The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.
Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction
Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.
Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Reading、Pennsylvania、アメリカ、19606
- Alvernia 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:
- Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
- Participants will be 18 years of age or older
- Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
- Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
- Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
- Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.
Exclusion Criteria:
- Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
- Participants with known or suspected pregnancy
Participants with confirmed diagnosis of any of the following conditions:
- Central nervous system disorder
- Rheumatoid Arthritis
- Spinal Fracture
- Spondyloarthropathy (i.e., Ankylosing Spondylitis)
- Tumor or infection of the spine
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：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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実験的：Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust manipulation
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Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
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偽コンパレータ：Sham Manipulation Group
Group that receives sham lumbar non-thrust manipulation
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Lumbar non-thrust manipulation without force applied
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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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Changes in Sacral Multifidus Muscle Thickness
時間枠：Change from Pre to immediately Post Manipulation/Sham
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Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
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Change from Pre to immediately Post Manipulation/Sham
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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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Changes in Lumbar Active Range of Motion
時間枠：Change from Pre to immediately Post Manipulation/Sham
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Inclinometry of Lumbar Active Range of Motion in Standing
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Change from Pre to immediately Post Manipulation/Sham
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Changes in Low Back Pain
時間枠：Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
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Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
時間枠：Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
時間枠：Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
時間枠：Change from Baseline to 24-48 hours post session
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Joshua Cleland, PhD、Nova Southeastern University
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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