- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07677189
Sensorimotor Balance Training for Chronic Nonspecific Low Back Pain (SENSOR-LBP)
Effects of Sensorimotor Balance Training on Pain and Spinal Alignment in Adults With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Chronic nonspecific low back pain is one of the most common causes of pain and disability worldwide. Many people with chronic low back pain experience difficulties with balance, posture, movement control, and daily activities. Sensorimotor balance training is a rehabilitation approach designed to improve balance, body awareness, and neuromuscular control.
The purpose of this randomized controlled trial is to investigate whether sensorimotor balance training is more effective than standard physiotherapy in reducing pain and improving spinal alignment in adults with chronic nonspecific low back pain. Participants will be randomly assigned to either a sensorimotor balance training group or a standard physiotherapy group. Both groups will receive treatment three times per week for 12 weeks.
Pain intensity, functional disability, and spinal alignment will be assessed before and after the intervention. Spinal alignment will be measured using the DIERS Formetric 4D system, a non-invasive and radiation-free technology that evaluates posture and spinal shape. The findings of this study may help identify effective rehabilitation strategies for improving pain, function, and spinal alignment in people with chronic nonspecific low back pain.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Chronic nonspecific low back pain (CNSLBP) is a major cause of disability and reduced quality of life worldwide. In addition to pain, individuals with CNSLBP frequently demonstrate impairments in sensorimotor control, proprioception, postural stability, and trunk muscle coordination. These impairments may contribute to persistent symptoms and functional limitations.
Sensorimotor balance training has emerged as a rehabilitation approach aimed at improving sensory integration, neuromuscular control, and dynamic postural stability. Previous studies have reported beneficial effects of sensorimotor-focused interventions on pain and functional outcomes; however, most investigations have relied primarily on self-reported measures, with limited assessment of objective biomechanical changes.
The DIERS Formetric 4D system provides a non-invasive, radiation-free method for evaluating spinal posture and alignment, including measures of trunk imbalance, pelvic tilt, and sagittal spinal curvature. The integration of objective spinal assessment with rehabilitation interventions may provide greater insight into the relationship between symptom improvement and structural-functional adaptations.
This randomized controlled trial aims to evaluate the effects of sensorimotor balance training on pain intensity and spinal alignment in adults with chronic nonspecific low back pain. The study will compare sensorimotor balance training with standard physiotherapy and examine whether improvements in pain are associated with measurable changes in spinal alignment. Findings from this study may contribute to the development of evidence-based rehabilitation strategies for the management of chronic nonspecific low back pain.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Adel Alshahrani, PhD, PT
- Numero di telefono: +966 54 822 6011
- Email: amsalshahrani@nu.edu.sa
Luoghi di studio
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Najran Region
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Najran, Najran Region, Arabia Saudita, 61441
- Physiotherapy Clinics, Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, Najran University
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Contatto:
- Husam Yahya Alfaifi, PhD
- Numero di telefono: +966560366600
- Email: Hyalfifi@nu.edu.sa
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Sub-investigatore:
- Husam Yahya Alfaifi, PhD
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Sub-investigatore:
- Mohammad Abdel Jarrar, Msc
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Sub-investigatore:
- Saeed Yahya Al Adal, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults aged 18 to 59 years. Diagnosis of chronic nonspecific low back pain lasting at least 3 months. Pain intensity score of 4 or greater on the Numeric Pain Rating Scale (NPRS). Body Mass Index (BMI) between 25 and 35 kg/m². Ability to safely participate in the exercise program and comply with study procedures.
Exclusion Criteria:
- Acute low back injury. History of spinal surgery. Neurological disorders affecting movement or balance. Musculoskeletal disorders affecting movement or balance. Professional athletes. Individuals engaged in heavy manual labor. Any medical condition that would prevent safe participation in the intervention program.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Sensorimotor Balance Training
Participants in this arm will receive sensorimotor balance training designed to improve proprioception, postural stability, and neuromuscular control.
The intervention will be delivered three times per week for 12 weeks.
Exercises include wobble board balance training, core activation exercises, and dynamic single-leg stance activities, with progressive increases in difficulty throughout the intervention period.
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Participants will receive a structured sensorimotor balance training program designed to improve proprioception, postural stability, and neuromuscular control.
The intervention will be delivered three times per week for 12 weeks, with each session lasting approximately 45 minutes.
Exercises include wobble board balance training, core activation exercises, and dynamic single-leg stance activities.
Exercise difficulty will be progressively increased every two weeks according to participant performance and
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Comparatore attivo: Standard Physiotherapy
Participants in this arm will receive standard physiotherapy treatment consisting of stretching and core strengthening exercises.
Treatment will be provided three times per week for 12 weeks using a standardized progression protocol.
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Participants will receive standard physiotherapy treatment consisting of stretching and core strengthening exercises.
The intervention will be delivered three times per week for 12 weeks, with each session lasting approximately 45 minutes.
A standardized progression protocol will be followed throughout the intervention period to ensure consistency of treatment delivery across participants.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Lasso di tempo: Baseline and Week 12
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The Numeric Pain Rating Scale (NPRS) is a self-reported measure of pain intensity scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
The primary outcome will be the change in pain intensity from baseline to the end of the 12-week intervention period.
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Baseline and Week 12
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Spinal Alignment Measured by DIERS Formetric 4D
Lasso di tempo: Baseline and Week 12
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Spinal alignment will be assessed using the DIERS Formetric 4D system, a non-invasive and radiation-free surface topography method.
Parameters evaluated will include trunk imbalance, pelvic tilt, and sagittal spinal curvature.
The outcome measure will be the change in spinal alignment parameters from baseline to the end of the intervention period.
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Baseline and Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional Disability Measured by the Oswestry Disability Index (ODI)
Lasso di tempo: Baseline and Week 12
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Functional disability will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring the impact of low back pain on daily activities and functional performance.
The outcome measure will be the change in ODI score from baseline to the end of the 12-week intervention period.
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Baseline and Week 12
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
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
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 202604-076-043471-094936
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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 .
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