Clinical trial NCT06750900: Visual Feedback Manipulation in Virtual Reality Alters Extension-evoked Pain Perception in Chronic LBP
Official title: Visual Feedback Manipulation in Virtual Reality Alters Movement-evoked Pain Perception in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low-back Pain (cLBP)
Keywords: chronic low back pain
virtual reality
ilusions
movement-evoked pain
visual-proprioceptive feedback
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: chronic low back pain

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Participants of both sexes.
* Aged between 18 and 65 years.
* Diagnosed with non-specific chronic low back pain (according to the European COST B13 guidelines).
* Presence of lumbar extension limitation.

Exclusion Criteria:

* Diagnosis of a spinal tumor.
* Presence of a spinal infection or fracture.
* Diagnosed systemic diseases.
* Diagnosis of fibromyalgia.
* Presence of cauda equina syndrome.
* History of prior spinal surgery.
* Musculoskeletal injuries of the lower extremities (including: sciatica; radiating pain in the lower extremities; symptoms of numbness or weakness in the lower extremities)

Primary outcomes:
measure: MOVEMENT EVOKED PAIN THRESHOLD
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
measure: Pain Intensity
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Secondary outcomes:
measure: Fear of movement
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
measure: Catastrophizing
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
measure: Disability
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Arnau de Vilanova Hospital
Study officials:
References:
citation: Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.