Potential of Virtual Reality in Primary Chronic Low Back Pain
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAveiro University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Pain science education and virtual reality
Other interventionThe 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Virtual reality and pain science educationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
Baseline (Day 1)2
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)3
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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)2
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)Sponsors and contacts
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Source ClinicalTrials.gov