- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07602816
Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain (core stability)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Various strategies are employed to help improve range of motion, alleviate pain, and enhance the overall quality of life for individuals dealing with lower back pain (LBP). These strategies encompass therapeutic exercises, manual therapy techniques, educating patients on lifestyle modifications, managing medications, and utilizing modalities like cryotherapy, heat therapy, ultrasound, and electrical stimulation. (Rulewska et al., 2025). So, Physical therapies and exercises, psychological and social support, reducing strain during physical work, and lifestyle changes are commonly practiced to manage non-specific chronic low back pain (NSCLBP). (Kumari et al., 2024)
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Giza Governorate
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Giza, Giza Governorate, Egypt, 6892
- Rania Reda
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Sixty-six patients with non-specific low back pain diagnosed by physician will be selected for the study from the outpatient clinic of faculty of physical therapy, October 6 university.
- Patients of both sex with age range from 20-45 years.
- Pain lasting for more than 12 weeks.
- Pain intensity score 2/10 or more on Visual Analog Scale (VAS).
- BMI ranged between 18.5 and 24.9 kg/m2.
Exclusion Criteria:
- Visual or cognitive impairments affecting VR participation.
- Pregnancy.
- specific LBP (Radiculopathy, spinal stenosis, spondylolisthesis, or recent spinal surgery.)
- neurological disorders,
- psychiatric disorders,
- physiotherapy during the last 6 months.
Exclusion Criteria:
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: group A: traditional physiotherapy
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
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hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
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Experimentální: group B: receive traditional physiotherapy plus virtual reality.
Participants will engage in VR rehabilitation sessions, 3 sessions per week for 4 weeks using interactive balance and movement-based VR programs, the patient will performe the exercises using VR video gaming, two games were selected, one for each exercise set: Epic roller coaster and Fit x.
In addition to being enjoyable for most of the participants, both games require frequent head motions and quick direction changes which facilitate activation of the core muscles.
(Abdelraoufet al., 2020)
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Participants will engage in VR rehabilitation sessions using interactive balance and movement-based VR programs using meta quest with android operating system and camera as a sensor technology, it includes VR headset,2 touch controllers, 2 AA batteries, silicone cover, glasses spacer, charging cable , power adapter
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Experimentální: group C: receive traditional physiotherapy plus core stability exercise.
Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. (Khaled et al., 2024). |
Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Oswestry Disability Index (ODI)
Časové okno: 4 weeks
|
The questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability, disability scores ranging from 0-19% indicate minimal disability, 20-39% indicate moderate disability,40-59% indicate severe disability, 60-79% indicate crippling disability, and scores ranging from 80-100% indicate people who are confined to bed. |
4 weeks
|
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visual analogue scale (VAS)
Časové okno: 4 weeks
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Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity. All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured using a ruler; a higher score indicates greater pain intensity. |
4 weeks
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Star excursion balance test (SEBT)
Časové okno: 4 weeks
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Leg length discrepancy will be measured before applying the (SEBT) for normalization of test results, SEBT will be accomplished while participants are standing on the dominant leg, and participants will be asked to reach as far as they could along a grid in the anterior, posteromedial, and posterolateral directions with the tip of the great toe of the non-stance limb.
Participant's hands held at the iliac crest during the test, If the individual touches heavily or comes to rest at the touch-down point, has to make contact with the ground with the reaching foot to maintain balance, or lifts or shifts any part of the foot of the stance limb during the trial, the trial is not considered complete.
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4 weeks
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BROM
Časové okno: 4 weeks
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The AROM was determined by BROM and done by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position.
(Suriyaamarit et al., 2024) First step in measuring ROM is finding the reference points, which consisted of the base of the sacrum and the spinous process of thoracic spine level 12.
The base of the sacrum was located by drawing a line between the posterior superior iliac spine (PSIS) (the same level as the S2 spinous process) and counting up from the base of the sacrum.
The spinous process of thoracic spine level 12 was located by counting up six levels from the 1st reference point.
These two references were used to place the flexion/extension unit and the BROM R/L unit.
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4 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tampa Scale of Kinesiophobia (TSK)
Časové okno: 4 weeks
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is a self-report questionnaire, in its original form, the TSK is a 17 item assessment checklist.
It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.
The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
(Lundberg et al., 2011) Scores above 37 suggest the presence of clinically significant kinesiophobia, while scores below 37 are considered to be within the normal range.
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4 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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