Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain (CLBP)

• Registration Number: NCT06757413
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study Start: 2024-11-10
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Disability	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	Roland-Morris Questionnaire (RMQ) is a 24-item patient-reported outcome measure those inquiries about pain-related disability. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24.
Emotional Distress	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The 4-item Brief Assessment of Distress about Pain (BADP) scale was developed to assess anxiety, fear, and depression related to pain, as well as an overall evaluation of distress about pain. Items are scored from 0 ("Not at all") to 4 ("Extreme"), for a total BADP score ranging from 0 to 16.
Pain Interference and Pain Intensity	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. The scale consists of 9 items with qualitative and quantitative data on the following dimensions: "Worst pain in last 24 hours", "Least pain in last 24 hours", "Pain on average" and "Pain right now".
Health related Quality of life	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The SF-12 Health Survey is a short, standardised questionnaire designed to assess people's health status and quality of life. It consists of 12 questions that evaluate 8 dimensions: physical functioning, limitations due to physical problems, bodily pain, general health, vitality, social functioning, limitations due to emotional problems, and mental health (anxiety and depression). Scores are reported on two scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each ranging from 0 to 100, with higher scores indicating better perceived physical and mental health.

Secondary Outcome Measures

Name	Time	Method
Fear of movement	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Tampa Scale for Kinesophobia (TSK-11SV) is an 11-item scale that measures kinesophobia with statements asking the subject to answer from 1 ("Strongly disagree"), to 4 ("Strongly agree").
Body Awareness	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a state-trait self-report questionnaire to measure multiple dimensions of interoception (awareness of bodily sensations). These dimensions have been chosen for their relationship to the intervention components and for their good psychometric quality. The scores range from 0 to 5, where higher scores indicate a higher level in that dimension.
Chronic Pain Acceptance	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	Chronic Pain Acceptance Questionnaire 8 (CPAQ-8). Numerical rating scale ranging from 0 "Never true" to 6 "Always true" where higher scores indicate a higher Chronic Pain Acceptance (Pain Willingness and Activity Engagement).
Body Appreciation	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	Body Appreciation Scale 2 (BAS-2) is a 10-item measure of one's acceptance, favorable opinions and respect of their own body with a numerical rating scale ranging from 1 "Never" to 5 "Always" where higher scores indicate a higher Appreciation of the body.
Appreciation of Body Functionality	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicate higher levels of appreciation of body functionality.
Pain Catastrophizing	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Pain Catastrophizing Scale (PCS) consists of 13 statements containing a number of thoughts and feelings typically present in the experience of pain. The items are divided into 3 categories: rumination, magnification and helplessness, with each item scored on a 5-point scale. The patient is asked to indicate the frequency with which these feelings or thoughts appear from 0 ("Not at all") to 4 ("All the time").
Depression	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Patient Health Questionnaire (PHQ-9). The scale is composed of 9 items to assess depressive symptoms and the patient is asked to indicate the frequency with which these feelings, thoughts or states appear from 0 ("Not at all) to 3 ("Nearly every day").
Anxiety	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Generalised Anxiety Disorder-7 (GAD-7) scale is composed of 7 items to assess the different dimensions of the Generalised Anxiety Disorder and the patient is asked to mark the frequency from 'Never' to 'almost every day' in the last two weeks.
Life satisfaction	Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).	The Satisfaction with Life Scale (SWLS) is a 5-item self-report tool measuring global life satisfaction-a cognitive component of subjective well-being

Trial Locations

Locations (1)

Clínica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain