Clinical trial NCT06410027: Effects of Pain Neuroscience Education and Virtual Reality in Patients with Chronic Low Back Pain
Official title: Effects of Pain Neuroscience Education and Virtual Reality in Patients with Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Pre-intervention
measure: Pain Intensity
timeFrame: 48-72h after the intervention
measure: Pain Intensity and Interference
timeFrame: Pre-intervention
measure: Pain Intensity and Interference
timeFrame: 48-72h after the intervention
measure: Neurophysiology of Pain
timeFrame: Pre-intervention
measure: Neurophysiology of Pain
timeFrame: 48-72h after the intervention
measure: Pain-Self Efficacy
timeFrame: Pre-intervention
measure: Pain-Self Efficacy
timeFrame: 48-72h after the intervention
measure: Awareness, Consciousness, Vigilance and Observation of pain
timeFrame: Pre-intervention
measure: Awareness, Consciousness, Vigilance and Observation of pain
timeFrame: 48-72h after the intervention
measure: Catastrophizing of pain
timeFrame: Pre-intervention
measure: Catastrophizing of pain
timeFrame: 48-72h after the intervention
measure: Fear and avoidance beliefs
timeFrame: Pre-intervention
measure: Fear and avoidance beliefs
timeFrame: 48-72h after the intervention
measure: Kinesiophobia
timeFrame: Pre-intervention
measure: Kinesiophobia
timeFrame: 48-72h after the intervention
measure: Health-related Quality of Life
timeFrame: Pre-intervention
measure: Health-related Quality of Life
timeFrame: 48-72h after the intervention
measure: Algometry
timeFrame: Pre-intervention
measure: Algometry
timeFrame: 48-72h after the intervention
measure: Temporal summation
timeFrame: Pre-intervention
measure: Temporal summation
timeFrame: 48-72h after the intervention
measure: Chronic pain modulation
timeFrame: Pre-intervention
measure: Chronic pain modulation
timeFrame: 48-72h after the intervention
measure: Electromyography
timeFrame: Pre-intervention
measure: Electromyography
timeFrame: 48-72h after the intervention
Secondary outcomes:
measure: Central Sensitization
timeFrame: Pre-intervention
measure: Disability
timeFrame: Pre-intervention
measure: Physical activity
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Irene Torres Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References: