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

NCT06757413 | Completed DMC

• 2 other identifiers: Cardenal Herrera University 69PID2020-115609RB-C22
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

VIRTUAL REALITY; PHYSICAL ACTIVITY; Pain; Disability; Kinesophobia; Psychology

Outcome Measures

Primary Outcomes (4)

• Body Disability

  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.

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Emotional Distress

  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.

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Pain Interference and Pain Intensity

  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".

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Health related Quality of life

  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.

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

Secondary Outcomes (9)

• Fear of movement

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Body Awareness

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Chronic Pain Acceptance

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Body Appreciation

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

• Appreciation of Body Functionality

  Baseline (pre-intervention) and immediately post-intervention (at 4 weeks).

Study Arms (2)

Enhanced Virtual reality

EXPERIMENTAL

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.

Other: Enhanced Virtual reality

Control Group (treatment as usual)

ACTIVE COMPARATOR

Participants will receive the usual treatment applied at the hospital.

Other: Active Comparator: Treatment as usual

Interventions

Enhanced Virtual reality OTHER

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. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School". Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. 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.

Also known as: Virtual Reality Group, Experimental Group

Enhanced Virtual reality

Active Comparator: Treatment as usual OTHER

Participants will receive the usual treatment applied at the hospital

Control Group (treatment as usual)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• University of Valencia: collaborator

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

• Alleva JM, Diedrichs PC, Halliwell E, Peters ML, Dures E, Stuijfzand BG, Rumsey N. More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program. J Consult Clin Psychol. 2018 Aug;86(8):666-676. doi: 10.1037/ccp0000317.

  PMID: 30035583 BACKGROUND

• Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.

  PMID: 28348526 BACKGROUND

• Bailey KA, Gammage KL, van Ingen C, Ditor DS. "It's all about acceptance": A qualitative study exploring a model of positive body image for people with spinal cord injury. Body Image. 2015 Sep;15:24-34. doi: 10.1016/j.bodyim.2015.04.010. Epub 2015 May 21.

  PMID: 26002149 BACKGROUND

• Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.

  PMID: 25691362 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Profesor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 3, 2025
• Study Start: November 10, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

ES (1)