Chronic Low-back Pain (cLBP)CLEVER BODYNCT06750900
Visual Feedback Manipulation in Virtual Reality Alters Extension-evoked Pain Perception in Chronic LBP
An observational study of Chronic Low-back Pain (cLBP), run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- NORMAL CONDITION, UNDERSTATED CONDITION and OVERSTATED CONDITION
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2024to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic low back pain
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- NORMAL CONDITION, UNDERSTATED CONDITION, OVERSTATED CONDITION
- Keywords
- chronic low back pain, virtual reality, ilusions, movement-evoked pain, visual-proprioceptive feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NORMAL CONDITIONOther
They perform 3 lumbar extensions until the onset of pain without virtual reality
UNDERSTATED CONDITIONOther
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 CONDITIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NORMAL CONDITION | The normal condition is measured as a lumbar extension without VR until the onset of pain. Receives: 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) Receives: 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) Receives: Other: OVERSTATED CONDITION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start4 Dec 2024
- Primary completion18 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750900
- Sponsor's protocol ID
- Cardenal Herrera University 67
- Other IDs
- PID2020-115609RB-C22
- Acronym
- CLEVER BODY
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 25691362
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Feedback Manipulation in Virtual Reality Alters Movement-evoked Pain Perception in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06750900
- Acronym / sponsor ID
- CLEVER BODY / Cardenal Herrera University 67
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- chronic low back pain, virtual reality, ilusions, movement-evoked pain, visual-proprioceptive feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NORMAL CONDITION | – | Other: NORMAL CONDITIONThe normal condition is measured as a lumbar extension without VR until the onset of pain. |
| UNDERSTATED CONDITION | – | Other: UNDERSTATED CONDITIONIt 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) |
| OVERSTATED CONDITION | – | Other: OVERSTATED CONDITIONIt 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic low back pain
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Diagnosis of a spinal tumor.
- Presence of a spinal infection or fracture.
- Diagnosed systemic diseases.
- Diagnosis of fibromyalgia.
- Presence of cauda equina syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NORMAL CONDITIONThey perform 3 lumbar extensions until the onset of pain without virtual reality | Other | NORMAL CONDITION |
| UNDERSTATED CONDITIONThey 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. | Other | UNDERSTATED CONDITION |
| OVERSTATED CONDITIONThey 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. | Other | OVERSTATED CONDITION |
Primary outcome
MOVEMENT EVOKED PAIN THRESHOLD
Time frame: 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
Time frame: 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)
3 secondary outcomes
Fear of movement
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Catastrophizing
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Disability
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Results publication: PubMed 25691362Harvie 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.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Low-back Pain (cLBP)
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Recruiting
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
Nonspecific Low Back Pain, Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain (cLBP), run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOVEMENT EVOKED PAIN THRESHOLD (time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.