Effects of Pain Neuroscience Education and Virtual Reality in Patients With Chronic Low Back Pain

NCT06410027 | Completed

• 1 other identifier: DLCRV-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (26)

• 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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  48-72h after the intervention

Secondary Outcomes (3)

• Central Sensitization

  Pre-intervention

• Disability

  Pre-intervention

• Physical activity

  Pre-intervention

Study Arms (2)

Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise

EXPERIMENTAL

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 Exercise

ACTIVE COMPARATOR

Therapeutic Exercise

Other: Therapeutic Exercise

Interventions

Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise OTHER

Patients will receive 1-hour pain neuroscience education session + 30-minutes exposure to exercise with virtual reality + therapeutic exercise

Pain Neuroscience Education + Virtual Reality + Therapeutic Exercise

Therapeutic Exercise OTHER

Patients will receive therapeutic exercise

Therapeutic Exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (2)

University of Granada

Granada, 18016, Spain

Location

University of Granada

Granada, Spain

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Irene Torres Sánchez, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

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: PT, PhD, Principal investigator

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 10, 2024
• Study Start: April 20, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2024-04

Locations

ES (2)