Immersive Healing: The Therapeutic Potential of Virtual Reality

October 29, 2025 updated by: Wake Forest University Health Sciences

Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience

Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of major limb amputation
  • Age > 18 years old
  • Presence of phantom limb pain or negative phantom sensation(s)

Exclusion Criteria:

  • Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
  • Those without phantom limb pain or negative phantom limb sensations
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality (VR) Intervention
Individuals undergoing virtual reality therapy intervention
Device: virtual reality therapy
6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
Other Names:
  • VR Intervention
Sham Comparator: Matched Control
The matched controls will receive standard care without the VR intervention
Other: matched control group
taking the same surveys as the VR intervention group on a weekly basis for 6 weeks
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Baseline
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Baseline
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Week 1
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Week 1
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Week 2
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Week 2
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Week 3
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Week 3
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Week 6
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory (BPI) scores
Time Frame: Hour 24
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference.
Hour 24
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
Time Frame: Week 6

A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores.
Week 6
Phantom Limb Experience Survey score
Time Frame: Baseline
it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience - assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping.
Baseline
Change in Virtual Reality (VR) Therapy Survey scores
Time Frame: Week 6
There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be "good" for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered "good".
Week 6
System Usability Scale
Time Frame: Week 6
Assesses subjective usability and satisfaction with the VR system - A perfect score of 100% signifies flawless usability and an exceptional user experience. The average SUS score is 68, and scores up to 70% are generally considered good; a good sus score indicates a decent level of usability.
Week 6
Simulator Sickness Questionnaire
Time Frame: Week 6
negligible (< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms. A simulator resulting in total scores above 20 is considered "bad"
Week 6
Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores
Time Frame: Week 6
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Glenn Gaston, MD, Atrium Health Musculoskeletal Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

October 31, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00100006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data that underlie the results reported in this article, after deidentification

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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