- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07577778
Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain
Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain: A Randomized Control Trial
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This randomized controlled trial was conducted to evaluate the effectiveness of virtual reality (VR) training in patients with chronic non-specific low back pain (CNSLBP). Chronic low back pain is a highly prevalent condition associated with impaired proprioception, altered motor control, and functional disability.
Fifty participants diagnosed with CNSLBP were randomly assigned into two groups. The intervention group received virtual reality-based training in addition to conventional physiotherapy, while the control group received conventional treatment alone.
Outcome measures included pain intensity assessed by the Visual Analogue Scale (VAS), functional disability assessed by the Oswestry Disability Index (ODI), and lumbar repositioning error measured using an iPhone inclinometer application.
The study aimed to determine whether VR training could significantly improve pain, functional outcomes, and proprioceptive accuracy in this population.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Giza, Egitto, 12613
- Cairo university
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients with low back pain ≥ 12 weeks Age: 21-45 years Both genders BMI: 18.5-24.9
Exclusion Criteria:
- iabetic neuropathy Sciatica Spine deformities Previous lumbar surgery Neurological or vestibular disorders Visual disorders Malignancy or trauma Structural spinal disorders (stenosis, osteoporosis, etc.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Arm 1
Participants in this group received conventional physiotherapy including TENS, therapeutic ultrasound, and proprioceptive exercises.
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TENS was applied in a prone position with electrodes placed over the painful area.
Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects.
Intensity was adjusted to produce a strong but comfortable tingling sensation.
Each session lasted 20-60 minutes.
Ultrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²).
Continuous or pulsed modes were selected based on the condition.
Each session lasted 5-10 minutes.
Participants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank.
Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week.
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Sperimentale: Group 2
Participants in this group received the same conventional physiotherapy program in addition to virtual reality (VR) training.
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TENS was applied in a prone position with electrodes placed over the painful area.
Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects.
Intensity was adjusted to produce a strong but comfortable tingling sensation.
Each session lasted 20-60 minutes.
Ultrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²).
Continuous or pulsed modes were selected based on the condition.
Each session lasted 5-10 minutes.
Participants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank.
Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week.
Participants underwent VR training using Xbox 360 Kinect system. The setup included a motion sensor and projector, allowing full-body interaction through game-based activities. Training consisted of interactive games (e.g., rafting, running, ball hitting) designed to improve trunk control and motor function. Sessions were conducted twice weekly for 30 minutes over 12 weeks. Exercises included movements such as jumping, trunk tilting, and arm coordination, with progressive difficulty levels. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Pain intensity (VAS)
Lasso di tempo: 1 Month
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1 Month
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Functional disability (Oswestry Disability Index)
Lasso di tempo: 1 Month
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1 Month
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Lumbar reposition error (iPhone inclinometer)
Lasso di tempo: 1 Month
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1 Month
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC/012/00604
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Transcutaneous Electrical Nerve Stimulation (TENS)
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Universidad Complutense de MadridColegio de Fisioterapeutas de la Comunidad de MadridReclutamento
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Universidad Complutense de MadridColegio de Fisioterapeutas de la Comunidad de MadridReclutamento