Phantom Pain Following Amputation of Lower LimbPLP Home-BasedNCT07044323
Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment
A study testing Active Virtual Reality Treatment in people with Phantom Pain Following Amputation of Lower Limb and Amputation, run by Albert Einstein Healthcare Network at 3 sites in United States.
Trial summary
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Phantom Pain Following Amputation of Lower Limb, Amputation
- What is being tested?
- Active Virtual Reality Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2025to 31 May 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 -100
- Capacity to provide Informed Consent
- Unilateral above or below knee amputation more than 3 months prior to enrollment
- Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater1.
- Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.
Who cannot join
- History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
- History of significant or poorly controlled psychiatric disorders
- Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
- Current abuse of alcohol or drugs, prescription or otherwise
- Nursing a child, pregnant, or intent to become pregnant during the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Jefferson Moss Rehabilitation Research Institute
Philadelphia, Pennsylvania, 19027
Rand Williamson, 215-663-6321, Rand.Williamson@jefferson.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19122
Elisabetta Ambron, 215-573-4336, eambron@pennmedicine.upenn.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Jing-Sheng Li, 215-663-6321, jsli@uw.edu
About this study
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).
Read the detailed description
Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom limb"Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP
The investigators recently completed the in-person part of the study in which they compared the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.
In the Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via the VR headset controller, and the program generated an image of the missing lower leg, visible as a first-person avatar. The "Distractor" treatment was the REAL i-Series® immersive VR experience: subjects navigated through a pleasant VR environment, without seeing any rendering of their body and making no movements with their legs. The results of the in-person study showed superior efficacy in reducing pain intensity of the Active Treatment as compared to the Distractor treatment.
The specific aim of the current study is to assess the feasibility and efficacy of a home-based, active VR treatment for PLP.
- Being tested
- Active Virtual Reality Treatment
- Keywords
- pain, phantom limb, lower limb amputation, treatment
- Medical subject headings
- Pain, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Virtual Reality TreatmentBehavioural
The self-administered active VR treatment will consist of 8 twice-weekly sessions, each approximately 1 hour in duration, during which subjects will participate in a variety of Virtual Reality active games that require leg movements while receiving high-quality visual feedback of the missing lower leg.
| Study group | Role | What they receive |
|---|---|---|
| Home-based treatment | Experimental | Self-administered Active Virtual Reality treatment Receives: Behavioral: Active Virtual Reality Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity
the change in phantom limb pain score pre and post each VR intervention, at baseline, after the VR intervention and in the follow-up sessions as assessed using an 11-point numerical rating pain scale (0 - minimum score/no pain; 10 maximum score/pain as bad as you can imagine) assessing the current PLP level.
Measured: pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention.
Changes in pain quality of the McGill Short Form Questionnaire
The change in the phantom limb pain quality between baseline, post-intervention, and follow-up sessions using McGill Short Form Questionnaire that measures the characteristics of pain (e.g., throbbing, etc.) using a 4-point rating pain scale (0 - minimum score - none: better outcome /4 maximum score - severe: worse outcome).
Measured: baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Secondary outcomes (1)
Changes in average pain after the treatment
average pain intensity since the previous intervention on an 11-point numerical rating pain scale; (0 - minimum score/no pain; 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2025
- Study start16 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Phantom Pain Following Amputation of Lower LimbStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Laurel Buxbaum, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044323
- Sponsor's protocol ID
- AEHN2022-775
- Other IDs
- 5R01HD104158-03
- Acronym
- PLP Home-Based
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
PubMed 9849105Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
PubMed 22981809Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
PubMed 6869117Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment
- ClinicalTrials.gov ID
- NCT07044323
- Acronym / sponsor ID
- PLP Home-Based / AEHN2022-775
- Keywords
- pain, phantom limb, lower limb amputation, treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 30 Jun 2025 (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.
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).
Detailed description
Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom limb"Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP
The investigators recently completed the in-person part of the study in which they compared the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.
In the Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via the VR headset controller, and the program generated an image of the missing lower leg, visible as a first-person avatar. The "Distractor" treatment was the REAL i-Series® immersive VR experience: subjects navigated through a pleasant VR environment, without seeing any rendering of their body and making no movements with their legs. The results of the in-person study showed superior efficacy in reducing pain intensity of the Active Treatment as compared to the Distractor treatment.
The specific aim of the current study is to assess the feasibility and efficacy of a home-based, active VR treatment for PLP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based treatment | Experimental | Behavioral: Active Virtual Reality TreatmentSelf-administered Active Virtual Reality treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 -100
- Capacity to provide Informed Consent
- Unilateral above or below knee amputation more than 3 months prior to enrollment
- Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater1.
- Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.
Key exclusion criteria (5 listed)
- History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
- History of significant or poorly controlled psychiatric disorders
- Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
- Current abuse of alcohol or drugs, prescription or otherwise
- Nursing a child, pregnant, or intent to become pregnant during the study
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 |
|---|---|---|
| Active Virtual Reality TreatmentThe self-administered active VR treatment will consist of 8 twice-weekly sessions, each approximately 1 hour in duration, during which subjects will participate in a variety of Virtual Reality active games that require leg movements while receiving high-quality visual feedback of the missing lower leg. | Behavioural | Home-based treatment |
Primary outcome
Changes in pain intensity
Time frame: pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention.
the change in phantom limb pain score pre and post each VR intervention, at baseline, after the VR intervention and in the follow-up sessions as assessed using an 11-point numerical rating pain scale (0 - minimum score/no pain; 10 maximum score/pain as bad as you can imagine) assessing the current PLP level.
Changes in pain quality of the McGill Short Form Questionnaire
Time frame: baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
The change in the phantom limb pain quality between baseline, post-intervention, and follow-up sessions using McGill Short Form Questionnaire that measures the characteristics of pain (e.g., throbbing, etc.) using a 4-point rating pain scale (0 - minimum score - none: better outcome /4 maximum score - severe: worse outcome).
1 secondary outcome
Changes in average pain after the treatment
Time frame: up to 4 weeks
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 8 Aug 2025.
- Results publication: PubMed 9849105Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
- Results publication: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Results publication: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Results publication: PubMed 22981809Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
- Results publication: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Results publication: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Results publication: PubMed 6869117Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
- Results publication: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Virtual Reality Treatment in people with Phantom Pain Following Amputation of Lower Limb and Amputation, run by Albert Einstein Healthcare Network at 3 sites 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 5 inclusion and 5 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 Laurel Buxbaum (215-663-6321, Laurel.Buxbaum@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity (time frame: pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044323, which also lists 8 linked publications.
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 8 Aug 2025.