Extended Reality-Assisted Therapy for Chronic Pain Management

Chronic Pain Clinical Trial

— XR-PAIN  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296433
• Other study ID #: HCB_2023_1196
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Institut d'Investigacions Biomèdiques August Pi i Sunyer
• Contact: Tony Donegan
• Phone: +34676606825
• Email: tonydonegan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Other:
• VR rehabilitation
VR software application containing education, exergames, therapeutic exercises and relaxation sections.
• VR video application
VR software application that plays 2D nature videos

Locations

Country	Name	City	State
Spain	IDIBAPS	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adherence to treatment	Measured automatically in the VR headset	4 weeks
Other	Embodiment	Self report questionnaire	4 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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