Chronic Low Back Pain (CLBP)CLEVER-BODYNCT06750887
Modifying Lumbar Flexion Pain Thresholds in Chronic LBP Using Virtual Reality and Visual-Proprioceptive Manipulation
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 8 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: 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.
Read the 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)
- Being tested
- Normal condition, Understated condition, OVERSTATED CONDITION
- Keywords
- chronic low back pain, virtual reality, flexion-evoked pain, illusions, central processing
- Medical subject headings
- Illusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal conditionOther
The normal condition IS measured as a lumbar extension without VR until the onset of pain.
Understated conditionOther
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 CONDITIONOther
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)
| Study group | Role | What they receive |
|---|---|---|
| NORMAL CONDITION | The normal condition is measured as a lumbar flexion 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 flexion until the onset of pain and they feel a 20% 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 flexion until the onset of pain and they feel a 20% 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 ROM 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 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
Measured: 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.
Measured: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
Secondary outcomes (1)
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)
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 completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- NCT06750887
- Sponsor's protocol ID
- Cardenal Herrera University 70
- 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 25691362Jordan-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.
PubMed 40537791
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
- Modifying Lumbar Flexion Pain Thresholds in Patients With Chronic Low Back Pain Through Visual-proprioceptive Manipulation With Virtual Reality: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06750887
- Acronym / sponsor ID
- CLEVER-BODY / Cardenal Herrera University 70
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- chronic low back pain, virtual reality, flexion-evoked pain, illusions, central processing
- 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
- 8 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 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.
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 flexion without VR until the onset of pain. |
| UNDERSTATED CONDITION | – | Other: Understated conditionIt 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 | – | Other: OVERSTATED CONDITIONIt 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) |
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 conditionThe normal condition IS measured as a lumbar extension without VR until the onset of pain. | Other | NORMAL CONDITION |
| Understated conditionIt 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 |
| OVERSTATED CONDITIONIt 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 |
Primary outcome
MOVEMENT EVOKED PAIN THRESHOLD
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
The maximum lumbar ROM without pain was measured in each condition using a 3-Space Fastrack motion analysis system.
Pain Interference and Pain Intensity
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
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
Fear of movement
Time frame: Baseline (pre-intervention) and immediately post-intervention (at 50 minutes)
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.
1 secondary outcome
Catastrophizing
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.
- Derived from this study: PubMed 40537791Jordan-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.
- Individual participant dataSharing planned: Yes
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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 3 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 NCT06750887, which also lists 2 linked publications.
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.