- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07921771
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Effects of Whole-Body Vibration and Cervical Stabilization Combined With Core Stabilization on Trunk Motor Control in Young Individuals With Non-Specific Low Back Pain
This study aims to investigate the immediate effects of three intervention approaches in young adults with nonspecific low back pain. Participants will be randomly assigned to one of three groups: core stabilization exercises, whole-body vibration combined with core stabilization exercises, or cervical stabilization combined with core stabilization exercises. Outcomes will be assessed before and immediately after the intervention. The study will evaluate trunk motor control, pain intensity, pressure pain threshold, trunk muscle endurance, and balance. The purpose is to compare the immediate effects of these approaches and determine whether adding whole-body vibration or cervical stabilization to core stabilization produces additional benefits.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mariam Abualkas Abualkas, Pt
- Numer telefonu: +905345526603
- E-mail: 2433095031@stu.istinye.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: Çiçek Günday Asst. Prof., Asst. Prof.
- Numer telefonu: +905071888848
Lokalizacje studiów
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Istanbul
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Istanbul, Istanbul, Turcja (Türkiye)
- Istinye University Physiotherapy and Rehabilitation Application and Research Center (ISUFIZYOTEM)
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Kontakt:
- Nurgül Elbaşı Elbaşı
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age between 18 and 30 years.
- Low back pain intensity of at least 3/10 on the Numeric Rating Scale.
- Low back pain symptoms for at least 6 months.
- Ability to understand and follow verbal instructions.
- No major neurological deficit.
- No physiotherapy for low back pain within the previous 6 weeks.
Exclusion Criteria:
- Low back pain with a specific etiology identified by a physician.
- Neurological, vestibular, rheumatological, or serious musculoskeletal disorders affecting balance or motor control.
- Use of medications that may affect balance or have potential neurotoxic effects.
- Degenerative diseases.
- Indication for surgical intervention.
- History of fracture or surgery within the previous 2 years.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Core Stabilization
Participants in this group will perform the standard core stabilization exercise program, including the abdominal drawing-in maneuver, heel slide, single-leg march, single-leg extended heel tap, bridge, bridge pulse, dead bug, modified curl-up, and semi-plank. The total intervention duration is approximately 20 minutes. |
Participants perform a core stabilization exercise program including the abdominal drawing-in maneuver, heel slide, single-leg march, single-leg extended heel tap, bridge, bridge pulse, dead bug, modified curl-up, and semi-plank. The program is designed to activate and control the deep trunk stabilizing muscles. |
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Eksperymentalny: Whole-Body Vibration + Core Stabilization
Participants in this group will receive 5 minutes of whole-body vibration before the core stabilization exercise program. The vibration platform will be set at 30 Hz with an amplitude of 2 mm, and participants will stand with the knees slightly flexed during the vibration. Immediately afterward, participants will perform the same core stabilization exercise program used in the core stabilization group. After completing the core stabilization exercises, an additional 5 minutes of whole-body vibration will be applied using the same parameters. The total intervention duration is approximately 30 minutes. |
Participants perform a core stabilization exercise program including the abdominal drawing-in maneuver, heel slide, single-leg march, single-leg extended heel tap, bridge, bridge pulse, dead bug, modified curl-up, and semi-plank. The program is designed to activate and control the deep trunk stabilizing muscles. Whole-body vibration will be applied using a vibration platform at a frequency of 30 Hz and an amplitude of 2 mm. Participants will stand on the platform with the knees slightly flexed for 5 minutes before the core stabilization exercise program and for an additional 5 minutes after the program. |
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Eksperymentalny: Cervical Stabilization + Core Stabilization
Participants in this group will perform cervical stabilization exercises before the core stabilization exercise program. The cervical exercises will be performed in supine using a pressure biofeedback unit placed under the cervical spine. Participants will perform controlled craniocervical flexion, progressing the target pressure from 20 mmHg to 30 mmHg in 2 mmHg increments. The cervical stabilization exercises will be performed for approximately 5 minutes before the core stabilization program and repeated for an additional 5 minutes afterward. The total intervention duration is approximately 30 minutes. |
Participants perform a core stabilization exercise program including the abdominal drawing-in maneuver, heel slide, single-leg march, single-leg extended heel tap, bridge, bridge pulse, dead bug, modified curl-up, and semi-plank. The program is designed to activate and control the deep trunk stabilizing muscles. Participants will perform cervical stabilization exercises in the supine position using a pressure biofeedback unit placed under the cervical spine. Controlled craniocervical flexion will be performed with progressive target pressures from 20 mmHg to 30 mmHg in 2 mmHg increments. The exercises will be performed for approximately 5 minutes before the core stabilization program and repeated for an additional 5 minutes afterward. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Trunk motor control (supine), Pressure Biofeedback Unit
Ramy czasowe: Baseline and immediately after the single intervention session
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Deep abdominal muscle activation and lumbopelvic stability assessed with a pressure biofeedback unit in crook lying during the abdominal drawing-in maneuver, starting at 40 mmHg. The score is the absolute deviation from 40 mmHg (best of three trials); smaller values indicate better motor control. |
Baseline and immediately after the single intervention session
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Trunk motor control (prone; transversus abdominis activation), Pressure Biofeedback Unit
Ramy czasowe: Baseline and immediately after the single intervention session
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Activation of the transversus abdominis assessed in prone lying with the pressure biofeedback unit placed under the abdomen and inflated to 70 mmHg. Participants draw the abdominal wall in without moving the spine or pelvis. The score is the pressure reduction from 70 mmHg held steadily (best of three trials); larger reductions indicate better activation. |
Baseline and immediately after the single intervention session
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain intensity, Numeric Pain Rating Scale (NPRS)
Ramy czasowe: Baseline and immediately after the single intervention session
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Self-reported low back pain intensity rated from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. |
Baseline and immediately after the single intervention session
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Pressure pain threshold, lumbar multifidus
Ramy czasowe: Baseline and immediately after the single intervention session
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Pressure pain threshold in kg/cm² measured with a pressure algometer 2 cm lateral to the L4 spinous process. The mean of three measurements is used. Higher values indicate lower pain sensitivity. |
Baseline and immediately after the single intervention session
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Pressure pain threshold, erector spinae
Ramy czasowe: Baseline and immediately after the single intervention session
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Pressure pain threshold in kg/cm² measured with a pressure algometer 3 cm lateral to the L3 spinous process. The mean of three measurements is used. Higher values indicate lower pain sensitivity. |
Baseline and immediately after the single intervention session
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Pressure pain threshold, thoracolumbar fascia
Ramy czasowe: Baseline and immediately after the single intervention session
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Pressure pain threshold in kg/cm² measured with a pressure algometer 5 cm lateral to the L3 level. The mean of three measurements is used. Higher values indicate lower pain sensitivity. |
Baseline and immediately after the single intervention session
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Y-Balance Test composite score, right leg
Ramy czasowe: Baseline and immediately after the single intervention session
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Maximum reach in the anterior, posteromedial and posterolateral directions while standing on the right leg, normalized to right lower limb length and expressed as a composite score (%). Higher scores indicate better dynamic balance. |
Baseline and immediately after the single intervention session
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Y-Balance Test composite score, left leg
Ramy czasowe: Baseline and immediately after the single intervention session
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Maximum reach in the anterior, posteromedial and posterolateral directions while standing on the left leg, normalized to left lower limb length and expressed as a composite score (%). Higher scores indicate better dynamic balance. |
Baseline and immediately after the single intervention session
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Trunk flexor endurance test
Ramy czasowe: Baseline and immediately after the single intervention session
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Isometric holding time in seconds in the trunk flexor endurance test (McGill). Longer holding time indicates greater trunk flexor endurance. |
Baseline and immediately after the single intervention session
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Prone plank test
Ramy czasowe: Baseline and immediately after the single intervention session
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Isometric holding time in seconds in the prone plank position. Longer holding time indicates greater trunk muscle endurance. |
Baseline and immediately after the single intervention session
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Right side bridge test
Ramy czasowe: Baseline and immediately after the single intervention session
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Isometric holding time in seconds in the right side bridge test (McGill). Longer holding time indicates greater lateral trunk endurance. |
Baseline and immediately after the single intervention session
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Left side bridge test
Ramy czasowe: Baseline and immediately after the single intervention session
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Isometric holding time in seconds in the left side bridge test (McGill). Longer holding time indicates greater lateral trunk endurance. |
Baseline and immediately after the single intervention session
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026/226
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data will not be shared in order to protect the privacy and confidentiality of the participants.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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