Potential of Virtual Reality in Primary Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain science education and virtual reality.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Pain intensity [Time frame: Baseline (Day 1)]
- Pain intensity [Time frame: Daily (from day 1 to day 35)]
- Pain intensity [Time frame: End of the intervention (day 35)]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- have a diagnosed psychiatric disorder;
- have a malignant disease;
- have serious cardiac conditions;
- have contraindications to physical exercise in general;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- General Community — Amarante
Identifiers
NCT: NCT07742111 · 25-CEIC-UA/2025-M