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

Modifying Lumbar Flexion Pain Thresholds in Patients With Chronic Low Back Pain Through Visual-proprioceptive Manipulation With Virtual Reality: a Cross-sectional Study

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.

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 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 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 flexion without VR until the onset of pain.	Other: Normal condition; The normal condition IS measured as a lumbar extension without VR until the onset of pain.
UNDERSTATED CONDITION; It involves an illusion with virtual reality where the patients perform a lumbar flexion until the onset of pain and they feel a 20% less movement in the VR (understated visual feedback)	Other: Understated condition; It involves an illusion with virtual reality where the patients perform a lumbar flexion until the onset of pain and they feel a 20% less movement in the VR (understated visual feedback)
OVERSTATED CONDITION; It involves an illusion with virtual reality where the patients perform a lumbar flexion until the onset of pain and they feel a 20% more movement in the VR (understated visual feedback)	Other: OVERSTATED CONDITION; It involves an illusion with virtual reality where the patients perform a lumbar flexion until the onset of pain and they feel a 20% more movement in the VR (understated visual feedback)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MOVEMENT EVOKED PAIN THRESHOLD	The maximum lumbar ROM 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 Interference and Pain Intensity	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	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
Fear of movement	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.	Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

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 8, 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; illusions; flexion-evoked pain; central processing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Cardenal Herrera University 70; 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