NCT04108702

Virtual Reality as a New Therapeutic Tool for Chronic Pain

Withdrawn NA Last updated 13 February 2023

What this trial tests

NA trial testing Virtual reality heart in Fibromyalgia. Withdrawn.

Timeline

17 December 2019

Primary endpoint
1 August 2023

1 October 2023

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Start date	17 December 2019
Primary completion	1 August 2023
Estimated completion	1 October 2023

Drugs / interventions tested

• Virtual reality heart
• Virtual reality control
• Standard therapy — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic pain is a major health problem and it has been estimate to account for approximately 40% of all medical visits, costing more than $600 billion annually in the United States alone. Given that pharmacological and non-pharmacological treatments for chronic pain are often difficult and may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option. Recent findings from cognitive neuroscience show that it is possible to manipulate the body schema and to induce a range of well-controlled illusory bodily experiences by exposing participants to conflicting multisensory bodily inputs using VR, that are associated with changes in pain perception and somatosensory processing in healthy subjects and chronic pain patients. In the current project the investigators plan to follow up on these findings in patients suffering from chronic pain affecting the whole body, e.g. fibromyalgia. The project is planned as a single center clinical study at the Department of Neurology and Psychosomatic Medicine, Inselspital Bern, in cooperation with the Pain Center Inselspital Bern, the Department of Biomedical Engineering; University Bern and the Department of Psychology, University of Bern. The investigators want to explore the analgesic effect of a specific multisensory illusion (e.g. the cardio-visual illusion) in patients suffering from chronic pain as compared to a control condition (single-blinded, randomized clinical trial) using psychometric and algometric methods. Moreover, the investigators would like to assess the physiological changes associated with pain reduction, study the reduction of psychological distress and improved well-being and assess the subjective acceptance of VR as a possible treatment option for patients with chronic pain. Importantly, the investigators plan to develop and test an easy to use, mobile VR setup as a long-term treatment option for patients with chronic pain. Given that chronic pain is a major health problem, the investigators believe that there is a huge market potential for an easy to use, noninvasive and effective treatment option and a possible technology transfer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.