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

June 1, 2026 updated by: Irene Torres Sánchez, Universidad de Granada

Effects of 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Granada, Spain, 18016
        • University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality-based high intensity interval training (VR-HIIT) group

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.
Active Comparator: High intensity interval training (HIIT) group

A single session of 70-90 minutes.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, during the intervention and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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
Baseline and 48-72 hours post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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).
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention
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
Baseline and 48-72 hours post-intervention
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.
Baseline and 48-72 hours post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
Adverse events
Time Frame: During the intervention
To measure the number of adverse events that may occur during the intervention.
During the intervention
Pain vigilance
Time Frame: During the intervention
To assess pain vigilance during the intervention with a numeric scale from 0 (none) to 10 (continuously).
During the intervention
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
48-72 hours post-intervention
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.
48-72 hours post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Actual)

May 28, 2026

Study Completion (Actual)

May 28, 2026

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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