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Completed

NCT Number: NCT07388134

Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain

One of the most prevalent causes of pain on a global scale is chronic musculoskeletal pain. Low back pain is a prevalent manifestation of chronic musculoskeletal pain.

There are a wide vary of no pharmacologic treatment for chronic pain. From a physiotherapy perspective, the chronic pain management should be oriented towards increasing the self-management of people with chronic pain. The management components in question are therapeutic exercise and education.

High-intensity interval training (HIIT) is a novel therapeutic exercise strategy that has been shown to reduce pain and disability in chronic low back pain. It is a hopeful strategy to enhance motivation to treatment. Pain neuroscience education (PNE) has also been demonstrated to enhance pain and disability in chronic low back pain. Finally, virtual reality (VR) has been demonstrated to be effective in the chronic low back pain management.

Despite the benefits mentioned in these three therapies being isolated, there are no studies that have compared VR-based HIIT (VR-HIIT) with PNE in chronic low back pain. The use of these interventions may increase the intervention benefits. The investigators hypothesise that VR-HIIT with PNE can reduce pain intensity, enhance fear of movement and improve motivation for treatment in chronic low back pain. Therefore, the aim of this study is to evaluate the effects of VR-HIIT with PNE in chronic low back pain.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18016, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults 18-65 years
  • Chronic low back pain
  • Pain intensity ≥ 3 points with the numeric pain rating scale
  • Ability to walk ≥ 15 minutes
  • Wish to participate in the study and sign the informed consent

Exclusion criteria

  • Pregnancy
  • Patients with severe comorbidities that interfere with the ability to perform the study
  • People who are currently participating in another study

Treatment and study plan

Virtual reality based high intensity interval training (VR-HIIT) group

Other

A single session of 70-90 minutes.

  • Pain neuroscience education
  • VR-HIIT. HIIT session will follow the outline: warm-up and HIIT. VR component will be carried out with the Nintendo Switch.

High intensity interval training (HIIT) group

Other

A single session of 70-90 minutes.

  • Pain neuroscience education
  • HIIT. HIIT session will follow the outline: warm-up and HIIT.

Primary outcomes

  1. Pain intensity

    Time frame: Baseline, during the intervention and 48-72 hours post-intervention

    To assess pain intensity using the Numeric Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater intensity.

  2. Pain pressure threshold

    Time frame: Baseline and 48-72 hours post-intervention

    To assess pain pressure threshold. The measurement will be taken in the paravertebral and tibialis anterior muscles with the algometer Force One FPIX 50. The measurement points will be lumbar region bilaterally 5 cm from the spinous processes of L3 and L5; and right tibialis anterior, 5 cm below the tibial tuberosity. The assessor will place the algometer perpendicular and applied increasing pressure. until the pressure became painful. The mean of 3 measurements was recorded.

  3. Pain modulation

    Time frame: Baseline and 48-72 hours post-intervention

    To assess pain modulation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the tibialis anterior muscle and the deltoid muscle. Then the conditioning stimulus will be introduced. A clamp will be placed on the earlobe for 60 seconds. When pain VAS of the earlobe become more than 60 mm, pain pressure threshold will be evaluated again

  4. Fear to movement

    Time frame: Baseline and 48-72 hours post-intervention

    To assess fear to movement using the TAMPA Scale of Kinesiophobia (TSK). Scores range from 1 (totally disagree) to 4 (totally agree). The final score can range between 11 and 44 points. Higher scores indicate greater perceived fear of movement.

  5. Catastrophizing of pain

    Time frame: Baseline and 48-72 hours post-intervention

    To assess catastrophizing of pain using the Pain Catastrophizing Scale (PCS). Scores range from 0 (nothing at all) to 4 (all the time). The final score range from 0 to 52. Higher scores indicate greater levels of catastrophism

Secondary outcomes

  1. Pain intensity and interference

    Time frame: Baseline and 48-72 hours post-intervention

    To assess pain intensity and interference using the Brief Pain Inventory (BPI). Scores range from 0 (no pain/does not interfere) to 10 (worst pain imaginable/completely interferes). Higher scores indicate greater intensity and interference.

  2. Pain vigilance and awareness

    Time frame: Baseline and 48-72 hours post-intervention

    To assess awareness, consciousness, vigilance and observation of pain using the Pain Vigilance and Awareness Questionnaire (PVAQ). Scores range from 0 (never) to 5 (always). The total scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.

  3. Pain beliefs

    Time frame: Baseline and 48-72 hours post-intervention

    To assess fear and avoidance beliefs using Fear and Avoidance Beliefs Questionnaire (FABQ). Scores range from 0 (totally disagree) to 6 (totally agree). The total score range from 0 to 96. Higher scores indicate a higher degree of fear avoidance beliefs.

  4. Health related quality of life

    Time frame: Baseline and 48-72 hours post-intervention

    To assess quality of life using the EuroQol-5D. Total score range from 1 (best health status) to 0 (death). The second part of the euroqol-5d is visual analogue scale that goes from 0 (worst state of health imaginable) to 100 (best state of health imaginable).

  5. Pain self-efficacy

    Time frame: Baseline and 48-72 hours post-intervention

    To assess pain-self efficacy using 10 items Pain Self-Efficacy Questionnaire (10-PSEQ). Scores range from 0 (not at all confident) and 6 (completely confident). A total score range from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.

  6. Sleep quality

    Time frame: Baseline and 48-72 hours post-intervention

    To assess sleep quality using a numeric scale from 0 (worst sleep quality) to 10 (best sleep quality). Higher scores indicate greater sleep quality

  7. Disability

    Time frame: Baseline and 48-72 hours post-intervention

    To assess disability using the Oswestry Disability Index (ODI). Total scores range from 0% (no limitation) to 100% (maximum functional limitation). Higher scores indicate higher levels of disability.

  8. Functional status

    Time frame: Baseline and 48-72 hours post-intervention

    To assess functional status using the Patient-Specific Functioning Scale (PSFS). Scores range from 0 to 10. Higher scores indicating better functional status

  9. Mobility

    Time frame: Baseline and 48-72 hours post-intervention

    To assess mobility using the Fingertip-to-Floor test. It will be used to examine the ability to bend forward while standing, measuring the distance between the tip of the longest finger and the floor. Lower scores are associated with decreased symptoms across all outcome measures.

Other outcomes

  1. Motivation for Treatment

    Time frame: Baseline

    To assess motivation to treatment with the 15-item Treatment Self-Regulation Questionnaire (TSRQ). Scores range from 1 to 7 per item. Higher scores indicate greater motivation

  2. Treatment-Generated motivation

    Time frame: 48-72 hours post-intervention

    To assess treatment-generated motivation with the 22-item Intrinsic Motivation Inventory (IMI). Scores range from 1 to 7 per item. Higher scores indicate greater motivation

  3. Satisfaction with the intervention

    Time frame: 48-72 hours post-intervention

    To assess satisfaction with the intervention with numeric scale from 0 (no satisfaction) to 10 (completely satisfaction). Higer scores indicate higher levels of satisfaction.

  4. Adverse events

    Time frame: During the intervention

    To measure the number of adverse events that may occur during the intervention.

  5. Pain vigilance

    Time frame: During the intervention

    To assess pain vigilance during the intervention with a numeric scale from 0 (none) to 10 (continuously).

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Effects of Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Jun 2, 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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