An interventional study of Pain science education and virtual reality in Low Back Pain, sponsored by Aveiro University. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Aveiro University · Not applicable, Interventional, and Treatment
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Aveiro University is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
There is only one arm. Participants will receive pain science education and virtual reality. This is a single case experimental design study.
Other: Pain science education and virtual reality
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: End of the intervention (day 35)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (day 1)
Perceived disability
Assessed using the Oswestry Disability Index; scores: 0 (minimum to 100 (maximum); higher scores mean higher disability
Time frame: 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.
Time frame: Baseline (day 1)
Catastrophizing
Assessed using the Pain Catastrophizing Scale; score range: 0 (minimum to 52 (maximum); higher scores mean higher catastrophizing.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: End of the intervention (day 35)
Catastrophizing
3 items of the Pain Catastrophizing Scale will be used daily (items 1, 2 and 13) each rated using a 5-item Likert scale; total score ranging from 0 (minimum) to 12 (maximum) with higher scores meaning higher catastrophizing.
Time frame: Daily (from day 1 to day 35)
Fear of movemently
3 items of the TAMPA Scale will be used daily (items 1, 3 and 12), each rated using a 4-item Likert scale; total score ranging from 3 (minimum) to 12 (maximum), with higher scores meaning higher fear of movement.
Time frame: Daily (from day 1 to day 35)
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