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NCT Number: NCT07742111

Potential of Virtual Reality in Primary Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Pain science education and virtual reality

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. pain mechanism

    Time frame: Baseline (day 1)

    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).

  2. pain mechanism

    Time frame: End of the intervention (day 35)

    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).

  3. Pain intensity during movement

    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.

  4. Pain intensity during movement

    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.

  5. Perceived disability

    Time frame: Baseline (day 1)

    Assessed using the Oswestry Disability Index; scores: 0 (minimum to 100 (maximum); higher scores mean higher disability

  6. Perceived disability

    Time frame: End of the intervention (day 35)

    Assessed using the Oswestry Disability Index; scores: 0 (minimum to 100 (maximum); higher scores mean higher disability

  7. Catastrophizing

    Time frame: Baseline (day 1)

    Assessed using the Pain Catastrophizing Scale; score range: 0 (minimum to 52 (maximum); higher scores mean higher catastrophizing.

  8. Catastrophizing

    Time frame: End of the intervention (day 35)

    Assessed using the Pain Catastrophizing Scale; score range: 0 (minimum to 52 (maximum); higher scores mean higher catastrophizing.

  9. Fear of movement

    Time frame: Baseline (day 1)

    Assessed using the Tampa Scale of kinesiophobia; score range: 13 (minimum to 52 (maximum); higher scores mean higher fear of movement.

  10. Fear of movement

    Time frame: End of the intervention (day 35)

    Assessed using the Tampa Scale of kinesiophobia; score range: 13 (minimum to 52 (maximum); higher scores mean higher fear of movement.

  11. Knowledge on pain neurophysiology

    Time frame: Baseline (day 1)

    Assessed using the Neurophysiology of Pain questionnaire; score range: 0 (minimum and 19 (maximum) and higher scores mean better pain knowledge.

  12. Knowledge on pain neurophysiology

    Time frame: End of the intervention (day 35)

    Assessed using the Neurophysiology of Pain questionnaire; score range: 0 (minimum and 19 (maximum) and higher scores mean better pain knowledge.

  13. Global perception of change

    Time frame: End of the intervention (day 35)

    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

Other outcomes

  1. Catastrophizing

    Time frame: Daily (from day 1 to day 35)

    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.

  2. Fear of movemently

    Time frame: Daily (from day 1 to day 35)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anabela Silva, PhD

CONTACT

[email protected]

+351 234247119

Emanuel Leite, BSc

CONTACT

[email protected]

+351 234401558

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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