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

NCT07388134 | Active Not Recruiting

• 1 other identifier: HIIT_DLC
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain (cLBP)

Outcome Measures

Primary Outcomes (5)

• Pain intensity

  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

  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

  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

  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

  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 Outcomes (9)

• Pain intensity and interference

  Baseline and 48-72 hours post-intervention

• Pain vigilance and awareness

  Baseline and 48-72 hours post-intervention

• Pain beliefs

  Baseline and 48-72 hours post-intervention

• Health related quality of life

  Baseline and 48-72 hours post-intervention

• Pain self-efficacy

  Baseline and 48-72 hours post-intervention

Other Outcomes (5)

• Motivation for Treatment

  Baseline

• Treatment-Generated motivation

  48-72 hours post-intervention

• Satisfaction with the intervention

  48-72 hours post-intervention

Study Arms (2)

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

EXPERIMENTAL

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

High intensity interval training (HIIT) group

ACTIVE COMPARATOR

Other: High intensity interval training (HIIT) group

Interventions

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.

High intensity interval training (HIIT) group

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

MeSH Terms

Interventions

Population Groups; High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 4, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

ES (1)