Influence of Supervised Stabilization Exercises on Postural Control in Patients After Spine Surgery.
Effect of Supervised, Short-term Stabilization Exercises on the Pain, Posture Control, Balance, Functional Tests and Pressure Distribution in Patients After First-time, Single-level Lumbar Spine Microdiscectomy.
調査の概要
詳細な説明
Back pain (LBP) has become a major public health problem. In the case of pain in the lumbar spine, conservative or surgical treatment is used. In conservative treatment, patients undergo an appropriate rehabilitation program or use painkillers / anti-inflammatory drugs. When conservative treatment is unsuccessful, patients based on the MRI image and neurosurgical consultation are referred to the lumbar spine microdiscectomy. Therefore, patients consciously and voluntarily can start research on the effect of supervised exercises to stabilize the lumbar spine after single-level lumbar spine microdiscectomy on pain reduction, pressure distribution, balance, posture control, and basic functional tests.
Before the operation, during the first examinations, patients are informed about the ergonomic and behavioral procedure after the operation, and rehabilitation program. After surgery, a supervised exercise program begins three times a week for a month, lead by a qualified physiotherapist. Supervision is carried out online using generally available applications, including WhatsApp, messenger. After one month, patients are re-examined in the same way as before the surgery. The rehabilitation program after the microdiscectomy of the lumbar spine enables the voluntary extension of rehabilitation for another two months. During subsequent meetings with a physiotherapist, patients are taught new exercises that differ from week to week in terms of difficulty in performing, the number of repetitions, and the time to maintain tension.
Moreover, in the third month of the rehabilitation program, exercises with the use of a sensorimotor disc are planned. After completing the rehabilitation program, patients are invited for follow-up examinations six months and one year after the end of rehabilitation.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Gdańsk、ポーランド、80-336
- Gdansk University of Physical Education and Sport
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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:
- age 20 to 65 years, neurosurgical assessment and MRI imagine,discopathy, pernament low back pain with or without radiating to the lower limb.
Exclusion Criteria:
- patients beyond the age range, a previous lumbar spinal operation, spinal tumors, new fractures, intolerance of rehabilitation programs.
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：並列代入
- 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 |
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実験的：Study group I: The first time of patients attending single-level lumbar microdiscectomy
Study group I: On the basis of neurosurgical examination and MRI imaging, 40 patients aged 20-65 years with pains in the lumbar spine will be referred for the first-time single-level microdiscectomy procedure. Microdiscectomy patients will begin a rehabilitation program that will be includes exercises to reduce pain and strengthen the stabilizing muscles of the lumbar spine. From week to week, exercises will be difficult, among others due to the change of initial positions, the number of repetitions of exercises, or a longer duration of isometric exercises. |
On the basis of neurosurgical examination and MRI imaging, 40 patients aged 20-65 years with pains in the lumbar spine will be referred for the first-time single-level microdiscectomy procedure.
Microdiscectomy patients will begin a rehabilitation program that will be includes exercises to reduce pain and strengthen the stabilizing muscles of the lumbar spine.
From week to week, exercises will be difficult, among others due to the change of initial positions, the number of repetitions of exercises, or a longer duration of isometric exercises.
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介入なし：Study group II: Control healthy people
Study group II: 40 people aged 20-65 years. Including criteria: healthy persons without lumbar spine pain for at least 6 months and without lumbar spine surgery. |
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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Modified Schober's Test
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The test is used to assess the flexibility, active range of motion of the lumbar spine.
During the examination, the patient assumes a standing position, and the examiner marks a point at the level of the intervertebral space L₅ - S₁. Then he marks the points: 10 cm above and 5 cm below.
The examined person is asked to bend the torso as far as possible, the examiner measures the difference in distance from the marked points.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Chair Stand Test (CST)
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The test is used to assess the ability to stand up and down on a chair and lower body strength.
The patient is asked to stand up to an upright position and sit with his arms crossed over his chest from a chair of standard height (43 cm) as many times as he can within 30 seconds.
Blood pressure and heart rate measurements are collected before and after the test.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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"Timed Get-up-and-Go" Test
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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This test determines fall risk and measures the progress of balance, sit to stand, and walking.
During the test, the patient must get up from the chair and walk 3 meters as quickly as possible and sit down again.
A patient has two trials.
The better sample is analyzed.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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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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Body Mass Index (BMI)
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Each participant's weight and height will be assessed to determine their BMI using the formula weight [kg] / height [m] 2. This will be interpreted in line with the international cut-off points.
In addition, body composition will be analyzed using bioelectric impedance.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Fingertip-to-Floor Test
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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During the test, the subject keeps the feet connected and does not lift them.
The patient is asked to bend his torso forward by reaching with his fingertips to the ground with straightened knees, elbows and toes.
The examiner measures the vertical distance between the tip of the middle finger and the ground.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Romberg's Trial
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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During the test, the subject keeps the feet connected and does not lift them.
The patient is asked to bend his torso forward by reaching with his fingertips to the ground with straightened knees, elbows and toes.
The examiner measures the vertical distance between the tip of the middle finger and the ground.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Tandem Romberg Test
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Tandem Romberg test (tandem stance without shoes and eyes closed) with a non-dominant foot in front of the dominant one.
The arms hang down along the body.
The examiner measures the time in seconds with a stopwatch.
During the test, the test is interrupted when the patient tears off his feet, opens his eyes, touches the wall with his hand / arm.
The test is performed three times and the arithmetic mean of these results is calculated.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Biodex Balance System SD
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The study will carry out three tests: a postural stability test on a stable platform, a dynamic test for assessing risk of fall using a difficulty level of 12 to 8, and a difficulty level of 8. During the test patient is asked to keep the market as close as possible to the center of the target appearing on the monitor screen. The patient's score in this test depends on the number of deviations from the center, therefore the lower the score the better. It will be performed during three attempts of 20 seconds each. The system calculates the mean of the three trials. The examine's person stands on a static platform without shoes and feet are placed freely. Three indicators are obtained: the Overall Postural Stability Index (OSI), the Anterior / Posterior Postural Stability Index (AP) and the Medial / Lateral Postural Stability Index (ML). The tests are performed with eyes open and closed. |
T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Visual Analogue Scale (VAS)
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The level of pain in the lumbar spine and lower extremities after microdiscectomy, it's assessed on the basis of the visual analog scale (VAS); A 10 cm scale where 0 means "no pain" and 10 "the worst pain imaginable.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Oswestry Low Back Pain Disability Questionnaire (ODI)
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The Oswestry Disability Index (ODI) is a tool that assesses the level of disability of patients with back pain syndromes and the associated limitations in functioning in various spheres of life.
ODI consists of 10 sections.The total score is multiplied by 2 and expressed as a percentage.
The result in the range of 0-20% indicates a minimum level of disability, while 81-100% indicates a significant disability.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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Spine Tango Questionnaire
時間枠：T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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The questionnaire, which includes questions, among others of pain intensity level measured separately on graphic scales of 0-10 ratings, overall quality of life, social disability and incapacity for work - each on a five-point scale.
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T1-pre-intervention,T2-after first month the intervention,T3-after second month the intervention, T4-after third month the intervention, T5- after six months the intervention, T6-after twelve months the intervention.
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協力者と研究者
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 (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
キーワード
その他の研究ID番号
- DZN/1/2021/PP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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