Visual Feedback Manipulation in Virtual Reality Alters Extension-evoked Pain Perception in Chronic LBP (CLEVER BODY)

Visual Feedback Manipulation in Virtual Reality Alters Movement-evoked Pain Perception in Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Other: NORMAL CONDITION; Other: UNDERSTATED CONDITION; Other: OVERSTATED CONDITION

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Arnau de Vilanova Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

chronic low back pain

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NORMAL CONDITION; The normal condition is measured as a lumbar extension without VR until the onset of pain.	Other: NORMAL CONDITION; They perform 3 lumbar extensions until the onset of pain without virtual reality
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% less movement in the VR (understated visual feedback)	Other: UNDERSTATED CONDITION; 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.
OVERSTATED 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 using the virtual reality. In this condition, they feel that they are moving a 10% more than they are really moving.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).

Collaborators and Investigators

• Sponsor: Cardenal Herrera University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: chronic low back pain; virtual reality; ilusions; movement-evoked pain; visual-proprioceptive feedback
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Cardenal Herrera University 67; PID2020-115609RB-C22 (Other Grant/Funding Number: MINISTRY OF SCIENCE AND INNOVATION OF SPAIN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No