Clinical trial NCT06757413: Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain
Official title: Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain: a Randomised Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: VIRTUAL REALITY
PHYSICAL ACTIVITY
Pain
Disability
Kinesophobia
Psychology
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Clinica Universidad de Navarra, Universidad de Navarra
name: University of Valencia
First posted: 2025-01-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this randomized controlled pilot trial is to investigate the efficacy of a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining a therapeutic exercise program in physiotherapy and a psychological intervention focused on positive body image in pain intensity, pain interference, emotional distress, kinesophobia and pain catastrophization. Both components are designed to operate in parallel over a 4-week period. The physiotherapy component consists of a therapeutic exercise program of 8 sessions, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises. The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.

Detailed description: This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.

Physiotherapy Component The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns.

Exercises are performed in two sets, with intensity and repetitions individualized using the Borg 6-20 scale for Rating of Perceived Exertion (RPE). During the first two weeks, exercises are performed at an RPE of 14 without additional load, while in weeks three and four, intensity increases to an RPE of 15 with progressively added weights. This program aims to improve outcomes such as pain, disability, kinesiophobia, catastrophizing, quality of life, and physical fitness.

Psychological Component

The psychological intervention aims to enhance positive body image and emotional resilience while addressing pain interference and emotional distress. It consists of four weekly sessions, each lasting approximately one hour, structured as follows:

1. Session 1: Pain Psychoeducation. Participants learn about chronic pain, its influencing factors, and the role of body image, with an overview of the intervention modules.
2. Session 2: Body Awareness. A virtual reality body scan is introduced to increase awareness of body sensations and perceptions.
3. Session 3: Pain Acceptance. Participants explore strategies to accept pain and address variables contributing to chronic pain, such as paradoxical control and avoidance, using a VR environment.
4. Session 4: Body Appreciation and Gratitude. Exercises focus on fostering appreciation for body functionality and gratitude for its abilities.

Participants will first undergo eligibility screening and baseline assessments before starting the intervention. The study complies with the ethical principles outlined in the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* diagnosed with non-specific cLBP according to the COST B13 European guideline
* age older than 18
* an average pain score of 3 or higher on the 11-point Pain Numerical Rating Scale (PNRS-11; with 0 indicating no pain and 10 indicating the worst pain imaginable) in the 6 months prior.

Exclusion criteria:

* spinal tumour, infection, or fracture
* systemic disease
* fibromyalgia
* cauda equina syndrome
* previous spinal surgery
* musculoskeletal injuries in the lower extremities (e.g., sciatica or radiating lower extremity pain, numbness, or weakness symptoms).

Primary outcomes:
measure: Body Disability
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Emotional Distress
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Pain Interference and Pain Intensity
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Health related Quality of life
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Secondary outcomes:
measure: Fear of movement
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Body Awareness
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Chronic Pain Acceptance
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Body Appreciation
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Appreciation of Body Functionality
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Pain Catastrophizing
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Depression
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Anxiety
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
measure: Life satisfaction
timeFrame: Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
Study officials:
References:
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