Embodied Virtual Reality for Chronic Pain

NCT05160038 | Completed

• 1 other identifier: EmbVRpain
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual reality creates interactive, multimodal sensory stimuli that have demonstrated considerable success in reducing pain. Much research so far has focused on VR's ability to shift patients' attention away from pain; however, these methods provide only transient relief through means of distraction and therefore do not offer long-term analgesic remediation. An alternative and promising approach is to utilize VR as an embodied simulation technique, where virtual body illusions are employed as tools to improve body perception and produce potentially more enduring analgesia. Disturbances in body perception (i.e., alterations in the way the body is perceived) are increasingly acknowledged as a pertinent feature of chronic pain, and include aberrations in perceived shape, size, or color that differ from objective assessment. The degree of body perception distortion positively correlates with pain, and prior interventions have evinced that treatments aimed at reducing body perception distortions correspondingly ameliorate pain. Several recent experimental research studies have demonstrated the analgesic efficacy of body illusions in a range of pain conditions. Immersive VR multisensory feedback training signifies a promising new avenue for the potential treatment of chronic pain by supporting the design of targeted virtual environments to alter (distorted) body perceptions. Various illusions have been described to alter pain perception; however, they. Have not been directly compared to each other. The multimodal stimulus control of VR enables physical-to-virtual body transfer illusions, resulting in the feeling that the virtual body is one's own. These virtual body illusions can modulate body perception with ease and could therefore be used to alter the perceived properties of pain, consequently utilizing a virtual avatar to specifically shape interactive processing between central and peripheral mechanisms.

Conditions

Complex Regional Pain Syndromes; Complex Regional Pain Syndrome Type I of the Upper Limb; Complex Regional Pain Syndrome I (CRPS I); Complex Regional Pain Syndrome I of Upper Limb; Complex Regional Pain Syndrome Type II; Complex Regional Pain Syndrome II of Upper Limb; Peripheral Nerve Injury Upper Limb; Osteoarthritis Hand; Osteoarthritis Finger

Keywords

virtual reality; embodiment; embodied pain

Outcome Measures

Primary Outcomes (6)

• Pain assessment baseline

  A first pain assessment will be made at baseline. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

• Pain assessment post - block 1 (session 1 - 4)

  Pain assessment will be made after the first block of VR, which lasts about 140 seconds. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

• Pain assessment post - block 2 (session 1 - 4)

  Pain assessment will be made after the second block of VR, which lasts about 140 seconds. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

• Pain assessment post - block 3 (session 1 - 4)

  Pain assessment will be made after the third block of VR, which lasts about 140 seconds. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

• Pain assessment post - block 4 (session 1 - 4)

  Pain assessment will be made after the fourth block of VR, which lasts about 140 seconds. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

• Pain assessment post - block 5 (session 1 - 4)

  Pain assessment will be made after the fifth block of VR, which lasts about 140 seconds. A pain-intensity numeric rating scale (NRS) will appear with the written instruction asking participants to judge the intensity of their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain). The pain intensity NRS during the VR sessions will be answered within the virtual environment, where questions will be presented to participants within the headmounted display (HMD), which participants can then answer using a cursor that is controlled by head movements.

  through study completion, an average of 2 weeks

Secondary Outcomes (9)

• Body perception disturbances - post VR session 1

  through study completion, an average of 2 weeks

• Body perception disturbances - post VR session 2

  through study completion, an average of 2 weeks

• Body perception disturbances - post VR session 3

  through study completion, an average of 2 weeks

• Body perception disturbances - post VR session 4

  through study completion, an average of 2 weeks

• Pain ratings for each bodily illusion during session 1 - bodily illusion 1

  through study completion, an average of 2 weeks

Other Outcomes (4)

• VR side effects - session 1

  through study completion, an average of 2 weeks

• VR side effects - session 2

  through study completion, an average of 2 weeks

• VR side effects - session 3

  through study completion, an average of 2 weeks

Study Arms (2)

Bodily illusions

EXPERIMENTAL

Participants in the experimental group see a bodily illusion applied to their embodied virtual avatar.

Device: Embodied virtual reality

No bodily illusions

NO INTERVENTION

Participants in the control group embody a virtual avatar, but without bodily illusions

Interventions

Embodied virtual reality DEVICE

An immersive headmounted display visually depicts a relaxing woods scene, coupled with a virtual avatar that either shows bodily illusions or no bodily illusions

Bodily illusions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent by the participants
• Presence of one of the following chronic pain conditions of the upper limbs:
• osteoarthritis (OA), complex regional pain syndrome (CRPS)

You may not qualify if:

• Inability to follow study procedures, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
• Extreme motion sickness, nausea, or dizziness to the virtual simulations
• Currently pregnant or breastfeeding women
• High risk populations for Covid-19 (i.e., high blood pressure, chronic respiratory condition, diabetes, presence of autoimmune disease, cardiovascular disease, presence of cancer)

Sponsors & Collaborators

• University of Zurich: lead
• Balgrist University Hospital: collaborator

Study Sites (1)

University of Zurich

Zurich, Canton of Zurich, 8050, Switzerland

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Causalgia

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuralgia

Study Design

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

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: December 16, 2021
• Study Start: May 31, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CH (1)