Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06296433

Extended Reality-Assisted Therapy for Chronic Pain Management

Led by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Updated on 2024-05-10

100

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Extended Reality-Assisted Therapy for Chronic Pain Management

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-65 of either sex
  • Diagnosis of chronic low back pain lasting more than 12 weeks, with or without somatic referred leg pain
  • Average pain intensity over the previous month between 2 and 7 on a 0 to 10 scale
Not Eligible

You will not qualify if you...

  • Spondylolysis, fracture, cauda equina syndrome, or active spinal infection
  • Acute radiculopathy or compromised nerve root
  • Recent spinal surgery within the past 12 months or lower limb surgery within the past 3 months
  • Major depressive symptoms with a Patient Health Questionnaire-2 score of 4 or more
  • Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases
  • Cardiopulmonary or pulmonary disorder that prevents physical exercise
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IDIBAPS

Barcelona, Spain, 08036

Actively Recruiting

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Research Team

T

Tony Donegan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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