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Influence of Supervised Stabilization Exercises on Postural Control in Patients After Spine Surgery.

12 września 2022 zaktualizowane przez: Gdansk University of Physical Education and Sport

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.

The aim of the study is to determine the impact of early rehabilitation in patients after lumbar spine surgery using microdiscectomy on balance, postural stability and foot pressure distribution. The tests will be carried out at the Physical Effort Laboratory in Gdańsk.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Polska
      • Gdańsk, Polska, 80-336
        • Gdansk University of Physical Education and Sport

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Experimental Study
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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Modified Schober's Test
Ramy czasowe: 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.
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.
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.
Chair Stand Test (CST)
Ramy czasowe: 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.
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.
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.
"Timed Get-up-and-Go" Test
Ramy czasowe: 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.
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.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Body Mass Index (BMI)
Ramy czasowe: 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.
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.
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.
Fingertip-to-Floor Test
Ramy czasowe: 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.
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.
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.
Romberg's Trial
Ramy czasowe: 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.
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.
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.
Tandem Romberg Test
Ramy czasowe: 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.
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.
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.
Biodex Balance System SD
Ramy czasowe: 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.

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.
Visual Analogue Scale (VAS)
Ramy czasowe: 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.
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.
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.
Oswestry Low Back Pain Disability Questionnaire (ODI)
Ramy czasowe: 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.
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.
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.
Spine Tango Questionnaire
Ramy czasowe: 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.
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.
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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gdansk University of Physical Education and Sport

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2021

Zakończenie podstawowe (Rzeczywisty)

10 maja 2021

Ukończenie studiów (Oczekiwany)

31 października 2024

Daty rejestracji na studia

Pierwszy przesłany

19 listopada 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 grudnia 2021

Pierwszy wysłany (Rzeczywisty)

13 stycznia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 września 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 września 2022

Ostatnia weryfikacja

1 września 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DZN/1/2021/PP

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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