Low Back PainNCT07742111
Potential of Virtual Reality in Primary Chronic Low Back Pain
A study testing Pain science education and virtual reality in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
Trial summary
This is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain science education and virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with primary chronic low back pain aged ≥18 years, who present a moderate pain intensity (≥4 on the Numeric Pain Rating Scale) and a mild level of fear of movement.
Who cannot join
- have a diagnosis of spondylolisthesis or lumbar spinal stenosis;
- are experiencing an exacerbation of low back pain symptoms at the time of screening;
- present with constant and widespread nonspecific pain;
- are in an active phase of rheumatoid arthritis;
- have a progressive neurological disease;
- are currently pregnant or within 6 months postpartum;
Show all 10Show fewer
- have a diagnosed psychiatric disorder;
- have a malignant disease;
- have serious cardiac conditions;
- have contraindications to physical exercise in general;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
General Community
Amarante, 4600
Emanuel Leite, BSc, +351 234401558, emanuelleite@ua.pt
About this study
This is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks.
Read the detailed description
The main objective of this study is to evaluate the potential of virtual reality in reducing pain intensity in individuals with primary chronic low back pain. Secondary objectives include analysing the impact of virtual reality on pain catastrophizing and fear of movement, as well as exploring participants' perspectives on the integration of virtual reality into the intervention plan.
The study will be divided into three phases: baseline assessment, intervention, and post-intervention assessment. The baseline assessment phase will have a different duration for each participant.
At baseline, participants will complete several paper-based questionnaires (sociodemographic and anthropometric data; pain location, intensity and characteristics; pain catastrophizing; fear of movement; pain during movement; and pain-related disability). After completing all questionnaires, participants will receive a paper diary to complete daily at home. This diary will record information such as pain intensity, fear of movement, and pain catastrophizing.
Participants will return to the office only on the first day of the intervention phase, which will coincide with the first session. Sessions will be individual, will last between 30 and 45 minutes, and will take place with an interval of one to two days. The intervention phase will end on the 29th day of the study for all participants and consists of pain science education and virtual reality.
On the final day of the study (i.e., the 35th day), participants will complete the same questionnaires administered at baseline, with the addition of the Global Perceived Effect scale. At that time, the diary provided at the beginning of the study will be collected.
- Conditions
- Low Back Pain
- Being tested
- Pain science education and virtual reality
- Keywords
- Low back pain, Virtual reality, Pain science education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain science education and virtual realityOther
The intervention period will take place between the 5th and the 29th day of the study (i.e., 3 weeks), noting that each participant will have a specific day to start the intervention. Three sessions will be conducted per week, with a total of 6 to 10 sessions per participant. The first 6 sessions will last 45 minutes, and the remaining 4 sessions will last 30 minutes.
The sessions will combine Pain Neuroscience Education (PNE) and Virtual Reality (VR) using the Meta Quest 3S.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and pain science education | Experimental | There is only one arm. Participants will receive pain science education and virtual reality.
This is a single case experimental design study. Receives: Other: Pain science education and virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Measured: Baseline (Day 1)
Pain intensity
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Measured: Daily (from day 1 to day 35)
Pain intensity
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Measured: End of the intervention (day 35)
Secondary outcomes (13)
pain mechanism
Assessed using the PainDetect questionnaire; range score: -1 (minimum) to 38 (maximum); scores are interpreted as a neuropathic component is unlikely (<12), result is ambiguous (13-18) and neuropathic component is likely (>19).
Measured: Baseline (day 1)
pain mechanism
Assessed using the PainDetect questionnaire; -1 (minimum) to 38 (maximum); scores are interpreted as a neuropathic component is unlikely (<12), result is ambiguous (13-18) and neuropathic component is likely (>19).
Measured: End of the intervention (day 35)
Pain intensity during movement
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Measured: Baseline (day 1)
Pain intensity during movement
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Measured: End of the intervention (day 35)
Perceived disability
Assessed using the Oswestry Disability Index; scores: 0 (minimum to 100 (maximum); higher scores mean higher disability
Measured: Baseline (day 1)
Perceived disability
Assessed using the Oswestry Disability Index; scores: 0 (minimum to 100 (maximum); higher scores mean higher disability
Measured: End of the intervention (day 35)
Catastrophizing
Assessed using the Pain Catastrophizing Scale; score range: 0 (minimum to 52 (maximum); higher scores mean higher catastrophizing.
Measured: Baseline (day 1)
Catastrophizing
Assessed using the Pain Catastrophizing Scale; score range: 0 (minimum to 52 (maximum); higher scores mean higher catastrophizing.
Measured: End of the intervention (day 35)
Fear of movement
Assessed using the Tampa Scale of kinesiophobia; score range: 13 (minimum to 52 (maximum); higher scores mean higher fear of movement.
Measured: Baseline (day 1)
Fear of movement
Assessed using the Tampa Scale of kinesiophobia; score range: 13 (minimum to 52 (maximum); higher scores mean higher fear of movement.
Measured: End of the intervention (day 35)
Knowledge on pain neurophysiology
Assessed using the Neurophysiology of Pain questionnaire; score range: 0 (minimum and 19 (maximum) and higher scores mean better pain knowledge.
Measured: Baseline (day 1)
Knowledge on pain neurophysiology
Assessed using the Neurophysiology of Pain questionnaire; score range: 0 (minimum and 19 (maximum) and higher scores mean better pain knowledge.
Measured: End of the intervention (day 35)
Global perception of change
Assessed using the Global Rating of Change Scale, which has 7 itens (1 = no changes; 2 = almost the same; 3 = slightly better; 4 = with some improvements; 5 = moderately better; 6 = better; and 7 = much better)and higher scores mean higher perceived improvement
Measured: End of the intervention (day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single case experimental design study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Study chair, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742111
- Sponsor's protocol ID
- 25-CEIC-UA/2025-M
- Status last verified
- Jul 2026
- First submitted
- 9 Apr 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Virtual Reality in Primary Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07742111
- Acronym / sponsor ID
- 25-CEIC-UA/2025-M
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Virtual reality, Pain science education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 Aug 2026 (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 is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks.
Detailed description
The main objective of this study is to evaluate the potential of virtual reality in reducing pain intensity in individuals with primary chronic low back pain. Secondary objectives include analysing the impact of virtual reality on pain catastrophizing and fear of movement, as well as exploring participants' perspectives on the integration of virtual reality into the intervention plan.
The study will be divided into three phases: baseline assessment, intervention, and post-intervention assessment. The baseline assessment phase will have a different duration for each participant.
At baseline, participants will complete several paper-based questionnaires (sociodemographic and anthropometric data; pain location, intensity and characteristics; pain catastrophizing; fear of movement; pain during movement; and pain-related disability). After completing all questionnaires, participants will receive a paper diary to complete daily at home. This diary will record information such as pain intensity, fear of movement, and pain catastrophizing.
Participants will return to the office only on the first day of the intervention phase, which will coincide with the first session. Sessions will be individual, will last between 30 and 45 minutes, and will take place with an interval of one to two days. The intervention phase will end on the 29th day of the study for all participants and consists of pain science education and virtual reality.
On the final day of the study (i.e., the 35th day), participants will complete the same questionnaires administered at baseline, with the addition of the Global Perceived Effect scale. At that time, the diary provided at the beginning of the study will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental design study
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and pain science education | Experimental | Other: Pain science education and virtual realityThere is only one arm. Participants will receive pain science education and virtual reality. This is a single case experimental design study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with primary chronic low back pain aged ≥18 years, who present a moderate pain intensity (≥4 on the Numeric Pain Rating Scale) and a mild level of fear of movement.
Key exclusion criteria (10 listed)
- have a diagnosis of spondylolisthesis or lumbar spinal stenosis;
- are experiencing an exacerbation of low back pain symptoms at the time of screening;
- present with constant and widespread nonspecific pain;
- are in an active phase of rheumatoid arthritis;
- have a progressive neurological disease;
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 |
|---|---|---|
| Pain science education and virtual realityThe intervention period will take place between the 5th and the 29th day of the study (i.e., 3 weeks), noting that each participant will have a specific day to start the intervention. Three sessions will be conducted per week, with a total of 6 to 10 sessions per participant. The first 6 sessions will last 45 minutes, and the remaining 4 sessions will last 30 minutes. The sessions will combine Pain Neuroscience Education (PNE) and Virtual Reality (VR) using the Meta Quest 3S. | Other | Virtual reality and pain science education |
Primary outcome
Pain intensity
Time frame: Baseline (Day 1)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Pain intensity
Time frame: Daily (from day 1 to day 35)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Pain intensity
Time frame: End of the intervention (day 35)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
13 secondary outcomes
pain mechanism
Time frame: Baseline (day 1)
pain mechanism
Time frame: End of the intervention (day 35)
Pain intensity during movement
Time frame: Baseline (day 1)
Pain intensity during movement
Time frame: End of the intervention (day 35)
Perceived disability
Time frame: Baseline (day 1)
Perceived disability
Time frame: End of the intervention (day 35)
Catastrophizing
Time frame: Baseline (day 1)
Catastrophizing
Time frame: End of the intervention (day 35)
Fear of movement
Time frame: Baseline (day 1)
Fear of movement
Time frame: End of the intervention (day 35)
Knowledge on pain neurophysiology
Time frame: Baseline (day 1)
Knowledge on pain neurophysiology
Time frame: End of the intervention (day 35)
Global perception of change
Time frame: End of the intervention (day 35)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
Anabela Silva, PhD study chair
University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain science education and virtual reality in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anabela Silva, PhD (+351 234247119, asilva@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline (Day 1)). 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?
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 3 Aug 2026.