Chronic Low-back Pain (cLBP)NCT07388134
Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain
A study testing Virtual reality based high intensity interval training (VR-HIIT) group and High intensity interval training (HIIT) group in people with Chronic Low-back Pain (cLBP), run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Virtual reality based high intensity interval training (VR-HIIT) group and High intensity interval training (HIIT) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2026to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Patients with severe comorbidities that interfere with the ability to perform the study
- People who are currently participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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)
- Being tested
- Virtual reality based high intensity interval training (VR-HIIT) group, High intensity interval training (HIIT) group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based high intensity interval training (VR-HIIT) groupOther
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) groupOther
A single session of 70-90 minutes.
- Pain neuroscience education
- HIIT. HIIT session will follow the outline: warm-up and HIIT.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-based high intensity interval training (VR-HIIT) group | Experimental | Not described Receives: Other: Virtual reality based high intensity interval training (VR-HIIT) group |
| High intensity interval training (HIIT) group | Active comparator | Not described Receives: Other: High intensity interval training (HIIT) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline and 48-72 hours post-intervention
Secondary outcomes (9)
Pain intensity and interference
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.
Measured: Baseline and 48-72 hours post-intervention
Pain vigilance and awareness
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.
Measured: Baseline and 48-72 hours post-intervention
Pain beliefs
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.
Measured: Baseline and 48-72 hours post-intervention
Health related quality of life
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).
Measured: Baseline and 48-72 hours post-intervention
Pain self-efficacy
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.
Measured: Baseline and 48-72 hours post-intervention
Sleep quality
To assess sleep quality using a numeric scale from 0 (worst sleep quality) to 10 (best sleep quality). Higher scores indicate greater sleep quality
Measured: Baseline and 48-72 hours post-intervention
Disability
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.
Measured: Baseline and 48-72 hours post-intervention
Functional status
To assess functional status using the Patient-Specific Functioning Scale (PSFS). Scores range from 0 to 10. Higher scores indicating better functional status
Measured: Baseline and 48-72 hours post-intervention
Mobility
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.
Measured: Baseline and 48-72 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start9 Feb 2026
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Torres Sánchez, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388134
- Sponsor's protocol ID
- HIIT_DLC
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07388134
- Acronym / sponsor ID
- HIIT_DLC
- Conditions
- Chronic Low-back Pain (cLBP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Patients with severe comorbidities that interfere with the ability to perform the study
- People who are currently participating in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality based high intensity interval training (VR-HIIT) groupA 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. | Other | Virtual reality-based high intensity interval training (VR-HIIT) group |
| High intensity interval training (HIIT) groupA single session of 70-90 minutes. * Pain neuroscience education * HIIT. HIIT session will follow the outline: warm-up and HIIT. | Other | High intensity interval training (HIIT) group |
Primary outcome
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.
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.
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
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.
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
9 secondary outcomes
Pain intensity and interference
Time frame: Baseline and 48-72 hours post-intervention
Pain vigilance and awareness
Time frame: Baseline and 48-72 hours post-intervention
Pain beliefs
Time frame: Baseline and 48-72 hours post-intervention
Health related quality of life
Time frame: Baseline and 48-72 hours post-intervention
Pain self-efficacy
Time frame: Baseline and 48-72 hours post-intervention
Sleep quality
Time frame: Baseline and 48-72 hours post-intervention
Disability
Time frame: Baseline and 48-72 hours post-intervention
Functional status
Time frame: Baseline and 48-72 hours post-intervention
Mobility
Time frame: Baseline and 48-72 hours post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based high intensity interval training (VR-HIIT) group and High intensity interval training (HIIT) group in people with Chronic Low-back Pain (cLBP), run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, during the intervention and 48-72 hours post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.