An interventional study of virtual reality therapy and matched control group in Phantom Limb Pain (PLP), sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 80 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Exclusion Criteria:
Individuals undergoing virtual reality therapy intervention
Device: virtual reality therapy
The matched controls will receive standard care without the VR intervention
Other: matched control group
6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
Also known as: VR Intervention
taking the same surveys as the VR intervention group on a weekly basis for 6 weeks
Also known as: control group
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: Baseline
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: Week 1
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: Week 2
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: Week 3
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: Week 6
Change in Brief Pain Inventory (BPI) scores
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.
Time frame: Hour 24
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
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.
Time frame: Week 6
Phantom Limb Experience Survey score
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.
Time frame: Baseline
Change in Virtual Reality (VR) Therapy Survey scores
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".
Time frame: Week 6
System Usability Scale
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.
Time frame: Week 6
Simulator Sickness Questionnaire
negligible (\< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms. A simulator resulting in total scores above 20 is considered "bad"
Time frame: Week 6
Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores
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
Time frame: Week 6
Plan to share: Yes — Individual Participant Data that underlie the results reported in this article, after deidentification
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 3 months and ending 5 years following article publication
Access criteria: Researchers who provide a methodologically sound proposal
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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