Clinical trial NCT06750887: Modifying Lumbar Flexion Pain Thresholds in Chronic LBP Using Virtual Reality and Visual-Proprioceptive Manipulation
Official title: Modifying Lumbar Flexion Pain Thresholds in Patients With Chronic Low Back Pain Through Visual-proprioceptive Manipulation With Virtual Reality: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain (CLBP)
Keywords: chronic low back pain
virtual reality
flexion-evoked pain
illusions
central processing
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 flexions until pain onset under three conditions: accurate visual feedback (control), feedback showing 20% less movement (F-), and feedback showing 20% more movement (F+). 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, or catastrophising are more susceptible to VR feedback manipulation. Pain thresholds, pain intensity, kinesiophobia, and catastrophising levels are assessed.

Detailed description: 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). The research aims to explore how altering the perception of movement through VR can influence pain experiences and motor behavior. A total of 50 patients with non-specific chronic LBP are planned to participate.

Participants will perform lumbar spine flexion movements until the onset of pain under three experimental conditions: (1) accurate visual feedback, without virtual reality (control); (2) underestimated movement feedback (F-), where the VR displays 20% less movement than performed; and (3) overestimated movement feedback (F+), where the VR shows 20% more movement than actually executed. These conditions are designed to evaluate how changes in visual feedback impact pain perception and range of motion (ROM).

Lumbar ROM will be objectively measured using a 3-space Fastrack motion analysis system to ensure precise tracking of movement. The study also seeks to identify whether individuals with higher levels of pain, kinesiophobia (fear of movement), or catastrophising (an exaggerated negative mindset about pain) are more susceptible to VR feedback manipulation.

Various psychological and physical metrics will be assessed using validated tools, including pain thresholds, pain intensity, kinesiophobia, and catastrophising levels. This comprehensive approach aims to identify patient subgroups who may benefit most from VR-based interventions and to shed light on the mechanisms by which altered visual feedback modifies pain perception and motor behavior in chronic LBP.

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 Interference and Pain Intensity
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
measure: Fear of movement
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
Secondary outcomes:
measure: Catastrophizing
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.