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Immersive Virtual Reality for Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03203772
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Chau, Loma Linda University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathy Phantom Limb Pain Complex Regional Pain Syndromes Neuropathic Pain Other: Immersive Virtual Reality Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Limb neuropathic conditions
Includes phantom limb pain, complex regional pain syndrome
 Other: Immersive Virtual Reality
Participants will engage in virtual visualization therapy in an immersive virtual reality environment


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203772


Contacts
Contact: Brian Chau, MD 909-558-6202

Locations
United States, California
Loma Linda University Health, East Campus Outpatient Rehabilitation Center Recruiting
Loma Linda, California, United States, 92354
Contact: Brian Chau, MD    909-558-6202    bchau@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Brian Chau, MD Loma Linda Univeristy
More Information
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Responsible Party: Brian Chau, Physician Instructor, Principle Investigator, Department of Physical Medicine and Rehabilitation, Loma Linda University
ClinicalTrials.gov Identifier: NCT03203772     History of Changes
Other Study ID Numbers: 5150437
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Phantom Limb
Neuralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Signs and Symptoms
Autonomic Nervous System Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes