Clinical trial NCT04108702: Virtual Reality as a New Therapeutic Tool for Chronic Pain
Official title: Virtual Reality as a New Therapeutic Tool for Chronic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria

* A diagnosis of fibromyalgia according to current diagnostic criteria
* Aged \> 18 years old
* Capable of judgement
* Willing to participate in the study (by signing the informed consent form)
* Able to follow the study protocol

Exclusion criteria

* Presence of psychosis or major depression with suicidal risk
* History of alcohol or drug abuse
* Inability to follow the procedures of the study, e.g. due to language problems, inability to wear head-mounted display
* Arrythmia, such as atrial fibrillation

Primary outcomes:
measure: Pain perception using numeric rating scale VR therapy vs. standard therapy
timeFrame: 6 weeks
measure: Pain perception using patient global impression of change VR therapy vs. standard therapy
timeFrame: 6 weeks
measure: Pain perception (algometry) VR therapy vs. standard therapy
timeFrame: 6 weeks
measure: Pain perception (algopeg) VR therapy vs. standard therapy
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain perception (numeric rating scale) VR therapy vs. VR control
timeFrame: 6 weeks and 10 weeks
measure: Pain perception (patient global impression of change) VR therapy vs. VR control
timeFrame: 6 weeks and 10 weeks
measure: Pain perception (algometric) VR therapy vs. VR control
timeFrame: 6 weeks and 10 weeks
measure: Pain perception (algopeg) VR therapy vs. VR control
timeFrame: 6 weeks and 10 weeks
measure: Heart rate variability
timeFrame: During each intervention, up to 6 weeks
measure: Hamilton anxiety and and depression scale (HADS)
timeFrame: 6 weeks and 10 weeks
measure: Beck depression inventory (BDI II)
timeFrame: 6 weeks and 10 weeks
measure: WHO 5 Well Being Index
timeFrame: 6 weeks and 10 weeks
measure: Pain perception (numeric rating scale)
timeFrame: After each intervention, up to 6 weeks
measure: Pain perception (algometer)
timeFrame: After each intervention, up to 6 weeks
measure: Pain perception (algopeg)
timeFrame: After each intervention, up to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Inselspital Bern, University of Bern
name: Lukas Heydrich, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: