Extended Reality-Assisted Therapy for Chronic Pain Management

NCT06296433 | Recruiting

• 1 other identifier: HCB_2023_1196
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Low Back Pain

Keywords

virtual reality; embodiment; chronic pain; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Roland-Morris Disability Questionnaire

  Baseline, 4 weeks, 8 weeks

• Short-Form 12

  Baseline, 4 weeks, 8 weeks

• Patient Global Impression of Change

  Baseline, 4 weeks, 8 weeks

• Pain Catastrophization Scale

  Baseline, 4 weeks, 8 weeks

Other Outcomes (3)

• Spinal Range of motion

  Baseline, 4 weeks, 8 weeks

• Adherence to treatment

  4 weeks

• Embodiment

  4 weeks

Study Arms (2)

VR rehabilitation treatment

EXPERIMENTAL

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 control treatment

PLACEBO COMPARATOR

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

Other: VR video application

Interventions

VR rehabilitation OTHER

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

VR rehabilitation treatment

VR video application OTHER

VR software application that plays 2D nature videos

VR control treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut d'Investigacions Biomèdiques August Pi i Sunyer: lead

Study Sites (1)

IDIBAPS

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Maria V Sanchez-Vives

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Donegan

CONTACT

+34676606825; tonydonegan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: April 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: No time limit. Data will be made available on completion of the trial.
• Access Criteria: Email request directly from Principle Investigator, Prof. Maria Sanchez-Vives (msanche3@recerca.clinic.cat)

Locations

ES (1)