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

NCT ID: NCT06750887

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2025-01-08

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.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

NORMAL CONDITION

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

Normal condition

Intervention Type: OTHER

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)

Understated condition

Intervention Type: OTHER

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)

OVERSTATED CONDITION

Intervention Type: OTHER

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)

Interventions

Normal condition

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Chair Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arnau de Vilanova Hospital

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 25691362 (View on PubMed)

Jordan-Lopez J, Arguisuelas MD, Domenech J, Penalver-Barrios ML, Miragall M, Herrero R, Banos RM, Amer-Cuenca JJ, Lison JF. Modifying lumbar flexion pain thresholds in patients with chronic low back pain through visual-proprioceptive manipulation with virtual reality: a cross-sectional study. J Neuroeng Rehabil. 2025 Jun 19;22(1):138. doi: 10.1186/s12984-025-01664-2.

Reference Type: DERIVED

PMID: 40537791 (View on PubMed)

Other Identifiers

PID2020-115609RB-C22

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Cardenal Herrera University 70

Identifier Type: -

Identifier Source: org_study_id