Virtual Reality - A New Vision on Pain

Completed

• Conditions: Musculoskeletal Pain; Musculoskeletal Diseases or Conditions; Musculoskeletal Neck Pain; Pain, Chronic; Musculoskeletal Disorder; Back Pain; Chronic Pain

• Registration Number: NCT06045741
• Lead Sponsor: Sykehuset i Vestfold HF

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Primary Completion: 2024-08-18
• Study Completion: 2024-08-18
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROMIS Pain interference	Three months	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.
PROMIS Pain intensity	Three months	Numeric rating scale (NRS (0-10)) How much a person hurts

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Three months	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
PROMIS Emotional Distress - Depression	Three months	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.
PROMIS Physical Health - Sleep Disturbance	Three months	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.
PROMIS Physical Health - Fatigue	Three months	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.
PROMIS Physical Function	Three months	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.
System Usability Scale (SUS)	Three months	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.
PROMIS Emotional Distress - Anxiety	Three months	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.
PROMIS Social Health - Ability to Participate in Social Roles and Activities	Three months	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.
RTWSE-11 Return ti work self efficacy	Three months	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.

Trial Locations

Locations (1)

Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold; 🇳🇴 Tønsberg, Norway