- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07700589
Comparison of Traditional, Synchronous, and Asynchronous Telerehabilitation in Office Workers With Chronic Nonspecific Low Back Pain
Comparison of the Effectiveness of Traditional, Synchronous, and Asynchronous Telerehabilitation Approaches in Chronic Nonspecific Low Back Pain in Office Workers
Chronic Nonspecific Low Back Pain (NLBP) is a common condition that occurs without a specific underlying pathology, resulting in muscle tension, pain, and a decreased quality of life. Office workers are particularly at risk due to prolonged sitting, ergonomic errors, and low physical activity. While exercise therapy is a primary approach for management, low adherence rates often limit its effectiveness. Telerehabilitation (remote, technology-supported physiotherapy) stands out for its potential to increase access and support continuity of care.
This study is a randomized controlled trial that will be conducted with 45 office workers aged 18-65 diagnosed with chronic NLBP. Participants will be randomly assigned to three parallel groups: traditional exercise (brochure-based), synchronous telerehabilitation (live sessions), and asynchronous telerehabilitation (pre-recorded videos). The intervention protocol will be implemented for 8 weeks. Evaluations will be performed before and after the 8-week period using the Visual Analog Scale (VAS) for pain intensity, Oswestry Disability Index (ODI) for functional disability, Short Form-36 (SF-36) for health-related quality of life, and a Patient Satisfaction Questionnaire.
The aim of this study is to compare the effects of traditional, synchronous, and asynchronous telerehabilitation approaches on pain, disability, quality of life, and satisfaction to determine the most effective management model for office workers with chronic nonspecific low back pain.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Özge Mine YILMAZ, Ass Prof
- Numer telefonu: +90 5075091175
- E-mail: ozgemineyilmaz@aydin.edu.tr
Lokalizacje studiów
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Istanbul, Turcja (Türkiye), 34295
- Istanbul Aydin University, Faculty of Health Sciences
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Kontakt:
- Özge Mine YILMAZ, Ass Prof
- Numer telefonu: +90 5075091175
- E-mail: ozgemineyilmaz@aydin.edu.tr
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Główny śledczy:
- Özge Mine YILMAZ, Ass Prof
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Being an office worker aged between 18 and 65 years.
- Diagnosed with chronic non-specific low back pain (symptoms persisting for more than 3 months).
- Volunteering to participate in the study and signing the informed consent form.
- Having a computer, smartphone, or tablet with a stable internet connection capable of supporting video calls.
Exclusion Criteria:
- - History of spinal surgery, structural spinal deformities (e.g., severe scoliosis), or specific causes of low back pain (e.g., disc herniation with severe radiculopathy, spinal stenosis, spondylolisthesis).
- Diagnosis of systemic, rheumatological, neurological, or inflammatory diseases affecting the musculoskeletal system.
- Serious cardiovascular or pulmonary conditions that contraindicate physical exercise.
- Currently receiving active physical therapy or regular medical intervention for low back pain elsewhere.
- Pregnancy.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Traditional Exercise Group
Participants will receive a standard physiotherapy program including stretching, core stabilization, and motor control exercises for low back pain, delivered face-to-face by a physiotherapist in a clinical environment at Istanbul Aydın University
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
It will be delivered face-to-face by a physiotherapist in a clinical environment at Istanbul Aydin University.
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Eksperymentalny: Synchronous Telerehabilitation Group
Participants will participate in the same exercise program (stretching, core stabilization, and motor control exercises) via live, real-time online video sessions supervised by a physiotherapist.
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
It will be delivered via live, real-time online video sessions supervised by a physiotherapist.
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Eksperymentalny: Asynchronous Telerehabilitation Group
Participants will be provided with pre-recorded instructional exercise videos containing the same program.
They will follow and perform the exercises individually at their own convenience.
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The exercise protocol consists of stretching, core stabilization, and motor control exercises for low back pain.
Frequency: Performed 3 days a week for 8 weeks, consisting of 2 sets of 10 repetitions (approximately 45-60 minutes per session).
Participants will be provided with pre-recorded instructional exercise videos and follow the exercises individually at their own convenience.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Functional Disability Level
Ramy czasowe: Baseline and Post-intervention (Week 8)
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Evaluated using the Oswestry Disability Index (ODI) to measure functional disability related to low back pain.
The questionnaire consists of 10 items, and the total score is expressed as a percentage ranging from 0% to 100%.
A score of 0% indicates no disability, while 100% represents the highest possible level of functional disability.
Higher percentages mean a worse functional outcome.
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Baseline and Post-intervention (Week 8)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Health-Related Quality of Life
Ramy czasowe: Baseline and Post-intervention (Week 8)
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Evaluated using the Short Form-36 (SF-36) questionnaire, which measures 8 health domains.
Scores range from 0 to 100 for each domain, where higher scores represent a better health-related quality of life.
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Baseline and Post-intervention (Week 8)
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Pain Intensity Assessed via Visual Analog Scale (VAS)
Ramy czasowe: Baseline and Post-intervention (Week 8)
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Measured using the Visual Analog Scale (VAS) for low back pain, where participants rate their pain on a 10-centimeter horizontal line.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the most severe imaginable pain.
Higher scores represent worse pain outcomes.
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Baseline and Post-intervention (Week 8)
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Patient Satisfaction
Ramy czasowe: Post-intervention (Week 8)
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Measured using the Physiotherapy and Rehabilitation Patient Satisfaction Questionnaire.
Total scores range from 0 to 100 (converted from the multi-item scale), where 0 indicates total dissatisfaction and 100 indicates the highest level of satisfaction.
Higher scores mean a better outcome.
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Post-intervention (Week 8)
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Współpracownicy i badacze
Sponsor
Współpracownicy
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TUBITAK-1919B012522773
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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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