Clinical trial NCT06296433: Extended Reality-Assisted Therapy for Chronic Pain Management
Official title: 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?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Low Back Pain
Keywords: virtual reality
embodiment
chronic pain
rehabilitation
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Short-Form 12
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Patient Global Impression of Change
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Pain Catastrophization Scale
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Spinal Range of motion
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Adherence to treatment
timeFrame: 4 weeks
measure: Embodiment
timeFrame: 4 weeks
Locations:
city: Barcelona
country: Spain
facility: IDIBAPS
Study officials:
affiliation: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Maria V Sanchez-Vives
role: PRINCIPAL_INVESTIGATOR
References: