- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Giza, Ägypten, 12613
- Cairo university
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Pain intensity (VAS)
Zeitfenster: 1 Month
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1 Month
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Functional disability (Oswestry Disability Index)
Zeitfenster: 1 Month
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1 Month
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Lumbar reposition error (iPhone inclinometer)
Zeitfenster: 1 Month
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1 Month
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P.T.REC/012/00604
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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