- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Adel Alshahrani, PhD, PT
- Telefonnummer: +966 54 822 6011
- E-mail: amsalshahrani@nu.edu.sa
Studiesteder
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Najran Region
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Najran, Najran Region, Saudi Arabien, 61441
- Physiotherapy Clinics, Department of Medical Rehabilitation Sciences, College of Applied Medical Sciences, Najran University
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Kontakt:
- Husam Yahya Alfaifi, PhD
- Telefonnummer: +966560366600
- E-mail: Hyalfifi@nu.edu.sa
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Underforsker:
- Husam Yahya Alfaifi, PhD
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Underforsker:
- Mohammad Abdel Jarrar, Msc
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Underforsker:
- Saeed Yahya Al Adal, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Disability Measured by the Oswestry Disability Index (ODI)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 202604-076-043471-094936
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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