Visual Feedback Manipulation in Virtual Reality Alters Extension-evoked Pain Perception in Chronic LBP

Completed

• Conditions: Chronic Low-back Pain (cLBP)

• Registration Number: NCT06750900
• 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 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

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: 2025-01-07
• 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 range of movement without pain was measured in each condition using a 3-Space Fastrack motion analysis system.
Pain Intensity	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).	The pain intensity perceived by participants is measured using the Numeric Pain Rating Scale (NPRS-11)

Secondary Outcome Measures

Name	Time	Method
Fear of movement	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).	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.
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.
Disability	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).	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)

Trial Locations

Locations (1)

Arnau de Vilanova Hospital; 🇪🇸 Valencia, Spain