Chronic Low-back PainNCT06410027
Effects of Pain Neuroscience Education and Virtual Reality in Patients With Chronic Low Back Pain
A study testing Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise and Therapeutic Exercise in people with Chronic Low-back Pain, run by Universidad de Granada at 2 sites in Spain.
Trial summary
The objective of our study is to evaluate the effects of a therapeutic intervention including 1-hour of pain neuroscience education session, 30-minutes of exposure to exercise with virtual realit and therapeutic exercise in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise and Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Apr 2024to 31 Jan 2025
- 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
- Chronic musculoskeletal pain (≥ 3 months)
- Adults (≥ 18 years and less than 65 years)
- Score ≤18 points in Pain Detect Scale
- Wish to participate in the study and sign the informed consent
- Speaking Spanish
Who cannot join
- Neuropathic pain (score >18 in Pain Detect Scale)
- Physical or psychological pathology of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.
Trial locations and contacts
2 sites in 1 country.
About this study
The objective of our study is to evaluate the effects of a therapeutic intervention including
1-hour of pain neuroscience education session, 30-minutes of exposure to exercise with virtual realit and therapeutic exercise in patients with chronic low back pain.
Read the detailed description
Chronic low back pain is the world's leading cause of years of life lived with disability. Negative thoughts and beliefs about pain experienced can lead to pain avoidance behaviours. Fear of movement is a common behaviour in this type of patients and is associated with avoidance of exercise. Virtual reality is a powerful distraction technique as it directs the patient's attention to an external stimulus rather than pain or body movement. Therefore, it can be beneficial to avoid some pain-related problems, such as kinesiophobia and inactivity. Moreover, pain neuroscience education aim to reconceptualise pain perceptions, beliefs, and avoidance behaviours. Then, the use of these interventions may be beneficial in the treatment of patients with chronic low back pain.
The objective of this study is to evaluate the effects of a therapeutic intervention using pain neuroscience education and virtual reality in patients with chronic low back pain.
- Conditions
- Chronic Low-back Pain
- Being tested
- Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise, Therapeutic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education + Virtual Reality + Therapeutic ExerciseOther
Patients will receive 1-hour pain neuroscience education session + 30-minutes exposure to exercise with virtual reality + therapeutic exercise
Therapeutic ExerciseOther
Patients will receive therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise | Experimental | 1-hour pain neuroscience education session + 30-minutes exposure to exercise with virtual reality + Therapeutic Exercise Receives: Other: Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise |
| Therapeutic Exercise | Active comparator | Therapeutic Exercise Receives: Other: Therapeutic Exercise |
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: Pre-intervention
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: 48-72h after the intervention
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: Pre-intervention
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: 48-72h after the intervention
Neurophysiology of Pain
To assess neurophysiology of pain using the Neurophysiology of Pain Questionnaire (NPQ). Scores range from 0 to 13 (sum of all correct items).
Measured: Pre-intervention
Neurophysiology of Pain
To assess neurophysiology of pain using the Neurophysiology of Pain Questionnaire (NPQ). Scores range from 0 to 13 (sum of all correct items).
Measured: 48-72h after the 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 is calculated by summing the scores for each of the 10 items, yielding a maximum possible score of 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: Pre-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 is calculated by summing the scores for each of the 10 items, yielding a maximum possible score of 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: 48-72h after the intervention
Awareness, Consciousness, Vigilance and Observation of pain
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 questionnaire scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.
Measured: Pre-intervention
Awareness, Consciousness, Vigilance and Observation of pain
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 questionnaire scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.
Measured: 48-72h after the 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 between 0 and 52 points, with higher scores indicating greater levels of catastrophism.
Measured: Pre-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 between 0 and 52 points, with higher scores indicating greater levels of catastrophism.
Measured: 48-72h after the intervention
Fear and avoidance 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, with a higher value reflecting a higher degree of fear avoidance beliefs.
Measured: Pre-intervention
Fear and avoidance 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, with a higher value reflecting a higher degree of fear avoidance beliefs.
Measured: 48-72h after the intervention
Kinesiophobia
To assess kinesiophobia 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, with higher scores indicating greater perceived kinesiophobia.
Measured: Pre-intervention
Kinesiophobia
To assess kinesiophobia 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, with higher scores indicating greater perceived kinesiophobia.
Measured: 48-72h after the intervention
Health-related Quality of Life
To assess health-related 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: Pre-intervention
Health-related Quality of Life
To assess health-related 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: 48-72h after the intervention
Algometry
To assess pain pressure threshold using algometer Force One FPIX 50. With the patient sitting in a comfortable position, the different bilateral points where sensitivity is to be evaluated will be marked on the skin. The chosen points are the nail phalanx of the thumb, the gracilis muscle at its insertion, the second rib, the supraspinatus muscle, and the middle portion of the trapezius. In the order described, pressure will be applied perpendicular to the point at a speed of 1 kg/sec until the patient stops the test when the sensation is no longer just "contact", but "discomfort". 3 repetitions will be done, leaving 1 minute between each of them and the average value will be calculated.
Measured: Pre-intervention
Algometry
To assess pain pressure threshold using algometer Force One FPIX 50. With the patient sitting in a comfortable position, the different bilateral points where sensitivity is to be evaluated will be marked on the skin. The chosen points are the nail phalanx of the thumb, the gracilis muscle at its insertion, the second rib, the supraspinatus muscle, and the middle portion of the trapezius. In the order described, pressure will be applied perpendicular to the point at a speed of 1 kg/sec until the patient stops the test when the sensation is no longer just "contact", but "discomfort". 3 repetitions will be done, leaving 1 minute between each of them and the average value will be calculated.
Measured: 48-72h after the intervention
Temporal summation
To assess temporal summation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the flexor digitorum muscle in both forearms. The average of both measurements will be calculated. A series of 15 stimuli will be presented to one arm at an interstimulus interval of 3s and then to the other arm at an interstimulus interval of 5s, separated by a 30s interseries interval. After a short break, the series of stimuli will be repeated in reverse order. Patients will be instructed to provide numerical ratings of the magnitude of the sensation experienced during the first, fifth, tenth, and fifteenth period after repeated brief taps. They will be also asked to report on the magnitude of after-sensations present 15 and 60 s after the last stimulus in each series.
Measured: Pre-intervention
Temporal summation
To assess temporal summation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the flexor digitorum muscle in both forearms. The average of both measurements will be calculated. A series of 15 stimuli will be presented to one arm at an interstimulus interval of 3s and then to the other arm at an interstimulus interval of 5s, separated by a 30s interseries interval. After a short break, the series of stimuli will be repeated in reverse order. Patients will be instructed to provide numerical ratings of the magnitude of the sensation experienced during the first, fifth, tenth, and fifteenth period after repeated brief taps. They will be also asked to report on the magnitude of after-sensations present 15 and 60 s after the last stimulus in each series.
Measured: 48-72h after the intervention
Chronic 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: Pre-intervention
Chronic 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: 48-72h after the intervention
Electromyography
To assess muscular activity using electromyography with Biosignalplux device (Research Kit Biosignalplux, PLUX Wireless Biosignal S.A). A functional task and flexion-relaxion fenomenon will be evaluated.
Measured: Pre-intervention
Electromyography
To assess muscular activity using electromyography with Biosignalplux device (Research Kit Biosignalplux, PLUX Wireless Biosignal S.A). A functional task and flexion-relaxion fenomenon will be evaluated.
Measured: 48-72h after the intervention
Secondary outcomes (3)
Central Sensitization
To identify when a patient's symptoms may be related to central sensitization using Central Sensitization Inventory (CSI). Responses are recorded for the frequency of each symptom on a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100. Higher scores are associated with a higher degree of self-reported symptomatology.
Measured: Pre-intervention
Disability
To assess disability using the Oswestry Disability Index (ODI). Total scores range from 0% (no limitation) to 100% (maximum functional limitation).
Measured: Pre-intervention
Physical activity
To assess physical activity using the International Physical Activity Questionnaire. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in Metabolic Equivalent (MET)-min/week and time spent sitting.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start20 Apr 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies 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
- 40 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
- Investigators
- Irene Torres Sánchez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410027
- Sponsor's protocol ID
- DLCRV-01
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 27 Jan 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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education and Virtual Reality in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06410027
- Acronym / sponsor ID
- DLCRV-01
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 May 2024 (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.
The objective of our study is to evaluate the effects of a therapeutic intervention including
1-hour of pain neuroscience education session, 30-minutes of exposure to exercise with virtual realit and therapeutic exercise in patients with chronic low back pain.
Detailed description
Chronic low back pain is the world's leading cause of years of life lived with disability. Negative thoughts and beliefs about pain experienced can lead to pain avoidance behaviours. Fear of movement is a common behaviour in this type of patients and is associated with avoidance of exercise. Virtual reality is a powerful distraction technique as it directs the patient's attention to an external stimulus rather than pain or body movement. Therefore, it can be beneficial to avoid some pain-related problems, such as kinesiophobia and inactivity. Moreover, pain neuroscience education aim to reconceptualise pain perceptions, beliefs, and avoidance behaviours. Then, the use of these interventions may be beneficial in the treatment of patients with chronic low back pain.
The objective of this study is to evaluate the effects of a therapeutic intervention using pain neuroscience education and virtual reality in patients with 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 |
|---|---|---|
| Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise | Experimental | Other: Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise1-hour pain neuroscience education session + 30-minutes exposure to exercise with virtual reality + Therapeutic Exercise |
| Therapeutic Exercise | Active comparator | Other: Therapeutic ExerciseTherapeutic Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic musculoskeletal pain (≥ 3 months)
- Adults (≥ 18 years and less than 65 years)
- Score ≤18 points in Pain Detect Scale
- Wish to participate in the study and sign the informed consent
- Speaking Spanish
Key exclusion criteria (2 listed)
- Neuropathic pain (score >18 in Pain Detect Scale)
- Physical or psychological pathology of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.
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 |
|---|---|---|
| Pain Neuroscience Education + Virtual Reality + Therapeutic ExercisePatients will receive 1-hour pain neuroscience education session + 30-minutes exposure to exercise with virtual reality + therapeutic exercise | Other | Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise |
| Therapeutic ExercisePatients will receive therapeutic exercise | Other | Therapeutic Exercise |
Primary outcome
Pain Intensity
Time frame: Pre-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 Intensity
Time frame: 48-72h after the 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 Intensity and Interference
Time frame: Pre-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.
Pain Intensity and Interference
Time frame: 48-72h after the 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.
Neurophysiology of Pain
Time frame: Pre-intervention
To assess neurophysiology of pain using the Neurophysiology of Pain Questionnaire (NPQ). Scores range from 0 to 13 (sum of all correct items).
Neurophysiology of Pain
Time frame: 48-72h after the intervention
To assess neurophysiology of pain using the Neurophysiology of Pain Questionnaire (NPQ). Scores range from 0 to 13 (sum of all correct items).
Pain-Self Efficacy
Time frame: Pre-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 is calculated by summing the scores for each of the 10 items, yielding a maximum possible score of 60. Higher scores reflect stronger self-efficacy beliefs.
Pain-Self Efficacy
Time frame: 48-72h after the 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 is calculated by summing the scores for each of the 10 items, yielding a maximum possible score of 60. Higher scores reflect stronger self-efficacy beliefs.
Awareness, Consciousness, Vigilance and Observation of pain
Time frame: Pre-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 questionnaire scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.
Awareness, Consciousness, Vigilance and Observation of pain
Time frame: 48-72h after the 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 questionnaire scores range between 0 and 80. Higher scores indicate greater awareness, consciousness, vigilance and observation of pain.
Catastrophizing of pain
Time frame: Pre-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 between 0 and 52 points, with higher scores indicating greater levels of catastrophism.
Catastrophizing of pain
Time frame: 48-72h after the 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 between 0 and 52 points, with higher scores indicating greater levels of catastrophism.
Fear and avoidance beliefs
Time frame: Pre-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, with a higher value reflecting a higher degree of fear avoidance beliefs.
Fear and avoidance beliefs
Time frame: 48-72h after the 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, with a higher value reflecting a higher degree of fear avoidance beliefs.
Kinesiophobia
Time frame: Pre-intervention
To assess kinesiophobia 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, with higher scores indicating greater perceived kinesiophobia.
Kinesiophobia
Time frame: 48-72h after the intervention
To assess kinesiophobia 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, with higher scores indicating greater perceived kinesiophobia.
Health-related Quality of Life
Time frame: Pre-intervention
To assess health-related 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).
Health-related Quality of Life
Time frame: 48-72h after the intervention
To assess health-related 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).
Algometry
Time frame: Pre-intervention
To assess pain pressure threshold using algometer Force One FPIX 50. With the patient sitting in a comfortable position, the different bilateral points where sensitivity is to be evaluated will be marked on the skin. The chosen points are the nail phalanx of the thumb, the gracilis muscle at its insertion, the second rib, the supraspinatus muscle, and the middle portion of the trapezius. In the order described, pressure will be applied perpendicular to the point at a speed of 1 kg/sec until the patient stops the test when the sensation is no longer just "contact", but "discomfort". 3 repetitions will be done, leaving 1 minute between each of them and the average value will be calculated.
Algometry
Time frame: 48-72h after the intervention
To assess pain pressure threshold using algometer Force One FPIX 50. With the patient sitting in a comfortable position, the different bilateral points where sensitivity is to be evaluated will be marked on the skin. The chosen points are the nail phalanx of the thumb, the gracilis muscle at its insertion, the second rib, the supraspinatus muscle, and the middle portion of the trapezius. In the order described, pressure will be applied perpendicular to the point at a speed of 1 kg/sec until the patient stops the test when the sensation is no longer just "contact", but "discomfort". 3 repetitions will be done, leaving 1 minute between each of them and the average value will be calculated.
Temporal summation
Time frame: Pre-intervention
To assess temporal summation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the flexor digitorum muscle in both forearms. The average of both measurements will be calculated. A series of 15 stimuli will be presented to one arm at an interstimulus interval of 3s and then to the other arm at an interstimulus interval of 5s, separated by a 30s interseries interval. After a short break, the series of stimuli will be repeated in reverse order. Patients will be instructed to provide numerical ratings of the magnitude of the sensation experienced during the first, fifth, tenth, and fifteenth period after repeated brief taps. They will be also asked to report on the magnitude of after-sensations present 15 and 60 s after the last stimulus in each series.
Temporal summation
Time frame: 48-72h after the intervention
To assess temporal summation using algometer Force One FPIX 50. The pressure pain threshold will be evaluated in the flexor digitorum muscle in both forearms. The average of both measurements will be calculated. A series of 15 stimuli will be presented to one arm at an interstimulus interval of 3s and then to the other arm at an interstimulus interval of 5s, separated by a 30s interseries interval. After a short break, the series of stimuli will be repeated in reverse order. Patients will be instructed to provide numerical ratings of the magnitude of the sensation experienced during the first, fifth, tenth, and fifteenth period after repeated brief taps. They will be also asked to report on the magnitude of after-sensations present 15 and 60 s after the last stimulus in each series.
Chronic pain modulation
Time frame: Pre-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.
Chronic pain modulation
Time frame: 48-72h after the 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.
Electromyography
Time frame: Pre-intervention
To assess muscular activity using electromyography with Biosignalplux device (Research Kit Biosignalplux, PLUX Wireless Biosignal S.A). A functional task and flexion-relaxion fenomenon will be evaluated.
Electromyography
Time frame: 48-72h after the intervention
To assess muscular activity using electromyography with Biosignalplux device (Research Kit Biosignalplux, PLUX Wireless Biosignal S.A). A functional task and flexion-relaxion fenomenon will be evaluated.
3 secondary outcomes
Central Sensitization
Time frame: Pre-intervention
Disability
Time frame: Pre-intervention
Physical activity
Time frame: Pre-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 27 Jan 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.
Irene Torres Sánchez, PhD principal investigator
Universidad de Granada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise and Therapeutic Exercise in people with Chronic Low-back Pain, run by Universidad de Granada at 2 sites 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 2 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Pre-intervention). The study lists 26 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 27 Jan 2026.