Modifying Lumbar Flexion Pain Thresholds in Chronic LBP Using Virtual Reality and Visual-Proprioceptive Manipulation

Completed

• Conditions: Chronic Low Back Pain (CLBP)

• Registration Number: NCT06750887
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study Start: 2024-12-04
• Primary Completion: 2024-12-18
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Study Completion: 2025-01-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MOVEMENT EVOKED PAIN THRESHOLD	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)	The maximum lumbar ROM without pain was measured in each condition using a 3-Space Fastrack motion analysis system.
Pain Interference and Pain Intensity	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)	The Brief Pain Inventory (BPI) is a pain assessment tool designed to measure pain intensity and interference with daily functioning in patients with low back pain
Fear of movement	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)	We 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.

Secondary Outcome Measures

Name	Time	Method
Catastrophizing	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)	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.

Trial Locations

Locations (1)

Arnau de Vilanova Hospital; 🇪🇸 Valencia, Spain