An observational study in Chronic Low-back Pain (cLBP), sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Cardenal Herrera University · Observational
This study investigates the potential to modify movement-evoked pain in individuals with chronic low back pain (LBP) by manipulating visual proprioceptive feedback through virtual reality (VR). Fifty patients with non-specific chronic LBP are planned to participate. Participants perform lumbar spine extension until pain onset under three conditions: accurate visual feedback (control), feedback showing 10% less movement (E-), and feedback showing 10% more movement (E+). Lumbar range of motion (ROM) is measured using a 3-space Fastrack motion analysis system. The study also explores whether individuals with higher pain levels, kinesiophobia, disability, or catastrophising are more susceptible to VR feedback manipulation. Pain thresholds, pain intensity, kinesiophobia, disability, and catastrophising levels are assessed.
This study explores the potential to influence movement-evoked pain in individuals with chronic low back pain (LBP) by altering visual proprioceptive feedback using virtual reality (VR). The researchers aim to understand whether manipulating visual feedback can change pain perception and movement behavior. A total of 50 patients with non-specific chronic LBP are expected to participate.
Participants will perform lumbar spine extension movements until the point of pain onset under three experimental conditions: (1) without virtual reality (control); (2) underestimated movement feedback (E-), where the VR shows 10% less movement than performed; and (3) overestimated movement feedback (E+), where the VR depicts 10% more movement than performed. These manipulations aim to investigate how changes in perceived movement affect pain perception and range of motion.
The lumbar range of motion (ROM) is objectively measured using a 3-space Fastrack motion analysis system to ensure precise tracking of physical movements. Additionally, the study examines whether psychological factors, such as pain intensity, kinesiophobia (fear of movement), disability, and catastrophising (exaggerated negative mental set about pain), influence susceptibility to VR feedback manipulation.
To provide a comprehensive assessment, participants' pain thresholds, pain intensity levels, kinesiophobia, disability, and catastrophising tendencies are measured through validated tools. By combining physical and psychological evaluations, the study aims to identify potential subgroups of patients who might benefit most from VR-based interventions and shed light on the mechanisms through which visual feedback alters pain perception and movement behavior in chronic LB
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 357 observational studies indexed under Back Pain.
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chronic low back pain
Exclusion Criteria:
The normal condition is measured as a lumbar extension without VR until the onset of pain.
Other: NORMAL CONDITION
It involves an illusion with virtual reality where the patients perform a lumbar extension until the onset of pain and the feel a 10% less movement in the VR (understated visual feedback)
Other: UNDERSTATED CONDITION
It involves an illusion with virtual reality where the patients perform a lumbar extension until the onset of pain and the feel a 10% more movement in the VR (understated visual feedback)
Other: OVERSTATED CONDITION
They perform 3 lumbar extensions until the onset of pain without virtual reality
They perform 3 lumbar extensions until the onset of pain using the virtual reality. In this condition, they feel that they are moving a 10%less than they are really moving.
They perform 3 lumbar extensions until the onset of pain using the virtual reality. In this condition, they feel that they are moving a 10% more than they are really moving.
MOVEMENT EVOKED PAIN THRESHOLD
The maximum lumbar range of movement without pain was measured in each condition using a 3-Space Fastrack motion analysis system.
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Pain Intensity
The pain intensity perceived by participants is measured using the Numeric Pain Rating Scale (NPRS-11)
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Fear of movement
The investigators will use the reliable and validated Spanish version of the Tampa Scale for Kinesiophobia (TSK), which consists of 11 independent phrases rated on a 4-point scale (1 = totally disagree to 4 = totally agree). Higher scores indicate higher levels of fear of movement.
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Catastrophizing
The validated Spanish version of the Pain Catastrophizing Scale (PCS) will be applied, which has demonstrated internal consistency, test-retest reliability, and sensitivity to change. The PCS comprises 13 items rated on a 5-point scale from 0 (never) to 4 (always) that measure 3 components of catastrophising: rumination, magnification, and helplessness. Higher scores indicate greater pain-related catastrophising.
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Disability
The degree of disability is measured using the validated and reliable Spanish version of the Roland-Morris Questionnaire (RMQ), which consists of 24 items whose scores range from 0 (no disability) to 24 (maximum disability)
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Plan to share: Yes
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Cardenal Herrera University