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

NCT06750900 | Completed DMC

• 2 other identifiers: Cardenal Herrera University 67PID2020-115609RB-C22
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

chronic low back pain; virtual reality; ilusions; movement-evoked pain; visual-proprioceptive feedback

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Fear of movement

  Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).

• Catastrophizing

  Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).

• Disability

  Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).

Study Arms (3)

NORMAL CONDITION

The normal condition is measured as a lumbar extension without VR until the onset of pain.

Other: NORMAL CONDITION

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

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

Interventions

NORMAL CONDITION OTHER

They perform 3 lumbar extensions until the onset of pain without virtual reality

NORMAL CONDITION

UNDERSTATED CONDITION OTHER

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.

UNDERSTATED CONDITION

OVERSTATED CONDITION OTHER

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.

OVERSTATED CONDITION

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic low back pain

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Arnau de Vilanova Hospital

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 25691362 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Profesor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 4, 2024
• Primary Completion: December 18, 2024
• Study Completion: January 7, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)