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CompletedNCT06077227ClinicalTrials.gov record

Immersive Healing: The Therapeutic Potential of Virtual Reality

Phantom Limb Pain (PLP)

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
80 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not randomized
Masking
No masking
Virtual Reality (VR) Intervention

Individuals undergoing virtual reality therapy intervention

Device: virtual reality therapy

Matched Control

The matched controls will receive standard care without the VR intervention

Other: matched control group

virtual reality therapy DEVICE

6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

matched control group OTHER

taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

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.

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.

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.

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.

Secondary measures

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.

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.

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.

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".

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.

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"

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

OrthoCarolina Hand CenterCharlotte, North Carolina, United StatesStatus unknown

Study team and timeline

Lead sponsor
Wake Forest University Health Sciences
Study start
Dec 21, 2023 Actual
Primary completion
Sep 4, 2026 Actual
Study completion
Sep 4, 2026 Actual
First posted
Oct 11, 2023 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026