Extended Reality-Assisted Therapy for Chronic Pain Management (XR-PAIN)

Extended Reality-Assisted Therapy for Chronic Pain Management: Can Immersive Virtual Reality Improve Range of Motion and Disability in Patients With Chronic Low Back Pain?

The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:

Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Chronic Pain
• Intervention / Treatment: Other: VR rehabilitation; Other: VR video application

Detailed Description

This is a two-arm randomized parallel controlled trial designed to test a prototype of a VR software application that the investigators have developed for patients with chronic low back pain. The app contains (1) educational messages delivered by a virtual therapist, (2) gamified exercises in which the patient has to move to reach goals or avoid objects, (3) therapeutic exercises, in which patients perform difficult or feared movements, (4) relaxation/mindfulness. There will be two groups consisting of adult patients of both sexes with persistent low back pain. Patients (n = 100) will be randomly assigned to either an interventional VR treatment (n = 50) or a control treatment (n = 50).

Patients in the VR intervention group will use the VR software application daily for a 20-minute training program. In the virtual reality application, they will be embodied into an avatar through congruent visuotactile and visuomotor stimulation (observed in first person) and will perform gamified movements and exercises for 15-20 minutes. These exercises will increase in difficulty for 3 weeks and will include educational and relaxation components. The control treatment will consist of a passive VR intervention in which the patient watches a TV show on a 2D screen but while wearing the virtual reality headset. They will be able to choose from three popular TV series with short episodes (20 minutes). The investigators will use validated outcome measures to assess changes in pain and function. These will be measured at baseline, after treatment (3 weeks), and at 1 month follow-up for both the treatment group and the control group. Both groups will be advised to continue their normal daily activities and routines, with no restrictions on activity or exercise, in addition to VR treatment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tony Donegan; Phone Number: +34676606825; Email: tonydonegan@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • IDIBAPS
    • Contact: Maria V Sanchez-Vives; Phone Number: 4302 93 227 5400; Email: msanche3@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-65 of either sex
• Diagnosis of chronic low back pain of >12 weeks, with or without associated somatic referred leg pain
• Average pain intensity over the previous month ≤7/10 and ≥ 2/10)

Exclusion Criteria:

• Spondylolysis, fracture, cauda equina syndrome, active spinal infection
• Acute radiculopathy or compromised nerve root
• Recent spinal surgery (<12 months) or lower limb surgery (<3 months)
• Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more.
• Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects.
• Cardiopulmonary or pulmonary disorder with contraindication to physical exercise
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR rehabilitation treatment; Daily use of VR rehabilitation program independently at home for a period of 3 weeks. Each daily session is 20 minutes.	Other: VR rehabilitation; VR software application containing education, exergames, therapeutic exercises and relaxation sections.
Placebo Comparator: VR control treatment; Daily watching 2D video independently at home using VR headset for a period of 20 minutes.	Other: VR video application; VR software application that plays 2D nature videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory	Allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Minimum score 0, maximum score 70, higher score = worse outcome.	Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris Disability Questionnaire	The Roland-Morris Disability Questionnaire is a self-reported measure consisting of 24 yes/no questions designed to assess functional disability related to back pain, with higher scores indicating greater disability. Minimum score 0, maximum score 24.	Baseline, 4 weeks, 8 weeks
Short-Form 12	The Short-Form-12 is a widely used, short-form health survey consisting of 12 questions that assess physical and mental health functioning, providing a concise measure of overall health status. Scores above 50 represent better than average quality of life, below 50 represents worse than average quality of life.	Baseline, 4 weeks, 8 weeks
Patient Global Impression of Change	The Patient Global Impression of Change is a self-reported assessment used to measure an individual's perceived change in health status or symptoms over time, typically ranging from "very much worse" to "very much improved." Minimum score 1, maximum score 7. Higher score indicated greater improvement in patient's condition (better outcome)	Baseline, 4 weeks, 8 weeks
Pain Catastrophization Scale	a self-report measure consisting of two subscales, assessing beliefs about how physical activity and work-related activities may exacerbate pain and lead to avoidance behaviors in individuals with low back pain. Minimum score 0, maximum score 52. Higher score indicates worse outcome.	Baseline, 4 weeks, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Range of motion	Video analysis will be used to measure spinal range of motion for flexion, extension and side flexion.	Baseline, 4 weeks, 8 weeks
Adherence to treatment	Measured automatically in the VR headset	4 weeks
Embodiment	Self report questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Investigators: Principal Investigator: Maria V Sanchez-Vives, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; rehabilitation; virtual reality; embodiment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: HCB_2023_1196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be made available on request from the study authors
• IPD Sharing Time Frame: No time limit. Data will be made available on completion of the trial.
• IPD Sharing Access Criteria: Email request directly from Principle Investigator, Prof. Maria Sanchez-Vives (msanche3@recerca.clinic.cat)
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No