Virtual Reality - A New Vision on Pain (VROP)

The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.

The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.

VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain; Musculoskeletal Pain; Chronic Pain; Musculoskeletal Diseases or Conditions; Pain, Chronic; Musculoskeletal Disorder; Musculoskeletal Neck Pain

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

• Study Contact: Name: Erling Becker Aarseth, MD; Phone Number: +4733134147; Email: erlaar@siv.no
• Study Contact Backup: Name: Inge Ringheim, PhD; Phone Number: +4799786276; Email: inring@siv.no

Study Locations

• Norway
  • Tønsberg, Norway
    • Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold
    • Contact: Erling Becker Aarseth, MD; Phone Number: +4733134147; Email: erlaar@siv.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain conditions, referred to the outpatient clinic at the division of physical medicine and rehabilitation at Vestfold Hospital Trust.

Description

Inclusion Criteria:

• pain duration > 3 moths
• Master Norwegian spoken language

Exclusion Criteria:

• History of malignant disease
• pain duration < 3 Months
• Does not master Norwegian spoken language
• Epilepsy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain interference	Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Pain intensity	Numeric rating scale (NRS (0-10)) How much a person hurts	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Three months
EQ-5D-5L	Health related quality of life; The Health Utilities Index is a rating scale used to measure general health status and health-related quality of life. Range fra	Three months
PROMIS Physical Function	Self-reported capability rather than actual performance of physical activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Emotional Distress - Anxiety	Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart,dizziness). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Emotional Distress - Depression	Negative mood (sadness, guilt), views of self (self- criticism,worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Physical Health - Sleep Disturbance	Perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Social Health - Ability to Participate in Social Roles and Activities	Perceived ability to perform one's usual social roles and activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
PROMIS Physical Health - Fatigue	Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
RTWSE-11 Return ti work self efficacy	The return to work self efficacy (RTW-SE) score quantifies an individual's confidence in their ability to work fully and perform work tasks while suffering from chronic pain conditions. The score ranges between 1 and 6, higher scores are better. Threshold values identified in Norwegian samples: Scores from 3.7 and lower are considered low and are associated with a lower probability of return to work. Scores from 4.6 and above are considered to be high and are associated with a higher probability of return to work.	Three months

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): June 5, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Long-term; VR; Long lasting pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Muscular Diseases; Chronic Pain; Neck Pain; Musculoskeletal Pain; Musculoskeletal Diseases
• Other Study ID Numbers: 21/00032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No