Extended Reality-Assisted Therapy for Chronic Pain Management

NCT ID: NCT06296433

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Chronic Pain; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR rehabilitation treatment

Daily use of VR rehabilitation program independently at home for a period of 3 weeks. Each daily session is 20 minutes.

Group Type: EXPERIMENTAL

VR rehabilitation

Intervention Type: OTHER

VR software application containing education, exergames, therapeutic exercises and relaxation sections.

VR control treatment

Daily watching 2D video independently at home using VR headset for a period of 20 minutes.

Group Type: PLACEBO_COMPARATOR

VR video application

Intervention Type: OTHER

VR software application that plays 2D nature videos

Interventions

VR rehabilitation

VR software application containing education, exergames, therapeutic exercises and relaxation sections.

Intervention Type: OTHER

VR video application

VR software application that plays 2D nature videos

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: lead

Responsible Party

Prof. Maria V. Sanchez-Vives

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria V Sanchez-Vives

Role: PRINCIPAL_INVESTIGATOR

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Locations

IDIBAPS

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Tony Donegan

Role: CONTACT

tonydonegan@gmail.com

+34676606825

Facility Contacts

Maria V Sanchez-Vives

Role: primary

msanche3@clinic.cat

93 227 5400 ext. 4302

Other Identifiers

HCB_2023_1196

Identifier Type: -

Identifier Source: org_study_id