Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
2019年10月7日 更新者：Taipei Medical University Shuang Ho Hospital
Lumbar degenerative disease surgery has been a routine clinical operation, and has good treatment effects.
Although the patient's neurological symptoms improve after surgery, many patients still have postoperative muscle soreness.
The postoperative rehabilitation intervention for the patients receiving traditional lumbar surgery has been confirmed to effectively improve pain and disability.
However, in recent years, minimally invasive lumbar spinal surgery has gradually replaced traditional surgery, postoperative pain has been greatly reduced.
Therefore, patients have the opportunity to receive early intervention in rehabilitation, but there is no standardization process for rehabilitation of minimally invasive lumbar spine surgery.
Therefore, this study aims to establish a health education program for patients receiving minimally invasive lumbar spinal surgery, and conduct clinical trials to test its effectiveness.
調査の概要
研究の種類
介入
入学 (予想される)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Taipei、台湾、235
- 募集
- Taipei Medical University-Shuang Ho Hospital
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コンタクト：
- Chiao-Ling Chen, Master
- 電話番号：8127 886-02-22490088
- メール：18395@s.tmu.edu.tw
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
45年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age between 45 and 90 years old.
- Low back pain has been persisting at least 3 months.
- Clinical degeneration diagnosis supports the need of MI-TLIF.
- Able to understand Chinese.
Exclusion Criteria:
- Emergency surgery.
- Unstable vital sign.
- Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
- Had spinal surgery before.
- Pregnancy.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
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：いつものケアグループ
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実験的：教育グループ
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Physical therapist will be consulted one day before and after the operation (OP) day.
On the day before the OP day, they focus on education, including how to get up from bed and stand up from a chair.
Five rehabilitation exercises are also demonstrated: 1) ankle flexion and extension, 2) knee flexion and extension, 3) hip joint abduction and adduction, 4) hip joint flexion and extension, and 5) drawing-in maneuver.
The participants will be required to repeat each component to confirm that they can do it correctly.
Each exercise is suggested to be done 10 times per day following MI-TLIF, and the number will be recorded 3 days (pre-OP day, post-OP day, and post-OP day 2).
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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 of Oswestry Disability Index
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's physical function.
The range is 0 to 1. Higher values represent a better outcome.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Visual Analogue Scale
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's pain intensity.
"0" indicates no pain and "10" indicates the worst possible pain.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Short Form 12 version 2
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's health-related quality of life.
We will record the subscales: physical component summary (PCS) and mental component summary (MCS).
Higher values represent a better outcome.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Functional reach test
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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It is a dynamic measure of balance.
A 100 cm yardstick will be horizontally set on the wall with the acromion height.
The patient will be asked to make a fit and reach forward as far as possible without moving his/her feet.
It will be measured twice and the better outcome will be recorded.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 30-second Chair Rise
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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It is used to evaluate the lower limb function and strength relating to the daily activities.
The patient starts with a sitting position, and need to repeat stand-to-sit movements.
He/She will be encouraged to move safely as soon as possible in 30 minutes.
Higher number indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Timed Up and Go test
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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It was developed to measure subjects' balance and mobility.
The patient starts with a sitting position, stands up, walks a 3-meter distance, turns, walks back, and sits down.
He/She will be encouraged to finish it safely as soon as possible.
A shorter time indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 15-m walk test
時間枠：The day before operation day, and 1, 3, 6 months after surgery
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Gait speed shows good reliability and is valid to assess physical mobility.
A 15-mile straight line will be mounted on a flat surface.
The patient will be required to walk down the line at the maximal speed.
He/She will be encouraged to finish it safely as soon as possible.
A shorter time indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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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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Length of hospitalization
時間枠：The duration between admission and discharge
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The duration between admission and discharge
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Narcotic use during hospitalization
時間枠：The duration between admission and discharge
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The duration between admission and discharge
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Return-to-work status
時間枠：up to 6 months after surgery
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up to 6 months after surgery
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Adverse events
時間枠：up to 6 months after surgery
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The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
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up to 6 months after surgery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Heng-Wei Liu, Doctor、Shuangho Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年4月25日
一次修了 (予想される)
2021年10月1日
研究の完了 (予想される)
2022年1月1日
試験登録日
最初に提出
2019年10月6日
QC基準を満たした最初の提出物
2019年10月7日
最初の投稿 (実際)
2019年10月9日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月9日
QC基準を満たした最後の更新が送信されました
2019年10月7日
最終確認日
2019年10月1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。