- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07602816
Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain (core stability)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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)
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Giza Governorate
-
Giza, Giza Governorate, Egitto, 6892
- Rania Reda
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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:
-
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
|
|
Sperimentale: 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)
|
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
|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Oswestry Disability Index (ODI)
Lasso di tempo: 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
|
|
visual analogue scale (VAS)
Lasso di tempo: 4 weeks
|
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
|
|
Star excursion balance test (SEBT)
Lasso di tempo: 4 weeks
|
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.
|
4 weeks
|
|
BROM
Lasso di tempo: 4 weeks
|
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.
|
4 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tampa Scale of Kinesiophobia (TSK)
Lasso di tempo: 4 weeks
|
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.
|
4 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 987054
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 group A
-
Universidad Central de VenezuelaCompletatoPulpite | Terapia canalare | Pulpite - Irreversibile | PulpotomiaVenezuela
-
Bursa City HospitalReclutamentoBlocco regionale per il controllo del dolore | Chirurgia toracoscopica videoassistita | Funzioni polmonari | Blocchi regionaliTacchino
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
-
Istituto Scientifico Italiano Colonna VertebraleAttivo, non reclutanteScoliosi idiopatica adolescenziale (AIS)Italia
-
M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
-
Northwell HealthThe Cleveland Clinic; University of Kansas Medical Center; Cedars-Sinai Medical... e altri collaboratoriReclutamentoProlasso della valvola mitraleStati Uniti
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalCompletato
-
Rush University Medical CenterCompletato
-
Greater Manchester Mental Health NHS Foundation...Manchester University NHS Foundation Trust; University of Manchester; Anna Freud... e altri collaboratoriCompletatoProblema di salute mentaleRegno Unito
-
Sunnybrook Health Sciences CentreRitiratoIl focus dello studio è sugli atteggiamenti del dentista nei confronti delle misurazioni della pressione arteriosaCanada