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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 |
時間枠 |
|---|---|
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Quantitative Sensory Testing (QST)
時間枠：Within 24 weeks
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Within 24 weeks
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Current Perception Threshold (CPT)
時間枠：Within 24 weeks
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Within 24 weeks
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Neck Walk Index (NWI)
時間枠：Within 24 weeks
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Within 24 weeks
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Cyclical Reach and Grasp Test (CRGT)
時間枠：Within 24 weeks
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Within 24 weeks
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Muscle Biology (cytokine analyses)
時間枠：Within 24 weeks
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Within 24 weeks
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Central Breathing Control Test
時間枠：Within 24 weeks
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Within 24 weeks
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Neck Disability Index
時間枠：Within 24 weeks
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Within 24 weeks
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Pain Intensity - Visual Analogue Scale (VAS)
時間枠：Within 24 weeks
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Within 24 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Global Perceived Effect (GPE)
時間枠：Within 24 weeks
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Within 24 weeks
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Disabilities of the Arm, Shoulder, and Hand (DASH)
時間枠：Within 24 weeks
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Within 24 weeks
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Pain Threshold and Pain Tolerance Algometry
時間枠：Within 24 weeks
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Within 24 weeks
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Head Flexion Endurance
時間枠：Within 24 weeks
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Within 24 weeks
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Range of Motion
時間枠：Within 24 weeks
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Within 24 weeks
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Quality of Life (SF-36v2)
時間枠：within 24 weeks
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within 24 weeks
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Joy C MacDermid, PhD、McMaster University
研究記録日
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。
Mobilizationの臨床試験
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Natália Maria Oliveira Campelo完了病理学的プロセス | 筋骨格疾患 | 関節疾患 | 変形性関節症 股関節