Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
The Putative Correlation Between Impaired Hip Flexor Passivity and Common Lower Back Pain: a Pilot Study.
Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the psoas muscles, even when the subject has been told not to contract any muscles. The psoas contraction is involuntary and cannot be controlled by the subject. This lack of passivity might be concomitant with lower back pain: the impairment may be present when lower back pain is present and/or absent when lower back pain is absent.
The study's primary objective is thus to determine the sensitivity and/or specificity of a clinical test for impaired hip flexor passivity in cases of lower back pain during passive flexion of the trunk (from the supine position,).
The secondary objective is to show that a negative test (after administration of correcting measures) is correlated with a decrease in pain (i.e. pain intensity and the functional repercussions of pain).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
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:
- Age between 18 and 30
- Social security coverage
- Ability to understand the study's objectives, procedures and risks and to provide informed, written consent
- Having been informed about the results of the prior clinical examination.
Exclusion Criteria:
- Past or concomitant infectious or cancerous diseases of the spine
- Vertebral osteosynthesis
- Acute neck or arm pain (recurrent dislocations of the glenohumeral joint, trauma in the previous 12 months, etc.)
- Lower back pain with irradiation of pain below the buttocks
- Known specific lower back pain or pain for which a differential diagnosis suggests an inflammatory, traumatic, cancerous or infectious cause
- Subjects under legal guardianship
- Known pregnancy
- Simultaneous participation in another biomedical research study of a drug or medical device.
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：防止
- 割り当て：なし
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：lower back pain
|
Description of the test: the subject lies in the supine position on an exercise mat with his/her feet together.
The subject is told to let his/her arms rest loosely by his/her side (as if they were ropes) and to keep the head aligned with the back.
The examiner pulls the subject into the sitting position by pulling on the subject's wrists, with passive flexion of the trunk until the hip joint is fully flexed..
|
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 |
|---|---|
|
Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).
時間枠：Visit 1 (Day 0)
|
Visit 1 (Day 0)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
- A visual analog scale for pain
時間枠：- Visit 0 (Day 0: inclusion visit)
|
- Visit 0 (Day 0: inclusion visit)
|
協力者と研究者
捜査官
- 主任研究者：Mutter Catherine, MD、Les Hopitaux Universitaires de Strasbourg
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。