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Clinical Trials/NCT03203772
NCT03203772CompletedNot Applicable

Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality

Loma Linda University1 site in 1 country14 target enrollmentStarted: August 14, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Pain Relief with Virtual Reality Therapy: Visual Analog Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Limb neuropathic conditions

Experimental

Includes phantom limb pain, complex regional pain syndrome

Intervention: Immersive Virtual Reality (Other)

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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