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OpenTrials
Completed

NCT Number: NCT03203772

Immersive Virtual Reality for Neuropathic Pain

Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb

Exclusion criteria

  • Cognitive impairment leading to inability to make own medical decisions
  • Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
  • History of seizures within the last year

Treatment and study plan

Immersive Virtual Reality

Other

Participants will engage in virtual visualization therapy in an immersive virtual reality environment

Primary outcomes

  1. Feasibility of Virtual Reality Environment Use Questionnaire

    Time frame: Immediately following final virtual reality session

    Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.

  2. Pain Relief with Virtual Reality Therapy: Wong-Baker Scale

    Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions

    Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.

  3. Pain Relief with Virtual Reality Therapy: Visual Analog Scale

    Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions

    Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.

  4. Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale

    Time frame: Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions

    Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2017
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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