Low Back PainCLEVER-BODYNCT05838924
Changing Lower Back Pain Through Virtual Reality
A study testing PHYSICAL ACTIVITY + VIRTUAL REALITY and PHYSICAL ACTIVITY in people with Low Back Pain, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- PHYSICAL ACTIVITY + VIRTUAL REALITY and PHYSICAL ACTIVITY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2023to 15 Dec 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
- Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.
Who cannot join
- Presence of spinal tumor.
- Presence of infection.
- Presence of fracture.
- Presence of systemic disease.
- Presence of fibromyalgia.
- Presence of cauda equina syndrome.
- Previous spinal surgery.
- Presence of musculoskeletal injuries of the lower extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial
The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
Read the detailed description
Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
- Conditions
- Low Back Pain
- Being tested
- PHYSICAL ACTIVITY + VIRTUAL REALITY, PHYSICAL ACTIVITY
- Keywords
- Virtual Reality, Physical Activity, Range of movement, Pain, Disability, Kinesophobia
- Medical subject headings
- Low Back Pain, Motor Activity, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHYSICAL ACTIVITY + VIRTUAL REALITYOther
The VR therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 VR exercises of "Back School" by manipulating visual proprioceptive information during all lumbar movements. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually.
PHYSICAL ACTIVITYOther
The 8 therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 exercises of "Back School" without VR. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity + Virtual Reality | Experimental | A program of 8 VR exercises will be applied, of a therapeutic nature, based on the applied exercises of the "Back School", aimed at gaining strength, stability, mobility and flexibility of the abdomino-lumbo-pelvic region and the lower extremities. For each exercise, the VR goggles will manipulate the visual proprioceptive information by modifying the perceived degree of lumbar flexion and extension, i.e., in the VR goggles they will perceive that your movements are different from what you are actually doing. Receives: Other: PHYSICAL ACTIVITY + VIRTUAL REALITY |
| Physical Activity | Active comparator | The same therapeutic exercise program will be applied as the experimental group, but without VR. The training methodology and progression of loads, evaluations and supervision by the physiotherapist will also be the same. Receives: Other: PHYSICAL ACTIVITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.
Measured: At six weeks
Range of movement
Measured with an electrogoniometer
Measured: At six weeks
Disability
Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.
Measured: At six weeks
Secondary outcomes (5)
Physical activity
Measured with the International Physical Activity Questionnaire (short-form). This is a 7-item scale used to assess physical activity. Results are divided into different activity levels (low or inactive, moderate, and high activity), and scores are obtained by multiplying the duration of physical activity by the intensity of a task that is metabolically equivalent for each activity level in the last 7 days.
Measured: At six weeks
The Quality of life
Measured with the Euro Quality of life five dimensions with five levels questionnaire (-0.59 to 1.0). Higher scores mean a better quality of life.
Measured: At six weeks
Kinesophobia
Measured with the Fear Avoidance Beliefs Questionnaire
Measured: At six weeks
Catastrophizing
Measured with the Pain Catastrophizing Scale (0-52 points). Higher scores indicate higher levels of fear-avoidance beliefs.
Measured: At six weeks
Physical capacity
Measured with the Sit-to-Stand 60 test. The STS-60 measures the number of times an individual can sit and stand up from a chair in 60 seconds. Higher number of repetitions indicate higher physical capacity.
Measured: At six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start25 Apr 2023
- Primary completion1 Dec 2023
- Study completion15 Dec 2023
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 Low Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- Investigators
- JUAN JOSÉ AMER-CUENCA, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838924
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-63
- Acronym
- CLEVER-BODY
- Status last verified
- Feb 2025
- First submitted
- 3 Apr 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Lower Back Pain Through Virtual Reality: a Randomised Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT05838924
- Acronym / sponsor ID
- CLEVER-BODY / UNIVERSITY CARDENAL HERRERA-63
- Conditions
- Low Back Pain
- Keywords
- Virtual Reality, Physical Activity, Range of movement, Pain, Disability, Kinesophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 3 May 2023 (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.
The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
Detailed description
Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity + Virtual Reality | Experimental | Other: PHYSICAL ACTIVITY + VIRTUAL REALITYA program of 8 VR exercises will be applied, of a therapeutic nature, based on the applied exercises of the "Back School", aimed at gaining strength, stability, mobility and flexibility of the abdomino-lumbo-pelvic region and the lower extremities. For each exercise, the VR goggles will manipulate the visual proprioceptive information by modifying the perceived degree of lumbar flexion and extension, i.e., in the VR goggles they will perceive that your movements are different from what you are actually doing. |
| Physical Activity | Active comparator | Other: PHYSICAL ACTIVITYThe same therapeutic exercise program will be applied as the experimental group, but without VR. The training methodology and progression of loads, evaluations and supervision by the physiotherapist will also be the same. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
- Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.
Key exclusion criteria (8 listed)
- Presence of spinal tumor.
- Presence of infection.
- Presence of fracture.
- Presence of systemic disease.
- Presence of fibromyalgia.
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 |
|---|---|---|
| PHYSICAL ACTIVITY + VIRTUAL REALITYThe VR therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 VR exercises of "Back School" by manipulating visual proprioceptive information during all lumbar movements. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually. | Other | Physical Activity + Virtual Reality |
| PHYSICAL ACTIVITYThe 8 therapeutic exercise program will be implemented for 6 weeks at a frequency of 2 sessions per week with the aim of improving pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness. This group will perform the 8 exercises of "Back School" without VR. They will be performed in 2 sets whose intensity and repetitions will be configured and individualized by a self-reported rating of perceived exertion (RPE) through the Borg 6-20 scale. The appropriate training intensity is established with an RPE score between 13 and 17; for this reason, the first 2 weeks will work at an RPE of 14, the 3rd and 4th weeks at an RPE of 15; and finally, the last 2 weeks will work at an RPE of 16. The first 3 weeks will work without additional load, and the last 3 weeks will work with weights, increasing their weekly load individually. | Other | Physical Activity |
Primary outcome
Low back pain
Time frame: At six weeks
Measured with a Visual Analogue Scale (0-10 points). Higher scores mean a worse pain.
Range of movement
Time frame: At six weeks
Measured with an electrogoniometer
Disability
Time frame: At six weeks
Measured with the Roland Morris Questionnaire (0-24 points). Higher scores mean a worse disability.
5 secondary outcomes
Physical activity
Time frame: At six weeks
The Quality of life
Time frame: At six weeks
Kinesophobia
Time frame: At six weeks
Catastrophizing
Time frame: At six weeks
Physical capacity
Time frame: At six weeks
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 12 Feb 2025.
- Background: 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: No
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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.
JUAN JOSÉ AMER-CUENCA, PhD principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHYSICAL ACTIVITY + VIRTUAL REALITY and PHYSICAL ACTIVITY in people with Low Back Pain, 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 2 inclusion and 8 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 12 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?
Low back pain (time frame: At six weeks). 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 NCT05838924, 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 12 Feb 2025.