Phantom Limb Pain (PLP)NCT06077227
Immersive Healing: The Therapeutic Potential of Virtual Reality
A study testing virtual reality therapy in people with Phantom Limb Pain (PLP), run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain (PLP)
- What is being tested?
- virtual reality therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of major limb amputation
- Age > 18 years old
- Presence of phantom limb pain or negative phantom sensation(s)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ben Connell contact
United States1 site, 1 recruiting
- Recruiting
OrthoCarolina Hand Center
Charlotte, North Carolina, 28207
Joshua Steinke, 704-942-4351, joshua.steinke@orthocarolina.com
ben Connell, ben.connell@orthocarolina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Phantom Limb Pain (PLP)
- Being tested
- virtual reality therapy, matched control group
- Keywords
- amputee, pain management, virtual reality (VR) therapy
- Medical subject headings
- Phantom Limb, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality therapyDevice
Also called VR Intervention
6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
matched control groupOther
Also called control group
taking the same surveys as the VR intervention group on a weekly basis for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Intervention | Experimental | Individuals undergoing virtual reality therapy intervention Receives: Device: virtual reality therapy |
| Matched Control | Sham comparator | The matched controls will receive standard care without the VR intervention Receives: Other: matched control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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"
Measured: 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
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start21 Dec 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb Pain (PLP)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pre- and post-intervention surveys will be used to assess the effects of virtual reality (VR) therapy on the phantom limb experience in the intervention group. Matched controls from the registry will be surveyed on their phantom limb symptoms at matching time intervals to the intervention group for comparison.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Gaston, MD, Principal investigator, Atrium Health Musculoskeletal Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077227
- Sponsor's protocol ID
- IRB00100006
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual Participant Data that underlie the results reported in this article, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience
- ClinicalTrials.gov ID
- NCT06077227
- Acronym / sponsor ID
- IRB00100006
- Conditions
- Phantom Limb Pain (PLP)
- Keywords
- amputee, pain management, virtual reality (VR) therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre- and post-intervention surveys will be used to assess the effects of virtual reality (VR) therapy on the phantom limb experience in the intervention group. Matched controls from the registry will be surveyed on their phantom limb symptoms at matching time intervals to the intervention group for comparison.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Intervention | Experimental | Device: virtual reality therapyIndividuals undergoing virtual reality therapy intervention |
| Matched Control | Sham comparator | Other: matched control groupThe matched controls will receive standard care without the VR intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of major limb amputation
- Age > 18 years old
- Presence of phantom limb pain or negative phantom sensation(s)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality therapyAlso: VR Intervention6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys | Device | Virtual Reality (VR) Intervention |
| matched control groupAlso: control grouptaking the same surveys as the VR intervention group on a weekly basis for 6 weeks | Other | Matched Control |
Primary outcome
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.
7 secondary outcomes
Change in Brief Pain Inventory (BPI) scores
Time frame: Hour 24
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
Time frame: Week 6
Phantom Limb Experience Survey score
Time frame: Baseline
Change in Virtual Reality (VR) Therapy Survey scores
Time frame: Week 6
System Usability Scale
Time frame: Week 6
Simulator Sickness Questionnaire
Time frame: Week 6
Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data that underlie the results reported in this article, after deidentification
Related trials for Phantom Limb Pain (PLP)
Not yet recruitingObservational study
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
Residual Limb Pain, Stump Pain
RecruitingPhase 2/3
Clinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved.
Phantom Limb Syndrome With Pain
Recruiting
Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS
Phantom Limb Pain After Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Connell contact
Glenn Gaston, MD principal investigator
Atrium Health Musculoskeletal Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality therapy in people with Phantom Limb Pain (PLP), run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Steinke (704-942-4351, joshua.steinke@orthocarolina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.